Всемирная организация здравоохранения (ВОЗ / WHO) · Publications

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

21 апреля 2016 г. Всемирная организация здравоохранения

Полный текст размещён на сайте публикующей организации. lawenc.com индексирует метаданные и ведёт на официальный источник.

Полный текст

WHO Library Cataloguing-in-Publication Data Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health. 1.Equipment and Supplies. 2.Reproductive Health. 3.Maternal Welfare. 4.Perinatal Care. 5.Child Welfare. 6.Biomedical Technology. I.World Health Organization. ISBN 978 92 4 156502 8 (NLM classification: WA 310)

© World Health Organization 2015 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Printed in Switzerland.

Interagency list of medical devices for essential interventions for Reproductive, Maternal, Newborn and Child Health

Acknowledgements Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health The Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and

child health was initiated in June 2012 through a joint collaboration between the United Nations Children’s Fund (UNICEF), the United Nations Population Fund (UNFPA), and the World Health Organization (WHO) under the auspices of the H4 partnership to update and expand three previous publications:

• Interagency list of essential medical devices for reproductive health, (2008); • Packages of interventions for family planning, safe abortion care, maternal, newborn and child health (2010);

• Essential interventions, commodities and guidelines for reproductive, maternal, newborn and child health (2011). The current document was developed from June 2012 to January 2014 through the continuous collaboration of a core working group of professionals from the following organizations:

• • •

UNFPA: Ms Agnes Chidanyika, Dr Wilma Doedens, Ms Isabel Lucas Manzano. UNICEF: Ms Monique Supiot, Ms Etleva Kadilli, Ms Shauna Mullally, Dr Helene Moller, Mr Ludo Scheerlinck and Ms Clara Aranda. WHO Department of Essential Medicines and Health Technologies (EMP): Dr Yukiko Nakatani, Ms Laura Alejandra Velez Ruiz Gaitan, Ms Megan M. Smith, Ms Adriana Velazquez Berumen. Various WHO departments: Dr Benedetta Allegranzi, Dr Maurice Bucagu, Mr James Farukai Tsimba Chitsva, Ms Alicia De Hoyos Reyes, Dr Neelam Dhingra-Kumar, Dr Mario Philip Festin, Dr Claudia M. Garcia Moreno Esteva, Dr Selma Khamassi, Dr Viviana Mangiaterra, Dr Meena Nathan Cherian, Dr Severin Ritter von Xylander, Ms Anita Sands, Dr Sheryl Ziemin Vanderpoel, Dr Wilson Milton Were, Dr Teodora Elvira Wi, Ms Susan Wilburn.

2014

•

The document was developed under the overall coordination of Adriana Velazquez and supervision of Dr Gilles Forte and Dr Kees de Joncheere of the WHO Department EMP. Technical support was received from Dr Bernadette Daelmans, WHO Department of Mother and Child Health who provided supervision for the development of the children’s section, and from Dr Kim Eva Dickson, UNICEF. The primary financial support was received from The Japanese Ministry of Health, Labour and Welfare through the WHO project “ Towards knowing global needs of medical devices”. Additional funds were provided by UNICEF through a grant from Foreign Affairs, Trade and Development Canada (DFATD) to the H4+ and by WHO through a grant from the United Nations Commission on Life Saving Commodities. Design and layout of the document was done by Jillian Reichenbach Ott (Genève Design)

Table of contents Abbreviations Overview Definitions . . . . . . . . . . . . . . . . . . . . . . . . . 3

. . . . . . . . . . . . . . . . . . . . . . . . . . 4 . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1. Background and methodology . . . . . . . . . . . . . . . . . . . 6 1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.2 Objective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.3 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1.4 Background methodology, workshops and peer-review meetings . . . . . . . . . . . . . . . . 7 1.5 Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.5.1 Identification of levels of care and health-care facilities . . . . . . . . . . . . . . . 9 Table 1. Level of care and health-care facility .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 9 1.5.2 Identification of essential interventions . . . . . . . . . . . . . . . . . . . . 9 1.5.3 Systematic search for evidence and documentation . . . . . . . . . . . . . . . 10 Table 2. Classification of interventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 1.5.4 Identification of commodities . . . . . . . . . . . . . . . . . . . . . . . 11 1.6 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn and child health . . . . . . . . . . . . . . . . .

2.1 Essential interventions for reproductive, maternal, newborn and child health . . . . . . . . . . . 13 Table 3. Essential interventions for reproductive, maternal, newborn and child health . . . . . . . . . . . . . . . . . . . . 14 2.2 Relevant evidence-based guidelines supporting essential interventions for reproductive, maternal, newborn and child health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Table 4. Evidence-based guidelines supporting essential interventions for family planning and reproductive health . 20 Table 5. Evidence-based guidelines supporting essential interventions for pregnancy . . . . . . . . . . . . . . . . . . . 24 Table 6. Evidence-based guidelines supporting essential interventions for childbirth .. .. .. .. .. .. .. .. .. .. 28 Table 7. Evidence-based guidelines supporting essential interventions for the postnatal mother . . . . . . . . . . . . . 30 Table 8. Evidence-based guidelines supporting essential interventions for the postnatal baby .. .. .. .. .. .. .. 32 Table 9. Evidence-based guidelines supporting essential interventions for infancy and childhood .. .. .. .. .. .. 36 Table 10. References .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 40 2.3 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

3. Medical devices for different health-care facilities

3.1 Medical devices for different health-care facilities . . . . . . . . . . . . . . . . . . . . . . 45 Table 11. Medical devices for different health-care facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 3.2 Groups of medical devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 3.2.1 Grouping of common medical equipment by clinical area in health-care facility . . . . . . 49 Table 12. Medical equipment for medical examination and diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Table 13. Medical equipment for emergency preparedness and referral .. .. .. .. .. .. .. .. .. .. .. .. .. .. 51 Table 14. Medical equipment for labour, delivery and recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Table 15. Medical equipment for surgery and anaesthesia .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 56 Table 16. Medical equipment for inpatient care - mother and newborn .. .. .. .. .. .. .. .. .. .. .. .. .. .. 58 Table 17. Medical equipment for inpatient care – child .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 59 Table 18. Medical equipment for intensive care (in district hospital or higher level) . . . . . . . . . . . . . . . . . . . . . 60

3.2.2 Grouping of medical device consumables by size and capacity . . . . . . . . . . . 62 Table 19. Medical device consumables by size and capacity .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 62 3.3 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

4. Matrix of medical devices in each stage of continuum of care, in each level of health-care facility 67 4.1 Continuum of care matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 20. Medical devices for Family planning and reproductive health at HEALTH POST . . . . . . . . . . . . . . . . . Table 21. Medical devices for pregnancy at HEALTH POST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 22. Medical devices for post-natal baby (newborn) at HEALTH POST . . . . . . . . . . . . . . . . . . . . . . . . . Table 23. Medical devices for infancy and childhood at HEALTH POST .. .. .. .. .. .. .. .. .. .. .. .. .. .. Table 24. Medical devices for family planning and reproductive health at HEALTH CENTRE . . . . . . . . . . . . . . . Table 25. Medical devices for pregnancy at HEALTH CENTRE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 26. Medical devices for childbirth at HEALTH CENTRE .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. Table 27. Medical devices for post-natal mother at HEALTH CENTRE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Table 28. Medical devices for post-natal baby (newborn) at HEALTH CENTRE . . . . . . . . . . . . . . . . . . . . . . .

67 68 70 72 74 76 78 82 84 86

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Table 29. Medical devices for infancy and childhood at HEALTH CENTRE .. .. .. .. .. .. .. .. .. .. .. .. .. 88 Table 30. Medical devices for family planning and reproductive health at DISTRICT HOSPITAL . . . . . . . . . . . . . 90 Table 31. Medical devices for pregnancy at DISTRICT HOSPITAL .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 94 Table 32. Medical devices for childbirth at DISTRICT HOSPITAL .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 100 Table 33. Medical devices for post-natal mother at DISTRICT HOSPITAL . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Table 34. Medical devices for post-natal baby (newborn) at DISTRICT HOSPITAL . . . . . . . . . . . . . . . . . . . . 108 Table 35. Medical devices for infancy and childhood at DISTRICT HOSPITAL .. .. .. .. .. .. .. .. .. .. .. .. 114

4.2 Devices and interventions in specialized care . . . . . . . . . . . . . . . . . . . . . . . . 118 Table 35. Medical devices for specialized care .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 118 4.3 Innovative health technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Table 36. Innovative health technologies for reproductive, maternal, newborn and child health .. .. .. .. .. .. .. 119 4.4 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

5. Laboratory supply and blood bank commodities Table 37. Laboratory supplies by health-care facilities .. ..

. ..

. .. ..

. ..

. .. ..

. ..

. .. ..

. ..

. .. ..

122 122 .. 122

5.1 Laboratory supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Diagnostic tests and Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

127

Table 38. Specific considerations for selection of diagnostics .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 127

5.3 Blood bank commodities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Table 39. Essential items for blood bank: blood collection, testing and processing, clinical transfusion, blood storage and blood transportation .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 129

5.4 Safe blood and clinical transfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . .

132

2014

Table 40. Essential Items for Blood Transfusion in Emergency Settings .. .. .. .. .. .. .. .. .. .. .. .. .. . 133

5.5 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

6. Surgery and Anaesthesia .

135 136 .. 136

6.1 Surgery and Anaesthesia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 6.2 Grouping of common surgical instruments by surgical procedure . . . . . . . . . . . . . . . Table 41. Contents of surgical instrument sets .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..

6.3 Surgical instrument stainless steel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 Table 42. Two main types of stainless steel .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 140 Table 43. Standard grades of steel for surgical instruments .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 141 6.4 Surgical sutures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142 Table 44. Size of non-absorbable and absorbable synthetic sutures .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 143 6.5 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

7. Infection prevention and control

. 145

7.1 Injection safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 7.2 Decontamination and Sterilization at healthcare facilities (9, 10, 11) . . . . . . . . . . . . . . . 146 7.3 Sterilization equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 Table 45. Basic sterilization equipment and other relevant equipment (12) .. .. .. .. .. .. .. .. .. .. .. .. . 148 7.4 Health care waste management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149 7.5 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

8. Technical notes regulation and management of medical devices

. 152

8.1 Regulations for Medical devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152 8.2 Labels and instructions for use of medical devices . . . . . . . . . . . . . . . . . . . . . . 156 8.3 Units and biomaterials used for medical devices . . . . . . . . . . . . . . . . . . . . . . . 158 8.4 Textiles used for linen and clothing in health-care facilities . . . . . . . . . . . . . . . . . . 163 8.5 Health Technology Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166 8.6 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

9. Other health products

. 170

9.1 Building services equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170 9.2 Health counselling, education and promotion . . . . . . . . . . . . . . . . . . . . . . . . 170 9.3 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Abbreviations MDG UN UNFPA UNICEF WHO Millennium Development Goal United Nations United Nations Population Fund United Nations Children’s Fund World Health Organization

Colour codes Family planning and reproductive health Clinical transfusion

Pregnancy/maternal health

Laboratory

Childbirth

Surgery and anesthesia

Post-Natal Mother

Injection safety

Post-Natal Baby (Newborn)

Health care facilities

Infancy and childhood

Overview Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health This publication is composed of the following sections:

Section 1 Describes the background, objectives, methodology and related definitions in the context of the current document.

Section 2 Includes the list of essential interventions in reference with current WHO evidence-based guidelines for reproductive, maternal, newborn and child health.

Section 3 Includes the sources of medical devices for the development of each matrix of medical devices by level of health-care facility.

Section 4 Presents the matrix of medical devices per continuum of care, for clinical procedures for reproductive, maternal, newborn and child health, by level of health-care facility, from health post to health centre to district hospital. The information is presented in 16 tables. Specific medical devices have been grouped under one name to avoid having a complicated extensive list of devices by intervention. For further analysis, the groupings of these devices are explained in Section 3.2. For example, to find the medical devices for intervention for pregnant women in a district hospital, please see the table entitled “Medical devices for pregnancy at district hospital”.

2014 4

Section 5 Lists medical devices and commodities for laboratory and blood bank. The laboratory supply is listed by 4 levels of health-care facility. The essential commodities for blood bank are listed by the steps of procedure for blood transfusion.

Section 6 Notes important guidance for providing safe surgery and anaesthesia and lists common surgical instruments by surgical procedure in the matrix of medical devices in Section 4.

Section 7 Describes key programs and technical information related to infection prevention and control in health-care facilities such as injection safety, sterilization and waste management.

Section 8 Guides technical point of view on medical devices regulation and health technology management including specifications and standards for quality of health products.

Section 9 Points out other health products required in health-care facilities to provide comprehensive services.

Definitions Health technology Health technology is the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life. The term is used interchangeably with “health-care technology” (1).

Medical device In the current document, the definition of medical devices, including in vitro diagnostic medical devices, is based on that documented by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory authorities and regulated industry (2): “Medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

• • • • • • •

diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices; providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. Products that may be considered to be medical devices in some jurisdictions but not in others include:

• • • •

disinfection substances; aids for people with disabilities; devices incorporating animal or human tissues; devices for in vitro fertilization or assisted reproduction technologies.

In vitro diagnostic medical devices are medical devices, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. In vitro diagnostic medical devices include reagents, calibrators, control materials, specimen receptacles, software, and related instruments, apparatus and other articles and are used for diagnosis, aiding diagnosis, screening, monitoring, predisposition and prognosis prediction, and determination of physiological status. In some jurisdictions, certain in vitro diagnostic medical devices may be covered by other regulations (3).

References 1. WHO 60.29 Health Technologies Resolution (http://apps.who.int/iris/bitstream/10665/22609/1/A60_R29-en.pdf?ua=1) 2. Definition of the terms “medical device” and “in vitro diagnostic (IVD) medical device”. GHTF/SG1/N071:2012. Tokyo: Global Harmonization Task Force; 2012 (http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012definition-of-terms-120516.pdf, accessed 22 May 2014). 3. Medical devices: managing the mismatch – an outcome of the Priority Medical Devices project. Geneva: World Health Organization; 2010 (http://whqlibdoc.who.int/publications/2010/9789241564045_eng.pdf, accessed 22 May 2014).

1. Background and methodology Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

1.1 Introduction At the present, the beginning of the twenty first century, many scientific, social, economic and technological advances have been made in health care. Yet every day, approximately 1000 women die from pregnancyrelated complications and childbirth, most of them in sub-Saharan Africa and South Asia (1). For every maternal death, another 30 women suffer long-lasting injury or illness that can result in lifelong pain, disability and socioeconomic exclusion. And every day, about 10 000 babies aged 28 days or younger die (2). This situation is unacceptable, as most of these deaths can be prevented. Millennium Development Goals (MDGs) 4 and 5 call for a reduction in child mortality and improvements in maternal health, respectively (3). New strategies have to be implemented to support the lives of these children and mothers. Innovative coordinated efforts are needed to achieve the MDGs and provide a better life for mothers and children, especially in low-resource settings. In July 2008, the heads of the United Nations Population Fund (UNFPA), the United Nations Children’s Fund (UNICEF), the World Bank and the World Health Organization (WHO) endorsed a working document that aimed to harmonize the support provided by these agencies to accelerate progress towards achieving MDGs 4 and 5 and to improve reproductive health (4). Resulting from this joint agreement, the need to prioritize the 25 countries with the highest burden of maternal mortality, and then identify the needs and gaps in those countries and define the necessary actions, was recognized. This agreement for joint work between agencies was called the H4 Partnership. One of the partnership’s objectives was to update the Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health. This work was done through a UNFPA, UNICEF and WHO collaboration. Strengthening health systems, and supporting universal health coverage, educating the population, and finding innovative technologies will support the delivery of better health services to achieve the MDGs. Health systems should also include adequate health infrastructure, available information, good policies, available human resources for health, and appropriate, affordable health technologies, including medical devices, medicines and vaccines. Medical devices are indispensable tools for health care in prevention, diagnosis, treatment and rehabilitation, but their selection and appropriate use pose a significant challenge for essential reproductive, maternal, newborn and child health interventions.

2014 6

1.2 Objective The objective of this project was to list the medical devices required to provide the essential reproductive, maternal, newborn and child health interventions defined by existing WHO guidelines and publications, in order to improve access to these devices in low- and middle-income countries, support quality of care, and strengthen health-care system. The medical devices are allocated across the reproductive, maternal, newborn and child health continuum of care according to the level of health-care delivery.

1.3 Scope In the context of this document, the scope was defined as:

1. Background and methodology

• •

Health interventions are limited to reproductive, maternal, newborn and child health, based on WHO recommendations. The level of health-care delivery is defined by the publication “Essential interventions, commodities and guidelines for reproductive, maternal, newborn and child health” (5) and is detailed in the next section. This classification defines three levels of care: community level/health post, health centre and district hospital. It should be reviewed and adapted to the local context as needed. The lists represent the technological options currently available, by type of medical device and hospital furniture. These lists should be adapted and reviewed according to national policies and regulatory frameworks. The target audience of this document consists of health professionals in the areas of reproductive, maternal, newborn and child health policies, strategic planning, health technology assessment, resource allocation, procurement, biomedical engineering, regulation, facility assessment and reproductive health specialties. Given the importance of the intervention generated, and in order to facilitate the use of these tools, a parallel web-based medical devices database is being developed. This database will contain all the interventions, levels of care, medical devices and technical information, increasing the availability of the data and facilitating decision-making.

• •

•

1.4 Background methodology, workshops and peer-review meetings The current document was developed by a consensus of UNICEF, UNFPA and WHO to update and expand the existing publications to describe more specifically the medical devices required for essential clinical interventions in reproductive, maternal, newborn and child health (Box 1).

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Box 1. Development process of the current document JUNE 2012 UNFPA, UNICEF and WHO held the first consultation on the Interagency list of essential medical devices and medicines for reproductive, maternal, newborn and child health in Copenhagen, Denmark, to define the scope of the project and devise a workplan. The following WHO publications were reviewed to determine the scope of the project by defining the continuum of care, the level of health-care facilities, and the medical devices associated with clinical interventions:

Interagency list of essential medical devices for reproductive health, 2008 (hereafter, ‘Interagency list, 2008’) (6); Packages of interventions for family planning, safe abortion care, maternal, newborn and child health, 2010 (hereafter, ‘Packages of interventions’) (7); Essential interventions, commodities and guidelines for reproductive, maternal, newborn and child health, 2011 (hereafter, ‘Essential interventions’) (5).

Figure 1 Previous publications

2008

2010

2011

2014 AUGUST 2012 A second meeting was held in Geneva, Switzerland during which experts in specific clinical areas could complete and verify the available information. A larger working group was invited to collaborate in the development and review of the data. The specialists were from the areas of blood transfusion, injection safety, safe surgery, diagnostic and laboratory work, reproductive health, maternal health, neonatal health, waste management, sexually transmitted infections, infertility and cancer. These peer reviews led to the first draft of the list in accordance with the latest recommendations by WHO. NOVEMBER 2012 A third meeting (Geneva) redefined the levels of care included in the first draft of the list, reflecting the importance of having an accurate list of medical devices to accommodate complex clinical areas. The referral level of care was split into district hospital and referral hospital. FEBRUARY 2013 The objectives of a fourth meeting (Copenhagen) were to agree on the most appropriate classification of medical devices, reviewing the specialists’ inputs, and investigating an appropriate way to present the information to end users. MAY 2013 First draft was presented to the members of the Interagency Pharmaceutical Coordination group, which includes the World Bank, the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF, UNFPA and WHO. The group supported the development of this tool, considered it useful for planning purposes and suggested it be linked to lists for procurement. NOVEMBER 2013 A workshop was held during the Second WHO Global Forum on Medical Devices (Geneva), during which comments regarding the use and implementation of the tool were received by approximately 40 participants from different countries. JANUARY 2014 A fifth meeting was held (Copenhagen) to review and agree on the final version of the document, including the grouping of commodities.

Throughout the entire process, the core working group held regular teleconferences to define medical devices necessary for each intervention at each level of health-care facility related to existing WHO guidelines and publications.

1. Background and methodology

1.5 Methodology 1.5.1 Identification of levels of care and health-care facilities To develop the current document, the definitions of level of care and health-care facilities were derived from Essential interventions (5). The classifications for interventions and medical devices proposed for these facilities should be adapted to national regulations and the local context. To ensure relevance of the continuum of care in the local environment, results in a continuum of care for the patient. According to the staff, capabilities, type of care and interventions required, three levels of delivery of care were defined (Table 1):

Table 1. Level of care and health-care facility Level of care Community level First level Referral level Health-care facility Health post Health centre District hospital or Referral hospital

COMMUNITY LEVEL The health post level includes community health workers and outreach workers that deliver interventions related to safe motherhood, nutrition and simple prevention and treatment. The community level of care is context-specific depending on the availability and development of infrastructure, services and socioeconomic resources.

FIRST LEVEL The health center level incudes trained health professionals. The interventions offered are related to maternity care (such as prenatal care, skilled birth attendance and family planning), childhood diseases (such as vaccinepreventable diseases, acute respiratory infections and diarrhoea), and prevention and treatment of major infectious diseases. These health facilities include outpatient services and observation areas for patients staying longer but do not generally include inpatient areas. They might have a labour room and outpatient surgery areas.

REFERRAL LEVEL This level of delivery of interventions requires more complex facilities and equipment, such as hospitals where providers are professional practitioners. In the current document, only district hospitals are considered in the reference tables. District hospitals usually include outpatient and inpatient areas, emergency services, surgical areas, health professionals and infrastructure in at least the following four areas of specialization: internal medicine, surgery, paediatrics and obstetric care. Many district hospitals also include other special areas, depending on the settings, context and resources available. Medical devices for highly specialized hospitals and other specialized technologies such as intensive care are described in Annex 3.

1.5.2 Identification of essential interventions With the objective of harmonizing an evidence-based set of essential interventions for reproductive, maternal, newborn and child health, two publications were used as the basis for the review and analysis for compiling the current document: Essential interventions (5) and Packages of interventions (7). Following the same strategy as the two previous reports, the current document interventions were classified by level of care, across the reproductive, maternal, newborn and child health continuum of care stages (Figure 2):

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Figure 2. Reproductive, maternal, newborn and child health continuum of health care Family planning and reproductive health

Pregnancy

Childbirth

Post-Natal (motherhood)

Post-Natal (newborn)

Infancy and childhood

Source: Adapted from PMNCH fact sheet: RMNCH continuum of care. Geneva: World Health Organization; 2011 (http://www.who.int/pmnch/media/press_materials/fs/continuum_of_care/en/index.html, accessed 22 May 2014).

2014

• • • • • •

family planning and reproductive health; pregnancy; childbirth; postnatal mother (up to six weeks after childbirth); postnatal baby (up to two months after birth); infancy and childhood (up to age five years).

Derived from this classification, research sought areas where updates were required in terms of interventions, commodities and facilities. The continued review of interventions and sub-interventions was due to the fact that different medical devices are required by sub-interventions, for example the diagnosis and the treatment of anaemia. Some clinical procedures for reproductive, maternal, newborn and child health and related medical devices are not presented in this publication because they do not impact on the scope of the project to reduce maternal and newborn mortality from a public health approach.

1.5.3 Systematic search for evidence and documentation Essential interventions (5) responds to the need to deliver information on evidence-based interventions and categorize them into three groups (Table 2). Interventions with well-documented evidence and an agreed delivery strategy fall into category A. Category B includes interventions that do not have consensus on the delivery strategy. Category C includes interventions with no evidence or consensus on the delivery strategy. Further research on these interventions, mostly from category A, leads to the identification of the required commodities (medical devices and medicines) described or named in the clinical guidelines and reports.

Table 2. Classification of interventions Category A B Evidence for intervention categories Delivery strategies Action Disseminate for rapid scale-up Collate evidence and define gaps in evidence for delivery strategies – seek consensus Further research required

1. Background and methodology

Intervention evidence agreed Delivery strategy agreed Intervention evidence agreed Delivery strategy no consensus Intervention evidence still questioned Delivery strategy no consensus

Source: Essential interventions, commodities and guidelines for reproductive, maternal, newborn and child health. Geneva: World Health Organization; 2011 (http://www.who.int/pmnch/topics/part_publications/essential_interventions_18_01_2012. pdf, accessed 22 May 2014).

Although evidence on the use of medicines is well documented, evidence is not widely available for medical devices, especially with regard to their performance in low-resource settings. In the literature review, case studies of medical devices used in high-income settings were found, but their applicability to low-resource settings is uncertain and not yet proven. Thus, a list of evidence-based guidelines and reports related to reproductive, maternal, newborn and child health was compiled, devices included in the current document were identified from clinical guidelines and later revised by the core working group and WHO specialists. This revision process was also applied to the interventions.

1.5.4 Identification of commodities In the areas of reproductive, maternal, newborn and child health, the commodities listed in Essential interventions (5) considered the Interagency list, 2008 (6), Packages of interventions (7) and the recommendations from the UN Commission on Life-Saving Commodities (8), comprising 13 life-saving commodities such as female condoms, neonatal resuscitation equipment and injectable antibiotics. The development of the medical devices section of the current document followed the methodology described in the Priority Medical Devices report from WHO (9): (1) identify the disease burden of the target population, (2) select the associated WHO evidence base clinical guidelines, (3) identify care pathways and protocols, (4) list medical devices according to the protocols and type of intervention (preventive, diagnostic, therapeutic or assistive), and (5) develop a list of medical devices needed to manage and treat the identified diseases. The development of the medical devices list is based on the Interagency list, 2008 (6) and UNICEF’s Supply Catalogue (10). Based on this methodology, the medical devices were identified according to the interventions for reproductive, maternal, newborn and child health. The list of medical devices had to be organized into categories and sub-categories to facilitate grouping and to make the list more user-friendly. This process was challenging because no WHO global harmonized nomenclature system currently exists for medical devices. Many of the terms used in the current document are based on the UNICEF reference specifications for the devices included in the UNICEF standard product range (10). These terms were used because they are commonly used in low- and middle-income countries. The list does not represent the complete description of the medical devices, particularly complex devices; the list must therefore be used as a reference, and technical specifications for these devices must be reviewed and developed thoroughly for planning purposes. The current document is not a restrictive list of priority medical devices: it covers only the minimum reference for the equipment of medical units to ensure that clinical interventions can be provided in a complete, safe and effective manner. Other devices can be added to match the specific infrastructure settings.

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

1.6 References 1. Trends in maternal mortality: 1990 to 2008. Geneva: World Health Organization, United Nations Children’s Fund, United Nations Population Fund and World Bank; 2010 (http://www.who.int/reproductivehealth/publications/ monitoring/9789241500265/en/, accessed 22 May 2014). 2. The state of the world’s children 2009: maternal and newborn health. New York: United Nations Children’s Fund; 2008 (http://www.unicef.org/cotedivoire/SOWC_2009_.pdf, accessed 22 May 2014). 3. Millennium Development Goals (MDGs). Geneva: World Health Organization; 2014 (http://www.who.int/topics/ millennium_development_goals/en/, accessed 22 May 2014). 4. Accelerated implementation of maternal and newborn continuum of care as part of improving reproductive health: mapping of in-country activities – joint country support. Geneva: World Health Organization; 2010 (http://whqlibdoc. who.int/publications/2010/9789241599733_eng.pdf, accessed 22 May 2014). 5. Essential interventions, commodities and guidelines for reproductive, maternal, newborn and child health. Geneva: World Health Organization; 2011 (http://www.who.int/pmnch/topics/part_publications/essential_ interventions_18_01_2012.pdf, accessed 22 May 2014). 6. Interagency list of essential medical devices for reproductive health. Geneva: World Health Organization, John Snow Inc., PATH, Population Action International, United Nations Population Fund and World Bank; 2008 (http://apps.who. int/medicinedocs/documents/s16440e/s16440e.pdf, accessed 22 May 2014). 7. Packages of interventions for family planning, safe abortion care, maternal, newborn and child health. Geneva: World Health Organization; 2010. (http://whqlibdoc.who.int/hq/2010/WHO_FCH_10.06_eng.pdf, accessed 22 May 2014). 8. Life-saving commodities. Washington, DC: United Nations Foundation; 2012 (http://www.everywomaneverychild.org/ resources/un-commission-on-life-saving-commodities/life-saving-commodities, accessed 22 May 2014). 9. Medical devices: managing the mismatch – an outcome of the Priority Medical Devices project. Geneva: World Health Organization; 2010 (http://whqlibdoc.who.int/publications/2010/9789241564045_eng.pdf, accessed 22 May 2014).

2014 12

10. UNICEF supply catalogue. New York: United Nations Children’s Fund; 2014 (https://supply.unicef.org/unicef_b2c/app/ displayApp/%28layout=7.0-12_1_66_67_115&carea=%24ROOT%29/.do?rf=y, accessed 22 May 2014).

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn and child health This section includes the sources of information for the development of each table of medical devices by level of health-care facility.

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

2.1 Essential interventions for reproductive, maternal, newborn and child health Based on Essential interventions (1), Table 3 contains the priority clinical interventions provided during the continuum of care for reproductive, maternal, newborn and child health, divided into six different stages:

• • • • • •

family planning and reproductive health; pregnancy; childbirth; postnatal mother; postnatal baby (newborn); infancy and childhood.

The column “Continuum of care” corresponds to the six stages of the continuum of care. The column “General action” corresponds to the interventions listed chronologically for each of the stages, from the first assessment, through the diagnosis and treatment of infections and illness, and ending with surgery or, in some cases, emergency and pre-referral treatment. The column “Conditions” corresponds to the specific conditions related to the interventions. The column “Steps of specific procedures” corresponds to the steps or procedures applied to deliver each intervention; the steps are labelled (a), (b), (c) and (d) to clarify the chronological steps for some procedures. In the table, each procedure shows the health-care facility (health post, health centre or district hospital) where it would be delivered according to the evidence-based guidelines presented in Tables 4–9. Note that sometimes the diagnosis can be done at a lower level than the assessment or treatment.

Table 3. Essential interventions for reproductive, maternal, newborn and child health and child health Table 3. Essential interventions for reproductive, maternal, newborn DISTRICT HOSPITAL X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Continuum of Care General Action by chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Conditions Steps of speciﬁc procedures HEALTH CENTER X X X X X X X X X X X X X

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Family Planning and Reproductive Health

First assessment

Basic Medical Examination Preventive Immunization

a) Check-up vital signs / measuring weight and height / Anthropometry b) Pelvic examination a) Vaccine for Hepatitis B a) Provision of oral contraceptives a) Provision of injectable contraceptives a) Insertion and removal of Intrauterine device (IUD)s a) Insertion and removal of contraceptive implants with local anaesthesia a) Provision of barriers methods a) Provision of emergency contraception a) Provision of vaginal rings and patches a) Vasectomy with local anaesthesia a) Tubal ligation

Provision of contraceptives

Contraceptive method selection

2014

Detection and management of Sexually Transmitted Infection (STI) and other infections

Syphilis Human Immunodeﬁciency Virus (HIV)

a) Screening / diagnosis of Syphilis by laboratory test b) Treatment for Syphilis a) Screening of Human Immunodeﬁciency Virus (HIV) b) Treatment for Human Immunodeﬁciency Virus (HIV) (Antiretroviral Therapy (ART) ) c) Provide post exposure prophylaxis for Human Immunodeﬁciency Virus (HIV) discordant couple

Gonorrhoea Chlamydia Malaria

a) Screening / diagnosis of Gonorrhoea b) Treatment for Gonorrhoea a) Screening / diagnosis of Chlamydia b) Treatment for Chlamydia a) Prophylactic antimalarial (Intermittent Preventive Treatment (IPT)) b) Diagnosis of malaria c) Management of malaria

Other infections

a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis a) Diagnosis and treatment for bacterial vaginosis, trichomonas, candidiasis

Screening and management of cancers of the reproductive system

Cervix cancer

a) Papanicolaou test b) Visual Inspection with Acetic Acid (VIA)/Magniﬁed VIA (VIAM) c) Human Papilloma Virus (HPV) test d) Colposcopy e) Colposcopy and Biopsy / Pathology lab-test f) Treatment for precancerous lesion (cryotherapy)

Breast cancer

a) Breast examination b) Diagnostic by image (mammography, ultrasound) c) Biopsy / Pathology lab-test

Management of gender-based violence (GBV)

Post-rape care a) Management of post-rape care

HEALTH POST X X X X

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Table 3. Essential interventions for reproductive, maternal, newborn and child health DISTRICT HOSPITAL X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Continuum of Care General Action by chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Conditions Steps of speciﬁc procedures HEALTH CENTER X X X X X X X X X X X X X X X X X X X X X X X X

Pregnancy

First assessment

Basic Medical Examination Preventive Immunization

a) Check-up vital signs / measuring weight and height / Anthropometry/ Vaginal examination a) Vaccine for Tetanus a) Emergency care and pre-referral treatment

Emergency assessment Detection and management of Sexually Transmitted Infection (STI) and other infections

Emergency preparedness and referral Syphilis Human Immunodeﬁciency Virus (HIV) Malaria

a) Screening / diagnosis of Syphilis by laboratory test b) Treatment for Syphilis a) Screening of Human Immunodeﬁciency Virus (HIV) b) Prevention Mother To Child Transmission (PMTCT) c) Treatment for Human Immunodeﬁciency Virus (HIV) ( Antiretroviral Therapy (ART) ) a) Prophylactic antimalarial (Intermittent Preventive Treatment (IPT)) b) Diagnosis of malaria c) Management of malaria

Rubella Tuberculosis Other infections

a) Diagnosis and treatment for rubella a) Diagnosis and treatment for tuberculosis a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis a) Diagnosis and treatment of other Sexually Transmitted Infection (STI) /Reproductive Tract Infections (RTI): Candida vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis

Detection and Iron Deﬁciency a) Diagnosis of Anaemia management of Anaemia b) Iron and folic acid supplementation maternal chronic c) Anthelminthic (deworm) medical conditions d) Management of severe Anaemia (considering blood transfusion) Hypertension and preeclampsia a) Diagnosis of Preclampsia-Eclampsia b) Supplemment calcium c) Low-dose aspirin d) Antihypertensive drugs e) Magnesium sulfate f) Fetal monitoring g) Induction of labour Diabetes Management of prelabour rupture of the membranes (PRM) a) Glucose testing for detection b) Treatment for insulin-dependent diabetic mother Assessment of a) Diagnosis and laboratory test PRM b) Fetal monitoring Preterm a) Provision antibiotics if indicated b) Provision of tocolytics to prolong pregnancy if indicated c) Provision of corticosteroids for prevention of neonatal respiratory distress syndrome d) Provision of magnesium sulfate for neuroprotection of the newborn Term Management of Malpresentamalpresentation at tion at term term Management of female genital mutilation a) Provision antibiotics if indicated b) Induction of labour a) Diagnosis of breech at term b) External Cephalic Version c) Monitoring progress of labour

Female genital a) Perineal incision with local anaesthesia mutilation b) Identify the need of caesarean section

HEALTH POST X X X X X X

Table 3. Essential interventions for reproductive, maternal, newborn and child health DISTRICT HOSPITAL X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Continuum of Care General Action by chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Conditions Steps of speciﬁc procedures HEALTH CENTER X X X X X X X

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Management of ectopic pregnancy

Ectopic pregnancy

a) Pregnancy test b) Ultrasound scan c) Laparotomy d) Blood transfusion

Management of miscarriage and abortion

Miscarriage and abortion Miscarriage

a) Pregnancy test b) Ultrasound scan a) Treatment of infections b) Management of bleeding (considering Vacuum Aspiration and blood transfusion) c) Management of major injuries (considering laparotomy)

Safe abortion a) Medical uterine evacuation for the ﬁrst trimester when indicated b) Vacuum Aspiration for the ﬁrst trimester and legally c) Medical uterine evacuation beyond the ﬁrst trimester permitted Childbirth First assessment Emergency assessment Basic Medical Examination Emergency preparedness and referral Childbirth a) Check-up vital signs / Vaginal examination a) Emergency care and pre-referral treatment

2014

Mother care

a) Monitoring progress of labour b) Active management of the third stage of labour (AMTSL): Prophylactic use of uterotonics c) Spontaneous delivery d) Assisted delivery (vacuum extraction) if needed

Management of Assessment complications of for labour and delivery complications Postpartum haemorrhage (PPH)

a) Diagnosis of complications b) Fetal monitoring a) Use of uterotonics of choice for the treatment of PPH b) Manual removal of placenta (include use of antibiotics and uterotonics) c) Blood transfusion d) Use of balloon tamponade e) Use of artery embolization f) Hysterectomy

Caesarean section due maternal/fetal indication Other surgical procedures depending on the complication

a) Use of prophylactic antibiotic b) Caesarean section c) Use of uterotonics a) Episiotomy a) Repair of ruptured uterus a) Correct uterine inversion a) Laparotomy or other abdominal surgical interventions during childbirth a) Craniotomy and craniocentesis a) Screening of Human Immunodeﬁciency Virus (HIV) b) Prevention Mother To Child Transmission (PMTCT)

Human Immunodeﬁciency Virus (HIV) positive women

HEALTH POST

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Table 3. Essential interventions for reproductive, maternal, newborn and child health DISTRICT HOSPITAL X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Continuum of Care General Action by chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Conditions Steps of speciﬁc procedures HEALTH CENTER X X X X X X X X X X X

Post-Natal Mother

First assessment

Basic Medical Examination

a) Check-up vital signs b) Screening for cervix and breast cancer

Support for a) Management of mastitis / breast abscess breast feeding Emergency assessment Prevention and management of post partum bleeding Emergency preparedness and referral Anaemia a) Emergency care and pre-referral treatment

a) Management of post partum bleeding b) Diagnosis of anaemia c) Iron supplementation d) Anthelminthic (deworm) e) Management of severe anaemia (considering blood transfusion)

Detection and management of post partum infection

Human Immunodeﬁciency Virus (HIV) Malaria Other infection

a) Diagnosis and treatment for Human Immunodeﬁciency Virus (HIV) (Antiretroviral Therapy (ART)) a) Diagnosis and management of malaria a) Diagnosis and management of postpartum endometritis and salpingitis a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis

Postoperative care Assessment of a) Postcaesarean care postoperative b) Diagnosis of pelvic abscess, peritonitis or other care postoperative complication Surgical procedure PostNatal Baby (Newborn) Childbirth: Essential newborn care Immediate care at birth c) Surgical management of pelvic abscess, peritonitis or other postoperative complication with laparotomy a) Dry baby thoroughly on mother's chest skin to skin and cover b) Assess breathing c) Clamp and cut cord / Check cord vessels / Check for bleeding and signs of cord infection d) Prevent hypothermia when skin to skin is not possible e) Support breastfeeding within the ﬁrst hour Emergency support Routine care a) Basic neonatal resuscitation b) Management of brain injury and intracranial haemorrhage (ICH) a) Full clinical examination / Check vital signs / measuring weight b) Thermal Care c) Breastfeeding support d) Vitamin K prophylaxis and Immunization e) Cord care f) Prophylaxis for eye infection g) Prophylactic antibiotics for neonates at risk of infection Detection and management of congenital infections Congenital infections a) Diagnosis of congenital syphilis b) Prophylactic treatment for congenital syphilis c) Screening of Human Immunodeﬁciency Virus (HIV) (Dried Blood Spot (DBS)) d) Prophylactic treatment for Human Immunodeﬁciency Virus (HIV) (Antiretroviral Therapy (ART))

HEALTH POST X

Table 3. Essential interventions for reproductive, maternal, newborn and child health DISTRICT HOSPITAL X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Continuum of Care General Action by chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Conditions Steps of speciﬁc procedures HEALTH CENTER X X X

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Detection and management of common infections, illness and complications in the neonate and young infant

Cord infection Jaundice Anaemia

a) Detection and management of cord infection a) Diagnosis of jaundice b) Management of jaundice a) Diagnosis of anaemia b) Management of anaemia c) Pre-referral treatment for severe anaemia (blood transfusion)

Pneumonia Diarrhoea Septicaemia and/or meningitis Speciﬁc interventions for small, low weight birth and pre-term babies Apnoea Respiratory Distress Syndrome (RDS)

a) Diagnosis of pneumonia b) Management of pneumonia and its complications a) Detection and management of diarrhoea a) Diagnosis of septicaemia and/or meningitis: Blood Culture, Lumbar Puncture, Urine Analysis b) Management of septicaemia and/or meningitis and its complications a) Prevention of Apnoea a) Diagnosis of RDS and provision of prophylaxis surfactant b) Apply Continuous Positive Airway Pressure (CPAP) with nasal cannula or face mask c) Ventilatory support and oxygen therapy including mechanical ventilation and Continuous Positive Airway Pressure (CPAP) a) Diagnosis of necrotizing enterocolitis b) Management of necrotizing enterocolitis a) Monitor blood glucose and management of hypoglycaemia b) Monitor nutrition and provision of tube feeding support c) Provision of intravenous therapy d) Monitor temperature and management of hypothermia (Kangaroo mother care) e) Monitor oxygenation and management of hypoxia

2014

Necrotizing enterocolitis Supportive care Supportive for all sick neonate care and sick young infant

Triage, emergency preparedness and referral Further assessment for all young infant Clinical visit

a) Detection of emergency signs, emergency care and prereferral treatment b) Advanced resuscitation a) Full clinical examination / check vital signs / measuring weight / check haemoglobin b) Provision of vaccines (Diphtheria Pertussis Tetanus (DPT) + Haemophilus Inﬂuenza type B (HIB), Oral Polio Vaccine (OPV), Hepatitis B) c) Breastfeeding support and replacement feeding if necessary d) Monitoring growth and development

Optional interventions

a) Male circumcision

HEALTH POST X X

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Table 3. Essential interventions for reproductive, maternal, newborn and child health DISTRICT HOSPITAL X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Continuum of Care General Action by chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Conditions Steps of speciﬁc procedures HEALTH CENTER X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Infancy and childhood

Essential care for monitoring growth and early childhood development

Routine care

a) Full clinical examination / check vital signs / measuring weight b) Provision of vaccines c) Growth monitoring d) Early childhood development monitoring e) Breastfeeding support and replacement feeding if necessary f) Vitamin A supplementation g) Deworming (Mebendazole)

Detection and management of common infections, illness and complications in infancy and childhood

Severe Acute Malnutrition (SAM) Anaemia

a) Diagnosis of SAM b) Feeding support c) Pre-referral treatment for SAM a) Diagnosis of anaemia b) Management of anaemia c) Pre-referral treatment for severe anaemia (Blood transfusion)

Pneumonia Wheeze (Asthma, Bronchiolitis) Tuberculosis Diarrhoea Septicaemia and/or meningitis Septicaemia and/or meningitis Malaria Dengue fever Measles Human Immunodeﬁciency Virus (HIV)

a) Differential diagnosis for pneumonia b) Management of pneumonia and its complications a) Diagnosis of condition with wheeze b) Management of condition with wheeze a) Diagnosis of tuberculosis b) Management of tuberculosis a) Differential diagnosis and management of diarrhoea and dysentery a) Diagnosis of septicaemia and/or meningitis : Blood Culture, Lumbar Puncture, Urine Analysis b) Management of septicaemia and/or meningitis and its complications a) Diagnosis and management of malaria a) Diagnosis and management of dengue fever a) Diagnosis and management of measles a) Diagnosis of Human Immunodeﬁciency Virus (HIV) b) Treatment for Human Immunodeﬁciency Virus (HIV) (Antiretroviral Therapy (ART)) c) Management of other opportunistic infections in Human Immunodeﬁciency Virus (HIV)

Eye infection Ear infection Mouth infection Skin infection Chicken pox Supportive care for all sick infant and child Supportive care

a) Detection and management of eye infection / conjunctivitis a) Detection and management of ear infection a) Detection and management of mouth infection / thrush a) Diagnosis and management of skin infections a) Detection and management of chicken pox a) Management of hypoglycaemia b) Tube feeding support c) Intravenous therapy d) Management of hypothermia e) Management of hypoxia f) Pain control

Triage, emergency preparedness and referral Further assessment for all infant and child Optional interventions

a) Detection of emergency signs, emergency care and prereferral treatment b) Advanced resuscitation a) Male circumcision

HEALTH POST X X X X X X X X

2.2 Relevant evidence-based guidelines supporting essential interventions for reproductive, maternal, newborn and child health This section contains the priority clinical interventions provided during the continuum of care for reproductive, maternal, newborn and child health presented in Tables 4–9 with respect to the relevant evidence-based guidelines published by WHO that support the procedures. Annex 1 lists more references to guide clinicians and other health workers in medical procedures.

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Table 4. Evidence-based guidelines supporting essential interventions for family planning and reproductive health Continuum of Care General Action by Conditions chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment First assessment Basic Medical Examination Preventive Immunization Provision of contraceptives Contraceptive method selection

Steps of speciﬁc procedures

Evidence based guidelines

Family Planning and Reproductive Health

a) Check-up vital signs / measuring weight and height / Anthropometry b) Pelvic examination a) Vaccine for Hepatitis B a) Provision of oral contraceptives b) Provision of injectable contraceptives c) Insertion and removal of Intrauterine device (IUD)s d) Insertion and removal of contraceptive implants with local anaesthesia e) Provision of barriers methods f) Provision of emergency contraception g) Provision of vaginal rings and patches h) Vasectomy with local anaesthesia i) Tubal ligation

Family planning: a global handbook for providers (2)

2014

Detection and management of Sexually Transmitted Infection (STI) and other infections

Syphilis

Human Immunodeﬁciency Virus (HIV)

Gonorrhoea Chlamydia Malaria

b) Diagnosis of malaria c) Management of malaria Other infections a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Evidence based guidelines

Optimizing health worker roles to improve access to key maternal and newborn health interventions through task shifting (3) Medical eligibility criteria for contraceptive use (4) Selected practice recommendations for contraceptive use (5) A guide to family planning for community health workers and their clients (6) Reproductive choices and family planning for people living with HIV - Counselling tool (7)

WHO Guidelines for safe surgery (8)

Reproductive choices and family planning for people living with HIV - Counselling tool (7)

WHO laboratory manual for the examination and processing of human semen (9)

Service delivery approaches to HIV testing and counselling (HTC): A strategic policy framework (10)

Updated WHO Policy Recommendation: Intermittent Preventive Treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP) (11)

Continuum of Care

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

General Action by Conditions chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment

Steps of speciﬁc procedures

Evidence based guidelines

a) Diagnosis and treatment for bacterial vaginosis, trichomonas, candidiasis Screening and management of cancers of the reproductive system Cervix cancer a) Papanicolaou test b) Visual Inspection with Acetic Acid (VIA)/Magniﬁed VIA (VIAM) c) Human Papilloma Virus (HPV) test d) Colposcopy e) Colposcopy and Biopsy / Pathology lab-test f) Treatment for precancerous lesion (cryotherapy) Breast cancer a) Breast examination b) Diagnostic by image (mammography, ultrasound) c) Biopsy / Pathology lab-test Management of gender-based violence (GBV) Post-rape care a) Management of post-rape care WHO guidelines: Use of cryotherapy for cervical intraepithelial neoplasia (12)

2014 22

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Evidence based guidelines

WHO guidelines: Use of cryotherapy for cervical intraepithelial neoplasia (12)

WHO laboratory manual for the examination and processing of human semen (9)

Table 5.Evidence-based Evidence-based guidelines supporting essential interventions Table 5. guidelines supporting essential interventions for pregnancy for pregnancy Continuum of Care General Action by Conditions chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment First assessment Basic Medical Examination Preventive Immunization Emergency assessment Detection and management of Sexually Transmitted Infection (STI) and other infections Emergency preparedness and referral Syphilis

Steps of speciﬁc procedures

Evidence based guidelines

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Pregnancy

a) Check-up vital signs / measuring weight and height / Anthropometry/ Vaginal examination a) Vaccine for Tetanus a) Emergency care and pre-referral treatment a) Screening / diagnosis of Syphilis by laboratory test b) Treatment for Syphilis a) Screening of Human Immunodeﬁciency Virus (HIV) b) Prevention Mother To Child Transmission (PMTCT) c) Treatment for Human Immunodeﬁciency Virus (HIV) ( Antiretroviral Therapy (ART) )

Human Immunodeﬁciency Virus (HIV)

2014

Malaria

a) Prophylactic antimalarial (Intermittent Preventive Treatment (IPT)) b) Diagnosis of malaria c) Management of malaria Guidelines on maternal, newborn, child and adolescent health: Recommendations on maternal and perinatal health (11)

Rubella Tuberculosis Other infections

a) Diagnosis and treatment for rubella a) Diagnosis and treatment for tuberculosis a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis a) Diagnosis and treatment of other Sexually Transmitted Infection (STI) / Reproductive Tract Infections (RTI): Candida vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis

Detection and management of maternal chronic medical conditions

Iron Deﬁciency Anaemia

a) Diagnosis of anaemia b) Iron and folic acid supplementation c) Anthelminthic (deworm) d) Management of severe anaemia (considering blood transfusion)

Hypertension and pre-eclampsia

a) Diagnosis of Pre-eclampsia-Eclampsia b) Supplement calcium c) Low-dose aspirin

d) Antihypertensive drugs e) Magnesium sulfate f) Fetal monitoring g) Induction of labour

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Evidence based guidelines

Counselling for maternal and newborn health care, a handbook for building skills (15)

Guideline: Vitamin A supplementation in pregnant women (16)

Updated WHO Policy Recommendation: Intermittent Preventive Treatment of malaria in pregnancy using SulfadoxinePyrimethamine (IPTp-SP) (11) WHO recommended interventions for improving maternal and newborn health (14) Optimizing health worker roles to improve access to key maternal and newborn health interventions through task shifting (3)

Guidelines for the treatment of Malaria (17)

Weekly iron-folic acid supplementation in women of reproductive age: its role in promoting optimal maternal and child health (18)

Guideline: Daily iron and folic acid supplementation in pregnant women (19)

Prevention and treatment of pre-eclampsia and eclampsia (20)

WHO recommendations for induction of labour (21)

Table 5. Evidence-based guidelines supporting essential interventions for pregnancy

Continuum of Care

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

General Action by Conditions chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Diabetes

Steps of speciﬁc procedures

Evidence based guidelines

a) Glucose testing for detection b) Treatment for insulin-dependent diabetic mother

Management of prelabour rupture of the membranes (PRM)

Assessment of PRM Preterm

a) Diagnosis and laboratory test b) Fetal monitoring a) Provision antibiotics if indicated b) Provision of tocolytics to prolong pregnancy if indicated c) Provision of corticosteroids for prevention of neonatal respiratory distress syndrome d) Provision of magnesium sulfate for neuroprotection of the newborn

Term

a) Provision antibiotics if indicated b) Induction of labour

2014

Management of malpresentation at term Management of female genital mutilation Management of ectopic pregnancy

Malpresentation at term

a) Diagnosis of breech at term b) External Cephalic Version c) Monitoring progress of labour a) Perineal incision with local anaesthesia b) Identify the need of caesarean section a) Pregnancy test b) Ultrasound scan c) Laparotomy d) Blood transfusion Guidelines on maternal, newborn, child and adolescent health: Recommendations on maternal and perinatal health

Female genital mutilation Ectopic pregnancy

Management of miscarriage and abortion

Miscarriage and abortion Miscarriage

Safe abortion when indicated and legally permitted

a) Medical uterine evacuation for the ﬁrst trimester b) Vacuum Aspiration for the ﬁrst trimester c) Medical uterine evacuation beyond the ﬁrst trimester

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Evidence based guidelines

Managing complications in pregnancy and childbirth: A guide for midwives and doctors (22)

WHO recommendations for induction of labour (21)

Managing complications in pregnancy and childbirth: A guide for midwives and doctors (22)

Safe abortion: technical and policy guidance for health systems (23)

Table 6. Evidence-based guidelines supporting essential interventions for childbirth Continuum of Care General Action by Conditions chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment First assessment Emergency assessment Mother care Basic Medical Examination Emergency preparedness and referral Childbirth

Steps of speciﬁc procedures

Evidence based guidelines

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Childbirth

a) Check-up vital signs / Vaginal examination a) Emergency care and pre-referral treatment a) Monitoring progress of labour b) Active management of the third stage of labour (AMTSL): Prophylactic use of uterotonics c) Spontaneous delivery d) Assisted delivery (vacuum extraction) if needed

Management of complications of labour and delivery

Assessment for complications Postpartum haemorrhage (PPH)

2014

Caesarean section due maternal/fetal indication Other surgical procedures depending on the complication

Human Immunodeﬁciency Virus (HIV) positive women

a) Screening of Human Immunodeﬁciency Virus (HIV) b) Prevention Mother To Child Transmission (PMTCT)

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Evidence based guidelines

Optimizing health worker roles to improve access to key maternal and newborn health interventions through task shifting (3)

Managing complications in pregnancy and childbirth: A guide for midwives and doctors (22) WHO Guidelines for safe surgery (8)

Table 7. Evidence-based guidelines supporting essential interventions for the postnatal mother Continuum of Care General Action by Conditions chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment First assessment Basic Medical Examination

Steps of speciﬁc procedures

Evidence based guidelines

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Post-Natal Mother

a) Check-up vital signs b) Screening for cervix and breast cancer

Support for breast feeding Emergency assessment Prevention and management of post partum bleeding Emergency preparedness and referral Anaemia

a) Management of mastitis / breast abscess a) Emergency care and pre-referral treatment a) Management of post partum bleeding b) Diagnosis of anaemia c) Iron supplementation d) Anthelminthic (deworm) e) Management of severe anaemia (considering blood transfusion) WHO recommended interventions for improving maternal and newborn health (14)

Post-Natal Mother

2014

Detection and management of post partum infection

Human Immunodeﬁciency Virus (HIV) Malaria

a) Diagnosis and treatment for Human Immunodeﬁciency Virus (HIV) (Antiretroviral Therapy (ART)) a) Diagnosis and management of malaria

Other infection

a) Diagnosis and management of postpartum endometritis and salpingitis a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis

Postoperative care

Assessment of postoperative care Surgical procedure

a) Postcaesarean care b) Diagnosis of pelvic abscess, peritonitis or other postoperative complication c) Surgical management of pelvic abscess, peritonitis or other postoperative complication with laparotomy

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Evidence based guidelines

WHO guidelines: Use of cryotherapy for cervical intraepithelial neoplasia (12)

WHO recommendations for the prevention and treatment of postpartum haemorrhage (24) Optimizing health worker roles to improve access to key maternal and newborn health interventions through task shifting (3) Updated WHO Policy Recommendation: Intermittent Preventive Treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP) (11)

Guidelines for the treatment of Malaria (17)

Managing complications in pregnancy and childbirth: A guide for midwives and doctors (22)

Table 8. Evidence-based guidelines supporting essential interventions the postnatal baby Table 8. Evidence-based guidelines supporting essential interventions for the postnatal for baby Continuum of Care General Action by Conditions chronologically: First assessment / Infections / Illness / Surgery / Emergency and Prereferral Treatment Steps of speciﬁc procedures

Evidence based guidelines

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Post-Natal Baby (Newborn)

Childbirth: Essential Immediate care at newborn care birth

a) Dry baby thoroughly on mother's chest skin to skin and cover b) Assess breathing c) Clamp and cut cord / Check cord vessels / Check for bleeding and signs of cord infection d) Prevent hypothermia when skin to skin is not possible e) Support breastfeeding within the ﬁrst hour

Emergency support a) Basic neonatal resuscitation

b) Management of brain injury and intracranial haemorrhage (ICH) Routine care

2014

a) Full clinical examination / Check vital signs / measuring weight b) Thermal Care c) Breastfeeding support Guidelines on maternal, newborn, child and adolescent health: Recommendations on newborn health (25) d) Vitamin K prophylaxis and Immunization e) Cord care f) Prophylaxis for eye infection g) Prophylactic antibiotics for neonates at risk of infection

Detection and management of congenital infections

Congenital infections

a) Diagnosis of congenital syphilis b) Prophylactic treatment for congenital syphilis c) Screening of Human Immunodeﬁciency Virus (HIV) (Dried Blood Spot (DBS)) d) Prophylactic treatment for Human Immunodeﬁciency Virus (HIV) (Antiretroviral Therapy (ART))

Detection and management of common infections, illness and complications in the neonate and young infant

Cord infection Jaundice

a) Detection and management of cord infection a) Diagnosis of jaundice b) Management of jaundice

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Evidence based guidelines

Baby-Friendly Hospital Initiative(BFHI), Breastfeeding promotion and support in a baby-friendly hospital: a 20-hour course for maternity staff (30) Recommendations for management of common childhood conditions (28) Guidelines on basic newborn resuscitation (31)

Pocket book of hospital care for children: guidelines for the management of common illnesses (26)

Integrated management of childhood illness (IMCI): Caring for Newborns and Children in the Community. Caring for the Sick Child, Chart Booklet (27)

Baby-Friendly Hospital Initiative(BFHI), Breastfeeding promotion and support in a babyfriendly hospital: a 20-hour course for maternity staff (30)

Integrated management of childhood illness(IMCI) for high HIV settings, chart booklet (31)

Antiretroviral therapy for HIV infection in infants and children: towards universal access, recommendations for a public health approach (32)

WHO recommendations on the diagnosis of HIV infection in infants and children (33)

Recommendations for management of common childhood conditions (28)

Table 8. Evidence-based guidelines supporting essential interventions for the postnatal baby Continuum of Care General Action by Conditions chronologically: First assessment / Infections / Illness / Surgery / Emergency and Prereferral Treatment Steps of speciﬁc procedures

Evidence based guidelines

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Post-Natal Baby (Newborn)

Anaemia

a) Diagnosis of anaemia b) Management of anaemia c) Pre-referral treatment for severe anaemia (blood transfusion)

Pneumonia

a) Diagnosis of pneumonia b) Management of pneumonia and its complications

Diarrhoea

a) Detection and management of diarrhoea

Septicaemia and/or a) Diagnosis of septicaemia and/ meningitis or meningitis: Blood Culture, Lumbar Puncture, Urine Analysis b) Management of septicaemia and/or meningitis and its complications Speciﬁc interventions for small, low weight birth and pre-term babies Apnoea Respiratory Distress Syndrome (RDS) a) Prevention of Apnoea a) Diagnosis of RDS and provision of prophylaxis surfactant b) Apply Continuous Positive Airway Pressure (CPAP) with nasal cannula or face mask c) Ventilatory support and oxygen therapy including mechanical ventilation and Continuous Positive Airway Pressure (CPAP) Necrotizing enterocolitis Supportive care for Supportive care all sick neonate and sick young infant a) Diagnosis of necrotizing enterocolitis b) Management of necrotizing enterocolitis a) Monitor blood glucose and management of hypoglycaemia Guidelines on maternal, newborn, child and adolescent health: Recommendations on newborn health (25)

2014

b) Monitor nutrition and provision of tube feeding support c) Provision of intravenous therapy d) Monitor temperature and management of hypothermia (Kangaroo mother care) e) Monitor oxygenation and management of hypoxia Triage, emergency preparedness and referral a) Detection of emergency signs, emergency care and pre-referral treatment

b) Advanced resuscitation Further assessment Clinical visit for all young infant a) Full clinical examination / check vital signs / measuring weight / check haemoglobin b) Provision of vaccines (Diphtheria Pertussis Tetanus (DPT) + Haemophilus Inﬂuenza type B (HIB), Oral Polio Vaccine (OPV), Hepatitis B) c) Breastfeeding support and replacement feeding if necessary d) Monitoring growth and development Optional interventions a) Male circumcision

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Evidence based guidelines

Pocket book of hospital care for children: guidelines for the management of common illnesses (26)

Integrated management of childhood illness (IMCI): Caring for Newborns and Children in the Community. Caring for the Sick Child, Chart Booklet (27)

Optimal feeding of low birthweight infants in low- and middleincome countries (34)

Manual for the health care of children in humanitarian emergencies (35)

Manual for early infant male circumcision under local anaesthesia (36)

Table 9.Evidence-based Evidence-based guidelines supporting essential interventions for infancy and childhood Table 9. guidelines supporting essential interventions for infancy and childhood Continuum of Care General Action by chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Conditions Steps of speciﬁc procedures

Evidence based guidelines

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Infancy and childhood

Essential care for monitoring growth and early childhood development

Routine care

f) Vitamin A supplementation g) Deworming (Mebendazole) Detection and management of common infections, illness and complications in infancy and childhood

2014

Severe Acute Malnutrition (SAM)

a) Diagnosis of SAM b) Feeding support c) Pre-referral treatment for SAM Guidelines on maternal, newborn, child and adolescent health: Recommendations on child health (37)

Anaemia

a) Diagnosis of anaemia b) Management of anaemia c) Pre-referral treatment for severe anaemia (Blood transfusion)

Pneumonia

a) Differential diagnosis for pneumonia b) Management of pneumonia and its complications

Wheeze (Asthma, Bronchiolitis) Tuberculosis Diarrhoea Septicaemia and/ or meningitis Septicaemia and/ or meningitis Malaria Dengue fever Measles

a) Diagnosis of condition with wheeze b) Management of condition with wheeze a) Diagnosis of tuberculosis b) Management of tuberculosis a) Differential diagnosis and management of diarrhoea and dysentery a) Diagnosis of septicaemia and/or meningitis : Blood Culture, Lumbar Puncture, Urine Analysis b) Management of septicaemia and/or meningitis and its complications a) Diagnosis and management of malaria a) Diagnosis and management of dengue fever a) Diagnosis and management of measles

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Evidence based guidelines

Baby-Friendly Hospital Initiative(BFHI), Breastfeeding promotion and support in a babyfriendly hospital: a 20-hour course for maternity staff (29)

Pocket book of hospital care for children: guidelines for the management of common illnesses (26)

Integrated management of childhood illness(IMCI): Caring for Newborns and Children in the Community. Caring for the Sick Child, Chart Booklet (27)

Integrated management of childhood illness (IMCI): Chart Booklet, standard (38)

Recommendations for management of common childhood conditions (28)

Optimal feeding of low birthweight infants in low- and middle- income countries (34)

Table 9. Evidence-based guidelines supporting essential interventions for infancy and childhood Continuum of Care General Action by chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Conditions Steps of speciﬁc procedures

Evidence based guidelines

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Infancy and childhood

Human Immunodeﬁciency Virus (HIV)

a) Diagnosis of Human Immunodeﬁciency Virus (HIV) b) Treatment for Human Immunodeﬁciency Virus (HIV) (Antiretroviral Therapy (ART)) c) Management of other opportunistic infections in Human Immunodeﬁciency Virus (HIV)

Eye infection Ear infection Mouth infection Skin infection Chicken pox Supportive care for Supportive care all sick infant and child

2014

Triage, emergency preparedness and referral

a) Detection of emergency signs, emergency care and pre-referral treatment b) Advanced resuscitation

Further assessment for all infant and child

Optional interventions

a) Male circumsicion

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Evidence based guidelines

Integrated management of childhood illness(IMCI) for high HIV settings, chart booklet (31)

Antiretroviral therapy for HIV infection in infants and children: towards universal access, recommendations for a public health approach (32)

WHO recommendations on the diagnosis of HIV infection in infants and children (33)

Pocket book of hospital care for children: guidelines for the management of common illnesses (26)

Integrated management of childhood illness(IMCI): Caring for Newborns and Children in the Community. Caring for the Sick Child, Chart Booklet (27)

Recommendations for management of common childhood conditions (28) Integrated management of childhood illness (IMCI): Chart Booklet, standard (38)

Optimal feeding of low birthweight infants in low- and middle- income countries (34)

Manual for the health care of children in humanitarian emergencies (35) Manual for early infant male circumcision under local anaesthesia (36)

Table 10. References Table 10. References Subject Title Monitoring national cervical cancer prevention and control programmes: quality control and quality assurance for visual inspection with acetic acid (VIA)based programmes A guide to family planning for community health workers and their clients (6) Optimizing health worker roles to improve access to key maternal and newborn health interventions through task shifting (3) Cryosurgical equipment for the treatment of precancerous cervical lesions and prevention of cervical cancer Female Condom: generic speciﬁcation, prequaliﬁcation and guidelines for procurement Year 2013 Link http://apps.who.int/iris/ bitstream/10665/79316/1/9789241505260_eng.pdf

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

2012 2012

http://www.who.int/reproductivehealth/publications/ family_planning/9789241503754/en/index.html http://www.who.int/reproductivehealth/publications/ maternal_perinatal_health/978924504843/en/ http://apps.who.int/iris/ bitstream/10665/75853/1/9789241504560_eng.pdf http://www.unfpa.org/webdav/site/global/shared/ procurement/08_QA/Female%20Condom%20 Generic%20Speciﬁcation%20EN.pdf http://www.who.int/reproductivehealth/publications/ family_planning/9780978856304/en/ http://whqlibdoc.who.int/ publications/2011/9789241502856_eng.pdf http://www.who.int/reproductivehealth/publications/ family_planning/9789241599900/en/ http://www.who.int/reproductivehealth/publications/ infertility/9789241547789/en/ http://www.who.int/reproductivehealth/publications/ family_planning/9789241500999/en/ http://whqlibdoc.who.int/ publications/2010/9789241563888_eng.pdf http://www.who.int/reproductivehealth/publications/ family_planning/9241562846index/en/ http://whqlibdoc.who.int/hq/2008/WHO_ RHR_08.17_eng.pdf http://www.who.int/reproductivehealth/publications/ family_planning/9241595132/en/index.html http://whqlibdoc.who.int/ publications/2006/9241547006_eng.pdf http://www.who.int/reproductivehealth/publications/ family_planning/9241593229/en/index.html http://whqlibdoc.who.int/ publications/2004/924159263X.pdf http://whqlibdoc.who.int/ publications/2004/924154628X.pdf http://www.who.int/maternal_child_adolescent/ documents/guidelines-recommendations-maternalhealth.pdf http://apps.who.int/iris/ bitstream/10665/77770/1/9789241501996_eng.pdf http://apps.who.int/iris/ bitstream/10665/70914/1/9789241548434_eng.pdf http://www.who.int/malaria/iptp_sp_updated_policy_ recommendation_en_102012.pdf http://apps.who.int/iris/ bitstream/10665/75411/1/9789241548502_eng.pdf http://www.who.int/nutrition/publications/ micronutrients/guidelines/vas_pregnant/en/ http://whqlibdoc.who.int/ publications/2011/9789241548335_eng.pdf http://whqlibdoc.who.int/ publications/2011/9789241501156_eng.pdf http://whqlibdoc.who.int/ publications/2010/9789241547925_eng.pdf http://www.who.int/nutrition/publications/ micronutrients/weekly_iron_folicacid.pdf http://www.who.int/maternal_child_adolescent/ documents/9789241547628/en/

2012

2012 2011 2011 2011 2010 2010

REPRODUCTIVE HEALTH

Family planning: a global handbook for providers (2) WHO guidelines: Use of cryotherapy for cervical intraepithelial neoplasia (12) Male Latex Condom: Speciﬁcation, Prequaliﬁcation and Guidelines for Procurement WHO laboratory manual for the examination and processing of human semen (9) The TCu380A Intrauterine Contraceptive Device (IUD): Speciﬁcation, Prequaliﬁcation and Guidelines for Procurement Medical eligibility criteria for contraceptive use (4) Selected practice recommendations for contraceptive use (5) Reproductive choices and family planning for people living with HIV - Counselling tool (7) Comprehensive cervical cancer control, a guide to essential practice Decision making tool for family planning clients and providers Clinical management of rape survivors: Developing protocols for use with refugees and internally displaced persons Guidelines for medico-legal care for victims of sexual violence Guidelines on maternal, newborn, child and adolescent health: Recommendations on maternal and perinatal health (13) Guideline: Daily iron and folic acid supplementation in pregnant women (19) Safe abortion: technical and policy guidance for health systems (23)

2014

2009 2008

2007 2006 2005 2004

2003 2013

2012 2012 2012

MATERNAL HEALTH

Updated WHO Policy Recommendation: Intermittent preventive treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP) (11) WHO recommendations for the prevention and treatment of postpartum haemorrhage (24) Guideline: Vitamin A supplementation in pregnant women (16) Prevention and treatment of pre-eclampsia and eclampsia (20) WHO recommendations for induction of labour (21) Guidelines for the treatment of Malaria (17) Weekly iron-folic acid supplementation in women of reproductive age: its role in promoting optimal maternal and child health (18) Counselling for maternal and newborn health care, a handbook for building skills (15)

2012 2011 2011 2011 2010 2009

2009

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Table 10. References Subject Title Managing complications in pregnancy and childbirth: A guide for midwives and doctors (22) WHO recommended interventions for improving maternal and newborn health (14) Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection, recommendations for a public health approach Guidelines on maternal, newborn, child and adolescent health: Recommendations on child health (37) Guidelines on maternal, newborn, child and adolescent health: Recommendations on newborn health (25) Pocket book of hospital care for children: guidelines for the management of common illnesses (26) Born too soon: The global action report on preterm birth Caring for the newborn at home: A training course for community health workers Guidelines on basic newborn resuscitation (30) Recommendations for management of common childhood conditions (28) Integrated management of childhood illness(IMCI): Caring for Newborns and Children in the Community. Caring for the Sick Child, Chart Booklet (27) Manual for early infant male circumcision under local anaesthesia (36) Optimal feeding of low birthweight infants in low-and middle-income countries (34) Antiretroviral therapy for HIV infection in infants and children: towards universal access, recommendations for a public health approach (32) WHO recommendations on the diagnosis of HIV infection in infants and children (33) Baby-Friendly Hospital Initiative(BFHI), Breastfeeding promotion and support in a baby-friendly hospital: a 20-hour course for maternity staff (29) Home visits for the newborn child: a strategy to improve survival Integrated management of childhood illness(IMCI) for high HIV settings, chart booklet (31) Integrated management of childhood illness(IMCI): Chart Booklet, standard (38) Manual for the health care of children in humanitarian emergencies (35) Emergency Triage Assessment and Treatment(ETAT), Manual for participants Kangaroo mother care, a practical guide Managing newborn problems: a guide for doctors, nurses, and midwives Year 2007 2007 2013 Link http://whqlibdoc.who.int/ publications/2007/9241545879_eng.pdf http://www.who.int/maternal_child_adolescent/ documents/who_mps_0705/en/index.html http://www.who.int/hiv/pub/guidelines/arv2013/ download/en/ http://www.who.int/maternal_child_adolescent/ documents/guidelines-recommendations-childhealth.pdf http://www.who.int/maternal_child_adolescent/ documents/guidelines-recommendations-newbornhealth.pdf http://www.who.int/maternal_child_adolescent/ documents/child_hospital_care/en/index.html http://www.who.int/pmnch/media/news/2012/ preterm_birth_report/en/ http://www.who.int/maternal_child_adolescent/ documents/caring_for_newborn/en/index.html http://www.who.int/maternal_child_adolescent/ documents/basic_newborn_resuscitation/en/ http://www.who.int/maternal_child_adolescent/ documents/management_childhood_conditions/en/ index.html http://whqlibdoc.who.int/ publications/2011/9789241548045_Chart_Booklet_ eng.pdf http://www.who.int/hiv/pub/malecircumcision/ manual_infant/en/index.html http://www.who.int/maternal_child_adolescent/ documents/9789241548366.pdf http://whqlibdoc.who.int/ publications/2010/9789241599801_eng.pdf http://whqlibdoc.who.int/ publications/2010/9789241599085_eng.pdf http://whqlibdoc.who.int/ publications/2009/9789241594981_eng.pdf http://whqlibdoc.who.int/hq/2009/WHO_FCH_ CAH_09.02_eng.pdf http://whqlibdoc.who.int/ publications/2008/9789241597388_eng.pdf http://whqlibdoc.who.int/ publications/2008/9789241597289_eng.pdf http://whqlibdoc.who.int/ publications/2008/9789241596879_eng.pdf http://www.who.int/maternal_child_adolescent/ documents/9241546875/en/index.html http://whqlibdoc.who.int/ publications/2003/9241590351.pdf http://whqlibdoc.who.int/ publications/2003/9241546220.pdf http://www.who.int/bloodsafety/ ScreeningDonatedBloodforTransfusion.pdf http://whqlibdoc.who.int/ publications/2009/9789241547888_eng.pdf http://www.who.int/entity/bloodsafety/transfusion_ services/Module1.pdf http://www.who.int/entity/bloodsafety/transfusion_ services/Module3.pdf http://www.who.int/entity/bloodsafety/Manual_on_ Management,Maintenance_and_Use_of_Blood_Cold_ Chain_Equipment.pdf http://www.who.int/entity/bloodsafety/EQA_in_ Blood_Group_Serology.pdf http://www.who.int/entity/bloodsafety/testing_ processing/components/en/BloodColdChain.pdf

2013 2013 2013 2012 2012 2012 2012 2011

CHILD HEALTH

2011 2011 2010

2010 2009

2009 2008 2008 2008 2005 2003 2003 2010 2009 2009 2009 2005

CLINICAL TRANSFUSION

Screening Donated Blood for Transfusion Transmissible Infections - Recommendations Screening Donated Blood for Transfusion Transmissible Infections - Recommendations Safe Blood and Blood Products: Module 1 - Safe Blood Donation Safe Blood and Blood Products: Module 3 - Blood Group Serology Safe Blood and Blood Products: Manual on the management, maintenance and use of blood cold chain equipment External Quality Assessment of Transfusion Laboratory Practice - Guidelines on Establishing an EQA Scheme in Blood Group Serology The Blood Cold Chain - Guide to the selection and procurement of equipment and accessories

2004

2002

Table 10. References Subject Title The Clinical Use of Blood - Handbook Year 2002 2001 Link http://www.who.int/entity/bloodsafety/clinical_use/ en/Handbook_EN.pdf http://www.who.int/entity/bloodsafety/clinical_use/ en/Manual_EN.pdf http://www.who.int/hiv/pub/vct/htc_framework/en/ http://apps.who.int/iris/ bitstream/10665/75971/1/9789241504522_eng.pdf http://www.wpro.who.int/health_technology/ documents/docs/Nationalhealthlab2_0F38.pdf http://whqlibdoc.who.int/ publications/2011/9789241501125_eng.pdf http://www.who.int/ihr/training/laboratory_quality/ en/index.html http://www.who.int/malaria/publications/malaria_ microscopy_QA_manual.pdf http://whqlibdoc.who.int/ publications/2010/9789241599412_eng.pdf http://whqlibdoc.who.int/ publications/2008/9789241596350_eng_low.pdf http://whqlibdoc.who.int/ publications/2005/9241593563_eng.pdf http://www.who.int/diagnostics_laboratory/ documents/guidance/hivrttraining_overview/en/ index.html http://whqlibdoc.who.int/ publications/2004/9241546506.pdf http://whqlibdoc.who.int/ publications/2003/9241545453.pdf http://whqlibdoc.who.int/ publications/2003/9241545305.pdf http://whqlibdoc.who.int/afro/2002/a82959_eng.pdf http://www.who.int/surgery/en/ http://www.who.int/surgery/activities/en/ http://www.who.int/surgery/publications/imeesc/en/ index.html http://apps.who.int/bookorders/anglais/detart1.jsp?co dlan=1&codcol=99&codcch=42 http://whqlibdoc.who.int/ publications/2009/9789241598552_eng.pdf http://www.who.int/surgery/publications/en/AideMemoire_surgery.pdf http://www.who.int/entity/injection_safety/toolbox/ en/AM_SafetyCampaigns.pdf http://www.healthcarewaste.org/ﬁleadmin/user_ upload/resources/Safe-Management-of-Wastes-fromHealth-Care-Activities-2.pdf http://www.who.int/injection_safety/sign/sign_ advocacy_booklet.pdf http://whqlibdoc.who.int/ publications/2010/9789241599252_eng.pdf http://www.who.int/entity/injection_safety/toolbox/ docs/en/InjEquQualityGuiden.pdf http://www.who.int/entity/injection_safety/toolbox/ docs/en/Guiding_Principle_Inj.pdf http://www.who.int/injection_safety/about/country/ en/AMENG.pdf http://www.who.int/entity/injection_safety/toolbox/ en/Bundling.pdf

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

The Clinical Use of Blood in General Medicine, Obstetrics, Paediatrics, Surgery & Anaesthesia, Trauma & Burns Service delivery approaches to HIV testing and counselling (HTC): A strategic policy framework WHO expert meeting report on short, medium, and longer term product development priorities in HIVrelated diagnostics (10) Development of National Health Laboratory Policy and Plan WHO Global Malaria Programme - Good practices for selecting and procuring rapid diagnostic tests for malaria Laboratory quality management system training toolkit

2012 2012

2011 2011

2009 2009 2009 2008 2005 2005 2004 2003 2003 2002 2013 2009

LABORATORY SURGERY AND ANESTHESIA

Malaria Microscopy Quality Assurance Manual Parasitological conﬁrmation of malaria diagnosis, Report of a WHO technical consultation Manual for Laboratory Equipmentm Maintenance Guidelines for assuring the accuracy and reliability of HIV rapid testing: Applying a quality system approach HIV rapid test training package Laboratory biosafety manual Basic Laboratory Procedure in Clinical Bacteriology Manual of Basic Techniques for a Health Laboratory Guidelines for Appropriate Evaluations of HIV Testing Technologies in Africa WHO Emergency and essential surgical care WHO Integrated management for emergency and essential surgical care (IMEESC) toolkit WHO Guidelines for safe surgery (8) WHO Aide memoire on surgical and emergency obstetrical care at ﬁrst referral level Department of Vaccines and Biologicals: Safety of mass immunization campaigns, aide-memoire and check list

2014

2009 2003 2013

INJECTION SAFETY

Safe management of wastes from health-care activities Safe Injection Global Network. Advocacy Booklet WHO Best practices for injections and related procedures A guide for the Quality Assurance of Single Use Injection Equipment WHO Guiding principles to ensure injection device security. Document No. WHO/BCT/03 WHO Aide memoire on injection safety WHOÐUNICEFÐUNFPA Joint statement on the use of autoÐdisable syringes in immunization services. Document No. WHO/V&B/99.25

2013 2011 2010 2003 2003 1999 1999

2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Table 10. References Subject Title Mercury and health. Fact sheet No. 361 Safe management of wastes from health-care activities Replacement of mercury thermometers and sphygmomanometers in health care: Technical guidance Year 2013 2013 2011 Link http://www.who.int/mediacentre/factsheets/fs361/ en/ http://www.healthcarewaste.org/ﬁleadmin/user_ upload/resources/Safe-Management-of-Wastes-fromHealth-Care-Activities-2.pdf http://whqlibdoc.who.int/ publications/2011/9789241548182_eng.pdf http://whqlibdoc.who.int/ publications/2009/9789241547857_eng.pdf http://www2.paho.org/hq/dmdocuments/2009/ sterilization_manual_2009.pdf http://whqlibdoc.who.int/ publications/2009/9789241597906_eng.pdf http://www.who.int/csr/resources/publications/ EPR_AM2_E7.pdf http://www.who.int/water_sanitation_health/ medicalwaste/mercurypolpap230506.pdf http://www.who.int/injection_safety/AM_ InfectionControl_Final.pdf http://www.who.int/water_sanitation_health/ medicalwaste/en/hcwmpolicye.pdf http://www.who.int/injection_safety/toolbox/docs/ en/AM_HCW_Safety.pdf http://www.who.int/water_sanitation_health/ medicalwaste/aidemem.pdf http://www.healthcarewaste.org/ http://www.healthcarewaste.org/resources/ technologies/

HEALTH CARE FACILITIES

Natural Ventilation for Infection Control in Health-Care Settings Sterilization manual for health centres WHO guidelines on Hand Hygiene in healthcare Standard precautions in healthcare Mercury in health care, Policy paper Infection control Safe health-care waste management, policy paper Healthcare worker safety, aide-memoire Safe health-care waste management, aide-memoire Useful site for Healthcare Waste Management

2009 2009 2009 2007 2005 2004 2004 2003 2000 n/a

2.3 References 1. Essential interventions, commodities and guidelines for reproductive, maternal, newborn and child health. Geneva: World Health Organization; 2011 (http://www.who.int/pmnch/topics/part_publications/essential_interventions_18_01_2012.pdf, accessed 22 May 2014). 2. Family planning: a global handbook for providers. Geneva: World Health Organization;2011. (http://www.who.int/ reproductivehealth/publications/family_planning/9780978856304/en/, accessed 22 May 2014). 3. Optimizing health worker roles to improve access to key maternal and newborn health interventions through task shifting. Geneva: World Health Organization;2012. (http://www.who.int/reproductivehealth/publications/maternal_perinatal_ health/978924504843/en/, accessed 22 May 2014). 4. Medical eligibility criteria for contraceptive use. Geneva: World Health Organization;2009. (http://whqlibdoc.who.int/ publications/2010/9789241563888_eng.pdf, accessed 22 May 2014). 5. Selected practice recommendations for contraceptive use. Geneva: World Health Organization;2008. (http://www.who.int/ reproductivehealth/publications/family_planning/9241562846index/en/ http://whqlibdoc.who.int/hq/2008/WHO_RHR_08.17_ eng.pdf, accessed 22 May 2014).” 6. A guide to family planning for community health workers and their clients. Geneva: World Health Organization;2012. (http://www. who.int/reproductivehealth/publications/family_planning/9789241503754/en/index.html, accessed 22 May 2014). 7. Reproductive choices and family planning for people living with HIV - Counselling tool. Geneva: World Health Organization;2007. (http://www.who.int/reproductivehealth/publications/family_planning/9241595132/en/index.html, accessed 22 May 2014). 8. WHO Guidelines for safe surgery. Geneva: World Health Organization;2009. (http://whqlibdoc.who.int/ publications/2009/9789241598552_eng.pdf, accessed 22 May 2014). 9. WHO laboratory manual for the examination and processing of human semen. Geneva: World Health Organization;2010. (http:// www.who.int/reproductivehealth/publications/infertility/9789241547789/en/, accessed 22 May 2014). 10. Service delivery approaches to HIV testing and counselling (HTC): A strategic policy framework . Geneva: World Health Organization;2012. (http://www.who.int/hiv/pub/vct/htc_framework/en/, accessed 22 May 2014). 11. Updated WHO Policy Recommendation: Intermittent preventive treatment of malaria in pregnancy using SulfadoxinePyrimethamine (IPTp-SP). Geneva: World Health Organization;2012. (http://www.who.int/malaria/iptp_sp_updated_policy_ recommendation_en_102012.pdf, accessed 22 May 2014). 12. WHO guidelines: Use of cryotherapy for cervical intraepithelial neoplasia. Geneva: World Health Organization;2011. (http:// whqlibdoc.who.int/publications/2011/9789241502856_eng.pdf, accessed 22 May 2014). 13. Guidelines on maternal, newborn, child and adolescent health: Recommendations on maternal and perinatal health. Geneva: World Health Organization;2013. (http://www.who.int/maternal_child_adolescent/documents/guidelines-recommendationsmaternal-health.pdf, accessed 22 May 2014). 14. WHO recommended interventions for improving maternal and newborn health. Geneva: World Health Organization;2007. (http:// www.who.int/maternal_child_adolescent/documents/who_mps_0705/en/index.html, accessed 22 May 2014). 15. Counselling for maternal and newborn health care, a handbook for building skills. Geneva: World Health Organization;2009. (http://www.who.int/maternal_child_adolescent/documents/9789241547628/en/, accessed 22 May 2014).

16. Guideline: Vitamin A supplementation in pregnant women. Geneva: World Health Organization;2011. (http://www.who.int/ nutrition/publications/micronutrients/guidelines/vas_pregnant/en/, accessed 22 May 2014). 17. Guidelines for the treatment of Malaria. Geneva: World Health Organization;2010. (http://whqlibdoc.who.int/ publications/2010/9789241547925_eng.pdf, accessed 22 May 2014). 18. Weekly iron-folic acid supplementation in women of reproductive age: its role in promoting optimal maternal and child health. Geneva: World Health Organization;2009. (http://www.who.int/nutrition/publications/micronutrients/weekly_iron_folicacid.pdf, accessed 22 May 2014).

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

19. Guideline: Daily iron and folic acid supplementation in pregnant women. Geneva: World Health Organization;2012. (http://apps. who.int/iris/bitstream/10665/77770/1/9789241501996_eng.pdf, accessed 22 May 2014). 20. Prevention and treatment of pre-eclampsia and eclampsia. Geneva: World Health Organization;2011. (http://whqlibdoc.who.int/ publications/2011/9789241548335_eng.pdf, accessed 22 May 2014). 21. WHO recommendations for induction of labour. Geneva: World Health Organization;2011. (http://whqlibdoc.who.int/ publications/2011/9789241501156_eng.pdf, accessed 22 May 2014). 22. Managing complications in pregnancy and childbirth: A guide for midwives and doctors (21). Geneva: World Health Organization;2007. (http://whqlibdoc.who.int/publications/2007/9241545879_eng.pdf, accessed 22 May 2014). 23. Safe abortion: technical and policy guidance for health systems. Geneva: World Health Organization;2012. (http://apps.who.int/ iris/bitstream/10665/70914/1/9789241548434_eng.pdf, accessed 22 May 2014). 24. WHO recommendations for the prevention and treatment of postpartum haemorrhage. Geneva: World Health Organization;2012. (http://apps.who.int/iris/bitstream/10665/75411/1/9789241548502_eng.pdf, accessed 22 May 2014). 25. Guidelines on maternal, newborn, child and adolescent health: Recommendations on newborn health. Geneva: World Health Organization;2013. (http://www.who.int/maternal_child_adolescent/documents/guidelines-recommendations-newborn-health. pdf, accessed 22 May 2014). 26. Pocket book of hospital care for children: guidelines for the management of common illnesses. Geneva: World Health Organization;2013. (http://www.who.int/maternal_child_adolescent/documents/child_hospital_care/en/index.html, accessed 22 May 2014). 27. Integrated management of childhood illness(IMCI): Caring for Newborns and Children in the Community. Caring for the Sick Child, Chart Booklet. Geneva: World Health Organization;2011. (http://whqlibdoc.who.int/publications/2011/9789241548045_Chart_ Booklet_eng.pdf, accessed 22 May 2014). 28. Recommendations for management of common childhood conditions. Geneva: World Health Organization;2012. (http://www.who. int/maternal_child_adolescent/documents/management_childhood_conditions/en/index.html, accessed 22 May 2014).

2014 44

29. Baby-Friendly Hospital Initiative(BFHI), Breastfeeding promotion and support in a baby-friendly hospital: a 20-hour course for maternity staff. Geneva: World Health Organization;2009. (http://whqlibdoc.who.int/publications/2009/9789241594981_eng.pdf, accessed 22 May 2014). 30. Guidelines on basic newborn resuscitation. Geneva: World Health Organization;2012. (http://www.who.int/maternal_child_ adolescent/documents/basic_newborn_resuscitation/en/, accessed 22 May 2014). 31. Integrated management of childhood illness(IMCI) for high HIV settings, chart booklet. Geneva: World Health Organization;2008. (http://whqlibdoc.who.int/publications/2008/9789241597388_eng.pdf, accessed 22 May 2014). 32. Antiretroviral therapy for HIV infection in infants and children: towards universal access, recommendations for a public health approach. Geneva: World Health Organization;2010. (http://whqlibdoc.who.int/publications/2010/9789241599801_eng.pdf, accessed 22 May 2014). 33. WHO recommendations on the diagnosis of HIV infection in infants and children. Geneva: World Health Organization;2010. (http://whqlibdoc.who.int/publications/2010/9789241599085_eng.pdf, accessed 22 May 2014). 34. Optimal feeding of low birthweight infants in low-and middle-income countries . Geneva: World Health Organization;2011. (http:// www.who.int/maternal_child_adolescent/documents/9789241548366.pdf, accessed 22 May 2014). 35. Manual for the health care of children in humanitarian emergencies. Geneva: World Health Organization;2008. (http://whqlibdoc. who.int/publications/2008/9789241596879_eng.pdf, accessed 22 May 2014). 36. Manual for early infant male circumcision under local anaesthesia. Geneva: World Health Organization;2011. (http://www.who.int/ hiv/pub/malecircumcision/manual_infant/en/index.html, accessed 22 May 2014). 37. Guidelines on maternal, newborn, child and adolescent health: Recommendations on child health. Geneva: World Health Organization;2013. (http://www.who.int/maternal_child_adolescent/documents/guidelines-recommendations-child-health.pdf, accessed 22 May 2014). 38. Integrated management of childhood illness(IMCI): Chart Booklet, standard. Geneva: World Health Organization;2008. (http:// whqlibdoc.who.int/publications/2008/9789241597289_eng.pdf, accessed 22 May 2014).

3. Medical devices for different health-care facilities 3.1 Medical devices for different health-care facilities Table 11 contains the complete list of medical devices needed for the application of the clinical interventions described in Table 3. To identify the location of the medical devices, the UNICEF classification of product groups was followed (first column), with each of the six major categories divided into sub-groups (second column). All products from this list are identified with a short general description. The technical specifications, accessories and disposables related to such products are mostly based on UNICEF’s Supply Catalogue (1). There are also two separate lists for the medical devices needed in the laboratory and the blood bank to complete the implementation of reproductive, maternal, newborn and child health interventions.

3. Medical devices for different health-care facilities

Table 11. Medical devices for different health-care facilities Colour coding used below X X Disposable Generic item line - see Table 19 (Medical device consumables by size and capacity) with related items covered by each Generic line Equipment grouping - see Table 12-18 (Medical equipment groups) District hospital

General type Grouping

Speciﬁc area / type

Name of devices Health center Health post

Blood Bank devices Blood Bank devices Blood Bank devices Blood Bank devices Blood Bank devices Blood Bank devices Blood Bank devices Blood Bank devices Clinical laboratory devices X Clinical laboratory devices Clinical laboratory devices X Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices X X Clinical laboratory devices Clinical laboratory devices

Blood Transfusion devices Blood Transfusion devices Blood Transfusion devices Blood Transfusion devices Blood Transfusion devices Blood Transfusion devices Blood Transfusion devices Blood Transfusion devices Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable

Anti-A blood group reagent, monoclonal Anti-B blood group reagent, monoclonal Anti-D blood group reagent (Saline/monoclonal) Blood administration set, sterile Glass slides, 25x75mm Markers, ﬁne point, permanent black, for glassware Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml Wooden or plastic applicator sticks Container, sample, 50 ml Lancet, blood, safety, sterile (Sizes*) Needle holder, vacuum tubes Needle, vacuum tube, sterile (Size*) Paper, dry blood spot, Swab, cotton-tip, tube, sterile Tube, blood collection, newborn cord blood, sterile Tube, capillary, Ethylene Diamine Tetraacetic Acid (EDTA) Tube, capillary, heparin Tube, vacuum, Ethylene Diamine Tetraacetic Acid (EDTA), sterile (Capacity*) Tube, vacuum, plain/dry, sterile (Capacity*) X X X X X

X X X X X X X X X X X X X X X X X X X

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Clinical laboratory devices - Equipment Clinical laboratory devices - Equipment Clinical laboratory devices - Equipment Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test strips Clinical laboratory devices - Test strips Clinical laboratory devices - Test strips Family planning devices Disposable Family planning devices Disposable Family planning devices Disposable Family planning devices Disposable Family planning devices Disposable Family planning devices Disposable Family planning devices Disposable Family planning devices Disposable

Analyzer, blood gas Blood glucometer, with accessories Hemoglobinometer, with accessories Cytology stain, kit Enzyme Immuno Assay (EIA), gonorrhea Ag, kit Enzyme Immuno Assay (EIA), Human Immunodeﬁciency Virus (HIV), kit Enzyme Immuno Assay (EIA), Rubella, kit Haemoglobin colour scale (reﬁll kit) Haemoglobin colour scale (starter kit) Nucleic Acid Test (NAT), chlamydia, kit Nucleic Acid Test (NAT), gonorrhea, kit Nucleic Acid Test (NAT), Human Papilloma Virus (HPV), kit Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit Rapid Diagnostic Test (RDT), Treponemal, syphilis, kit Rapid Plasma Reagin (RPR), syphilis, kit Treponema Pallidum Haemagglutination Assay (TPHA), syphilis, kit Test strip, pregnancy Test strip, urinalysis (10 parameter) Test strip, vaginal infection, pH Cervical cap Diaphragm Female condoms Intra-Uterine Devices (only prequaliﬁed copper IUDs) Levonorgestrel Intra-Uterine Device (IUD) Lubricants Male condoms Sub-dermal implants (included the insertion device) X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

2014

District hospital

General type Grouping

Speciﬁc area / type

Name of devices Health center Health post

X X X X X X X

X X X X X X X X X X X X X X X X X X X

3. Medical devices for different health-care facilities

Medical devices - Disposable Medical devices - Disposable X X Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable X Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable X Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable X X X Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable X Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable X X X Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable X X Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable X Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable X X X Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable

Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain

Bandage, elastic, 7.5cmx5m, roll Blanket, survival, 220x140cm, non-sterile Bracelet, identiﬁcation (Sizes*) Compress, gauze,sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Umbilical clamp, sterile,single use Umbilical tape, 3mmx50m, roll, non-sterile Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) Catheter, Intra Venous (IV) umbilical vein, sterile, single use Infusion giving set, burette 100-150ml, sterile, single use Infusion giving set, sterile, single use Needles, luer, sterile, single use (Sizes G*) Needles, scalp vein, sterile, single use (Sizes G*) Needles, spinal, sterile, single use (Sizes*) Safety box, for used syringes/needles Stopcock, 3-way, sterile, single use Syringes, auto-disable (AD), (Capacities ml*) Syringe for insulin, sterile, single use Syringe for tuberculin, sterile, single use Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Airway, Guedel, translucent (Sizes*) Bag, urine, collecting, 2000ml Catheter, balloon tamponade, post partum hemorrhage Catheter, Foley, sterile, single use (Sizes CH*) Catheter, urethral, sterile, single use (Sizes CH*) Collector, urine, adhesive, 10-100ml Prongs, nasal, oxygen, non sterile, single use (Sizes *) Syringe, feeding, catheter tip, 50ml, sterile, single use Syringe, feeding, luer tip, 50ml, sterile, single use Tube, endotracheal, without cuff, sterile, single use (Sizes ID*) Tube, endotracheal, with cuff, sterile, single use (Sizes ID*) Tube, feeding/aspirating, L120cm,catheter tip, sterile, single use (Sizes CH*)

X X X X X

X X X X X X X X X

X X X X X

X X

X X X X

X X

District hospital

General type Grouping

Speciﬁc area / type

Name of devices Health center Health post

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

X X X X X X

Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable

Tube/catheter/drain Tube/catheter/drain Gloves Gloves Gloves Surgical sutures

Tube, feeding, L40cm, luer tip, sterile, single use (Sizes CH*) Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) Gloves, examination, latex, non-sterile, single use (Sizes*) Gloves, gynaecological, sterile, single use, pair (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) Suture, synthetic, absorbable (Sizes USP/ DEC*) with needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Apnoea monitor Auditory, function screening devices, newborn Bilirubinometer Breast biopsy system Breastpump, manual, with accessories Cardiotocograph (CTG), with accessories Colposcope with biopsy set Cryosurgical unit with tank and accesories Doppler, foetal heart rate (FHR) detector, with accessories Magnifying lens for Visual Inspection with Acetic Acid Mammograph with printer and accesories Non-Pneumatic Anti-Shock Garment (NASG) Phototherapy light, mobile, with accessories Commodities for medical examination & diagnosis (see table 12) Commodities for emergency preparedness and referral (see table 13) Commodities for labour, delivery & recovery (see table 14) Commodities for surgery & anesthesia (see table 15) Commodities for inpatient mother and newborn Commodities for inpatient child Commodities for intensive care of mother Commodities for intensive care of child Commodities for intensive care of newborn Counselling material X X X X X X X X X X X X X X X X X X X X

Medical devices - Disposable

Surgical sutures

Medical devices - Equipment Medical devices - Equipment Medical devices - Equipment

Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Medical Equipment Group Medical Equipment Group Medical Equipment Group Medical Equipment Group Medical Equipment Group Medical Equipment Group Medical Equipment Group Medical Equipment Group Medical Equipment Group Counselling material

2014

Medical devices - Equipment Medical devices - Equipment Medical devices - Equipment Medical devices - Equipment Medical devices - Equipment Medical devices - Equipment Medical devices - Equipment Medical devices - Equipment Medical devices - Equipment Medical devices - Equipment X X X X X X X X X Medical devices - Equipment Grouping Medical devices - Equipment Grouping Medical devices - Equipment Grouping Medical devices - Equipment Grouping Medical devices - Equipment Grouping Medical devices - Equipment Grouping Medical devices - Equipment Grouping Medical devices - Equipment Grouping Medical devices - Equipment Grouping Counselling material

District hospital

General type Grouping

Speciﬁc area / type

Name of devices Health center Health post

X X X X X X

X X X X X X X X X X X X X X X X X X X X X X X

3. Medical devices for different health-care facilities

3.2 Groups of medical devices The majority of medical devices, including equipment and surgical instruments sets, are required for multiple interventions across the continuum of care. To simplify the main matrix, many of these devices were grouped together. Many consumable devices are available in various sizes, and these were also grouped together. It is important to apply judgement and knowledge of the local context to interpret the groupings, particularly when used in supply planning, as each facility and system is different.

3.2.1 Grouping of common medical equipment by clinical area in health-care facility The equipment commodities were grouped according to the clinical area of a health-care facility in which they would most commonly be found, such as an examination room or intensive care unit (Table 12-18). These medical device equipment groupings were then allocated to interventions across the continuum. The groupings also correspond, to a certain extent, to the types of intervention performed in particular clinical areas. For example, basic medical examinations typically happen in an examination area or room, while ventilation typically occurs within an intensive care setting.

Table 12. Medical equipment for medical examination and diagnosis Table 12. Medical equipment for medical examination and diagnosis General type Speciﬁc area / type District hospital Name of devices for medical examination and diagnosis Health center Health post

Medical devices Equipment

Medical furniture

Bedscreen, hospital, on castors Cabinet, instruments, double door Cabinet, medicine, double door Footstool, two steps Stand, infusion, double hook, on castors Stool, adjustable, on castors Stretcher, foldable Stretcher, patient, with side rails Table, examination Table, gynaecology, delivery, with accessories Table, instruments, Mayo type, stainless steel, on castors Trolley, dressing, stainless steel, 2 trays Trolley, soiled linen

X X X

X X X X X X

X X X X X X X X X X X X X X X X X X X X X X X X X X X

X X

X X X X X

X X X X X X X X X X X X X

X X X X X X X X X X X X X X X X

Medical utensils

Basin, kidney, polypropylene Basin, kidney, stainless steel Bedpan, polypropylene Bowl, polypropylene Brush, hand, scrubbing, plastic Jar, forceps, polypropylene Jar, thermometer, polypropylene Receptacle, waste, stainless steel, pedal action Tray, dressing, stainless steel ,approx. 300x200x30mm

Medical devices Renewable

Clothing medical and accessories

Cap, surgical, non-woven Coat, medical, woven, white - # sizes Drape, surgical woven - # sizes Drawsheet, plastic, approx. 90x180cm Gown, patient, woven

Table 12. Medical equipment for medical examination and diagnosis District hospital General type Health center Speciﬁc area / type Name of devices for medical examination and diagnosis Health post

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Medical devices Equipment

Anthropometric equipment

Measuring board, portable infant/child length/height Mid Upper Arm Circumference (MUAC) measuring tape, infant/ newborn Scale, electronic, mother/child, 150kgx100g Scale, electronic, infant,10kgx5g Scale, beamtype, infant,16kgx10g Scale,beamtype, adult, 6-180kg x100g Scale, springtype,infant,25kg x 100g with set of weighing trousers

X X

X X X X X X X X X

X X X X X

Hospital equipment Medical diagnostic equipment

Light, examination, mobile, with accessories Electrocardiogram (ECG) recorder, portable, with accessories Ophtalmoscope, set Otoscope, set Scanner, ultrasound, mobile, with accessories Sphygmomanometer, adult, aneroid Sphygmomanometer, child, aneroid Stethoscope, adult, binaural Stethoscope, foetal, monaural Stethoscope, pediatric, binaural Thermometer, clinical, digital 32-43 °C Timer, respiration, for Acute Respiratory Infection (ARI) Tourniquet, rubber, approx. 50cm Tongue depressor,wooden,single use X-ray system, ﬁxed, with accessories and infrastructure X-ray system, mobile, with accessories X-ray, viewer (negatoscope), 1 to 3 bodies

X X X X

X X X X X X X X

X X X X X X X X X X X X X X

2014

X X X

X X X X

X X

Resuscitation/ Anaesthesia equipment Medical devices - Surgical instruments Surgical instrument

Pulse oximeter, portable, with accessories

Pulse oximeter, spotcheck, with accessories Forceps, dressing, Cheron, 250mm Speculum, vaginal, Graves, 75x20mm Speculum, vaginal, Graves, 95x35mm Speculum, vaginal, Graves, 115x35mm Surgical instruments set Surgical instruments, dressing set (see table 41) X X

X X X X X X

3. Medical devices for different health-care facilities

Table 13. Medical equipment for emergency preparedness and referral Table 13. Medical equipment for emergency preparedness and referral General type Speciﬁc area / type District hospital Name of devices for emergency preparedness and referral Health center Health post

Medical devices Equipment

Medical furniture

Bedscreen, hospital, on castors Bucket, kick, stainless steel, on castors Cabinet, instruments, double door Cabinet, medicine, double door Footstool, two steps Stand, infusion, double hook, on castors Stool, adjustable, on castors Stretcher, foldable Stretcher, patient, with side rails Table, examination Table, instruments, Mayo type, stainless steel, on castors Table, instruments, stainless steel, on castors Trolley, dressing, stainless steel, 2 trays Trolley, emergency, with drawers Trolley, soiled linen Wheel chair, adult Wheel chair, child

X X X

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

X X

X X X X

X X

X X X X X

X X

X X X X X

Medical utensils

Basin, kidney, polypropylene Basin, kidney, stainless steel Bedpan, polypropylene Bowl, polypropylene Bowl, round, stainless steel, approx. 4L Bowl, stainless steel, approx. 180ml Bowl, stainless steel, approx. 600ml Brush, hand, scrubbing, plastic Jar, forceps, polypropylene Jar, thermometer, polypropylene Receptacle, waste, stainless steel, pedal action Tray, dressing, stainless steel ,approx. 300x200x30mm

X X X

X X X X X X X

X X X X X

X X X X X X X X

Medical devices Renewable

Clothing medical and accessories

Apron, protection, plastic Cap, surgical, non-woven Clogs, plastic - # sizes Coat, medical, woven, white - # sizes Drape, surgical woven - # sizes Drawsheet, plastic, approx. 90x180cm Glasses, safety, regular size Gown, patient, woven Gown, surgical, woven - # sizes Mask, surgical, non-woven, Trousers, surgical, woven - # sizes Tunic, surgical, woven - # sizes X X X

X X X X X X X X X

Table 13. Medical equipment for emergency preparedness and referral District hospital General type Health center Speciﬁc area / type Name of devices for emergency preparedness and referral Health post

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Medical devices Equipment

Anthropometric equipment

Measuring board, portable infant/child length/height Scale, electronic, mother/child, 150kgx100g Scale, electronic, infant,10kgx5g Scale, beamtype, infant,16kgx10g Scale,beamtype, adult, 6-180kg x100g Scale, springtype,infant,25kg x 100g with set of weighing trousers

X X X X X X

X X X X X X X X

X X X X X X X X X X X X X X X X X X X X X X X X X

Hospital equipment

Light, examination, mobile, with accessories Pump, suction, electrical, 1 bottle, with accessories Pump, suction, electrical, 2 bottles, with accessories Electrocardiogram (ECG) recorder, portable, with accessories Ophtalmoscope, set Otoscope, set Sphygmomanometer, adult, aneroid Sphygmomanometer, child, aneroid Stethoscope, adult, binaural

Medical diagnostic equipment

X X X X

X X X X X X X

2014

Stethoscope, foetal, monaural Stethoscope, pediatric, binaural Thermometer, clinical, digital 32-43 °C Timer, respiration, for Acute Respiratory Infection (ARI) Tourniquet, rubber, approx. 50cm Tongue depressor,wooden,single use X-ray system, ﬁxed, with accessories and infrastructure X-ray system, mobile, with accessories X-ray, viewer (negatoscope), 1 to 3 bodies Resuscitation/ Anaesthesia equipment Continuous Positive Airway Pressure (CPAP) system, with accessories Deﬁbrillator, basic, with accessories Forceps, Magill, adult Forceps, Magill, child Incubator, newborn, transport, with accessories Infusion pump, with accessories Laryngoscope, adult/child, set Laryngoscope, newborn, set Monitor, patient, portable, with accessories Nebulizer, with accessories Oxygen concentrator, with accessories Pulse oximeter, portable, with accessories Pulse oximeter, spotcheck, with accessories Pump, suction, foot-operated Pump, suction, newborn resuscitation Resuscitator, hand-operated, adult, set Resuscitator, hand-operated, child, set Resuscitator, hand-operated, newborn, set Suction, bulb X X X

X X X X

X X X X X X X X

X X X X X X X X X

X X X X X X X X X X

3. Medical devices for different health-care facilities

Syringe pump, with accessories Table, resuscitation, newborn, with accessories Ventilator medical, adult, with accessories Ventilator medical, adult, transport, with accessories Ventilator medical, child/newborn, with Continuous Positive Airway Pressure (CPAP) and accessories Ventilator medical, child/newborn, transport, with accessories Warmer, heating pad, newborn, with accessories Warmer, sleeping bag, newborn, with accessories Warmer, radiant heater, freestanding, with accessories Medical devices - Surgical instruments Surgical instrument Forceps, dressing, Cheron, 250mm Scalpel blade, no.22, sterile, single use (for Scalpel Handle n0.4) Scalpel blade, no.10, sterile, single use (for Scalpel Handle n0.3) Speculum, vaginal, Graves, 75x20mm Speculum, vaginal, Graves, 95x35mm Speculum, vaginal, Graves, 115x35mm Surgical instruments set Surgical instruments, dressing set (see table 41) Surgical instruments, suture set (see table 41) X X X X X X X X X X X X

X X X X X X X X X X X X X X X X X

Table 14.Medical Medical equipment for labour, delivery and recovery Table 14. equipment for labour, delivery and recovery District hospital General type Health center Speciﬁc area / type Name of devices for labour, delivery and recovery Health post

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Medical devices Equipment

Medical furniture

Bed, labour/delivery, with mattress & accessories Bucket, kick, stainless steel, on castors Cabinet, instruments, double door Cabinet, medicine, double door Footstool, two steps Stand, infusion, double hook, on castors Stand, single bowl, on castors Stool, adjustable, on castors Stretcher, patient, with side rails Table, baby dressing Table, gynaecology, delivery, with accessories Table, instruments, Mayo type, stainless steel, on castors Trolley, dressing, stainless steel, 2 trays Trolley, emergency, with drawers Trolley, soiled linen

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

2014

Medical utensils

Medical devices Renewable

Clothing medical and accessories

Apron, protection, plastic Cap, surgical, non-woven Clogs, plastic - # sizes Drape, surgical woven - # sizes Drawsheet, plastic, approx. 90x180cm Glasses, safety, regular size Gown, patient, woven Gown, surgical, woven - # sizes Mask, surgical, non-woven, Trousers, surgical, woven - # sizes Tunic, surgical, woven - # sizes

Medical devices Equipment

Anthropometric equipment Hospital equipment

Scale, electronic, infant,10kgx5g Scale, beamtype, infant,16kgx10g Light, examination, mobile, with accessories Pump, suction, electrical, 1 bottle, with accessories Vacuum extractor, Bird, manual, complete set

3. Medical devices for different health-care facilities

Table 14. Medical equipment for labour, delivery and recovery District hospital General type Health center Speciﬁc area / type Name of devices for labour, delivery and recovery Health post

Medical diagnostic equipment

Partograph Scanner, ultrasound, mobile, with accessories Sphygmomanometer, adult, aneroid Stethoscope, adult, binaural Stethoscope, foetal, monaural Thermometer, clinical, digital 32-43 °C Tourniquet, rubber, approx. 50cm

X X X X X X X X X X X X X X X X X X X X X X X

X X X X X X X X X X X X X X X X X X X X X X X X

Resuscitation/ Anaesthesia equipment

Oxygen concentrator, with accessories Pulse oximeter, portable, with accessories Pulse oximeter, spotcheck, with accessories Pump, suction, foot-operated Pump, suction, newborn resuscitation Resuscitator, hand-operated, adult, set Resuscitator, hand-operated, newborn, set Suction, bulb Table, resuscitation, newborn, with accessories

Medical devices - Surgical instruments

Surgical instrument

Forceps, dressing, Cheron, 250mm Scalpel blade, no.22, sterile, single use (for Scalpel Handle n0.4) Speculum, vaginal, Graves, 75x20mm Speculum, vaginal, Graves, 95x35mm Speculum, vaginal, Graves, 115x35mm

Surgical instruments set

Surgical instruments, delivery set Surgical instruments, dressing set Surgical instruments, suture set

Table 15.Medical Medical equipment for surgery and anaesthesia Table 15. equipment for surgery and anaesthesia District hospital General type Health center Speciﬁc area / type Name of devices for surgery and anaesthesia Health post

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Medical devices Equipment

Medical furniture

Bucket, kick, stainless steel, on castors Cabinet, instruments, double door Cabinet, medicine, double door Footstool, two steps Stand, infusion, double hook, on castors Stand, single bowl, on castors Stool, adjustable, on castors Stretcher, patient, with side rails Table, baby dressing Table, instruments, Mayo type, stainless steel, on castors Table, instruments, stainless steel, on castors Trolley, dressing, stainless steel, 2 trays Trolley, emergency, with drawers Trolley, soiled linen

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Medical utensils

2014 Medical devices Renewable

Clothing medical and accessories

Medical devices Equipment

Hospital equipment

Electrosurgical unit, with accessories Table, operating theater, with accessories Light, operating theatre, ceiling, with accessories Light, operating theatre, mobile, with accessories Electrical vacuum aspiration (EVA), complete set Manual vacuum aspiration (MVA), complete set Pump, suction, electrical, 1 bottle, with accessories Pump, suction, electrical, 2 bottles, with accessories

3. Medical devices for different health-care facilities

Table 15. Medical equipment for surgery and anaesthesia District hospital General type Health center Speciﬁc area / type Name of devices for surgery and anaesthesia Health post

Medical diagnostic equipment

Sphygmomanometer, adult, aneroid Stethoscope, adult, binaural Tourniquet, rubber, approx. 50cm X-ray system, mobile, with accessories X-ray, viewer (negatoscope), 1 to 3 bodies

X X X X

X X X X X X X X X X X

Resuscitation/ Anaesthesia equipment

Anaesthesia system, basic, free-standing, with accessories Anaesthesia unit, with ventilator and accessories Deﬁbrillator, basic, with accessories Forceps, Magill, adult Laryngoscope, adult/child, set Monitor, patient, portable, with accessories Oxygen concentrator, with accessories Pulse oximeter, portable, with accessories Pulse oximeter, spotcheck, with accessories Pump, suction, foot-operated Pump, suction, newborn resuscitation Resuscitator, hand-operated, adult, set Resuscitator, hand-operated, newborn, set Suction, bulb Table, resuscitation, newborn, with accessories X X X

X X X X X X X X X X X X X X X X X

Medical devices - Surgical instruments

Surgical instrument

Surgical instruments set (see table 41)

Surgical instruments, basic surgery set Surgical instruments, delivery set Surgical instruments, dilatation/evacuation (D&E) set Surgical instruments, dressing set Surgical instruments, early infant male circumcision, set Surgical instruments, embryotomy set Surgical instruments, examination/suturing, vaginal/cervical, set Surgical instruments, intra uterin device (IUD) insertion/removal, set Surgical instruments, laparotomy (Gyn/Obs) set Surgical instruments, suture set Surgical instruments, vacuum aspiration set Surgical instruments, vasectomy set Surgical instruments, vasectomy non-scalpel set X X X X X

X X X X X X X X X X

Table 16. Medical equipment for inpatient care - mother Table 16. Medical equipment for inpatient care - mother and newborn and newborn District hospital General type Speciﬁc area / type Name of devices for inpatient mother and newborn Health center

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Medical devices Equipment

Medical furniture

Bed, hospital, standard,adult,with mattress Bedscreen, hospital, on castors Cabinet, bedside, standard Cabinet, medicine, double door Cot, baby, hospital, with bassinet, on castors Stand, infusion, double hook, on castors Stretcher, patient, with side rails Table, baby dressing Table, instruments, Mayo type, stainless steel, on castors Trolley, dressing, stainless steel, 2 trays Trolley, soiled linen Wheel chair, adult

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Medical utensils

2014

Medical devices Renewable

Clothing medical and accessories

Coat, medical, woven, white - # sizes Drape, surgical woven - # sizes Drawsheet, plastic, approx. 90x180cm Gown, patient, woven

Medical devices Equipment

Anthropometric equipment Hospital equipment Medical diagnostic equipment

Scale, electronic, mother/child, 150kgx100g Scale, electronic, infant,10kgx5g Scale, beamtype, infant,16kgx10g Light, examination, mobile, with accessories Sphygmomanometer, adult, aneroid Stethoscope, adult, binaural Thermometer, clinical, digital 32-43 °C Timer, respiration, for Acute Respiratory Infection (ARI) Tourniquet, rubber, approx. 50cm Tongue depressor,wooden,single use X-ray system, mobile, with accessories X-ray, viewer (negatoscope), 1 to 3 bodies

Resuscitation/ Anaesthesia equipment

Infusion pump, with accessories Nebulizer, with accessories Oxygen concentrator, ﬂowsplitter for newborn/child Oxygen concentrator, with accessories Pulse oximeter, portable, with accessories Pulse oximeter, spotcheck, with accessories Syringe pump, with accessories Warmer, heating pad, newborn, with accessories Warmer, sleeping bag, newborn, with accessories Warmer, radiant heater, freestanding, with accessories X X X X X X X X

X X X X X X X X X X X

Medical devices - Surgical instruments

Surgical instrument Surgical instruments set

Forceps, dressing, Cheron, 250mm Surgical instruments, dressing set

3. Medical devices for different health-care facilities

Table 17. Medical equipment for inpatient care – child Table 17. Medical equipment for inpatient care – child District hospital General type Speciﬁc area / type Name of devices for inpatient child Health center

Medical devices Equipment

Medical furniture

Bed, hospital, standard, child, with mattress Bedscreen, hospital, on castors Cabinet, bedside, standard Cabinet, medicine, double door Stand, infusion, double hook, on castors Stretcher, patient, with side rails Table, baby dressing Trolley, dressing, stainless steel, 2 trays Trolley, soiled linen Wheel chair, adult Wheel chair, child

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Medical utensils

Medical devices Renewable Medical devices Equipment

Clothing medical and accessories Anthropometric equipment

Coat, medical, woven, white - # sizes Drape, surgical woven - # sizes Drawsheet, plastic, approx. 90x180cm Scale, electronic, mother/child, 150kgx100g Scale, electronic, infant,10kgx5g Scale, beamtype, infant,16kgx10g Scale, springtype,infant,25kg x 100g with set of weighing trousers

Hospital equipment Medical diagnostic equipment

Light, examination, mobile, with accessories Sphygmomanometer, child, aneroid Stethoscope, pediatric, binaural Thermometer, clinical, digital 32-43 °C Timer, respiration, for Acute Respiratory Infection (ARI) Tourniquet, rubber, approx. 50cm Tongue depressor,wooden,single use X-ray system, mobile, with accessories X-ray, viewer (negatoscope), 1 to 3 bodies

Resuscitation/ Anaesthesia equipment

X X X X X X X X X X

Medical devices - Surgical instruments

Surgical instrument Surgical instruments set

Forceps, dressing, Cheron, 250mm Surgical instruments, dressing set

Table 18.Medical Medical equipment for intensive care (in district hospital Table 18. equipment for intensive care (in district hospital or higher level) or higher level) General type Speciﬁc area / type Name of devices for intensive care (in district hospital) Intensive care of:

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Newborn

Mother

Medical devices Equipment

Medical furniture

Bed, hospital, Intensive Care Unit (ICU), with mattress Bed, hospital, standard, child, with mattress Bedscreen, hospital, on castors Cabinet, bedside, standard Cabinet, instruments, double door Cabinet, medicine, double door Cot, baby, hospital, with bassinet, on castors Stand, infusion, double hook, on castors Stretcher, patient, with side rails Table, baby dressing Table, instruments, Mayo type, stainless steel, on castors Trolley, dressing, stainless steel, 2 trays Trolley, emergency, with drawers Trolley, soiled linen

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

2014

Medical utensils

Medical devices Renewable

Clothing medical and accessories

Cap, surgical, non-woven Clogs, plastic - # sizes Drape, surgical woven - # sizes Drawsheet, plastic, approx. 90x180cm Gown, patient, woven Gown, surgical, woven - # sizes Mask, surgical, non-woven, Trousers, surgical, woven - # sizes Tunic, surgical, woven - # sizes

Medical devices Equipment

Anthropometric equipment

Mid Upper Arm Circumference (MUAC) measuring tape, infant/ newborn Scale, electronic, infant,10kgx5g Scale, beamtype, infant,16kgx10g Scale, springtype,infant,25kg x 100g with set of weighing trousers

Hospital equipment

Light, examination, mobile, with accessories Pump, suction, electrical, 1 bottle, with accessories

Child

3. Medical devices for different health-care facilities

Table 18. Medical equipment for intensive care (in district hospital or higher level) General type Speciﬁc area / type Name of devices for intensive care (in district hospital) Intensive care of:

Newborn

Mother

Medical diagnostic equipment

Electrocardiogram (ECG) recorder, portable, with accessories Sphygmomanometer, adult, aneroid Sphygmomanometer, child, aneroid Stethoscope, adult, binaural Stethoscope, pediatric, binaural Thermometer, clinical, digital 32-43 °C Timer, respiration, for Acute Respiratory Infection (ARI) Tourniquet, rubber, approx. 50cm Tongue depressor,wooden,single use X-ray system, mobile, with accessories X-ray, viewer (negatoscope), 1 to 3 bodies

X X

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Resuscitation/ Anaesthesia equipment

Continuous Positive Airway Pressure (CPAP) system, with accessories Deﬁbrillator, basic, with accessories Forceps, Magill, adult Forceps, Magill, child Incubator, newborn, automatic, basic, with accessories Infusion pump, with accessories Laryngoscope, adult/child, set Laryngoscope, newborn, set Monitor, patient, portable, with accessories Oxygen concentrator, ﬂowsplitter for newborn/child Oxygen concentrator, with accessories Pulse oximeter, portable, with accessories Pulse oximeter, spotcheck, with accessories Pump, suction, foot-operated Pump, suction, newborn resuscitation Resuscitator, hand-operated, adult, set Resuscitator, hand-operated, child, set Resuscitator, hand-operated, newborn, set Suction, bulb Syringe pump, with accessories Ventilator medical, adult, with accessories Ventilator medical, child/newborn, with Continuous Positive Airway Pressure (CPAP) and accessories Warmer, heating pad, newborn, with accessories Warmer, sleeping bag, newborn, with accessories Warmer, radiant heater, freestanding, with accessories

Medical devices - Surgical instruments

Surgical instrument Surgical instruments set

Forceps, dressing, Cheron, 250mm Surgical instruments, dressing set (see table 41)

Child

X X

3.2.2 Grouping of medical device consumables by size and capacity The majority of medical device consumables are required for multiple interventions across the continuum of care, and in many cases the same product types are required in different sizes and capacities. To simplify the main matrix, one generic item line reflecting one product type is allocated to interventions across the continuum, and product ranges related to each generic item line are listed in the master list (Table 19).

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Table 19. Medical device consumables by size and capacity Colour coding used below X x Disposable Generic item line (see Table 11 Medical devices for different health-care facilities) Related items covered by the Generic line (note: sizes listed from smaller to bigger) District hospital

Table 19. Medical device consumables by size and capacity

General type

Speciﬁc area / type

Name of devices Health center Health post

X x x

Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable

Clinical laboratory Lancet, blood, safety, sterile (Sizes*) devices - Disposable Clinical laboratory Lancet, safety, 2.0 mm, sterile devices - Disposable Clinical laboratory Lancet, safety, 2.4 mm, sterile devices - Disposable Clinical laboratory Needle, vacuum tube, sterile (Size*) devices - Disposable Clinical laboratory Needle, vacuum tube, 20 G, sterile devices - Disposable Clinical laboratory Needle, vacuum tube, 22 G, sterile devices - Disposable Clinical laboratory Tube, vacuum, Ethylene Diamine Tetra-acetic Acid devices - Disposable (EDTA), sterile (Capacity*) Clinical laboratory Tube, vacuum, Ethylene Diamine Tetra-acetic Acid devices - Disposable (EDTA), 2 ml, sterile Clinical laboratory Tube, vacuum, Ethylene Diamine Tetra-acetic Acid devices - Disposable (EDTA), 4 ml, sterile Clinical laboratory Tube, vacuum, plain/dry, sterile (Capacity*) devices - Disposable Clinical laboratory Tube, vacuum, plain/dry, 4 ml, sterile devices - Disposable Clinical laboratory Tube, vacuum, plain/dry, 6 ml, sterile devices - Disposable Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Injection devices Injection devices Bracelet, identiﬁcation (Sizes*) Bracelet, identiﬁcation newborn Bracelet, identiﬁcation infant Bracelet, identiﬁcation adult Compress, gauze,sterile & non-sterile, single use Compress, gauze, 10x10cm, non-sterile Compress, gauze, 10x10cm, sterile, single use Compress, gauze, parafﬁn, 10 x 10cm, sterile, single use Tape, medical, roll (Sizes*) Tape, medical, 2.5cmx5m,roll Tape, medical, 10cmx5m, roll Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) Cannula, IV short, 24G, sterile, single use

2014

X x x X x x X x x X x x x X x x x X x x X x

3. Medical devices for different health-care facilities

Table 19. Medical device consumables by size and capacity District hospital

General type

Speciﬁc area / type

Name of devices Health center Health post

x x x x X x x x x X x x X x x X x x X x x x x x X x x x x x X x x x x x x x X x

Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable

Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Injection devices Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain

Cannula, IV short, 22G, sterile, single use Cannula, IV short, 20G, sterile, single use Cannula, IV short, 18G, sterile, single use Cannula, IV short, 16G, sterile, single use Needles, luer, sterile, single use (Sizes G*) Needle, luer, 25G(0.5x16mm), sterile, single use Needle, luer, 23G(0.6x25mm), sterile, single use Needle, luer, 21G(0.8x40mm), sterile, single use Needle, luer, 19G(1.1x40mm), sterile, single use Needles, scalp vein, sterile, single use (Sizes G*) Needle, scalp vein, 25G, sterile, single use Needle, scalp vein, 21G, sterile, single use Needles, spinal,sterile, single use (Sizes*) Needle, spinal, 22G (0.7x40mm),sterile, single use Needle, spinal, 25G(0.5x90mm), sterile, single use Syringes, auto-disable (AD), (Capacities ml*) Syringe, auto-disable, 0.05 ml Syringe, auto-disable, 0.5 ml Syringes, luer, sterile, single use (Capacities ml*) Syringe, luer, 1ml, sterile, single use Syringe, luer, 2ml, sterile, single use Syringe, luer, 5ml, sterile, single use Syringe, luer, 10ml, sterile, single use Syringe, luer, 20ml, sterile, single use Syringes, reuse prevention (RUP), (Capacities ml*) Syringe, reuse prevention(RUP), 1ml Syringe, reuse prevention(RUP), 2ml Syringe, reuse prevention(RUP), 5ml Syringe, reuse prevention(RUP), 10ml Syringe, reuse prevention(RUP), 20ml Airway, Guedel, translucent (Sizes*) Airway, Guedel, translucent, size 000 Airway, Guedel, translucent, size 00 Airway, Guedel, translucent, size 0 Airway, Guedel, translucent, size 1 Airway, Guedel, translucent, size 2 Airway, Guedel, translucent, size 3 Airway, Guedel, translucent, size 4 Catheter, Foley, sterile, single use (Sizes CH*) Catheter, Foley, CH08, sterile, single use X X X X X X X X X X X X X X X X X X

Table 19. Medical device consumables by size and capacity District hospital

General type

Speciﬁc area / type

Name of devices Health center Health post

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

x x x X x x X x x x X x

Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain

Catheter, Foley, CH10, sterile, single use Catheter, Foley, CH12, sterile, single use Catheter, Foley, CH14, sterile, single use Catheter, urethral, sterile, single use (Sizes CH*) Catheter, urethral, CH12, sterile, single use Catheter, urethral, CH14, sterile, single use Prongs, nasal, oxygen, non sterile, single use (Sizes *) Prongs, nasal, oxygen, neonate, non sterile, single use Prongs, nasal, oxygen, infant, non sterile, single use Prongs, nasal, oxygen, adult, non sterile, single use Tube, endotracheal, without cuff, sterile, single use (Sizes ID*) Tube, endotracheal, 2.5, without cuff, sterile, single use Tube, endotracheal, 3, without cuff, sterile, single use Tube, endotracheal, 3.5, without cuff, sterile, single use Tube, endotracheal, 4, without cuff, sterile, single use Tube, endotracheal, 4.5, without cuff, sterile, single use Tube, endotracheal, 5, without cuff, sterile, single use Tube, endotracheal, 5.5, without cuff, sterile, single use Tube, endotracheal, with cuff, sterile, single use (Sizes ID*) Tube, endotracheal, 6.5, with cuff, sterile, single use Tube, endotracheal, 7, with cuff, sterile, single use Tube, endotracheal, 7.5, with cuff, sterile, single use Tube, endotracheal, 8, with cuff, sterile, single use Tube, feeding/aspirating, L120cm,catheter tip, sterile, single use (Sizes CH*) Tube, aspirating/feeding, CH06, L120cm, catheter tip, sterile, single use Tube, aspirating/feeding, CH08, L120cm, catheter tip, sterile, single use Tube, aspirating/feeding, CH10, L120cm, catheter tip, sterile, single use Tube, aspirating/feeding, CH12, L120cm, catheter tip, sterile, single use Tube, aspirating/feeding, CH16, L120cm, catheter tip, sterile, single use Tube, feeding, L40cm, luer tip, sterile, single use (Sizes CH*) X X X X X X X X

2014 64

x x x x x x X x x x x X x x x x x X

3. Medical devices for different health-care facilities

Table 19. Medical device consumables by size and capacity District hospital

General type

Speciﬁc area / type

Name of devices Health center Health post

x x x x X x x x x x x X x x x X x x x X x x x x x X x x x

Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Gloves Gloves Gloves Gloves Gloves Gloves Gloves Gloves Gloves Gloves Gloves Gloves Gloves Gloves Surgical sutures Surgical sutures Surgical sutures Surgical sutures

Tube, feeding, CH05, L40cm, luer tip, sterile, single use Tube, feeding, CH08, L40cm, luer tip, sterile, single use Tube, feeding, CH10, L40cm, luer tip, sterile, single use Tube, feeding, CH12, L40cm, luer tip, sterile, single use Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) Tube, suction, CH06, L50cm, catheter tip, sterile, single use Tube, suction, CH08, L50cm, catheter tip, sterile, single use Tube, suction, CH10, L50cm, catheter tip, sterile, single use Tube, suction, CH12, L50cm, catheter tip, sterile, single use Tube, suction, CH14, L50cm, catheter tip, sterile, single use Tube, suction, CH16, L50cm, catheter tip, sterile, single use Gloves, examination, latex, non-sterile, single use (Sizes*) Gloves, examination, latex,small, non-sterile,single use Gloves, examination, latex, medium, non-sterile, single use Gloves, examination, latex, large, non-sterile, single use Gloves, gynaecological, sterile, single use, pair (Sizes*) Gloves, gynaecological, small, sterile, single use, pair Gloves, gynaecological, medium, sterile, single use, pair Gloves, gynaecological, large, sterile, single use, pair Gloves, surgical, sterile, single use, pair (Sizes*) Gloves, surgical, 6.5, sterile, single use, pair Gloves, surgical, 7, sterile, single use, pair Gloves, surgical, 7.5, sterile, single use, pair Gloves, surgical, 8, sterile, single use, pair Gloves, surgical, 8.5, sterile, single use, pair Suture, synthetic, absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Suture,synthetic,absorbable,DEC2(USP3/0),need le 3/8 18mm,round,ster,s.u. Suture,synthetic,absorbable,DEC2(USP3/0),need le 3/8,26mm,triangular, sterile, single use Suture,synthetic,absorbable,DEC3(USP2/0),need le 1/2 30mm,round, sterile, single use X X X X X X X X X X

Table 19. Medical device consumables by size and capacity District hospital

General type

Speciﬁc area / type

Name of devices Health center Health post

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

x x X

Medical devices - Disposable Medical devices - Disposable Medical devices - Disposable

Surgical sutures Surgical sutures Surgical sutures

Suture,synthetic,absorbable,DEC4(USP1), needle 1/2 30mm,round, sterile, single use Suture,synthetic,absorbable,DEC4(USP1),needle 3/8 50mm,round, sterile, single use Suture, synthetic, non-absorbable (Sizes USP/ DEC*) with needle (Shapes* and sizes*), sterile, single use Suture,synthetic,non-absorbable,DEC2(USP3/0),n eedle3/8 18mm,triangular, sterile, single use Suture,synthetic,nonabsorbable,DEC3(USP2/0),needle 3/8 30mm,triangular, sterile, single use Suture,synthetic,nonabsorbable,DEC4(USP1),needle 1/2 30mm,round, sterile, single use X X

x x

Medical devices - Disposable Medical devices - Disposable

Surgical sutures Surgical sutures

Medical devices - Disposable

Surgical sutures

3.3 References

2014 66

1. UNICEF supply catalogue. New York: United Nations Children’s Fund; 2014 (https://supply.unicef.org/unicef_b2c/app/ displayApp/%28layout=7.0-12_1_66_67_115&carea=%24ROOT%29/.do?rf=y, accessed 22 May 2014).

4. Matrix of medical devices in each stage of continuum of care, in each level of health-care facility 4.1 Continuum of care matrix This section contains 17 different tables (Tables 20–35). For each of the six stages of the continuum of care described in Section 2.1, three levels of health-care facility are considered: health posts, health centres and district hospitals. For childbirth, only health centres and district hospitals are considered because delivery in a health post is not recommended. The title of the table shows the stage and health-care facility referenced; for example, “Medical devices for family planning and reproductive health at health post” covers the stage of family planning and reproductive health in a health post. The priority interventions included in Table 3 are listed in the horizontal axis. The vertical axis consists of the medical devices included in Table 11. To read the tables, locate the “X” below each priority intervention and trace it to the left to find the associated medical device. References to other tables indicate that the intervention is associated with a group of medical devices. The tables can be found in Section 3.2.

4.Matrix of medical devices in each stage of continuum of care

Table 20. Medical devices for Family planning and reproductive health at HEALTH POST

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

General type

Name of devices

Clinical laboratory devices

Lancet, blood, safety, sterile (Sizes*) Swab, cotton-tip, tube, sterile Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit

2014

Test strip, pregnancy Family planning devices Female condoms Lubricants Male condoms Medical devices - Disposable Compress, gauze,sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Needles, luer, sterile, single use (Sizes G*) Safety box, for used syringes/needles Syringes, auto-disable (AD), (Capacities ml*) Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Gloves, examination, latex, non-sterile, single use (Sizes*) Medical devices - Equipment Grouping Counselling material Commodities for medical examination & diagnosis Counselling material

PrevenBasic Medical tive Examination Immunization

X First assessment

X X b) Pelvic examination

a) Check-up vital signs / measuring weight and height / Anthropometry

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X a) Screening of HIV b) Treatment for HIV (Antiretroviral Therapy (ART)) c) Provide post exposure prophylaxis for HIV discordant couple a) Prophylactic antimalarial (IPT) Malaria b) Diagnosis of malaria a) Breast examination a) Provision of oral contraceptives a) Provision of barriers methods

a) Vaccine for Hepatitis B

Provision of contraceptives

Contraceptive method selection

a) Provision of emergency contraception a) Screening / diagnosis of Syphilis by laboratory test

Syphilis Human Immunodeﬁciency Virus (HIV)

c) Management of malaria

Breast cancer

Screening and manag- Management Detection and management of Sexually Transmitted ment of can- of genderInfection (STI) and other infections cers of the based vioreproductive lence (gbv) system

Post-rape care

a) Management of post-rape care

4.Matrix of medical devices in each stage of continuum of care

Table 21. Medical devices for pregnancy at HEALTH POST First assessment Emergency assessment

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Basic Medical Examination

Preventive Immunization

Emergency preparedness and referral a) Emergency care and pre-referral treatment X

a) Check-up vital signs / measuring weight and height / Anthropometry/ Vaginal examination

General type

Name of devices

Clinical laboratory devices

Lancet, blood, safety, sterile (Sizes*) Swab, cotton-tip, tube, sterile Blood glucometer, with accessories Hemoglobinometer, with accessories

2014

Haemoglobin colour scale (reﬁll kit) Haemoglobin colour scale (starter kit) Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Test strip, pregnancy Test strip, urinalysis (10 parameter) Family planning devices Female condoms Lubricants Male condoms Medical devices Disposable Compress, gauze,sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Needles, luer, sterile, single use (Sizes G*) Safety box, for used syringes/needles Syringes, auto-disable (AD), (Capacities ml*) Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Gloves, examination, latex, non-sterile, single use (Sizes*) Medical devices Equipment Grouping Counselling material Commodities for medical examination & diagnosis Commodities for emergency preparedness Counselling material X X X X X X X

a) Vaccine for Tetanus

Syphilis

X X X X a) Screening of HIV

a) Screening / diagnosis of Syphilis by laboratory test

Human Immunodeﬁciency Virus (HIV)

Detection and management of Sexually Transmitted Infection (STI) and other infections

X c) Treatment for HIV (Antiretroviral Therapy (ART)) a) Prophylactic antimalarial (IPT) X X b) Diagnosis of malaria X X X X c) Management of malaria X X X X a) Diagnosis of anaemia b) Iron and folic acid supplementation c) Anthelminthic (deworm) X X X a) Glucose testing for detection

b) Prevention Mother To Child Transmission (PMTCT)

Malaria

Iron Deﬁciency Anaemia

Detection and management of maternal chronic medical conditions

Diabetes

4.Matrix of medical devices in each stage of continuum of care

Table 22. Medical devices for post-natal baby (newborn) at HEALTH POST

Childbirth: Essential newborn care

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Routine care

a) Full clinical examination / Check vital signs / measuring weight

General type

Name of devices

d) Vitamin K prophylaxis and Immunization

c) Breastfeeding support

b) Thermal Care

Clinical laboratory Haemoglobin colour scale (reﬁll kit) devices Haemoglobin colour scale (starter kit) Medical devices Disposable Blanket, survival, 220x140cm, non-sterile Compress, gauze, sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Safety box, for used syringes/needles Syringes, auto-disable (AD), (Capacities ml*) Gloves, examination, latex, non-sterile, single use (Sizes*) Medical devices Equipment Medical devices - Equipment Grouping Counselling material Breastpump, manual, with accessories Commodities for medical examination & diagnosis Counselling material X X X X X X X X X X

2014

e) Cord care

Further assessment for all young infant

X X X X Clinical visit X X X X X d) Monitoring growth and development X c) Breastfeeding support and replacement feeding if necessary X X b) Provision of vaccines (Diphtheria Pertussis Tetanus (DPT) + Haemophilus Inﬂuenzae type B (HIB), Oral Polio Vaccine (OPV), Hepatitis B)

a) Full clinical examination / check vital signs / measuring weight / check haemoglobin

4.Matrix of medical devices in each stage of continuum of care

Table 23. Medical devices for infancy and childhood at HEALTH POST

Essential care for monitoring growth and early childhood development

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Routine care

a) Full clinical examination / check vital signs / measuring weight

e) Breastfeeding support and replacement feeding if necessary

d) Early childhood development monitoring

General type

Name of devices

Clinical laboratory devices

Lancet, blood, safety, sterile (Sizes*) Swab, cotton-tip, tube, sterile Haemoglobin colour scale (reﬁll kit) Haemoglobin colour scale (starter kit)

2014

Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Medical devices Disposable Compress, gauze, sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Needles, luer, sterile, single use (Sizes G*) Safety box, for used syringes/needles Syringes, auto-disable (AD), (Capacities ml*) Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Gloves, examination, latex, non-sterile, single use (Sizes*) Medical devices Equipment Medical devices - Equipment Grouping Counselling material Breastpump, manual, with accessories X X X X X X X X

Commodities for medical examination & diagnosis

Counselling material

g) Deworming (Mebendazole) X

f) Vitamin A supplementation

b) Provision of vaccines

c) Growth monitoring

Severe Acute Malnutrition (SAM)

X Pneumonia X X X X X X X X X X X X X X a) Diagnosis of condition with wheeze b) Management of pneumonia and its complications Wheeze (Asthma, Bronchiolitis) a) Differential diagnosis for pneumonia

a) Diagnosis of SAM

b) Management of condition with wheeze

Diarrhoea

Detection and management of common infections, illness and complications in infancy and childhood

X X X X X X X X X X X X X X X X X

a) Differential diagnosis and management of diarrhoea and dysentery

Human Immunodeﬁciency Virus (HIV)

a) Diagnosis of HIV

b) Treatment for HIV (Antiretroviral Therapy (ART)) c) Management of other opportunistic infections in HIV

Eye infection

X X X X X X X X

a) Detection and management of eye infection / conjunctivitis a) Detection and management of ear infection a) Detection and management of mouth infection / thrush

Ear Mouth Skin Chickinfec- infec- infecen pox tion tion tion

X X X

X X X X

X X

a) Diagnosis and management of skin infections a) Detection and management of chicken pox

4.Matrix of medical devices in each stage of continuum of care

Table 24. Medical devices for family planning and reproductive health at HEALTH CENTRE

First assessment

Provision of contraceptives

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

PrevenBasic Medical tive Examination Immunization a) Check-up vital signs / measuring weight and height / Anthropometry a) Provision of oral contraceptives

Contraceptive method selection

a) Provision of barriers methods

General type

Name of devices

Clinical laboratory devices

Container, sample, 50 ml Lancet, blood, safety, sterile (Sizes*) Swab, cotton-tip, tube, sterile Cytology stain, kit Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit

2014

Rapid Diagnostic Test (RDT), malaria, kit Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Rapid Plasma Reagin (RPR), syphilis, kit Test strip, pregnancy Test strip, urinalysis (10 parameter) Test strip, vaginal infection, pH Family planning Female condoms devices Intra-Uterine Devices (only prequaliﬁed copper IUDs) Lubricants Male condoms Sub-dermal implants (included the insertion device) Medical devices Disposable Blanket, survival, 220x140cm, non-sterile Compress, gauze,sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Needles, luer, sterile, single use (Sizes G*) Needles, scalp vein, sterile, single use (Sizes G*) Safety box, for used syringes/needles Syringes, auto-disable (AD), (Capacities ml*) Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Gloves, examination, latex, non-sterile, single use (Sizes*) Gloves, gynaecological, sterile, single use, pair (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) Suture, synthetic, absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Medical devices Magnifying lens for Visual Inspection with Acetic - Equipment Acid Grouping Commodities for medical examination & diagnosis X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Commodities for surgery & anaesthesia Counselling material Counselling material X X X

X X X X X

a) Provision of vaginal rings and patches X

a) Insertion and removal of contraceptive implants with anaesthesia

a) Insertion and removal of Intrauterine device (IUD)s

a) Provision of emergency contraception

a) Vaccine for Hepatitis B

a) Provision of injectable contraceptives

b) Pelvic examination

X X X X X a) Screening / diagnosis of Syphilis by laboratory test Syphilis b) Treatment for Syphilis X X X a) Screening of HIV b) Treatment for HIV (Antiretroviral Therapy (ART)) c) Provide post exposure prophylaxis for HIV discordant couple X X X X a) Screening / diagnosis of Gonorrhoea b) Treatment for Gonorrhoea X X X X X X Human Immunodeﬁciency Gonorrhoea Virus (HIV) X X X X a) Screening / diagnosis of Chlamydia b) Treatment for Chlamydia a) Prophylactic antimalarial (IPT) X X Malaria b) Diagnosis of malaria c) Management of malaria X X X X X Chlamydia X X X X X X X X X X X X X X Detection and management of Sexually Transmitted Infection (STI) and other infections Other infections a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis a) Diagnosis and treatment for bacterial vaginosis, trichomonas, candidiasis X X a) Papanicolaou test X b) Visual Inspection with Acetic Acid (VIA / VIAM) X c) Human Papilloma Virus (HPV) test a) Breast examination X X X Cervix cancer Screening and management of cancers of the reproductive system X X X X X X X X X X X X X X X Breast Post-rape cancer care a) Management of post-rape care

a) Vasectomy with local anaesthesia

Management of genderbased violence (GBV)

4.Matrix of medical devices in each stage of continuum of care

Table 25. Medical devices for pregnancy at Table 25 Medical devices for pregnancy at Health centre HEALTH CENTRE First assessment

Emergency assessment

Detection and management of Sexually Transmitted Infection (STI) and other infections

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Basic Preven- Emergency Medical tive preparedExamina- Immuni- ness and tion zation referral a) Emergency care and pre-referral treatment

Syphilis

Human Immunodeﬁciency Virus (HIV) c) Treatment for HIV (Antiretroviral Therapy (ART))

a) Screening / diagnosis of Syphilis by laboratory test

General type

Name of devices

Clinical laboratory devices

Container, sample, 50 ml Lancet, blood, safety, sterile (Sizes*) Swab, cotton-tip, tube, sterile Blood glucometer, with accessories X X X X X X

2014

Hemoglobinometer, with accessories Enzyme Immuno Assay (EIA), gonorrhea Ag, kit Haemoglobin colour scale (reﬁll kit) Haemoglobin colour scale (starter kit) Nucleic Acid Test (NAT), chlamydia, kit Nucleic Acid Test (NAT), gonorrhea, kit Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Rapid Plasma Reagin (RPR), syphilis, kit Test strip, pregnancy Test strip, urinalysis (10 parameter) Family planning Female condoms devices Lubricants Male condoms Medical devices Disposable Bandage, elastic, 7.5cmx5m, roll Blanket, survival, 220x140cm, non-sterile Compress, gauze, sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) Infusion giving set, sterile, single use Needles, luer, sterile, single use (Sizes G*) Safety box, for used syringes/needles Stopcock, 3-way, sterile, single use Syringes, auto-disable (AD), (Capacities ml*) X X X X X X

X X

X X X X X X X X X X X X X X

b) Prevention Mother To Child Transmission (PMTCT) X X X

a) Check-up vital signs / measuring weight and height / Anthropometry/ Vaginal examination

b) Treatment for Syphilis

a) Vaccine for Tetanus

a) Screening of HIV

a) Prophylactic antimalarial (IPT) Malaria X X b) Diagnosis of malaria c) Management of malaria TuRu- berbella culosis X a) Diagnosis and treatment for rubella a) Diagnosis and treatment for tuberculosis X X a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis

X Other infections X X X X X a) Diagnosis and treatment of other STI/Reproductive Tract Infections (RTI): Candida vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis a) Diagnosis of anaemia b) Iron and folic acid supplementation c) Anthelminthic (deworm) X X X X Iron Deﬁciency Anaemia X a) Diagnosis of Pre-eclampsiaEclampsia b) Supplement calcium c) Low-dose aspirin d) Antihypertensive drugs e) Magnesium sulfate X X X a) Glucose testing for detection Diabetes Hypertension and pre-eclampsia X X b) Treatment for insulin-dependent diabetic mother a) Diagnosis and laboratory test b) Fetal monitoring a) Provision antibiotics if indicated Assessment of PRM Preterm

Detection and management of maternal chronic medical conditions

Management of prelabour rupture of the membranes (PRM)

4.Matrix of medical devices in each stage of continuum of care

Table 25 Medical devices for pregnancy at Health centre First assessment Emergency assessment Detection and management of Sexually Transmitted Infection (STI) and other infections

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Basic Preven- Emergency Medical tive preparedExamina- Immuni- ness and tion zation referral a) Emergency care and pre-referral treatment

Syphilis

Human Immunodeﬁciency Virus (HIV) c) Treatment for HIV (Antiretroviral Therapy (ART))

a) Screening / diagnosis of Syphilis by laboratory test

General type

Name of devices

Syringe for insulin, sterile, single use Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) X X X X

Bag, urine, collecting, 2000ml

X X X

2014

Catheter, Foley, sterile, single use (Sizes CH*) Prongs, nasal, oxygen, non sterile, single use (Sizes*) Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) Gloves, examination, latex, non-sterile, single use (Sizes*) Gloves, gynaecological, sterile, single use, pair (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) Medical devices Equipment Medical devices Equipment Grouping Counselling material Cardiotocograph (CTG), with accessories Doppler, foetal heart rate (FHR) detector, with accessories Commodities for medical examination & diagnosis Commodities for emergency preparedness Counselling material X X

X X

X X X

X X X X X X X X X X

b) Prevention Mother To Child Transmission (PMTCT)

a) Check-up vital signs / measuring weight and height / Anthropometry/ Vaginal examination

b) Treatment for Syphilis

a) Vaccine for Tetanus

a) Screening of HIV

X X Malaria

X X X X b) Diagnosis of malaria c) Management of malaria a) Diagnosis and treatment for rubella a) Diagnosis and treatment for tuberculosis X X

a) Prophylactic antimalarial (IPT)

X TuRu- berbella culosis

X X X X X X

X X X X a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis

Other infections

X X X X X X X X b) Iron and folic acid supplementation

X X X X X X

a) Diagnosis and treatment of other STI/Reproductive Tract Infections (RTI): Candida vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis a) Diagnosis of anaemia

Iron Deﬁciency Anaemia

c) Anthelminthic (deworm) a) Diagnosis of Pre-eclampsiaEclampsia b) Supplement calcium c) Low-dose aspirin d) Antihypertensive drugs e) Magnesium sulfate

Hypertension and pre-eclampsia

Detection and management of maternal chronic medical conditions

X X X X X X X X X X X X X X X

a) Glucose testing for detection

Diabetes

b) Treatment for insulin-dependent diabetic mother X X X X a) Diagnosis and laboratory test b) Fetal monitoring a) Provision antibiotics if indicated

Management of prelabour rupture of the membranes (PRM) Assessment of PRM Preterm

4.Matrix of medical devices in each stage of continuum of care

Table 26. Medical devices for childbirth at HEALTH CENTRE First assessment Emergency assessment

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Basic Medical Examination a) Check-up vital signs / Vaginal examination

Emergency preparedness and referral

General type

Name of devices

Clinical laboratory devices

Container, sample, 50 ml Lancet, blood, safety, sterile (Sizes*) Swab, cotton-tip, tube, sterile Blood glucometer, with accessories Hemoglobinometer, with accessories Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Test strip, pregnancy Test strip, urinalysis (10 parameter) X X X X X X X X X X X

2014

Medical devices Disposable

Medical devices Cardiotocograph (CTG), with accessories - Equipment

Doppler, foetal heart rate (FHR) detector, with accessories Non-Pneumatic Anti-Shock Garment (NASG) X

Medical devices Commodities for medical examination & diagnosis - Equipment Commodities for emergency preparedness (see table 12) Grouping

Commodities for labour, delivery & recovery (see table 13) Counselling material

Counselling material (see table 14)

a) Emergency care and prereferral treatment X X X X X X X X X X X X X X X X

X X X X

Mother care

Childbirth

X X X X X X X X X X b) Active management of the third stage of labour (AMTSL): Prophylactic use of uterotonics X X X c) Spontaneous delivery X X X X X X X X d) Assisted delivery (vacuum extraction) if needed X X X X X X X X X X a) Diagnosis of complications Assessment for complications b) Fetal monitoring X X X X X X X X X Postpartum haemorrhage (PPH) a) Use of uterotonics of choice for the treatment of PPH X X X a) Screening of HIV Management of complications of labour and delivery Human Immunodeﬁciency Virus (HIV) positive women b) Prevention Mother To Child Transmission (PMTCT)

a) Monitoring progress of labour

4.Matrix of medical devices in each stage of continuum of care

Table 27. Medical devices for post-natal mother at HEALTH CENTRE First assessment

Emergency assessment

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Basic Medical Examination

Support for breast feeding a) Management of mastitis / breast abscess

Emergency preparedness and referral

General type

Name of devices

Clinical laboratory devices

2014

Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit Test strip, urinalysis (10 parameter) Test strip, vaginal infection, pH Medical devices Disposable Bandage, elastic, 7.5cmx5m, roll Blanket, survival, 220x140cm, non-sterile Compress, gauze, sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) Infusion giving set, sterile, single use Needles, luer, sterile, single use (Sizes G*) Safety box, for used syringes/needles Stopcock, 3-way, sterile, single use Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Bag, urine, collecting, 2000ml Catheter, Foley, sterile, single use (Sizes CH*) Prongs, nasal, oxygen, non sterile, single use (Sizes*) Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) Gloves, examination, latex, non-sterile, single use (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) Medical devices Equipment Medical devices Equipment Grouping (see tables 12, 13 and 16) Counselling material Breastpump, manual, with accessories Commodities for medical examination & diagnosis Commodities for emergency preparedness Commodities for inpatient mother and newborn Counselling material X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

a) Emergency care and pre-referral treatment

b) Screening for cervix and breast cancer

a) Check-up vital signs

X X X X X b) Diagnosis of anaemia Anaemia c) Iron supplementation d) Anthelminthic (deworm) X X HIV a) Diagnosis and treatment for HIV (Antiretroviral Therapy (ART)) X X Malaria X X X a) Diagnosis and management of malaria X X X X X X a) Diagnosis and management of postpartum endometritis and salpingitis Other infection X X X X X X a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis

a) Management of post partum bleeding

Prevention and management of post partum bleeding

Detection and management of post partum infection

4.Matrix of medical devices in each stage of continuum of care

Table 28. Medical devices for post-natal baby (newborn) at HEALTH CENTRE Childbirth: Essential newborn care

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Immediate care at birth

Emergency support e) Support breastfeeding within the ﬁrst hour

Routine care a) Full clinical examination / Check vital signs / measuring weight X X X

c) Clamp and cut cord / Check cord vessels / Check for bleeding and signs of cord infection

a) Dry baby thoroughly on mother's chest skin to skin and cover

General type

Name of devices

b) Management of brain injury and intracranial haemorrhage (ICH)

d) Prevent hypothermia when skin to skin is not possible

a) Basic neonatal resuscitation

b) Assess breathing

Clinical laboratory devices

Container, sample, 50 ml Lancet, blood, safety, sterile (Sizes*) Swab, cotton-tip, tube, sterile Hemoglobinometer, with accessories Haemoglobin colour scale (reﬁll kit) Haemoglobin colour scale (starter kit) Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Plasma Reagin (RPR), syphilis, kit Treponema Pallidum Haemagglutination Assay (TPHA), syphilis, kit

2014

Medical devices Disposable

Medical devices Breastpump, manual, with accessories - Equipment Medical devices Commodities for medical examination & diagnosis - Equipment (see table 12) Grouping Commodities for emergency preparedness (see table 13) Commodities for labour, delivery & recovery (see table 14) Commodities for inpatient mother and newborn (see table 16) Counselling material

X X

Counselling material

b) Thermal Care X

X X X X X d) Vitamin K prophylaxis and Immunization e) Cord care f) Prophylaxis for eye infection g) Prophylactic antibiotics for neonates at risk of infection X X X X a) Diagnosis of congenital syphilis X X X X X X X X X X b) Prophylactic treatment for congenital syphilis X X X c) Screening of HIV (Dried Blood Spot (DBS)) d) Prophylactic treatment for HIV (Antiretroviral Therapy (ART)) X Congenital infections Detection and management of congenital infections X X X X X X X Cord infection a) Detection and management of cord infection Pneumonia a) Diagnosis of pneumonia X X X X Diarrhoea a) Detection and management of diarrhoea X X X X Triage, emergency preparedness and referral a) Detection of emergency signs, emergency care and pre-referral treatment X X X X X X X a) Full clinical examination / check vital signs / measuring weight / check haemoglobin X X b) Provision of vaccines (Diphtheria Pertussis Tetanus (DPT) + Haemophilus Inﬂuenzae type B (HIB), Oral Polio Vaccine (OPV), Hepatitis B) c) Breastfeeding support and replacement feeding if necessary d) Monitoring growth and development Clinical visit Further assessment for all young infant

c) Breastfeeding support

Detection and management of common infections, illness and complications in the neonate and young infant

4.Matrix of medical devices in each stage of continuum of care

Table 29. Medical devices for infancy and childhood at HEALTH CENTRE

Essential care for monitoring growth and early childhood development

Detection and management of common infections, illness and complications in infancy and childhood Severe Acute Malnutrition Anaemia (SAM)

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Routine care

a) Full clinical examination / check vital signs / measuring weight

c) Pre-referral treatment for SAM

d) Early childhood development monitoring e) Breastfeeding support and replacement feeding if necessary

g) Deworming (Mebendazole)

f) Vitamin A supplementation

General type

Name of devices

Clinical laboratory devices

Lancet, blood, safety, sterile (Sizes*) Swab, cotton-tip, tube, sterile Blood glucometer, with accessories Hemoglobinometer, with accessories Haemoglobin colour scale (reﬁll kit) Haemoglobin colour scale (starter kit) Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit Test strip, urinalysis (10 parameter)

X X X X X

X X X

2014

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Medical devices Disposable

Bandage, elastic, 7.5cmx5m, roll Blanket, survival, 220x140cm, non-sterile Bracelet, identiﬁcation (Sizes*) Compress, gauze, sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) Infusion giving set, burette 100-150ml, sterile, single use Needles, luer, sterile, single use (Sizes G*) Needles, scalp vein, sterile, single use (Sizes G*) Safety box, for used syringes/needles Stopcock, 3-way, sterile, single use Syringes, auto-disable (AD), (Capacities ml*) Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Prongs, nasal, oxygen, non sterile, single use (Sizes*) Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) Gloves, examination, latex, non-sterile, single use (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*)

X X

Medical devices Equipment Medical devices Equipment Grouping Counselling material

Breastpump, manual, with accessories Commodities for medical examination & diagnosis (see table 12) Commodities for emergency preparedness (see table 13) Commodities for inpatient child (see table 17) Counselling material X X X X

X X

X X X

X X

b) Management of anaemia X X

a) Diagnosis of anaemia

b) Provision of vaccines

c) Growth monitoring

a) Diagnosis of SAM

b) Feeding support

X X

X X X X X X

Wheeze Pneumo- (Asthma, nia Bronchiolitis)

X X a) Diagnosis of condition with wheeze b) Management of condition with wheeze X X X X

a) Differential diagnosis for pneumonia b) Management of pneumonia and its complications

Tuberculosis

X X X X X X X X X X X b) Management of tuberculosis X X

a) Diagnosis of tuberculosis

DiarMalaria rhoea

X X X X X X X X X X X

a) Differential diagnosis and management of diarrhoea and dysentery a) Diagnosis and management of malaria a) Diagnosis and management of dengue fever a) Diagnosis and management of measles

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Dengue fever

Measles

Triage, Human Immu- Eye Ear Mouth Skin Chick- emergency nodeﬁciency infec- infec- infec- infecen pox preparedness Virus (HIV) tion tion tion tion and referral

a) Diagnosis of HIV

b) Treatment for HIV (Antiretroviral Therapy (ART)) c) Management of other opportunistic infections in HIV a) Detection and management of eye infection / conjunctivitis a) Detection and management of ear infection a) Detection and management of mouth infection / thrush a) Diagnosis and management of skin infections a) Detection and management of chicken pox

Supportive care for all sick infant and child

a) Detection of emergency signs, emergency care and pre-referral treatment

4.Matrix of medical devices in each stage of continuum of care

Table 30. Medical devices forplanning family planning and Table 30 Medical devices for family and reproductive health at DISTRICT HOSPITAL reproductive health at DISTRICT HOSPITAL First assessment Provision of contraceptives

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

PrevenBasic Meditive cal ExaminaImmunition zation a) Check-up vital signs / measuring weight and height / Anthropometry a) Provision of oral contraceptives

Contraceptive method selection

a) Provision of injectable contraceptives a) Insertion and removal of Intrauterine device (IUD)s a) Insertion and removal of contraceptive implants with anaesthesia

General type

Name of devices

Clinical laboratory devices

Container, sample, 50 ml Lancet, blood, safety, sterile (Sizes*) Needle holder, vacuum tubes, sterile Needle, vacuum tube, sterile (Size*) Swab, cotton-tip, tube, sterile Tube, capillary, Ethylene Diamine Tetra-acetic Acid (EDTA) Tube, vacuum, Ethylene Diamine Tetra-acetic Acid (EDTA), sterile (Capacity*) Tube, vacuum, plain/dry, sterile (Capacity*) Cytology stain, kit Enzyme Immuno Assay (EIA), gonorrhea Ag, kit Enzyme Immuno Assay (EIA), Human Immunodeﬁciency Virus (HIV), kit Nucleic Acid Test (NAT), chlamydia, kit Nucleic Acid Test (NAT), gonorrhea, kit Nucleic Acid Test (NAT), Human Papilloma Virus (HPV), kit Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Rapid Plasma Reagin (RPR), syphilis, kit Treponema Pallidum Haemagglutination Assay (TPHA), syphilis, kit Test strip, pregnancy Test strip, urinalysis (10 parameter) X

2014

Test strip, vaginal infection, pH Family planning Cervical cap devices Diaphragm Female condoms Intra-Uterine Devices (only prequaliﬁed copper IUDs) Levonorgestrel Intra Uterin Device (IUD) Lubricants Male condoms Sub-dermal implants (included the insertion device) X X X

X X X X X X

a) Provision of emergency contraception a) Provision of vaginal rings and patches a) Vasectomy with local anaesthesia

a) Provision of barriers methods

a) Vaccine for Hepatitis B

b) Pelvic examination

a) Tubal ligation Syphilis X b) Treatment for Syphilis Human Immunodeﬁciency Virus (HIV) X X X X X X X X X a) Screening of HIV X X X X a) Screening / diagnosis of Syphilis by laboratory test

Gonorrhoea

Detection and management of Sexually Transmitted Infection (STI) and other infections

X X b) Treatment for Gonorrhoea X X X b) Treatment for Chlamydia X X b) Diagnosis of malaria c) Management of malaria X X X X X a) Papanicolaou test X X X X d) Colposcopy X X a) Breast examination b) Diagnostic by image (mammography, ultrasound) c) Biopsy / Pathology lab-test X X X X X X X X X X X X X X

b) Treatment for HIV (Antiretroviral Therapy (ART)) c) Provide post exposure prophylaxis for HIV discordant couple a) Screening / diagnosis of Gonorrhoea

a) Screening / diagnosis of Chlamydia

Chlamydia

a) Prophylactic antimalarial (IPT) Malaria

Other infections

a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis a) Diagnosis and treatment for bacterial vaginosis, trichomonas, candidiasis

b) Visual Inspection with Acetic Acid (VIA / VIAM) c) Human Papilloma Virus (HPV) test

Cervix cancer

Screening and management of cancers of the reproductive system

e) Colposcopy and Biopsy / Pathology lab-test f) Treatment for precancerous lesion (cryotherapy)

Breast cancer

Management of genderbased violence (GBV)

Post-rape care

a) Management of post-rape care

4. Matrix of medical devices in each stage of continuum of care

Table 30 Medical devices for family planning and reproductive health at DISTRICT HOSPITAL First assessment Provision of contraceptives

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

PrevenBasic Meditive cal ExaminaImmunition zation a) Check-up vital signs / measuring weight and height / Anthropometry a) Provision of oral contraceptives

Contraceptive method selection

a) Provision of injectable contraceptives a) Insertion and removal of Intrauterine device (IUD)s a) Insertion and removal of contraceptive implants with anaesthesia

General type

Name of devices

Medical devices Disposable

Blanket, survival, 220x140cm, non-sterile Compress, gauze,sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile X X X X X X X X

2014

Tape, medical, roll (Sizes*) Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) Infusion giving set, sterile, single use Needles, luer, sterile, single use (Sizes G*) Needles, scalp vein, sterile, single use (Sizes G*) Needles, spinal, sterile, single use (Sizes*) Safety box, for used syringes/needles Syringes, auto-disable (AD), (Capacities ml*) Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Airway, Guedel, translucent (Sizes*) Catheter, urethral, sterile, single use (Sizes CH*) Prongs, nasal, oxygen, non sterile, single use (Sizes*) Tube, endotracheal, with cuff, sterile, single use (Sizes ID*) Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) Gloves, examination, latex, non-sterile, single use (Sizes*) Gloves, gynaecological, sterile, single use, pair (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) Suture, synthetic, absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/ DEC*) with needle (Shapes* and sizes*), sterile, single use Breast biopsy system Colposcope with biopsy set Cryosurgical unit with tank and accesories Magnifying lens for Visual Inspection with Acetic Acid Mammograph with printer and accessories Medical devices Equipment Grouping Counselling material

X X

X X X

X X

X X X X X

Medical devices Equipment

Commodities for medical examination & diagnosis Commodities for surgery & anaesthesia Commodities for inpatient mother and newborn Counselling material

X X

a) Provision of emergency contraception a) Provision of vaginal rings and patches a) Vasectomy with local anaesthesia

a) Provision of barriers methods

a) Vaccine for Hepatitis B

b) Pelvic examination

X X X X X

X X

X X X

X X

X X a) Screening / diagnosis of Syphilis by laboratory test X X Syphilis

X X X X X X b) Treatment for Syphilis a) Screening of HIV

X X

a) Tubal ligation

Human Immunodeﬁciency Virus (HIV)

Detection and management of Sexually Transmitted Infection (STI) and other infections

X X X X

Gonorrhoea

X X X X X X b) Treatment for Gonorrhoea

b) Treatment for HIV (Antiretroviral Therapy (ART)) c) Provide post exposure prophylaxis for HIV discordant couple a) Screening / diagnosis of Gonorrhoea

X X X X

X X X X X X X

a) Screening / diagnosis of Chlamydia b) Treatment for Chlamydia a) Prophylactic antimalarial (IPT)

Chlamydia

X X X X X X X X

Malaria

X X

b) Diagnosis of malaria

X X X X X X X X X X

X X X X X X X X X X X

c) Management of malaria

X X X X X X X X X X X

Other infections

X X X X X X X X X X X X X X X X X

X X X X X X

a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis a) Diagnosis and treatment for bacterial vaginosis, trichomonas, candidiasis a) Papanicolaou test X

Cervix cancer

b) Visual Inspection with Acetic Acid (VIA / VIAM) c) Human Papilloma Virus (HPV) test X d) Colposcopy X

e) Colposcopy and Biopsy / Pathology lab-test f) Treatment for precancerous lesion (cryotherapy) a) Breast examination b) Diagnostic by image (mammography, ultrasound) X c) Biopsy / Pathology lab-test

Screening and management of cancers of the reproductive system

Breast cancer

X X X

Management of genderbased violence (GBV)

Post-rape care

a) Management of post-rape care

4. Matrix of medical devices in each stage of continuum of care

Table 31. Medical devices for pregnancy at DISTRICT HOSPITAL Table 31. Medical devices for pregnancy at DISTRICT HOSPITAL

First assessment

Emerand management of Sexually gency Detection (STI) and other assess- Transmitted Infection infections ment Emergency Human Tuprepar- Syphilis Immuno- Malaria Ru- beredness deﬁciency bella culoand Virus (HIV) sis referral

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Basic Medical Examination

Preventive Immunization

a) Screening / diagnosis of Syphilis by laboratory test b) Treatment for Syphilis

a) Diagnosis and treatment for rubella X X

a) Check-up vital signs / measuring weight and height / Anthropometry/ Vaginal examination

a) Screening of HIV b) Prevention Mother To Child Transmission (PMTCT) c) Treatment for HIV (Antiretroviral Therapy (ART)) a) Prophylactic antimalarial (IPT)

a) Emergency care and pre-referral treatment

Blood Bank devices

Anti-A blood group reagent, monoclonal Anti-B blood group reagent, monoclonal Anti-D blood group reagent (Saline/monoclonal) Blood administration set, sterile

2014

Glass slides, 25x75mm Markers, ﬁne point, permanent black, for glassware Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml Wooden or plastic applicator sticks Clinical laboratory devices Container, sample, 50 ml Lancet, blood, safety, sterile (Sizes*) Needle holder, vacuum tubes, sterile Needle, vacuum tube, sterile (Size*) Swab, cotton-tip, tube, sterile Tube, capillary, Ethylene Diamine Tetra-acetic Acid (EDTA) Tube, vacuum, Ethylene Diamine Tetra-acetic Acid (EDTA), sterile (Capacity*) Tube, vacuum, plain/dry, sterile (Capacity*) Blood glucometer, with accessories Hemoglobinometer, with accessories Enzyme Immuno Assay (EIA), gonorrhea Ag, kit Enzyme Immuno Assay (EIA), Human Immunodeﬁciency Virus (HIV), kit Enzyme Immuno Assay (EIA), Rubella, kit Nucleic Acid Test (NAT), chlamydia, kit Nucleic Acid Test (NAT), gonorrhea, kit Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Rapid Plasma Reagin (RPR), syphilis, kit Treponema Pallidum Haemagglutination Assay (TPHA), syphilis, kit Test strip, pregnancy Test strip, urinalysis (10 parameter) Test strip, vaginal infection, pH X X X X X X X X X X X X X X X X X X X X

a) Vaccine for Tetanus

General type

Name of devices

a) Diagnosis and treatment for tuberculosis

c) Management of malaria

b) Diagnosis of malaria

X Other Iron Deﬁcieninfections cy Anaemia X X X X X b) Iron and folic acid supplementation c) Anthelminthic (deworm) X X X X X X X X X d) Management of severe anaemia (considering blood transfusion) a) Diagnosis of Pre-eclampsia-Eclampsia b) Supplement calcium c) Low-dose aspirin d) Antihypertensive drugs e) Magnesium sulfate f) Fetal monitoring g) Induction of labour X X X X a) Glucose testing for detection b) Treatment for insulin-dependent diabetic mother a) Diagnosis and laboratory test b) Fetal monitoring Hypertension and pre-eclampsia Detection and management of maternal chronic medical conditions AssessDiabe- ment tes of PRM Preterm Management of prelabour rupture of the membranes (PRM) a) Provision antibiotics if indicated b) Provision of tocolytics to prolong pregnancy if indicated c) Provision of corticosteroids for prevention of neonatal respiratory distress syndrome d) Provision of magnesium sulfate for neuroprotection of the newborn a) Provision antibiotics if indicated b) Induction of labour a) Diagnosis of breech at term b) External Cephalic Version c) Monitoring progress of labour a) Perineal incision with local anaesthesia b) Identify the need of caesarean section a) Pregnancy test b) Ultrasound scan c) Laparotomy X X X X X X X X X d) Blood transfusion a) Pregnancy test b) Ultrasound scan X X X X X X X X X MisMalpre- Female carsenta- genital Ectopic riage Term tion at mutila- pregnancy and term tion abortion Miscarriage Safe abortion when indicated and legally permitted a) Treatment of infections b) Management of bleeding (considering Vacuum Aspiration and blood transfusion) c) Management of major injuries (considering laparotomy) a) Medical uterine evacuation for the ﬁrst trimester b) Vacuum Aspiration for the ﬁrst trimester c) Medical uterine evacuation beyond the ﬁrst trimester

a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis a) Diagnosis and treatment of other STI/ Reproductive Tract Infections (RTI): Candida vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis a) Diagnosis of anaemia

Manage- Management of ment of Managemalpre- female ment of Management of miscarriage senta- genital ectopic and abortion tion at mutila- pregnancy term tion

4. Matrix of medical devices in each stage of continuum of care

Table 31. Medical devices for pregnancy at DISTRICT HOSPITAL First assessment Emerand management of Sexually gency Detection (STI) and other assess- Transmitted Infection infections ment Emergency Human Tuprepar- Syphilis Immuno- Malaria Ru- beredness deﬁciency bella culoand Virus (HIV) sis referral

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Basic Medical Examination

Preventive Immunization

a) Screening / diagnosis of Syphilis by laboratory test b) Treatment for Syphilis

a) Diagnosis and treatment for rubella X X X X X

a) Check-up vital signs / measuring weight and height / Anthropometry/ Vaginal examination

a) Screening of HIV b) Prevention Mother To Child Transmission (PMTCT) c) Treatment for HIV (Antiretroviral Therapy (ART)) a) Prophylactic antimalarial (IPT)

a) Emergency care and pre-referral treatment

Family planning Female condoms devices Lubricants Male condoms Medical devices Bandage, elastic, 7.5cmx5m, roll - Disposable Blanket, survival, 220x140cm, non-sterile Bracelet, identiﬁcation (Sizes*) Compress, gauze,sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) Infusion giving set, burette 100-150ml, sterile, single use Infusion giving set, sterile, single use Needles, luer, sterile, single use (Sizes G*) Needles, spinal, sterile, single use (Sizes*) Safety box, for used syringes/needles Stopcock, 3-way, sterile, single use Syringes, auto-disable (AD), (Capacities ml*) Syringe for insulin, sterile, single use Syringe for tuberculin, sterile, single use Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Airway, Guedel, translucent (Sizes*) Bag, urine, collecting, 2000ml Catheter, Foley, sterile, single use (Sizes CH*) X X X X X X X X X X X X X X X X X X X X X X X X

a) Vaccine for Tetanus

General type

Name of devices

X X X X X

2014

X X X X

X X

a) Diagnosis and treatment for tuberculosis X X X X X X X X X

c) Management of malaria

b) Diagnosis of malaria

X X X X X X X b) Iron and folic acid supplementation c) Anthelminthic (deworm) X X X X X X d) Management of severe anaemia (considering blood transfusion) a) Diagnosis of Pre-eclampsia-Eclampsia b) Supplement calcium c) Low-dose aspirin d) Antihypertensive drugs e) Magnesium sulfate f) Fetal monitoring X X X X X X g) Induction of labour X X X X X X X X X X X X Other Iron Deﬁcieninfections cy Anaemia X X X X X X

Detection and management of maternal chronic medical conditions

X X X X X X X X X X X X a) Glucose testing for detection b) Treatment for insulin-dependent diabetic mother a) Diagnosis and laboratory test b) Fetal monitoring X X X X X X X X X X X X X X X X X X X X X X X X a) Provision antibiotics if indicated b) Provision of tocolytics to prolong pregnancy if indicated c) Provision of corticosteroids for prevention of neonatal respiratory distress syndrome d) Provision of magnesium sulfate for neuroprotection of the newborn a) Provision antibiotics if indicated b) Induction of labour a) Diagnosis of breech at term b) External Cephalic Version c) Monitoring progress of labour a) Perineal incision with local anaesthesia b) Identify the need of caesarean section X a) Pregnancy test b) Ultrasound scan X X X c) Laparotomy d) Blood transfusion a) Pregnancy test b) Ultrasound scan X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X a) Treatment of infections b) Management of bleeding (considering Vacuum Aspiration and blood transfusion) c) Management of major injuries (considering laparotomy) a) Medical uterine evacuation for the ﬁrst trimester b) Vacuum Aspiration for the ﬁrst trimester c) Medical uterine evacuation beyond the ﬁrst trimester

Hypertension and pre-eclampsia

X X

AssessDiabe- ment tes of PRM

Management of prelabour rupture of the membranes (PRM)

Preterm

X X

X X X X X

X X

MisMalpre- Female carsenta- genital Ectopic riage Term tion at mutila- pregnancy and term tion abortion

Manage- Management of ment of Managemalpre- female ment of Management of miscarriage senta- genital ectopic and abortion tion at mutila- pregnancy term tion

X X

Miscarriage

Safe abortion when indicated and legally permitted

4. Matrix of medical devices in each stage of continuum of care

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Basic Medical Examination

Preventive Immunization

a) Screening / diagnosis of Syphilis by laboratory test b) Treatment for Syphilis

a) Diagnosis and treatment for rubella X X X

a) Check-up vital signs / measuring weight and height / Anthropometry/ Vaginal examination

a) Screening of HIV b) Prevention Mother To Child Transmission (PMTCT) c) Treatment for HIV (Antiretroviral Therapy (ART)) a) Prophylactic antimalarial (IPT)

a) Emergency care and pre-referral treatment

Catheter, urethral, sterile, single use (Sizes CH*) Prongs, nasal, oxygen, non sterile, single use (Sizes*) Tube, endotracheal, with cuff, sterile, single use (Sizes ID*) Tube, feeding/aspirating, L120cm,catheter tip, sterile, single use (Sizes CH*) Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) Gloves, examination, latex, non-sterile, single use (Sizes*) Gloves, gynaecological, sterile, single use, pair (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) Suture, synthetic, absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Medical devices Cardiotocograph (CTG), with accessories Equipment Doppler, foetal heart rate (FHR) detector, with accessories Medical devices Commodities for medical examination & diagnosis - Equipment (see table 12) Grouping Commodities for emergency preparedness (see table 13) Commodities for labour, delivery & recovery (see table 14) Commodities for surgery & anaesthesia (see table 15) Commodities for inpatient mother and newborn (see table 16) Commodities for intensive care of mother (see table 18) Counselling material Counselling material X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

2014

a) Vaccine for Tetanus

General type

Name of devices

a) Diagnosis and treatment for tuberculosis

c) Management of malaria

b) Diagnosis of malaria

X X X X X X b) Iron and folic acid supplementation c) Anthelminthic (deworm) X X d) Management of severe anaemia (considering blood transfusion) a) Diagnosis of Pre-eclampsia-Eclampsia b) Supplement calcium c) Low-dose aspirin d) Antihypertensive drugs e) Magnesium sulfate f) Fetal monitoring X X X g) Induction of labour X X Other Iron Deﬁcieninfections cy Anaemia X X X X X Hypertension and pre-eclampsia X X X Detection and management of maternal chronic medical conditions X X X X X X X X X AssessDiabe- ment tes of PRM X X a) Glucose testing for detection b) Treatment for insulin-dependent diabetic mother a) Diagnosis and laboratory test b) Fetal monitoring X X X X X X X X X Preterm X X Management of prelabour rupture of the membranes (PRM) X a) Provision antibiotics if indicated b) Provision of tocolytics to prolong pregnancy if indicated c) Provision of corticosteroids for prevention of neonatal respiratory distress syndrome d) Provision of magnesium sulfate for neuroprotection of the newborn a) Provision antibiotics if indicated X X b) Induction of labour a) Diagnosis of breech at term b) External Cephalic Version c) Monitoring progress of labour X X a) Perineal incision with local anaesthesia X X b) Identify the need of caesarean section X a) Pregnancy test b) Ultrasound scan X X X X X c) Laparotomy X X d) Blood transfusion a) Pregnancy test b) Ultrasound scan X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X MisMalpre- Female carsenta- genital Ectopic riage Term tion at mutila- pregnancy and term tion abortion X X X X X X X Miscarriage X X X X X X X X X X X X X X X X X X X X X X X X X X Safe abortion when indicated and legally permitted X a) Treatment of infections b) Management of bleeding (considering Vacuum Aspiration and blood transfusion) c) Management of major injuries (considering laparotomy) a) Medical uterine evacuation for the ﬁrst trimester b) Vacuum Aspiration for the ﬁrst trimester c) Medical uterine evacuation beyond the ﬁrst trimester

X X

X X X X

Manage- Management of ment of Managemalpre- female ment of Management of miscarriage senta- genital ectopic and abortion tion at mutila- pregnancy term tion

4. Matrix of medical devices in each stage of continuum of care

Table 32. Medical devices for childbirth at HOSPITAL Table 32. Medical devices for childbirth at DISTRICT DISTRICT HOSPITAL

First Emergency assessment assessment

Mother care

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Emergency Basic Medipreparedcal Examinaness and tion referral

Childbirth

a) Monitoring progress of labour

a) Check-up vital signs / Vaginal examination

b) Active management of the third stage of labour (AMTSL): Prophylactic use of uterotonics

General type

Name of devices

Blood Bank devices

Anti-A blood group reagent, monoclonal Anti-B blood group reagent, monoclonal Anti-D blood group reagent (Saline/monoclonal) Blood administration set, sterile

2014

Glass slides, 25x75mm Markers, ﬁne point, permanent black, for glassware Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml Wooden or plastic applicator sticks Clinical laboratory devices Container, sample, 50 ml Lancet, blood, safety, sterile (Sizes*) Needle holder, vacuum tubes, sterile Needle, vacuum tube, sterile (Size*) Swab, cotton-tip, tube, sterile Tube, capillary, Ethylene Diamine Tetra-acetic Acid (EDTA) Tube, vacuum, Ethylene Diamine Tetra-acetic Acid (EDTA), sterile (Capacity*) Tube, vacuum, plain/dry, sterile (Capacity*) Blood glucometer, with accessories Hemoglobinometer, with accessories Enzyme Immuno Assay (EIA), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Test strip, pregnancy Test strip, urinalysis (10 parameter) Medical devices Bandage, elastic, 7.5cmx5m, roll - Disposable Blanket, survival, 220x140cm, non-sterile Bracelet, identiﬁcation (Sizes*) Compress, gauze,sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Umbilical clamp, sterile,single use Umbilical tape, 3mmx50m, roll, non-sterile Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) Infusion giving set, burette 100-150ml, sterile, single use X X X X X X X X X X X X X X X X X X X X X X X X X X X X

100

d) Assisted delivery (vacuum extraction) if needed

a) Emergency care and prereferral treatment

c) Spontaneous delivery

PostAssessment partum for complica- haemtions orrhage (PPH)

X b) Fetal monitoring a) Use of uterotonics of choice for the treatment of PPH b) Manual removal of placenta (include use of antibiotics and uterotonics) X X X X X X X X X c) Blood transfusion d) Use of balloon tamponade e) Use of artery embolization f) Hysterectomy a) Use of prophylactic antibiotic b) Caesarean section Caesarean section due maternal/fetal indication c) Use of uterotonics Management of complications of labour and delivery a) Episiotomy a) Repair of ruptured uterus a) Correct uterine inversion Other surgical procedures depending on the complication a) Laparotomy or other abdominal surgical interventions during childbirth a) Craniotomy and craniocentesis Human Immunodeﬁciency Virus (HIV) positive women X X X X X X X a) Screening of HIV b) Prevention Mother To Child Transmission (PMTCT)

a) Diagnosis of complications

4. Matrix of medical devices in each stage of continuum of care

101

Table 32. Medical devices for childbirth at DISTRICT HOSPITAL First Emergency assessment assessment Mother care

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Emergency Basic Medipreparedcal Examinaness and tion referral

Childbirth

a) Monitoring progress of labour

a) Check-up vital signs / Vaginal examination

b) Active management of the third stage of labour (AMTSL): Prophylactic use of uterotonics

General type

Name of devices

Infusion giving set, sterile, single use

Needles, luer, sterile, single use (Sizes G*) Needles, spinal, sterile, single use (Sizes*) Safety box, for used syringes/needles Stopcock, 3-way, sterile, single use

X X X X X X X

X X X X X X

2014

Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Airway, Guedel, translucent (Sizes*) Bag, urine, collecting, 2000ml Catheter, balloon tamponade, post partum haemorrhage Catheter, Foley, sterile, single use (Sizes CH*) Catheter, urethral, sterile, single use (Sizes CH*) Prongs, nasal, oxygen, non sterile, single use (Sizes*) Syringe, feeding, catheter tip, 50ml, sterile, single use Tube, endotracheal, with cuff, sterile, single use (Sizes ID*) Tube, feeding/aspirating, L120cm,catheter tip, sterile, single use (Sizes CH*) Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) Gloves, examination, latex, non-sterile, single use (Sizes*) Gloves, gynaecological, sterile, single use, pair (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) Suture, synthetic, absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Medical devices Equipment Cardiotocograph (CTG), with accessories Doppler, foetal heart rate (FHR) detector, with accessories Non-Pneumatic Anti-Shock Garment (NASG) Medical devices Equipment Grouping Commodities for medical examination & diagnosis (see table 12) Commodities for emergency preparedness (see table 13) Commodities for labour, delivery & recovery (see table 14) Commodities for surgery & anaesthesia (see table 15) Counselling material X

X X X X X X X X X X X X X X X X X X X X X X X X X X X X

X X X X X X X X

Counselling material

102

d) Assisted delivery (vacuum extraction) if needed X

a) Emergency care and prereferral treatment

c) Spontaneous delivery

PostAssessment partum for complica- haemtions orrhage (PPH)

X b) Fetal monitoring X

X X X X X X X X X a) Use of uterotonics of choice for the treatment of PPH X

a) Diagnosis of complications

X X X X X X X X X X X X X X b) Manual removal of placenta (include use of antibiotics and uterotonics) c) Blood transfusion X

X X X X X X

X X X X X X X X X X X X X X X d) Use of balloon tamponade X

X X X X X X X X X X X X X X X

Management of complications of labour and delivery

X X X X X X X X X X X X X X f) Hysterectomy X

X X X X X X X X

e) Use of artery embolization

X X X X X X X X X X X X X X X

Caesarean section due maternal/fetal indication

X X X X X X X X

a) Use of prophylactic antibiotic

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

b) Caesarean section

c) Use of uterotonics

a) Episiotomy

Other surgical procedures depending on the complication

a) Repair of ruptured uterus

a) Correct uterine inversion

a) Laparotomy or other abdominal surgical interventions during childbirth X

a) Craniotomy and craniocentesis

a) Screening of HIV

Human Immunodeﬁciency Virus (HIV) positive women

b) Prevention Mother To Child Transmission (PMTCT)

4. Matrix of medical devices in each stage of continuum of care

103

Table 33. Medical devices for post-natal at Table 33. Medical devices for post-natal mother atmother DISTRICT HOSPITAL DISTRICT HOSPITAL First assessment

Emergency assessment

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Support for Basic Medical breast feedExamination ing b) Screening for cervix and breast cancer

Emergency preparedness and referral

a) Management of mastitis / breast abscess

General type

Name of devices

Blood Bank devices

Anti-A blood group reagent, monoclonal Anti-B blood group reagent, monoclonal Anti-D blood group reagent (Saline/monoclonal) Blood administration set, sterile

2014

Glass slides, 25x75mm Markers, ﬁne point, permanent black, for glassware Pasteur pipettes with integral bulb, disposable, plastic nonsterile, 3 ml Wooden or plastic applicator sticks Clinical laboratory devices Container, sample, 50 ml Lancet, blood, safety, sterile (Sizes*) Needle holder, vacuum tubes, sterile Needle, vacuum tube, sterile (Size*) Swab, cotton-tip, tube, sterile Tube, capillary, Ethylene Diamine Tetra-acetic Acid (EDTA) Tube, vacuum, Ethylene Diamine Tetra-acetic Acid (EDTA), sterile (Capacity*) Hemoglobinometer, with accessories Cytology stain, kit Enzyme Immuno Assay (EIA), Human Immunodeﬁciency Virus (HIV), kit Nucleic Acid Test (NAT), Human Papilloma Virus (HPV), kit Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit Test strip, urinalysis (10 parameter) Test strip, vaginal infection, pH Medical devices Bandage, elastic, 7.5cmx5m, roll - Disposable Blanket, survival, 220x140cm, non-sterile Compress, gauze,sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) Infusion giving set, sterile, single use Needles, luer, sterile, single use (Sizes G*) Needles, spinal, sterile, single use (Sizes*) X X X X X X X X X X X X X X X X

104

a) Emergency care and prereferral treatment

a) Check-up vital signs

Anaemia

Prevention and management of post partum bleeding

X X X b) Diagnosis of anaemia c) Iron supplementation d) Anthelminthic (deworm) X X X X X X X X X X e) Management of severe anaemia (considering blood transfusion) X X X X X X X a) Diagnosis and treatment for HIV (Antiretroviral Therapy (ART)) X Human Immunodeﬁcien- Malaria cy Virus (HIV) a) Diagnosis and management of malaria X X a) Diagnosis and management of postpartum endometritis and salpingitis X a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis a) Postcaesarean care Other infection b) Diagnosis of pelvic abscess, peritonitis or other postoperative complication X Assessment Surgical of postopprocedure erative care c) Surgical management of pelvic abscess, peritonitis or other postoperative complication with laparotomy

a) Management of post partum bleeding

Detection and management of post Postoperative care partum infection

4. Matrix of medical devices in each stage of continuum of care

105

Table 33. Medical devices for post-natal mother at DISTRICT HOSPITAL First assessment Emergency assessment

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Support for Basic Medical breast feedExamination ing b) Screening for cervix and breast cancer

Emergency preparedness and referral

a) Management of mastitis / breast abscess

General type

Name of devices

Safety box, for used syringes/needles

Stopcock, 3-way, sterile, single use Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) X X

2014

Airway, Guedel, translucent (Sizes*) Bag, urine, collecting, 2000ml Catheter, Foley, sterile, single use (Sizes CH*) Prongs, nasal, oxygen, non sterile, single use (Sizes*) Tube, endotracheal, with cuff, sterile, single use (Sizes ID*) Tube, feeding/aspirating, L120cm,catheter tip, sterile, single use (Sizes CH*) Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) Gloves, examination, latex, non-sterile, single use (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) Suture, synthetic, absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Medical devices Equipment Medical devices Equipment Grouping Breastpump, manual, with accessories Colposcope with biopsy set Commodities for medical examination & diagnosis (see table 12) Commodities for emergency preparedness (see table 13) Commodities for labour, delivery & recovery (see table 14) Commodities for surgery & anaesthesia (see table 15) Commodities for inpatient mother and newborn (see table 16) Counselling material Counselling material X X X X X X X X X

106

a) Emergency care and prereferral treatment X

a) Check-up vital signs

X X X X X X X X

X X X X X

X X

Anaemia

X b) Diagnosis of anaemia c) Iron supplementation d) Anthelminthic (deworm) X

a) Management of post partum bleeding

Prevention and management of post partum bleeding

X X X e) Management of severe anaemia (considering blood transfusion)

X X X

X X X X X X

Human Immunodeﬁcien- Malaria cy Virus (HIV)

Detection and management of post Postoperative care partum infection

X X X X X X

a) Diagnosis and treatment for HIV (Antiretroviral Therapy (ART))

X X X X X X

X X X X X X X

a) Diagnosis and management of malaria

Other infection

X X X X X X X X X X X X X X X X X X

a) Diagnosis and management of postpartum endometritis and salpingitis a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis a) Postcaesarean care

Assessment Surgical of postopprocedure erative care

b) Diagnosis of pelvic abscess, peritonitis or other postoperative complication

c) Surgical management of pelvic abscess, peritonitis or other postoperative complication with laparotomy

4. Matrix of medical devices in each stage of continuum of care

107

Table 34. Medical devices for post-natal baby Table 34. Medical devices for post-natal baby (newborn) at DISTRICT HOSPITAL (newborn) at DISTRICT HOSPITAL Childbirth: Essential newborn care

Detection and management of congenital infections

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Immediate care at birth

Emergency support b) Management of brain injury and intracranial haemorrhage (ICH)

Routine care

Congenital infections

g) Prophylactic antibiotics for neonates at risk of infection

a) Dry baby thoroughly on mother's chest skin to skin and cover

c) Clamp and cut cord / Check cord vessels / Check for bleeding and signs of cord infection d) Prevent hypothermia when skin to skin is not possible e) Support breastfeeding within the ﬁrst hour

General type Name of devices

Blood Bank Anti-A blood group reagent, monoclonal devices Anti-B blood group reagent, monoclonal Anti-D blood group reagent (Saline/ monoclonal)

2014

Blood administration set, sterile Glass slides, 25x75mm Markers, ﬁne point, permanent black, for glassware Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml Wooden or plastic applicator sticks

Clinical laboratory devices

Container, sample, 50 ml Lancet, blood, safety, sterile (Sizes*) Needle holder, vacuum tubes, sterile Needle, vacuum tube, sterile (Size*) Paper, dry blood spot Swab, cotton-tip, tube, sterile Tube, blood collection, newborn cord blood, sterile Tube, capillary, Ethylene Diamine Tetra-acetic Acid (EDTA) Tube, capillary, heparin, Tube, vacuum, Ethylene Diamine Tetra-acetic Acid (EDTA), sterile (Capacity*) Tube, vacuum, plain/dry, sterile (Capacity*) Analyzer, blood gas Blood glucometer, with accessories Hemoglobinometer, with accessories Enzyme Immuno Assay (EIA), Human Immunodeﬁciency Virus (HIV), kit Haemoglobin colour scale (reﬁll kit) Haemoglobin colour scale (starter kit) Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Rapid Plasma Reagin (RPR), syphilis, kit Treponema Pallidum Haemagglutination Assay (TPHA), syphilis, kit Test strip, urinalysis (10 parameter) X

X X X

X X X X

108

b) Prophylactic treatment for congenital syphilis c) Screening of HIV (Dried Blood Spot (DBS)) d) Prophylactic treatment for HIV (Antiretroviral Therapy (ART))

a) Full clinical examination / Check vital signs / measuring weight b) Thermal Care

a) Diagnosis of congenital syphilis

f) Prophylaxis for eye infection

a) Basic neonatal resuscitation

c) Breastfeeding support d) Vitamin K prophylaxis and Immunization e) Cord care

b) Assess breathing

X X

a) Detection and management of cord infection

Cord in- Jaunfec- dice tion

Detection and management of common infections, illness and complications in the neonate and young infant

X b) Management of jaundice

a) Diagnosis of jaundice

X X X Anaemia b) Management of anaemia

a) Diagnosis of anaemia

X X

X a) Diagnosis of pneumonia b) Management of pneumonia and its complications a) Detection and management of diarrhoea

c) Pre-referral treatment for severe anaemia (blood transfusion)

X X

NeSepticaecrotizRespiratory Pneu- Diar- mia and/ Aping Distress Synmonia rhoea or menin- noea endrome (RDS) gitis terocolitis

X X X X X X X X X a) Prevention of Apnoea

X X X X

X X X

a) Diagnosis of septicaemia and/or meningitis: Blood Culture, Lumbar Puncture, Urine Analysis b) Management of septicaemia and/or meningitis and its complications

a) Diagnosis of RDS and provision of prophylaxis surfactant b) Apply Continuous Positive Airway Pressure (CPAP) with nasal cannula or face mask c) Ventilatory support and oxygen therapy including mechanical ventilation and CPAP a) Diagnosis of necrotizing enterocolitis

b) Management of necrotizing enterocolitis a) Monitor blood glucose and management of hypoglycaemia b) Monitor nutrition and provision of tube feeding support c) Provision of intravenous therapy

Supportive care

d) Monitor temperature and management of hypothermia (Kangaroo mother care) e) Monitor oxygenation and management of hypoxia a) Detection of emergency signs, emergency care and pre-referral treatment b) Advanced resuscitation

Triage, emergency preparedness and referral

Speciﬁc interventions for Supportive care for all sick Further assessment for all small, low weight birth neonate and sick young young infant and pre-term babies infant

Clinical visit

a) Full clinical examination / check vital signs / measuring weight / check haemoglobin b) Provision of vaccines (Diphtheria Pertussis Tetanus (DPT) + Haemophilus Inﬂuenzae type B (HIB), Oral Polio Vaccine (OPV), Hepatitis B) c) Breastfeeding support and replacement feeding if necessary d) Monitoring growth and development

Optional interventions

a) Male circumcision

4. Matrix of medical devices in each stage of continuum of care

109

Table 34. Medical devices for post-natal baby (newborn) at DISTRICT HOSPITAL Childbirth: Essential newborn care

Detection and management of congenital infections

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Immediate care at birth

Emergency support b) Management of brain injury and intracranial haemorrhage (ICH)

Routine care

Congenital infections

g) Prophylactic antibiotics for neonates at risk of infection

a) Dry baby thoroughly on mother's chest skin to skin and cover

c) Clamp and cut cord / Check cord vessels / Check for bleeding and signs of cord infection d) Prevent hypothermia when skin to skin is not possible e) Support breastfeeding within the ﬁrst hour

General type Name of devices

Medical devices Disposable

Bandage, elastic, 7.5cmx5m, roll Blanket, survival, 220x140cm, non-sterile Bracelet, identiﬁcation (Sizes*)

X X X X

2014

Compress, gauze, sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Umbilical clamp, sterile, single use Umbilical tape, 3mmx50m, roll, non-sterile Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) Catheter, Intra Venous (IV) umbilical vein, sterile, single use Infusion giving set, burette 100-150ml, sterile, single use Needles, luer, sterile, single use (Sizes G*) Needles, scalp vein, sterile, single use (Sizes G*) Needles, spinal, sterile, single use (Sizes*) Safety box, for used syringes/needles Stopcock, 3-way, sterile, single use Syringes, auto-disable (AD), (Capacities ml*) Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Airway, Guedel, translucent (Sizes*) Collector, urine, adhesive, 10-100ml Prongs, nasal, oxygen, non sterile, single use (Sizes*) Syringe, feeding, catheter tip, 50ml, sterile, single use Syringe, feeding, luer tip, 50ml, sterile, single use Tube, endotracheal, without cuff, sterile, single use (Sizes ID*) Tube, feeding/aspirating, L120cm,catheter tip, sterile, single use (Sizes CH*) Tube, feeding, L40cm, luer tip, sterile, single use (Sizes CH*) Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) Gloves, examination, latex, non-sterile, single use (Sizes*)

X X X X

X X X X X X X X

X X X X X X X X X X X X X

X X X X X X X X X X X X X X X X X X X X

110

b) Prophylactic treatment for congenital syphilis c) Screening of HIV (Dried Blood Spot (DBS)) d) Prophylactic treatment for HIV (Antiretroviral Therapy (ART))

a) Full clinical examination / Check vital signs / measuring weight b) Thermal Care

a) Diagnosis of congenital syphilis

f) Prophylaxis for eye infection

a) Basic neonatal resuscitation

c) Breastfeeding support d) Vitamin K prophylaxis and Immunization e) Cord care

b) Assess breathing

Cord in- Jaunfec- dice tion

X X X a) Diagnosis of jaundice

X X X

a) Detection and management of cord infection

Detection and management of common infections, illness and complications in the neonate and young infant

X X X a) Diagnosis of anaemia

X X

b) Management of jaundice

Anaemia

X X

b) Management of anaemia c) Pre-referral treatment for severe anaemia (blood transfusion) a) Diagnosis of pneumonia

X X

X X X X X X X X X X b) Management of pneumonia and its complications a) Detection and management of diarrhoea

X X

NeSepticaecrotizRespiratory Pneu- Diar- mia and/ Aping Distress Synmonia rhoea or menin- noea endrome (RDS) gitis terocolitis

X X X X X X X X X X X X X X X X X X X X

X X X X X X X X X X X X a) Prevention of Apnoea

X X X X X X X X X X X X

X X X X X X X X X X

X X X X X X X X X X X X X X X X X X X X

X X X X X X X X X X X X

X X X X X X X X X X X

a) Diagnosis of septicaemia and/or meningitis: Blood Culture, Lumbar Puncture, Urine Analysis b) Management of septicaemia and/or meningitis and its complications

Speciﬁc interventions for Supportive care for all sick Further assessment for all small, low weight birth neonate and sick young young infant and pre-term babies infant

X X X X X X X X X X X X

X X X X X X X X X

X X X X X X X X X X X X X X

X X X X X X X X X X X X X X X X X X

X X X X X X X X X X

X X

Supportive care

b) Management of necrotizing enterocolitis a) Monitor blood glucose and management of hypoglycaemia b) Monitor nutrition and provision of tube feeding support c) Provision of intravenous therapy

Triage, emergency preparedness and referral

Clinical visit

Optional interventions

a) Male circumcision

4. Matrix of medical devices in each stage of continuum of care

111

Table 34. Medical devices for post-natal baby (newborn) at DISTRICT HOSPITAL Childbirth: Essential newborn care

Detection and management of congenital infections

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Immediate care at birth

Emergency support b) Management of brain injury and intracranial haemorrhage (ICH)

Routine care

Congenital infections

g) Prophylactic antibiotics for neonates at risk of infection

a) Dry baby thoroughly on mother's chest skin to skin and cover

c) Clamp and cut cord / Check cord vessels / Check for bleeding and signs of cord infection d) Prevent hypothermia when skin to skin is not possible e) Support breastfeeding within the ﬁrst hour

General type Name of devices

Gloves, surgical, sterile, single use, pair (Sizes*) Suture, synthetic, absorbable (Sizes USP/ DEC*) with needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Apnoea monitor

2014

Medical devices Equipment

Auditory, function screening devices, newborn Bilirubinometer Breastpump, manual, with accessories Phototherapy light, mobile, with accessories Commodities for medical examination & diagnosis (see table 12) Commodities for emergency preparedness (see table 13)

X X

X X X X X X

Medical devices Equipment Grouping

Commodities for labour, delivery & recovery (see table 14) Commodities for surgery & anaesthesia (see table 15) Commodities for inpatient mother and newborn (see table 16) Commodities for intensive care of newborn (see table 17)

X X X X X X X X X X X X

Counselling Counselling material material

112

b) Prophylactic treatment for congenital syphilis c) Screening of HIV (Dried Blood Spot (DBS)) d) Prophylactic treatment for HIV (Antiretroviral Therapy (ART))

a) Full clinical examination / Check vital signs / measuring weight b) Thermal Care

a) Diagnosis of congenital syphilis

f) Prophylaxis for eye infection

a) Basic neonatal resuscitation

c) Breastfeeding support d) Vitamin K prophylaxis and Immunization e) Cord care

b) Assess breathing

X X

X X X X X X a) a) Diagnosis Diagnosis of of jaundice jaundice b) b) Management Management of of jaundice jaundice a) a) Diagnosis Diagnosis of of anaemia anaemia b) b) Management Management of of anaemia anaemia c) Pre-referral treatment c) Pre-referral treatment for for severe severe anaemia anaemia (blood (blood transfusion) transfusion) a) a) Diagnosis Diagnosis of of pneumonia pneumonia

a) a) Detection Detection and and management management of of cord cord infection infection

Cord Cord in- JaunJauninAnaemia fec- dice dice Anaemia fection tion

X X X X X X X X X X X X X X PneuPneumonia monia

X X X X X X X X X X X X X X

Detectionand andmanagement managementof ofcommon common Detection infections,illness illnessand andcomplications complicationsin inthe the infections, neonateand andyoung younginfant infant neonate

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X a) a) Prevention Prevention of of Apnoea Apnoea

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X a) a) Male Male circumcision circumcision

b) b) Management Management of of pneumonia pneumonia and and its its complications complications a) a) Detection Detection and and management management of of diarrhoea diarrhoea a) a) Diagnosis Diagnosis of of septicaemia septicaemia and/or and/or meningitis: meningitis: Blood Blood Culture, Culture, Lumbar Lumbar Puncture, Puncture, Urine Urine Analysis Analysis b) b) Management Management of of septicaemia septicaemia and/or and/or meningitis meningitis and and its its complications complications

a) a) Diagnosis Diagnosis of of RDS RDS and and provision provision of of prophylaxis prophylaxis surfactant surfactant b) b)Apply ApplyContinuous ContinuousPositive PositiveAirway AirwayPresPressure sure(CPAP) (CPAP)with withnasal nasalcannula cannulaor orface facemask mask c) Ventilatory support and oxygen therapy c) Ventilatory support and oxygen therapy including including mechanical mechanical ventilation ventilation and and CPAP CPAP a) a) Diagnosis Diagnosis of of necrotizing necrotizing enterocolitis enterocolitis b) b) Management Management of of necrotizing necrotizing enterocolitis enterocolitis a) Monitor blood glucose a) Monitor blood glucose and and managemanagement ment of of hypoglycaemia hypoglycaemia b) Monitor nutrition and provision b) Monitor nutrition and provision of of tube tube feeding feeding support support c) c) Provision Provision of of intravenous intravenous therapy therapy d) d) Monitor Monitor temperature temperature and and management management of of hypothermia hypothermia (Kangaroo (Kangaroo mother mother care) care) e) e) Monitor Monitor oxygenation oxygenation and and management management of of hypoxia hypoxia a) a) Detection Detection of of emergency emergency signs, signs, emeremergency gency care care and and pre-referral pre-referral treatment treatment

NeNeSepticaecrotizSepticaeRespiratory crotizRespiratory Diar- mia miaand/ and/ ApAping DiarSupportivecare care Distress Syn- ing Supportive rhoeaor ormeninmenin-noea noea Distress Syn- enenrhoea drome(RDS) (RDS) drome gitis terogitis terocolitis colitis

Speciﬁ cinterventions interventionsfor for Supportive Supportivecare carefor forall allsick sick Speciﬁ c Further assessment for all small,low lowweight weightbirth birth neonateand andsick sickyoung young Further assessment for all small, neonate younginfant infant young andpre-term pre-termbabies babies infant and infant

X X

Triage, Triage, emeremergency gency preparpreparedness edness and and referral referral

X X

Clinicalvisit visit Clinical

X X

X X X X

b) b) Advanced Advanced resuscitation resuscitation a) Full a) Full clinical clinical examination examination / / check check vital vital signs signs / / measuring measuring weight weight / / check check haemoglobin haemoglobin b) b) Provision Provision of of vaccines vaccines (Diphtheria (Diphtheria Pertussis Pertussis Tetanus Tetanus (DPT) (DPT) + + Haemophilus Haemophilus Inﬂ uenzae Inﬂ uenzae type type B B (HIB), (HIB), Oral Oral Polio Polio Vaccine Vaccine (OPV), (OPV), Hepatitis Hepatitis B) B) c) c) Breastfeeding Breastfeeding support support and and replacement replacement feeding feeding if if necessary necessary d) d) Monitoring Monitoring growth growth and and development development

OpOptional tional interintervenventions tions

4. Matrix of medical devices in each stage of continuum of care

113

Table 35. Medical devices for infancy and at Table 35. Medical devices for infancy and childhood DISTRICT HOSPITAL childhood at DISTRICT HOSPITAL

Essential care for monitoring growth and early childhood development

Detection and management of common infections, illness and complications in infancy and childhood

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Routine care

Severe Acute Malnutrition (SAM)

Anaemia

Wheeze Pneu- (Asthma, monia Bronchiolitis)

c) Pre-referral treatment for severe anaemia (Blood transfusion) a) Differential diagnosis for pneumonia b) Management of pneumonia and its complications a) Diagnosis of condition with wheeze X X X X X X X X X X X X X X

a) Full clinical examination / check vital signs / measuring weight

Blood Bank Anti-A blood group reagent, monoclonal devices Anti-B blood group reagent, monoclonal Anti-D blood group reagent (Saline/ monoclonal) Blood administration set, sterile Glass slides, 25x75mm Markers, ﬁne point, permanent black, for glassware Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml Wooden or plastic applicator sticks

2014

Clinical Container, sample, 50 ml laboratory Lancet, blood, safety, sterile (Sizes*) devices Needle holder, vacuum tubes, sterile Needle, vacuum tube, sterile (Size*) Paper, dry blood spot Swab, cotton-tip, tube, sterile Tube, capillary, Ethylene Diamine Tetra-acetic Acid (EDTA) Tube, capillary, heparin, Tube, vacuum, Ethylene Diamine Tetra-acetic Acid (EDTA), sterile (Capacity*) Tube, vacuum, plain/dry, sterile (Capacity*) Analyzer, blood gas Blood glucometer, with accessories Hemoglobinometer, with accessories Enzyme Immuno Assay (EIA), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), Human Immunodeﬁciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit Test strip, urinalysis (10 parameter)

b) Feeding support

Name of devices

a) Diagnosis of SAM

General type

X X

Medical Bandage, elastic, 7.5cmx5m, roll devices Disposable Blanket, survival, 220x140cm, non-sterile Bracelet, identiﬁcation (Sizes*) Compress, gauze, sterile & non-sterile, single use Cotton wool, 500g, roll, non-sterile Tape, medical, roll (Sizes*) Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) Catheter, Intra Venous (IV) umbilical vein, sterile, single use X X

X X X X

X X X X X X X X

X X X

114

b) Management of condition with wheeze

d) Early childhood development monitoring e) Breastfeeding support and replacement feeding if necessary

c) Pre-referral treatment for SAM

g) Deworming (Mebendazole)

f) Vitamin A supplementation

b) Management of anaemia

a) Diagnosis of anaemia

b) Provision of vaccines

c) Growth monitoring

X X

a) Diagnosis of tuberculosis b) Management of tuberculosis

Im- Eye Ear Mouth Skin ChickSepticae- Ma- Den- Mea- Human Tuber- Diar- mia munodeﬁininand/or gue infec- en culosis rhoea meningitis laria fever sles ciency Virus fec- fec- infec(HIV) tion tion tion tion pox

X X X X X X X X X

X X X X a) Diagnosis and management of dengue fever a) Diagnosis and management of measles X X X X X X X a) Diagnosis of HIV b) Treatment for HIV (Antiretroviral Therapy (ART)) c) Management of other opportunistic infections in HIV a) Detection and management of eye infection / conjunctivitis a) Detection and management of ear infection a) Detection and management of mouth infection / thrush a) Diagnosis and management of skin infections a) Detection and management of chicken pox X X a) Management of hypoglycaemia b) Tube feeding support c) Intravenous therapy d) Management of hypothermia X e) Management of hypoxia f) Pain control X a) Detection of emergency signs, emergency care and pre-referral treatment b) Advanced resuscitation Supportive care

X a) Male circumcision

a) Differential diagnosis and management of diarrhoea and dysentery a) Diagnosis of septicaemia and/or meningitis : Blood Culture, Lumbar Puncture, Urine Analysis b) Management of septicaemia and/ or meningitis and its complications a) Diagnosis and management of malaria

Further assessSupportive care for all sick infant ment for and child all infant and child

Triage, emergency Optional prepared- intervenness and tions referral

4. Matrix of medical devices in each stage of continuum of care

115

Table 35. Medical devices for infancy and childhood at DISTRICT HOSPITAL

Essential care for monitoring growth and early childhood development

Detection and management of common infections, illness and complications in infancy and childhood

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Routine care

Severe Acute Malnutrition (SAM)

Anaemia

Wheeze Pneu- (Asthma, monia Bronchiolitis)

c) Pre-referral treatment for severe anaemia (Blood transfusion) a) Differential diagnosis for pneumonia b) Management of pneumonia and its complications a) Diagnosis of condition with wheeze

a) Full clinical examination / check vital signs / measuring weight

Infusion giving set, burette 100-150ml, sterile, single use Needles, luer, sterile, single use (Sizes G*) Needles, scalp vein, sterile, single use (Sizes G*) Needles, spinal, sterile, single use (Sizes*) Safety box, for used syringes/needles Stopcock, 3-way, sterile, single use Syringes, auto-disable (AD), (Capacities ml*) Syringe for tuberculin, sterile, single use Syringes, luer, sterile, single use (Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Airway, Guedel, translucent (Sizes*) Collector, urine, adhesive, 10-100ml Prongs, nasal, oxygen, non sterile, single use (Sizes*) Syringe, feeding, catheter tip, 50ml, sterile, single use Syringe, feeding, luer tip, 50ml, sterile, single use Tube, endotracheal, without cuff, sterile, single use (Sizes ID*) Tube, feeding/aspirating, L120cm,catheter tip, sterile, single use (Sizes CH*) Tube, feeding, L40cm, luer tip, sterile, single use (Sizes CH*) Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) Gloves, examination, latex, non-sterile, single X use (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) Suture, synthetic, absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/ DEC*) with needle (Shapes* and sizes*), sterile, single use

b) Feeding support

Name of devices

a) Diagnosis of SAM

General type

X X X X X X X X X X X

X X X X X X

X X X X

X X X X X

X X X X X X X

2014

X X X X X X X X X X X

X X

X X X

X X X X X X X X X X X X

Medical Auditory, function screening devices, newborn devices Equipment Breastpump, manual, with accessories Commodities for medical examination & diagnosis (see table 12) Commodities for emergency preparedness Medical (see table 13) devices Commodities for surgery & anaesthesia (see Equipment table 14)

X X X X X X X X X X X X X X X X X X X X X

Grouping

Commodities for inpatient child (see table 17) Commodities for intensive care of child (see table 18)

X X X X X X X X X

X X

116

Counselling Counselling material material

b) Management of condition with wheeze

d) Early childhood development monitoring e) Breastfeeding support and replacement feeding if necessary

c) Pre-referral treatment for SAM

g) Deworming (Mebendazole)

f) Vitamin A supplementation

b) Management of anaemia

a) Diagnosis of anaemia

b) Provision of vaccines

c) Growth monitoring

X X

a) Diagnosis of tuberculosis

X X X X X X X X X X

b) Management of tuberculosis

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X a) Diagnosis and management of dengue fever a) Diagnosis and management of measles a) Diagnosis of HIV

X X X X X X X X X X X X X X X X b) Treatment for HIV (Antiretroviral Therapy (ART)) c) Management of other opportunistic infections in HIV a) Detection and management of eye infection / conjunctivitis a) Detection and management of ear infection a) Detection and management of mouth infection / thrush

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X b) Tube feeding support

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X f) Pain control

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

a) Diagnosis and management of skin infections a) Detection and management of chicken pox a) Management of hypoglycaemia

c) Intravenous therapy d) Management of hypothermia e) Management of hypoxia

Supportive care

Further assessSupportive care for all sick infant ment for and child all infant and child

Triage, emergency Optional prepared- intervenness and tions referral

a) Detection of emergency signs, emergency care and pre-referral treatment b) Advanced resuscitation

a) Male circumcision

4. Matrix of medical devices in each stage of continuum of care

117

4.2 Devices and interventions in specialized care Other optional devices, which are considered to be useful in specialized hospitals and optional surgery procedures are not covered by the main matrix. The use of such devices and procedures in low-resource settings should be assessed according to the principle of health technology assessment in future work. In specialized hospitals, it would be better to consider the use of procedures and devices such as a laparoscopy system and proctoscope and anoscope system. Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health The current document does not include guidance on quantification for the medical devices, sets and kits covered in the list. This will depend on many different factors within a health-care facility, and quantification activities should be led locally. The quantity of medical devices needed per intervention will be based on assessments at the national level and will systematically take the following factors into consideration:

• • •

health system – policies and protocols; health facility – capacity, activities and organization; existing replenishment/inventory system for medical devices – renewable/consumable and equipment.

Table 35. Medical devices for specialized care Name Laparoscope system

Link http://www.who.int/surgery/ publications/scdh_manual/ en/

Description An assembly of sterile laparoscopes and their accessories used for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). The insertion is typically through an incision(s) made in the abdominal wall (routinely just below the umbilicus or in the near vicinity). This system is mostly used for gynaecological procedures involving the evaluation/treatment of abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, or for female sterilization. A complete mammographic radiographic system includes an x-ray generator, an x-ray tube and gantry, and a recording medium. The x-ray generator modiﬁes incoming voltage to provide the x-ray tube with the power necessary to produce an x-ray beam. They also include a “paddle” for compression and placement of the breasts during imaging. This technology is effective in arthrography, bronchography, gastrointestinal and biliary tree studies, hysterosalpingography, intravenous and retrograde pyelography, myelography, and sialography. Other applications include locating ingested foreign materials; localizing lesions for needle aspiration or biopsy; highlighting congenital anatomic abnormalities; diagnosing congestive heart failure; and evaluating chest pain.

2014

Mammography unit

http://www.who.int/ medical_devices/innovation/ mammography.pdf

Radiographic, Fluoroscopic system

http://www.who.int/ medical_devices/innovation/ radiographic_ﬂuorescence. pdf

Radiotherapy Systems

http://www.who.int/ medical_devices/innovation/ radiotherapy_system.pdf http://www.who.int/ medical_devices/innovation/ radiotherapy_planning.pdf

Linear accelerators (linacs) and cobalt radiotherapy units are used in external-beam radiation therapy to treat cancer. Cobalt units and low-energy linacs are used primarily to treat bone cancer and tumors of the head, neck, and breast. Devices that consist of an x-ray subsystem, a gantry, a patient table, and a controlling computer. These scanners are used for a wide variety of diagnostic procedures, including spine and head injuries, lesions, and abdominal and pelvic malignancies; to examine the cerebral ventricles, the chest wall, and the large blood vessels; and to assess musculoskeletal degeneration. An MRI unit consists of a magnet, shimming magnets, an RF transmitter/receiver system with an antenna coil, a gradient system, a patient table, a computer, display monitors, and an operator console. It is primarily used to identify diseases of the central nervous system, brain, and spine and to detect musculoskeletal disorders. It is also used to view cartilage, tendons, and ligaments. MRI can be used to help diagnose infectious diseases; to detect metastatic liver disease; to display heart-wall structure; to stage prostate, bladder, and uterine cancer; to evaluate kidney transplant viability; and to study marrow diseases.

Scanning System, Computed Tomography

http://www.who.int/ medical_devices/innovation/ scanning_CT.pdf

Scanning System, Magnetic Resonance Imaging

http://www.who.int/ medical_devices/innovation/ scanning_MRI_full_body.pdf

118

4.Matrix of medical devices in each stage of continuum of care

4.3 Innovative health technologies Since 2011 the Essential Health Technologies Department and later the Essential Medicines and Health Products department of WHO has published three editions of the Compendium of innovative health technologies for lowresource settings to distribute information about alternative, new or adapted technologies designed to fill existing gaps in the availability of health products to vulnerable populations, especially with regard to innovative medical devices for newborn and children’s health, such as bedside newborn phototherapy, compact portable ultrasound, fetal heart rate monitoring, infant warming, and oxygen concentrator-driven bubble continuous positive airway pressure. The choice of technology depends on the capabilities of the medical unit and the intention of use. For example, to maintain the proper temperature in a baby, a traditional incubator can be used if there is a source of electricity; if not, the Compendium describes an innovative infant warmer that does not require a constant supply of electricity.

Table 36. Innovative health technologies for reproductive, maternal, newborn and child health Table 36. Innovative health technologies for reproductive, maternal, newborn and child health

Name Bedside newborn phototherapy

Link http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2013_1.pdf?ua=1

Description Bedside Newborn Phototherapy is a device designed to treat jaundice in the mother’s room in rural clinics. The double-sided, high-power LED lighting cures the most severe cases of jaundice and dramatically reduces treatment time.

Birthing simulator for training

http://www.who.int/ medical_devices/innovation/ compendium_other2012_2. pdf?ua=1

The birthing simulator enables the instructor to create very compelling simulations of normal to more complex birthing scenarios, and is particularly suitable for training control of post-partum haemorrhage.

Compact portable ultrasound

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2013_2.pdf?ua=1

This device provides a non-invasive look inside the body for immediate visual validation of what a clinician can feel or hear. The device is small and lightweight, which makes it easy to carry and its battery capacity provides over one hour of scanning on a single charge, giving it enough power for a full day’s worth of patient exams.

Fetal heart rate monitor

http://www.who.int/ medical_devices/innovation/ compendium_med_dev2011_1. pdf?ua=1

Using advanced Doppler ultrasound technology, the monitor detects and measures the fetal heart rate. This vital indicator of fetal stress allows rural healthcare workers to make life-saving decisions during childbirth. Destined for use in low resource settings, its design focuses on simplicity of use, durability and electrical power independence.

Infant radiant warmer

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2013_6.pdf?ua=1

The device consists of a biocompatible bed on which to place the infant, and an overhead heater that delivers radiant heat. A skin temperature probe monitors infant temperature. Heat output can be controlled manually or through baby mode (feedback mode) for thermoregulation. Visual and audio alarms are present for safety. An APGAR timer helps to efﬁciently take APGAR scores post-delivery. The infant warmer works without a constant supply of electricity. It has no moving parts, and is safe and easy to use. It consists of three parts - a sleeping bag to place the baby, a pouch of phase change material and an electric heater. The pouch is heated for 30 mins in the heater (second version uses boiling water instead of electricity to heat) and then placed in the sleeping bag. It maintains the WHO recommended temperature of 37 deg C for 4-6 hours, after which it can be reheated. The device emits light through an array of high-powered light emitting diodes (LEDs). These LEDs have been speciﬁcally selected to emit a narrow wavelength of blue light (dominant wavelength 458nm) that maximises the rate of bilirubin breakdown. The arrangement of the LEDs along with the optics have been designed to provide uniformity of light on the patient, while minimizing unwanted spill and glare outside the treatment surface.

Infant warmer (neonatal sleeping bag warmer)

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2013_7.pdf?ua=1

LED phototherapy for neonatal jaundice

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2013_9.pdf?ua=1

119

Table 36. Innovative health technologies for reproductive, maternal, newborn and child health

Name Newborn simulator for resuscitation training

Link http://www.who.int/ medical_devices/innovation/ compendium_other2011_1. pdf?ua=1

Description The proposed solution is a highly realistic and affordable newborn simulator. The baby’s status can be simulated as desired to facilitate role playing in relevant scenarios covering basic newborn care as well as standard resuscitation measures. The simulator is available with therapeutic tools.

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Non-invasive hypothermia indicator for newborns

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2012_11.pdf?ua=1

The hypothermia indicator is a 12mm diameter disc with a black ‘face’ with two small white “dots” on one side, the other side has a self-adhesive facility. This device comes in a strip of 5 units. Liquid crystal technology provides function for it to perform reliably and accurately within an operating tolerance of +/- 0.5 degree Celsius.

Non-pneumatic anti-chock garment

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2011_5.pdf?ua=1

For women suffering from uncontrollable PPH, a method to control the bleeding, reverse the shock, and stabilize the patient for safe transport to a comprehensive obstetric care facility could be lifesaving. One method to manage PPH is the use of a non-pneumatic anti-shock garment (NASG).

Non-surgical male circumcision device

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2012_13.pdf?ua=1

The device consists of an Inner Ring, Elastic Ring and Applicator. The device applies controlled radial elastic pressure to compress the foreskin and cut off circulation. The distal foreskin becomes necrotic and is removed after 5-7 days. The procedure takes less than 5 minutes, is bloodless, requires no injected anaesthesia, no sutures, no sterile settings.

2014

Oxygen concentratordriven bubble CPAP

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2013_14.pdf?ua=1

This device generates and delivers a safe, easily controllable mixture of humidiﬁed oxygen and air for CPAP treatment. It is driven by an oxygen concentrator that generates oxygen from atmospheric air, eliminating the need for expensive cylinders of compressed gases. The device delivers ﬂows of up to 8L/min of both oxygen and air. Pressure in the system is controlled by a bubble bottle that depends on the depth of tubing under water, and is set by a simple dial on the bottle. A compact, preﬁlled, auto-disable injection system is used to deliver Oxytocin. A time-temperature indicator on each package indicates heat exposure. Oxytocin in this device can enable minimally trained health workers to provide the PPH prevention dose.

Oxytocin in preﬁlled auto-disable injection system

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2011_6.pdf?ua=1

Phototherapy for neonatal jaundice treatment

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2011_8.pdf?ua=1

Phototherapy is an efﬁcient mean to treat Hyperbilirubinemia. By emitting blue light over the patient’s skin, it converts toxic bilirubin molecules in the blood into less toxic isomeric forms, by photo-oxidation and photoisomerization. The device uses high power LEDs for treatment and negligible emission of UV / IR radiation.

Reusable neonatal suction device

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2011_13.pdf?ua=1

The proposed solution is a bulb suction device that is particularly suitable for use in developing countries. It is easy to use and reusable when disinfected in accordance with instructions, over the product’s lifespan.

Transcutaneous bilirubin measurement system for infants

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2011_16.pdf?ua=1

The device provides a numerical measurement of predicted bilirubin count in mg/dL or µmol/L within a clinically beneﬁcial range that has been correlated with total serum bilirubin concentration measured by High Pressure Liquid Chromatography (HPLC).

120

4.Matrix of medical devices in each stage of continuum of care

Table 36. Innovative health technologies for reproductive, maternal, newborn and child health

Name Umbilical artery doppler analyser

Link http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2013_16.pdf?ua=1

Description The technology measures blood ﬂow in the umbilical artery of the fetus at greater than 24 weeks gestation. From such a measurement, decisions can be made about the ability for the placenta to provide sufﬁcient nutrients and oxygen in order to sustain adequate fetal development. The ultrasonic Doppler probe connects to the USB port of a standard Pentium PC or laptop on which proprietary software is installed. The product consists of a graphic user interface, operational software and the physical mechanical parts of the probe (hosing, acoustic nose, etc.). CPAP assists infants with respiratory distress in maintaining continuous positive airway pressure while breathing on their own. This solution is customized for the use in hospitals with basic infrastructure and limited resources.

Ventilator using continuous positive airway pressure

http://www.who.int/ medical_devices/innovation/ compendium_med_ dev2011_17.pdf?ua=1

Source: WHO Compendium of innovative health technologies for low-resource settings 2011 - 2013 http://www.who.int/medical_devices/innovation/compendium/en/index3.html

4.4 References 1. Health technology assessment of medical devices. Geneva: World Health Organization; 2011 (http://www.who.int/medical_devices/ assessment/en/, accessed 22 May 2014). 2. Compendium of innovative health technologies for low-resource settings. Geneva: World Health Organization; 2014 (http://www. who.int/medical_devices/innovation/compendium/en/index3.html, accessed 22 May 2014).

121

5. Laboratory supply and blood bank commodities Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

5.1 Laboratory supply To implement the various priority interventions described in this document, laboratory studies may be required. A nonexclusive list of recommended laboratory supplies for health posts, health centres and district hospitals is given in Table 37.

Table 37. Laboratory supplies by health-care facilities Classiﬁcation Name of medical device Potential Use at Community level Regional/ Provincial Hospital

CD4 enumeration technologies (instruments) Chemicals and analytical testing

PoC CD4 instrument, portable, with accessories Dedicated ﬂow cytometer, with accessories Classical ﬂow cytometry, with accessories Acetic acid, 36 %, bottle Acetone, bottle Aglutination latex test for meningitis Bromine solution Buffer, tablets, PH 7.2, box Diethyl ether, bottle Drug susceptibility testing Ethanol, denaturised, 70 %, bottle Ethanol, denaturised, 95 %, bottle Formaldehyde, 10%, 10ml, ampoule Gentian violet, solution, bottle Glycerol, bottle Hydrochloric acid, 40 %, bottle Indian ink, black, bottle KI starch solution Lugol iodine, bottle Methanol, bottle Methylene blue, bottle Nitric acid Oil, immersion, bottle Oxidase test Petroleum gel, parafﬁn, bottle Plates, culture, agar - chocolate Plates, culture, agar- blood Potassium iodide Silica gel (desiccant for DBS), pouch Sodium bicarbonate Sodium chloride, powder, bottle Sodium hypochlorite, tablets Sodium persulfate Stain, Field A, solution Stain, Field B, solution Stain, Giemsa, solution Stain, Gram, set Stain, May-Grunwald Giemsa, set Stain, Ziehl–Neelsen, solution, bottle Sugar fermentation tests

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

2014

122

District Hospital

Health Center

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

5. Laboratory supply and blood bank commodities

Classiﬁcation

Name of medical device

Potential Use at Community level Regional/ Provincial Hospital

Sulphuric acid, 95 % Test, Nickerson or saboraud medium, kit Test, potassium hydroxide KOH, preparation Trichloroacetic acid, crystals, bottle Urine culture agar: 5% sheep BAP and MAC Xylene, bottle Clinical chemistry Test strip, urinalysis (10 parameter) Blood glucometer, with accessories Analyser, clinical chemistry (inc. blood gas, electrolytes) Blood cold chain Refrigerator, laboratory, 2 to 8C, 110L/250 L Refrigerator/freezer, laboratory, 2 to 8C/-20C, 180L/40L Freezer, laboratory, -20C/-80C, 140L General equipment Microscope, binocular Cabinet for microscope Counter, hand tally, mechanical Counter, cell, manual differential Counting chamber, Neubauer Centrifuge, micro - haematocrit Centrifuge, complete with accessories for serology Shaker, orbital Rotator, blood specimen Rotator, agglutination test Vortex, test tube Scale, precision, digital, 500g/0.01g Scale, digital, 1500g/0.1g Pipette, digital, 2-20 ul Pipette, digital, 10-100 ul Pipette, digital, 20-200 ul Pipette, digital, 100-1000 ul Pipette, digital, 8 channel, 5-50 ul Pipette, digital, 8 channel, 20-200 ul Pipette, repeating, 5 volume Pipette, stand, 4 positions Pipette, ﬁller, wheel-run, set/2 Pipettes, blood graduated, 0.05 ml Hot plate, with stirrer Incubator, 30 L, up to 80 C Water bath, 7 L Distillation unit, 2 L/h, with tank Sterilizer steam autoclave, 24 L Biosafety cabinet,class II,stand alone Timer, digital Timer, 60 min, mechanical Thermometer, glass, min/max -20C/100C Thermometer, min/max -30C/60C Magnifying glass Spatula, stainless steel, # sizes Forceps, dressing,155mm, straight Marker, diamond Punch, Dry Blood Spot (DBS), 3.0mm Brush, bottles and ﬂasks, # sizes X X X X X X X X X X X X X X X X X X X X X X

District Hospital

Health Center

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

X X X X X X X X X X X X X X

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

123

Classiﬁcation

Name of medical device

Potential Use at Community level Regional/ Provincial Hospital

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Brush, test tubes, # sizes Clamp, test tubes Rack, test tubes, 24 positions Rack, ESR, 5 positions Rack,tubes, 0.5/2.0/5.0 ml,24 positions Rack, drying glass & plastic ware Rack, drying slides, 12 positions Rack, staining slides, horizontal, 12 positions Box,storage 0.5/2/5 ml tubes,100 positions Box, reﬁll, pipette tips, empty Box, storage, 100 slides Box, specimen transport, 2L/4 L Biosafe, puncture-proof waste disposal box, for used syringes/needles, sharps Wash bottle, 250 ml Bottle, plastic, 1 L Goggles, protective Eye wash station Tourniquet, with buckle X X X X X

District Hospital

Health Center

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

2014

Spectrophotometer, ultraviolet / visible pH meter Cytology stain kit Water distilled, bottle Glass and plastic ware Cylinder, measuring, glass, 10 ml /100 ml / 500 ml/ 100 ml Beaker, glass, 100 ml / 250 ml Bottle, amber, dropper, 30 ml Bottle, amber, screw cap, 100 ml / 250 ml / 1000 ml Bottle, culture, blood, aerobic Bottle, culture, blood, anaerobic Jar, Coplain, staining Funnel, glass Funnel, plastic Slide, microscope, frosted Slide, microscope Cover glass, slides Petri dish, glass, with lid Rod, glass Haematology Haemoglobin colour scale (starter kit) Haemoglobin colour scale (reﬁll kit) Hemoglobinometer, with accessories Analyser, haematology, 8 parameter Analyser, haematology, 18 parameter Nucleic Acid Testing (NAT) (qualitative and/ or quantitative molecular technologied instruments) Nucleic acid testing platform, with accessories, closed system Nucleic acid testing platform, with accessories, closed system (POC)

X X X

124

5. Laboratory supply and blood bank commodities

Classiﬁcation

Name of medical device

Potential Use at Community level Regional/ Provincial Hospital

Reagents

Reagents, HIV-1/2 RDT Reagents, HIV-1/2 (antigen and antibody) EIA Reagents, HIV-1/2 supplemental assay Reagents, CD4 enumeration (absolute, %) POC Reagents, CD4 enumeration (absolute, %) dedicated cytometer Reagents, CD4 enumeration (absolute, %) classical ﬂow cytomer Reagents, HIV qualitative NAT Reagents, HIV quantitative NAT Reagents, Treponemal (syphilis) RDT Reagents, TPHA Reagents, RPR Reagents, Treponemal (syphilis) EIA Reagents, HCV RDT Reagents, HCV EIA Reagents, HCV quantitative NAT Reagents, HBsAg RDT Reagents, HBsAg EIA Reagents, HBsAg quantitative NAT Reagents, malaria RDT, Pf/pan Reagents, malaria RDT, Pf Reagents, chlamydia EIA Reagents, chlamydia NAT Reagents, gonorrhea antigen EIA Reagents, gonorrhea NAT Reagents, tuberculosis NAT (POC) Reagents, HPV NAT Reagents, HSV II NAT Reagents, rubella EIA

District Hospital

Health Center

X X X X

X X X X X X

X X X X X X X X X

X X

X X X X

X X

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Renewable

Paper, lens Paper, pH indicator 2.0 to 9.0 Paper, ﬁlter #1 Paper, dry blood spot Rack, drying DBS cards, 10 positions Paper, weighing Film, sealing, ﬂexible, 10cmx38m, roll Sealant, compound Inoculation loop, plastic, sterile Microplate, ELISA, 96 U-well Tube, capillary, heparin Tube, capillary, EDTA Tube, screw cap, 0.2 ml / 0.5 ml / 2.0 ml / 5.0 ml, sterile Tube, screw cap, 0.2 ml / 0.5 ml / 2.0 ml / 5.0 ml, non-sterile Tube, screw cap, conic, 15/50ml,non-sterile Tube, push cap, 0.2 ml, PCR, sterile Tube, push cap, 5.0 ml, non-sterile Tube, vacuum, EDTA, 2 ml / 4 ml / 6 ml, sterile Tube, vacuum, serum, 4 ml / 6 ml, sterile Tube, vacuum, plain/dry, 4 ml / 6 ml,sterile Needle, vacuum tube, 20 G / 22 G, sterile Needle holder, vacuum tubes, sterile

X X X

X X

X X X X X X X

X X

X X X X X X X X X X X X

125

Classiﬁcation

Name of medical device

Potential Use at Community level Regional/ Provincial Hospital

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Blood collection tube, neonatal cord blood, sterile Lancet, 2mm, safety, sterile Bandage, adhesive, 3.0 cm, box/100 Compress, gauze, 10x10cm, non-sterile Compress, gauze, anti-septic, 6x3cm, sterile Pipette, transfer, 3 ml, sterile Pipette, transfer, 3 ml, non-sterile Pipette, tip, white, 2-20 ul Pipette, tip, yellow, 10-100 ul / 20-200 ul Pipette, tip, blue, 100-1000 ul Pipette, tip, barrier, 200 ul / 1000 ul,sterile Pipette, repeat, tip 2.5/5.0 ml, 10/25 ml Marker pen, glassware Marker pen, cryoware, color Applicator, wood, non-sterile Swab, cotton-tip, tube, sterile Reservoir, reagent, 60 ml Container, sample, 50 ml X X X X X X X X X X

District Hospital

Health Center

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

X X X X X X X X X X X X X X X X X X X X X X X X

2014

Monitor card,humidity,passive/cumulative Sheet,absorbent,bench,50x40cm Coat, lab work, medium size Gloves, nitrile, powder-free, non-sterile,single use Bag, re-sealeable, plastic Bag, biohazard, 20 L Label, self-adhesive, 5x10 cm Label, self-adhesive, freezer Label, biohazard, adhesive, 3x4cm Envelope, packing, 27x36 cm Cotton wool, 500g, roll, non-sterile Dressing strip, adhesive, diam 3.0 cm, sterile Kato-Katz, kit, stool sample preparation Serology EIA, reader, 8 channel EIA, washer, 8 channel EIA, incubator, 4 plate Test strip Test strip, pregnancy Test strip, vaginal infection, pH X X X X X

X X X X X X X X

126

5. Laboratory supply and blood bank commodities

5.2 Diagnostic tests and Laboratory Uninterrupted provision of testing services requires a continuous supply of diagnostics/reagents and the required consumables—for example, specimen transfer devices, lancets, alcohol swabs, and blood collection equipment. This requires accurate forecasting of testing needs, efficient planning and distribution of test kits and consumables, and continuous post-market surveillance to report any quality problems. Certain types of diagnostics will require laboratory equipment/analyzers that must be correctly installed, then maintained and used properly to prevent breakdown. Testing facilities should be clean with adequate room and storage, and due care should be given to temperature and humidity as these factors may affect the reliable functioning of certain test kits, and equipment/analyzers. Any country considering the selection and use of diagnostics and laboratory technologies should have:

• • • •

A national laboratory policy and national laboratory strategic plan (1, 2); A national quality assurance programme including quality control, external quality assessment, equipment maintenance, documentation/recordkeeping, etc. (3,4,5); A national list of testing services to be provided for each level of the health system (by analyte, and by test format), including use of nationally validated testing algorithms with back-up options, as appropriate (6, 7); Accurate forecasting to avoid stock-outs of test kits and related consumables.

WHO recommends standardized testing strategies1 to maximize the accuracy of test results while minimizing cost. Validated testing algorithms should ideally use the assay with highest sensitivity first, then assays with highest specificity used second and/or third, depending on the required predictive values (99% is desirable). When two or more assays are used, it is essential to use assays with different antigen preparations (components) to minimize the potential for shared false non-reactivity or false reactivity. The following considerations should be taken into account when validating a set of potential testing algorithms, see Table 38.

Table 38. Specific considerations for selection of diagnostics Parameter Performance characteristics Clinical sensitivity Clinical specificity Seroconversion sensitivity Limit of detection/ dynamic range Misclassification rate Inter-reader variability, if subjectively read format Invalid rate, devices/test results, test runs Operational characteristics Test format RDTs (immunochromatographic, immunofiltration) Simple (comb formats, agglutination assays) EIAs (manual plate-based EIAs, immunoanalysers) Supplemental assays (Western blot, line immunoassays) Nucleic Acid Testing (qualitative, quantitative) Serum/plasma, venous or capillary whole blood, dried blood spot, oral fluid If HIV; discriminatory detection of HIV-1 and HIV-2 antibodies or combined detection of HIV-1/2 antibodies. If HIV; simultaneous or combined detection of HIV-1 antigen and HIV-1/2 antibodies If HIV; M, N, O subtypes If RDT; immunochromatographic (less than 30 minutes with fewer steps) or immunofiltration (less than 5 minutes with more steps). If EIA; random access analyser or not? How long is the result stable? Is longer reading time or shorter reading time desirable? (depends on service delivery model) If RDT; depends on a combination of: • nature of specimen collection (fingerstick whole blood by lancet or venous whole blood by venipuncture); • number of steps in the test procedure; • ease of reading the test band, line, spot; • ease of interpretation of testing results; • addition of procedural quality control (band appears when human specimen is added versus band appears when running buffer is added). Set a minimum acceptable criteria Set a minimum acceptable criteria Important for blood screening Set a minimum acceptable criteria that relates to a clinically relevant level. Important for monitoring of disease and/or treatment Set a minimum acceptable criteria Set a minimum acceptable criteria Considerations

Specimen type Detection type

Subtype detection Time to result

Endpoint stability Ease of use

1 In this context, a testing strategy generically describes a testing approach for a specific need (for example, transfusion and transplantation screening, surveillance, and/or diagnosis of infection) taking into consideration the presumed prevalence in the population being tested. A testing algorithm describes the combination and sequence of specific assays used within a giventesting strategy. It has been shown that combinations of EIAs or combinations of RDTs or mixed combinations of EIAs and RDTs can provide reliable results.

127

Table 38. Specific considerations for selection of diagnostics Parameter Degree of laboratory infrastructure required i.e. which level of the health system Equipment/consumables required but not provided in the test kit Considerations

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Refrigeration for storage of test kits and/or reconstituted reagents. Temperature-controlled work space. Electricity/generator. Lancets, alcohol swabs for fingerstick whole blood. Blood collection equipment for venous whole blood. Other general laboratory consumables. Specimen through-put and individual RDTs if ≤40 specimens per day per operator with limited laboratory infrastructure. testing service delivery models EIAs if ≥40 specimens per day per operator with laboratory infrastructure. Technical skill of staff conducting Including both laboratory and phlebotomy skills. testing Availability of test kit controls and Some are available but separate from test kit. compatibility with QC materials See also note above on procedural in-built quality control. Shelf-life of test kits Must be negotiated as part of the procurement contract. Access to referral laboratory Particularly important when 4th generation assays are used.

WHO Prequalification of Diagnostics programme Through the WHO Prequalification of Diagnostics programme, WHO conducts independent and impartial assessments of the quality and performance of commercially available diagnostics and laboratory technologies that are best suited to resource-limited settings. Performance and operational characteristics are assessed using panels of biological specimens. In addition, WHO assesses the quality management system under which the product is made through dossier review and site inspection to provide continual assurance of quality. Further information concerning the prequalification of diagnostics is available on the WHO website at http://www.who.int/diagnostics_laboratory.

UN Bulk Procurement Scheme

2014 128

Diagnostics found to meet minimum standards for WHO prequalification are then eligible for procurement by WHO and United Nations (UN) agencies. Further information concerning the list of products eligible for procurement is available on the WHO website at http://www.who.int/diagnostics_laboratory/procurement/purchase/en/index.html or by contacting WHO at diagnostics@who.int

Further reading Guidelines for organizing national external quality assessment schemes for HIV serological testing. Geneva: United Nations Programme on HIV/AIDS; 1996 (http://www.who.int/diagnostics_laboratory/quality/en/EQAS96.pdf, accessed 22 May 2014). Maintenance manual for laboratory equipment, 2nd edition. Spain: World Health Organization; 2008 (http://whqlibdoc.who.int/ publications/2008/9789241596350_eng_low.pdf, accessed 22 May 2014). Manual of Basic Techniques for a Health Laboratory, 2nd edition. Geneva: World Health Organization; 2003 (http://apps.who.int/ medicinedocs/documents/s16537e/s16537e.pdf, accessed 22 May 2014). Basic Laboratory Procedure in Clinical Bacteriology, 2nd edition. Geneva: World Health Organization; 2003 (http://whqlibdoc. who.int/publications/2003/9241545453.pdf, accessed 22 May 2014). Laboratory Biosafety Manual, 3rd edition. Geneva: World Health Organization; 2004 (http://www.who.int/csr/resources/ publications/biosafety/en/Biosafety7.pdf, accessed 22 May 2014)

5. Laboratory supply and blood bank commodities

5.3 Blood bank commodities Considering the significant positive impact of increasing the availability of blood transfusions on maternal health outcomes, Table 39 contains a list of essential items for a blood bank. Table 39. Essential items for blood bank: blood collection, testing and processing, clinical transfusion, blood storage and blood transportation Blood Collection, Testing and Processing a) Collection Classiﬁcation Description Indication For application after blood donation and patients' sample collection For haemoglobin estimation during donor selection For management of donor reactions For applying pressure on the venepuncture site after blood donation, during patients' sample collection For donors' arm cleansing before blood donation Suitable for estimation of donors' haemoglobin during donor selection 350 ml or 450 ml

Consumables: non-perishable Adhesive plasters, 6x2cm Consumables: non-perishable Blood lancets, sterile, disposable Consumables: non-perishable Emergency medicines (Crystalloids, corticosteroid, adrenaline, antihistamine and other essential medicines) Consumables: non-perishable Gauze swabs, 8-ply, 10x10cm/Cotton swabs

Consumables: non-perishable Impregnated medicated swabs, chlorhexadine or isopropanol Consumables: non-perishable Rapid test for haemoglobin estimation Consumables: non-perishable Single blood collection bags, CPD-A1 (needle must be in-built preventing re-use) Consumables: non-perishable Surgical plaster roll Consumables: non-perishable Test tubes, round bottom, polystyrene, 10 ml Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Recommended stationery Recommended stationery Recommended stationery Artery forceps (Clamp) Sphygmomanometer Spring balance, range 250 – 600 gm Surgical scissors Test tube racks, 30 holes, plastic/wooden Tourniquets, arm, adjustable Tube stripper Weighing scale, range 0 –150 Kg Blood donor questionnaires Labels for blood bags Registers, hard-cover, A4

For collecting blood samples for donation testing and patients' blood samples for blood grouping For use during blood donation For measuring blood pressure during donor selection For monitoring blood volume during blood donation For use during blood donation and patient sample collection For holding sample tubes with donors and patients

For checking donors' weight during donor selection For use during donor selection To include patient and cross-match information on the blood unit For donor and patient records

b) Blood group serology testing Classiﬁcation Description Indication For performing blood grouping on donated blood and patient sample For cross-matching* For labelling on glassware For blood grouping and screening of donated blood for TTIs For patients' blood grouping and cross- matching For mixing of reagents and blood samples while blood grouping Required for ABO blood grouping Required for ABO blood grouping

Consumables: non-perishable Glass slides, 25x75mm Consumables: non-perishable Markers, ﬁne point, permanent black, for glassware Consumables: non-perishable Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml Consumables: non-perishable Wooden or plastic applicator sticks

Perishable items: must be stored at 2°C to 8°C Perishable items: must be stored at 2°C to 8°C Perishable items: must be stored at 2°C to 8°C

Anti-A blood group reagent, monoclonal Anti-B blood group reagent, monoclonal

Anti-D blood group reagent (Saline/monoclonal) Required for Rh D blood grouping

129

Table 39. Essential items for blood bank: blood collection, testing and processing, clinical transfusion, blood storage and blood transportation c) Screening donated blood for transfusion transmissible infections Classiﬁcation Description Indication For labelling on glassware For blood grouping and screening of donated blood for TTIs For patients' blood grouping and cross- matching Required for screening of donated blood for HBsAg Required for screening of donated blood for HCV Required for screening of donated blood for HIV 1+2 Required for screening of donated blood for syphilis

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Consumables: non-perishable Markers, ﬁne point, permanent black, for glassware Consumables: non-perishable Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml Perishable items: must be stored at 2°C to 8°C Perishable items: must be stored at 2°C to 8°C Perishable items: must be stored at 2°C to 8°C Perishable items: must be stored at 2°C to 8°C HBsAg rapid tests HCV rapid tests HIV 1+2 rapid tests RPR rapid test

NOTE: This list of commodities is recommended only for the Referral level. Clinical Transfusion a) Blood Cross-Matching Classiﬁcation Description Indication For performing blood grouping on donated blood and patient sample For cross-matching*

Consumables: non-perishable Glass slides, 25x75mm

Consumables: non-perishable Markers, ﬁne point, permanent black, for glassware For labelling on glassware

2014

Consumables: non-perishable Needle, hypo, disposable, 21G x1.5”, sterile Consumables: non-perishable Needle, hypo, disposable, 23 G x 1”, sterile Consumables: non-perishable Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml Consumables: non-perishable Syringe 5ml, hypo, disposable Consumables: non-perishable Test tube racks, 30 holes, plastic/wooden Consumables: non-perishable Test tubes, round bottom, polystyrene, 10 ml Consumables: non-perishable Wooden or plastic applicator sticks Perishable items: must be stored at 2°C to 8°C Perishable items: must be stored at 2°C to 8°C Perishable items: must be stored at 2°C to 8°C Recommended stationery Recommended stationery b) Blood Transfusion Classiﬁcation Description Indication Required for administration of blood to the patients Used for blood administration depending on size of vein and desired rate of transfusion Anti-A blood group reagent, monoclonal Anti-B blood group reagent, monoclonal For blood grouping and screening of donated blood for TTIs For patients' blood grouping and cross- matching For collecting patients' blood samples For holding sample tubes with donors and patients For collecting blood samples for donation testing and patients' blood samples for blood grouping For mixing of reagents and blood samples while blood grouping Required for ABO blood grouping Required for ABO blood grouping

Anti-D blood group reagent (Saline/monoclonal) Required for Rh D blood grouping Labels for blood bags Registers, hard-cover, A4 To include patient and cross-match information on the blood unit For donor and patient records

Consumables: non-perishable Blood administration set with have an integral ﬁlter with pore size 170–200 micron Consumables: non-perishable IV catheter, 20 G x1Ð”, sterile, disposable, with wing Consumables: non-perishable IV catheter, 22 G x1”, sterile, disposable, with wing Consumables: non-perishable IV catheter, 23 G xÐ ”, sterile, disposable, with wing Medical Device Surgical scissors Medical Device Recommended stationery Tourniquets, arm, adjustable Transfusion request forms

For use during blood donation and patient sample collection For requesting blood transfusion for a patient

NOTE: This list of commodities is linked with interventions in the main matrix.

130

5. Laboratory supply and blood bank commodities

Table 39. Essential items for blood bank: blood collection, testing and processing, clinical transfusion, blood storage and blood transportation Equipment in the Blood Centre Classiﬁcation Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Recommended stationery Recommended stationery Recommended stationery Recommended stationery Recommended stationery Recommended stationery Recommended stationery Recommended stationery Recommended stationery Recommended stationery Recommended stationery Recommended stationery Recommended stationery Description Autoclaves Automated sample processor Automatic pipette Binocular microscopes Blood collection bag weighing balances Cell washer centrifuge Colorimeters Cryoprecipitate bath (40C) Donor weighing scale Double beam balance Electronic balance ELISA plate reader ELISA plate washers Equipment necessary for producing chemically pure and /or pyrogen-free water (e.g. still; deionizer) Haematology autoanalyzer with platelet counts Haemocue/instrument for Haemoglobin Estimation Incubators Laboratory bench top centrifuge for separation of samples Laboratory thermometers Laminar Airﬂow cabinet Micro plate shaker Oxygen supply equipment (such as cylinder) pH Meter Plasma extractors Plasma freezer –300C Plasma thawing bath Platelet incubator and shaker Serologic rotators Spectrophotometers Sphygmomanometers Tube sealers Blast freezer Blood bank refrigerator Blood transportation box Container for safe disposal of sharps Deep freezer -80 C Donor beds/couches Hot Air ovens PC with accessories and software Refrigerated centrifuges Stop watches/timers Vehicles for outdoor blood donation sessions Voltage stabilizers Water bath It covers the administration set (mask) For weighing blood donors For weighing blood packs For weighing chemicals Indication

For laboratory serology tests

131

Table 39. Essential items for blood bank: blood collection, testing and processing, clinical transfusion, blood storage and blood transportation Equipment in the Hospital Blood Storage Centre and for Blood Transportation Classiﬁcation Medical Device Description Binocular microscopes Indication

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Medical Device Medical Device Medical Device Medical Device Recommended stationery Recommended stationery Recommended stationery Recommended stationery

For temporary storage and transportation of blood Incubators for laboratory serology tests For temporary storage and transportation of blood Laboratory bench top centrifuge for separation of For temporary storage and transportation of samples blood Plasma freezer –300C Platelet incubator and shaker Blood bank refrigerator Blood transportation box Deep freezer -80 C Insulated cool box, 10 L (capacity depending on need) For temporary storage and transportation of blood For temporary storage and transportation of blood For storage of blood and reagents For temporary storage and transportation of blood For temporary storage and transportation of blood For temporary storage and transportation of blood

NOTE: The list of equipment should be adapted to be used for the blood centres in various levels in the country where assessment is conducted. If national standards for equipment requirements at various level of blood transfusion services are available, this list should be based on these standards. Standard Precautions Classiﬁcation Description Indication For standard precautions For safety disposal of sharps For disposal of general waste For disposal of contaminated swabs

2014 132

Consumables: non-perishable Gloves, latex, disposable for single use (in different sizes) Consumables: non-perishable Sharps containers Consumables: non-perishable Waste bags, 35 L, black plastic Consumables: non-perishable Waste bags, 35 L, yellow

Blood screening laboratories should have appropriate quality standards, based on national standards, to ensure process control and valid results. Globally recognized international standards could also be adopted by blood transfusion services to ensure a consistent approach to quality throughout their activities and to ensure the overall safety and efficacy of blood and blood products prepared for therapeutic use. The standards should take into account relevant existing legislation and other national requirements. All donations, blood components, blood samples, test kits and reagents should be stored in suitable equipment in which defined storage temperatures and conditions are strictly maintained, monitored and recorded. These lists of supplies should be adapted for use at various levels in the country where assessment is conducted, depending on national regulations and infrastructure.

5.4 Safe blood and clinical transfusion Checklist of Essential Items for Collection, Testing and Transfusion of 50 Units of Whole Blood Blood transfusion contributes to saving millions of lives every year, improves life expectancy and the quality of life of patients suffering from life-threatening conditions, and supports complex medical and surgical procedures. Every country should put in place policies, systems and structures to ensure the safety, quality, accessibility and timely availability of blood and blood products to meet the needs of all patients who require transfusion.

Provision of safe blood and blood products Blood transfusion services should comply with national policies and strategies to ensure they implement standards and meet targets for the provision of safe blood and blood products. To perform their functions efficiently, BTS should have:

• •

Adequate number of qualified, skilled and experienced personnel in human resource management, finance and administration, quality systems, transfusion medicine, blood donor programme and laboratory testing and blood processing Suitable infrastructure and facilities in all centres in which blood collection, testing, processing and storage of blood and blood products take place.

5. Laboratory supply and blood bank commodities

Requirements include:

• • • • • • • • •

Effective quality system within which all activities are performed in a quality-focused way and are continuously monitored Sustainable donor education, motivation, voluntary none remunerated blood donor recruitment and retention programme Safe blood collection process, including donor selection and deferral, donor care, notification, counselling and referral, and confidentiality Testing and processing using the most appropriate and effective methodologies and best laboratory practices Efficient inventory management system for optimum blood stocks and minimal wastage Effective blood cold chain for safe storage and distribution of blood and blood products Information management system encompassing all activities from blood donors to distribution of blood and blood products to hospitals, and issue and transfusion of blood and blood products to patients Liaison with hospitals in the implementation of transfusion guidelines and staff training Participation in national haemovigilance system.

Table 40. Essential Items for Blood Transfusion in Emergency Settings Item Description Perishable items: must be stored at 2°C to 8°C 1. Anti-A blood group reagent, monoclonal 2. Anti-B blood group reagent, monoclonal 3. Anti-D blood group reagent (Saline/ monoclonal) 4. HIV 1+2 rapid tests 5. HBsAg rapid tests 6. HCV rapid tests 7. RPR rapid test Consumables: non-perishable 8. Single blood collection bags, CPD-A1 (needle must be in-built preventing re-use) 9. Blood administration set with have an integral filter with pore size 170–200 micron 10. IV catheter, 20 G x1¼”, sterile, disposable, with wing 11. IV catheter, 22 G x1”, sterile, disposable, with wing 12. IV catheter, 23 G x¾ ”, sterile, disposable, with wing 13. Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml Pack with 6 9 packs (50-60 350 ml or 450 ml blood collection bags) bags each 50 sets 50 pieces 50 pieces 50 pieces 100 pipettes 1 x 50 sets 1 x 50 pieces 1 x 50 pieces 1 x 50 pieces 2 x 100 pipettes • For blood grouping and screening of donated blood for TTIs • For patients' blood grouping and crossmatching For haemoglobin estimation during donor selection • For applying pressure on the venepuncture site after blood donation • During patients' sample collection For application after blood donation and patients' sample collection For labelling on glassware For donors' arm cleansing before blood donation For collecting blood samples for donation testing and patients' blood samples for blood grouping • For performing blood grouping on donated blood and patient sample • For cross-matching* For mixing of reagents and blood samples while blood grouping Required for administration of blood to the patients Used for blood administration depending on size of vein and desired rate of transfusion 5 ml vial 5 ml vial 5 ml vial 100 tests 100 tests 100 tests 100 tests 1 x 5 ml 1 x 5 ml 1 x 5 ml 1 x 100 1 x 100 1 x 100 1 x 100 Required for Rh D blood grouping Required for screening of donated blood for transfusion- transmissible infections (TTIs), including HIV 1+2, hepatitis B and C, and syphilis Required for ABO blood grouping Usual or preferred presentation Recommended Remarks quantity

14. Blood lancets, sterile, disposable 15. Gauze swabs, 8-ply, 10x10cm/Cotton swabs

100 100 swabs

1 x 100 2 x 100 swabs

16. Adhesive plasters, 6x2cm 17. Surgical plaster roll 18. Markers, fine point, permanent black, for glassware 19. Impregnated medicated swabs, chlorhexadine or isopropanol 20.Test tubes, round bottom, polystyrene, 10 ml

100 pieces 2 pieces 10 markers 100 pieces 100 tubes

1 x 100 pieces 1 x 2 pieces 1 x 10 markers 2 x 100 2 x 100 tubes

21. Glass slides, 25x75mm

4 x 50 slides

22. Wooden or plastic applicator sticks

200

2 x 200

133

Table 40. Essential Items for Blood Transfusion in Emergency Settings Item Description 23. Syringe 5ml, hypo, disposable 24. Needle, hypo, disposable, 21G x1.5”, sterile Usual or preferred presentation 100 syringes 100 needles 100 needles Depending on the available products 50 pairs Depending on the available products Depending on the available products 20 a roll 20 a roll Recommended Remarks quantity 1 x 100 1 x 100 1 x 100 For up to 100 tests 2 x 50 pairs 1 Suitable for estimation of donors' haemoglobin during donor selection For standard precautions For management of donor reactions For collecting patients' blood samples

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

25. Needle, hypo, disposable, 23 G x 1”, sterile 26. Rapid test for haemoglobin estimation

27. Gloves, latex, disposable for single use (in different sizes) 28. Emergency medicines (Crystalloids, corticosteroid, adrenaline, antihistamine and other essential medicines) 29. Sharps containers

For disposal of sharps

30. Waste bags, 35 L, black plastic 31. Waste bags , 35 L, yellow Recommended stationery 32. Blood donor questionnaires 33. Labels for blood bags 34. Registers, hard-cover, A4 35. Transfusion request forms

1 roll 1 roll

For disposal of general waste For disposal of contaminated swabs

For use during donor selection

50 of each type To include patient and cross-match information on the blood unit 5 50 For donor and patient records For requesting blood transfusion for a patient

One-off items – if above are re-ordered, these should not be repeated

2014

36. Sphygmomanometer 37. Surgical scissors 38. Tourniquets, arm, adjustable 39. Weighing scale, range 0 –150 Kg 40. Spring balance, range 250 – 600 gm 41. Artery forceps (Clamp) 42. Tube stripper 43. Test tube racks, 30 holes, plastic/wooden 44. Insulated cool box, 10 L 45. Blood bank refrigerator * In settings where tube method cannot be used.

1 2 2 1 2 2 2 5 2 1

For measuring blood pressure during donor selection For use during blood donation and patient sample collection For checking donors' weight during donor selection For monitoring blood volume during blood donation For use during blood donation For holding sample tubes with donors and patients For temporary storage of donated blood For storage of blood

5.5 References 1. Development of national health laboratory policy and plan. India: World Health Organizations; 2011 (http://www.wpro.who.int/ health_technology/documents/docs/Nationalhealthlab2_0F38.pdf, accessed 22 May 2014). 2. Service delivery approaches to HIV testing and counselling (HTC): A strategic policy framework. Geneva: World Health Organization; 2012 (http://www.who.int/hiv/pub/vct/htc_framework/en/, accessed 22 May 2014). 3. Guidelines for assuring the accuracy and reliability of HIV rapid testing: applying a quality system approach. Geneva: World Health Organization; 2005 (http://whqlibdoc.who.int/publications/2005/9241593563_eng.pdf, accessed: 22 May 2014). 4. HIV rapid test training package. Geneva: World Health Organization; 2005 (http://www.who.int/diagnostics_laboratory/ documents/guidance/hivrttraining_overview/en/index.html, accessed: 22 May 2014). 5. Laboratory quality management system training toolkit. Geneva: World Health Organization, U.S. Centers for Disease Control and Prevention, the Clinical and Laboratory Standards Institute; 2009 (http://www.who.int/ihr/training/laboratory_quality/en/index. html, accessed 22 May 2014). 6. Guidelines for appropriate evaluations of HIV testing technologies in Africa. Geneva: World Health Organization Regional Office for Africa, U.S. Centers for Disease Control and Prevention, Association of Public Health Laboratories; 2002 (http://whqlibdoc. who.int/afro/2002/a82959_eng.pdf, accessed 22 May 2014). 7. WHO expert meeting report on short, medium, and longer term product development priorities in HIV-related diagnostics, 6–7 June 2012 Geneva, Switzerland. Geneva: World Health Organization; 2012 (http://apps.who.int/iris/ bitstream/10665/75971/1/9789241504522_eng.pdf, accessed 22 May 2014)

134

6. Surgery and Anaesthesia 6.1 Surgery and Anaesthesia As a first estimate, conditions treatable by surgery account for 11% of the global burden of disease(Debas H, Gosselin R, McCord C, et al. 2006). Surgically addressable burden of disease at the first referral level include the following (1):

6. Surgery and Anaesthesia

• • • • • • •

Injuries (e.g. from road traffic accidents - from which 1.3 million people lose their lives each year, violence, falls, and burns) Pregnancy related complications - every year over 287,000 women die before, during or after childbirth (complications requiring surgical intervention include haemorrhage, obstructed labour, unsafe abortion, ectopic pregnancy). Anaesthesia is an integral component of surgical care systems and anaesthesia-related complications have also been cited as a significant cause of maternal deaths Infection (e.g. wound infections, abscesses, and bone infections) Acute abdominal conditions (e.g. gastro-intestinal obstruction, perforation and strangulation) Congenital anomalies (e.g. club foot) Other surgical conditions

Often surgical procedures cannot be performed or referred to higher level health facilities due to lack of or nonfunctioning equipment such as oxygen supply and anaesthesia machine (2,3,4). To maximize the effectiveness of district and sub-district health facilities in the management of pregnancy-related complications, injuries, congenital anomalies and prevention of infection, and enable them to meet the MDGs 4, 5, and 6, the following strategies should be implemented: 1. Personnel with appropriate education and training in (5):

• • • • • • • • • • • • • • • • • • • • •

Anesthesia and resuscitation Obstetrics and gynecology General surgery Traumatology Orthopedics

2. Practical skills training and continuing education programmes in the management of essential anesthesia and surgical (emergency, obstetrics, trauma) care, to maintain the quality and safety of care through: Evaluation of training needs Coordinated plan for education and training Educational resources and best practice protocols at the point of care Monitoring and evaluation of the progress and impact of education and training

3. Appropriate physical facilities for: Casualty area, operating room, labour room, high dependency area Continuous oxygen supply Blood bank and laboratory Diagnostic imaging Sterilization Water, electricity, safe waste disposal and communications

4. Equipment (including basic monitoring) and instruments to meet the needs of district surgical services for minor and major surgical interventions in : Obstetrics and gynecology surgery Abdominal surgery Orthopedic surgery Common pediatric surgical conditions Anesthesia Resuscitation

135

5. A reliable system for the supply of :

• • • Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Medication, blood and intravenous fluids Surgical materials Other consumables

6. A quality assurance system for:

• • • • •

Patient safety Management Communication Supervision Evaluation

The WHO Integrated Management for Emergency & Essential Surgical (IMEESC) toolkit was developed to provide guidance on strengthening surgical care health systems. It contains (6):

• • • • • • • • •

Policies to ensure quality and safety in provision of anesthesia, obstetrics, trauma and surgical care Planning tool to guide incorporation of district surgical services within the national health plan Guidance on organization and management of district hospital Education and training tools to enable health providers to provide an effective surgical, obstetrics, trauma and anesthetic service Essential emergency equipment generic list Guidance to infrastructure and supplies at various levels of health care facilities to assure adequate and reliable supplies of medicines, anaesthesia and surgical materials and other consumables Best practice protocols on anesthesia, obstetrics, common pediatric surgical conditions, trauma, disaster situations and surgical care, infection control and for referral to higher level health facilities. Situation analysis tool to assess emergency, anesthesia, obstetrics, pediatrics, trauma and surgical services at various levels of care Monitoring and Evaluation tool to monitor progress of improvement in surgical care systems

2014 136

6.2 Grouping of common surgical instruments by surgical procedure Surgical instruments are often packed into sets related to the surgical procedures for which they are required. These sets can often be used for multiple procedures. Contents of each surgical instrument set is listed in Table 41.

Table Contents of surgical instrument Table 41. 41. Contents of surgical instrument setssets 1. Basic surgery set The basic surgery set is used for minor surgery and/or exploratory of complex wounds. Set content: 4 x Clamp,towel,Backhaus,130mm 2 x Forceps,tissue seizing,Allis,150mm 6 x Forceps, artery, Halsted-Mosquito, 125mm, curved 1 x Forceps,artery,Kocher,140mm,straight 1 x Forceps,dressing,standard,155mm,straight 1 x Forceps,tissue holding,Collin,160mm 1 x Forceps,tissue,standard,145mm,straight 1 x Forceps,dressing & polypus,Cheron,250mm 1 x Needle holder,Mayo-Hegar,180mm,straight 1 x Probe,double-ended,145mm 1 x Retractor,Farabeuf,double-ended,120mm,pair 1 x Scalpel handle,no.4 1 x Scissors,Metzembaum,140mm,curved, blunt/blunt 1 x Scissors,Mayo,140mm,curved, blunt/blunt 1 x Bowl, stainless steel, 180 ml

2. Delivery set The delivery set is used for spontanous delivery to clamp/cut the umbilical cord and it is also be used in combination with the suture set when episiotomy is necessary. Set content:

6. Surgery and Anaesthesia

Table 41. Contents of surgical instrument sets 1 x Scissors,Mayo,140mm,curved, blunt/blunt 1 x Scissors,gynecological,200mm,curved, blunt/blunt 2 x Forceps,artery,Kocher,140mm,straight

3. Dilatation/Evacuation (D&E) set The dilatation and evacuation set is used for surgical methods of safe abortion beyond the ﬁrst trimester. The evacuation reququires electric or manual vacuum aspiration equipment with different sizes of plastic cannulae, ranging from 12 16mm in diameter and long forceps. Set content: 1 x Dilators, uterine, tapered, up to 51 mm 1 x Forceps, dressing, ring 1x Forceps, uterine, ovum, Bierer, large 1x Forceps, uterine, ovum, Bierer, small 1x Forceps, uterine, ovum, Sopher, small 1 x Retractor, vaginal, Doyen, 45 x 85 mm 1 x Retractor, vaginal, Auvard, 38 x 80 mm 1 x Curette, postpartum ﬂexible, large 1 x Forceps, tenaculum, atraumatic 1 x Speculum, vaginal, Graves, wide mouth 1 x Bowl, stainless steel, 180 ml Footnotes: Recommendation: Vacuum aspiration is the recommended technique of surgical abortion for pregnancies of up to 12 to 14 weeks of gestation. The procedure should not be routinely completed by sharp currettage. Dilation and sharp currettage (D&C), if still practised should be replaced by vacuum aspiration (page.2 in the reference). Dilatation and curettage: Where it is still practised, all possible efforts should be made to replace D&C with vacuum aspiration, to improve the safety and quality of care of women. At sites where vacuum aspiration has yet to be introduced, manegers must ensure that proper painmanagement protocols are followed, and that D&C procedures are performed by well-trained staff under adequate supervision. Reference: Safe abortion second edition, 2012: http://www.who.int/reproductivehealth/publications/unsafe_ abortion/9789241548434/en/

4. Dressing set The dressing set is used for simple wound dressings, basic instrument donation for medical staff. Set content: 1 x Forceps,artery,Kocher,140mm,str 1 x Forceps,dressing,standard,155mm,str 1 x Scissors,Deaver,140mm,str,s/b

5. Early infant male circumcision set The early infant male circumcision set is used for male circumcision in ealy infancy, mostly within the ﬁrst two months of life in case of full-term baby. Three different circumcision devices are existing. The circumcision device should be selected by a surgeon based on his learning technique and experiences accordingly. Set content: One 7.5-cm to 12.5-cm (3-inch to 5-inch) ﬂexible probe Three small mosquito haemostats, two curved and one straight ( 80 - 125 mm) Small straight scissors, (115 - 140 mm) Desired male circumcision device (Mogen, Gomco or Plastibell) and all appropriate parts Reference; Manual for early infant male circumcision under local anaethesia, 2010: http://www.who.int/hiv/pub/malecircumcision/ manual_infant/en/ Speciﬁcations and picures of male circumcision devices in Page 42 to 51.

6. Embryotomy set The set is used for embryotomy (cranioclasy, craniotomy). Set content: 1 x Cranioclast,Braun,420mm 1 x Perforator,Smellie,250mm 1 x Scissors,gynecological,200mm,curved, blunt/blunt 1 x Hook,decapitation,Braun,310mm

7. Examination/suturing, vaginal/cervical set The set is used for checking and repairing cervical tears and deep vaginal tears. Set content: 1 x Scissors,Mayo,170mm,curved, blunt/blunt 1 x Needle holder,Mayo-Hegar,180mm,straight 2 x Retractor,vaginal,Doyen,45x85mm 1 x Speculum,vaginal,Graves,75x20mm

137

Table 41. Contents of surgical instrument sets 1 x Speculum,vaginal,Graves,95x35mm 1 x Speculum,vaginal,Graves,115x35mm 2 x Forceps,dressing & polypus,Cheron,250mm

8. Intra uterin device (IUD) insertion/removal set Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health The intra uterin device (IUD) set is used for insertion and removal of intra uterin devices through vigina as one of contraseptive methods. Set content: 1 x Speculum, vaginal, Graves, 75 x 20mm 1 x Speculum, vaginal, Graves, 115 x 35mm 1 x Speculum, vaginal, Graves, 115 x 35mm 1 x Forceps,dressing & polypus,Cheron,250mm 1 x Forceps, artery,Pean/Rochester, 220mm, straight 1 x Forceps,uterine, vulsellum,Duplay,280mm,curved 1 x Sound, uterine, Martin, 320mm 1 x Scissors, gynaecological, 200mm, curved 1 x Bowl, approx. 180ml 1 x Basin, kidney, approx. 825ml

9. Laparotomy (gyn/obs) set The laparotomy set is used for exploratory laparotomy, ceasarean section & related complications (uterin rupture, hysterectomy..), salpingectomy, ectopic pregnancy, and other gynaecological operations. Set content: 4 x Clamp,towel,Backhaus,130mm 1 x Forceps,artery,Kelly,140mm,curved

2014 138

2 x Forceps,artery,Kocher,140mm,straight 2 x Forceps,artery,Pean/Rochester,200mm,curved 2 x Forceps,artery,Pean/Rochester,240mm,curved 6 x Forceps, artery, Halsted-Mosquito, 125mm, curved 1 x Forceps,artery,Mixter,230mm 1 x Forceps,dressing,standard,155mm,straight 1 x Forceps,dressing,standard,250mm,straight 1 x Forceps,dressing & polypus,Cheron,250mm 2 x Forceps,intestinal,clamp,Doyen,230mm,curved 2 x Forceps,uterine, haemostatic, Phaneuf,215mm,curved 1 x Forceps,uterine, vulsellum,Duplay,280mm,curved 2 x Forceps,tissue seizing,Allis,150mm 1 x Forceps,tissue & organ holding,Babcock,200mm 2 x Forceps,tissue holding,Duval,230mm 1 x Forceps,tissue,standard,145mm,straight 1 x Forceps,tissue,standard,250mm,straight 1 x Needle holder,Mayo-Hegar,180mm,straight 1 x Retractor,abdominal,Collin,3 blades 1 x Retractor,abdominal,Balfour,3 blades 1 x Retractor,Farabeuf,double-ended,180mm,pair 1 x Scalpel handle,no.4 1 x Scissors,Metzembaum/Nelson,180mm,curved, blunt/blunt 1 x Scissors,Metzembaum/Nelson,230mm,curved, blunt/blunt 1 x Scissors,Mayo,170mm,curved, blunt/blunt 1 x Scissors,Mayo,230mm,curved, blunt/blunt 2 x Spatula,abdominal,malleable,270mm 1 x Tube suction,Yankauer,270mm 1 x Bowl,stainless steel,600ml

6. Surgery and Anaesthesia

Table 41. Contents of surgical instrument sets 10. Suture set The suture set is used in addition to the delivery set for episiotomy, perineum repairs, and/or simple suturing ,complex dressings. It can also be used (Family Planning) for Sub-dermal implants removal if needed. Set content: 1 x Scissors,Deaver,140mm,curved, sharp/blunt 1 x Needle holder,Mayo-Hegar,180mm,straight 1 x Forceps,artery,Kocher,140mm,straight 1 x Scalpel handle,no.4 1 x Forceps,tissue,standard,145mm,straight 1 x Probe,double-ended,145mm

11. Vacuum Aspiration set The vacuum aspiration set is used for surgical methods of sage abortion up to gestational age less than 15 weeks. Vacuum Aspiration requires electric or manual vacuum aspiration equipment with different sizes of plastic cannulae, ranging from 4 - 16mm in diameter. Set content: 1 x Dilators, uterine, Hegar, double-ended, 3-4mm to 17-18mm, stainless steel 1 x Forceps, dressing, ring 1 x Forceps, tenaculum, atraumatic 1 x Speculum, vaginal, Graves, 95 x 35 mm 1 x Bowl, stainless steel, 180 ml Footnotes; Recommendation: Vacuum aspiration is the recommended technique of surgical abortion for pregnancies of up to 12 to 14 weeks of gestation. The procedure should not be routinely completed by sharp currettage. Dilation and sharp currettage (D&C), if still practised should be replaced by vacuum aspiration (page.2 in the reference). Dilatation and curettage: Where it is still practised, all possible efforts should be made to replace D&C with vacuum aspiration, to improve the safety and quality of care of women. At sites where vacuum aspiration has yet to be introduced, manegers must ensure that proper painmanagement protocols are followed, and that D&C procedures are performed by well-trained staff under adequate supervision. Reference: Safe abortion second edition, 2012: http://www.who.int/reproductivehealth/publications/unsafe_ abortion/9789241548434/en/

12. Vasectomy set The vasectomy set is used for vasectomy as one of contraseptive methods. This method requires also scissors for clipping scrotal hair and disposables for local anaesthesia. Set content: 1 x Bowl, 180ml, stainless steel 4 x Clamp, towel, Jones, 50 mm 4 x Forceps, artery, Kelly, 140 mm,straight, 2 x Forceps, artery, Halsted/Mosquito, 125 mm, curved 2 x Forceps,tissue seizing, Allis, 150 mm 1 x Scalpel handle, no.3 1 x Scissors, 120 mm, curved

13. Vasectomy non-scalpel set The non-scalpel set is used for vasectomy with non-scalpel technique which requires the extracutaneous ringed forceps, called Ringed clamp, for grasping the vas voth extracutaneously and directly, and Dissecting forceps for puncturing the scrotal skin and spreading the tissues. This method requires also scissors for clipping scrotal hair and disposables for local anaesthesia . Set content: Ringed clamp (inside dimensions of clamp 3.0, 3.5, or 40. mm) Dissecting forceps Straight, scissors Reference: No-Scalpel Vasectomy third edition (http://www.engenderhealth.org/ﬁles/pubs/family-planning/no-scalpel.pdf) Page 7 to 9.

139

6.3 Surgical instrument stainless steel Surgical stainless steel is a specific type of stainless steel, used in medical applications. The word ‘surgical’ refers to the fact that these types of steel are well-suited for making surgical instruments: they are strong, corrosion-resistant, easy to clean and sterilize. Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health Surgical stainless steel includes elements of: chromium, nickel and molybdenum. The chromium gives the metal its scratch resistance and corrosion resistance. The nickel provides a smooth and polished finish. The molybdenum gives greater hardness and helps maintain a cutting edge. Although there are myriad of variations, there are two main categories of stainless steel: martensitic and austenitic (Table 42); Surgical stainless steels are defined by the standard EN ISO 7153-1: Surgical instruments - Metallic materials – Part 1: Stainless steel.

Table 42. Two main types of stainless steel Martensitic stainless steels These are quenched, magnetic steels. They contain: CARBON => 0,1 to 1 % Gives hardness and tensile strength Lowers corrosion resistance CHROMIUM => 12 to 14 % Essential alloying element Austenitic stainless steels These are non-quenched, non-magnetic steels. They contain: CHROMIUM => 16 to 20 % Essential alloying element Gives corrosion resistance MOLYBDENUM => 2 to 3 % Gives corrosion and impact resistance NICKEL => 8 to 12 % SILICON => 0,5 to 1 % MANGANESE => 0,4 to 2 %

2014

Gives corrosion resistance MOLYBDENUM => 0,2 to 1 % Improves the cutting qualities Gives corrosion and impact resistance Cannot be used for pressure force instruments, as it makes them brittle SILICON => 0,5 to 1 % MANGANESE => 0,4 to 2 %

Note: Most surgical instruments are made out of martensitic stainless steel, it is much harder than austenitic stainless steel, and easier to keep sharp. Depending on the type of surgical instruments, the stainless steel composition & manufacturing process vary slightly to get more sharpness or more strength.

Families of products 1. Pressure force instruments and springs => martensitic steel

• • • • • • • • • • • •

Haemostatic forceps Dissecting forceps Gripping forceps Surgical towel clamp Needle-holding forceps Threading forceps Clamping forceps

The steel used must be springy and highly impact resistant. Carbon gives them hardness, while chromium gives them corrosion resistance. The proportions must be very exact. Instruments made of these steels have to undergo a complex, rigorous heat treatment which allows the steel to be hardened; otherwise they will bend the first time they are used. Instruments made of these steels must be carefully polished; the quality of the polishing determines the corrosion resistance. The steel used has a higher percentage of carbon than for the pressure force instruments in order to increase hardness. The percentage of chromium is the same to give corrosion resistance, while incorporation of molybdenum makes up the balance and improves the cutting qualities.

2. Instruments that cut by shearing => martensitic steel Scissors Curettes Raspatories Gouge shears Cutting forceps

140

6. Surgery and Anaesthesia

3. Instruments that cut by percussion => martensitic steel

• • • • • • • • • • •

Chisel shears Osteotomes Gouges

For the cutting part, the heat treatment and polishing are the same as for instruments that cut by shearing. For the non cutting part, the heat treatment and polishing are the same as for pressure force instruments.

4. Static function instruments => martensitic or austenitic steel Autostatic retractors Long-handled retractors Valves Speculums Dilators Instrument box Obstetrical hook Manual drill etc.

5. Miscellaneous instruments => austenitic steel

Table 43. Standard grades of steel for surgical instruments Composition of the steel MOLYBDENUM MANGANESE 1 1 1 1 1 1 1 % % % % % % % 0.4 % 1% 1% 1% 1% 1% 1% 1% 2 2 2 2 2 % % % % % CHROMIUM CARBON

Families of products

Type of steel

1. Pressure force instruments & springs Haemostatic forceps Dissecting forceps Gripping forceps Surgical towel clamps Needle-holding forceps Threading forceps Clamping forceps 2. Instruments that cut by shearing Scissors Curettes Raspatories Gouge shears Cutting forceps Martensitic Martensitic Martensitic Martensitic Martensitic 0.4 % 0.2 % 0.2 % 0.3 % 0.3 % 14 % 13 % 13 % 13 % 13 % 0.5 % 1% 1% 1% 1% Martensitic Martensitic Martensitic Martensitic Martensitic Martensitic Martensitic 0.2 0.2 0.2 0.2 0.2 0.2 0.2 % % % % % % % 13 13 13 13 13 13 13 % % % % % % % 1 1 1 1 1 1 1 % % % % % % %

3. Instruments that cut by percussion Chisel shears Osteotomes Gouges 4. Static function instruments Autostatic retractors Long-handled retractors Valves Speculums Dilators 5. Miscellaneous instruments Instrument box etc. Austenitic Martensitic Austenitic Austenitic Austenitic Austenitic 13 % 18 % 16–18 % 16–18 % 18 % 8-10 % 10-12 % 10-12 % 8-10 % 1 1 1 1 1 % % % % % Martensitic Martensitic Martensitic 0.5–0.7 % 0.5–0.7 % 0.3 % 13–14 % 13–14 % 13 % 0.5-0.9 % 0.5-0.9 % 1% 1% 1%

0.3 %

2-3 % 2-3 %

SILICON

NICKEL

141

6.4 Surgical sutures A surgical suture is a sterile single use medical device used to hold body tissues together after an injury or surgery. Needle-suture combination (atraumatic suture), needle with attached length of thread, is recommended. Note: Swaged needles are eyeless needles attached onto sutures threads at the factory, allowing a smooth junction between them. They are therefore less traumatic for the tissues. A number of different needles shapes, sizes and thread materials have been developed over its millennia of history. Sutures threads are made from numerous materials and exist in very specific sizes. Suture material can be classified on the basis of the characteristics absorbability, origin of material and thread structures. The original sutures were made from biological materials either absorbable, such as collagen derived from healthy beef and sheep (catgut) or non-absorbable, such as organic protein called fibrin (silk). Most modern sutures are from synthetic polymers, such as polyamide, polyolefines and polyesters, including non-absorbable as well as absorbable derived from polyglycolic acid. Sutures must be strong enough to hold tissue securely but flexible enough to be knotted. They must be hypoallergenic and avoid the “wick effect” (capillary action) that would allow fluids and thus infection to penetrate the body along the suture tract.

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Type of thread Suture absorbable (naturally biodegradable in the body),

• •

Natural:(i.e. catgut),

»»

Absorption by enzymatic process, varying resorption time.

2014

Synthetic (i.e. polyglycolic acid, polylactic acid)

»» • • •

Absorption by hydrolysis.

Suture non absorbable Natural: (i.e. silk) Synthetic (i.e nylon,polypropylene).

Structure of thread - Monofilament thread made of one single filament presenting a unique physical structure, knot tying more difficult, have no capillarity.

»» »» »» • »» »» »»

Multifilament thread made of several braided filaments, easier to handle and to tie, usely coated to reduce capillarity.

142

6. Surgery and Anaesthesia

Classification of suture thread sizes The tensile strength and knot-tying properties of a surgical suture material are determined not only by the starting material and structure, but also by the thickness of the thread. Classification of thread size must therefore be precise. Suture thread sizes are defined by two parralele systems: The United States Pharmacopeia (U.S.P.),

• •

range from 10-0 (or 10/0) to 5 Size refers to the diameter of the suture strand and is denoted as zeroes. The more zeroes characterizing a suture size, the smaller the resultant strand diameter (eg, 4-0 is larger than 5-0).

The European Pharmacopia (E.P.) metric, according to decimal system.

• • •

range from 0.2 to 7 (this denotes the diameter of the suture strand as a multiple of 0.1 mm.) Size refers to the diameter of the suture strand and is denoted asa multiple of 0.1 mm expressed as a DEC number (DEC2 = 0.20 mm)

Table 44. Size of non-absorbable and absorbable synthetic sutures USP EP (metric) Ø in mm

Non-absorbable & absorbable synthetic materials 10-0 9-0 8-0 7-0 6-0 5-0 4-0 3-0 2-0 0 1 2 3 and 4 5

Non-absorbable & absorbable synthetic materials 0.2 0.3 0.4 0.5 0.7 1 1.5 2 3 3.5 4 5 6 7

Limit on average diam Min - Max (mm) 0.020-0.029 0.030-0.039 0.040-0.049 0.050-0.069 0.070-0.099 0.100-0.149 0.150-0.199 0.200-0.249 0.300-0.349 0.350-0.399 0.400-0.499 0.500-0.599 0.600-0.699 0.700-0.799

Non-needled suture (spooled suture) Threads for non-swaged needles are supplied in spools and must be threaded on surgical needles with eyes by the user only at the time of use. They are more traumatic when passing through the tissues and increase the risk of accident (including users stick injuries). Consequently they need to be avoided.

Needle-suture combination (atraumatic suture) Atraumatic sutures are defined as needle-suture combinations. Swaged needles are eyeless needles attached onto sutures threads at the factory, allowing a smooth junction between them in order to reduce tissue trauma. Threads of needle-suture combinations have an average length of 75 cm. Nowdays, atraumatic sutures are widely used. There is a wide range of needles, they are made of stainless steel. They are defined by their curvature (longitudinal shape), their body (cross section) - point, their length.

143

Box 2. Needle shape 1. Curved needle, 1/2 circle (= half) (= 4/8) Deep sutures, stomatology, gynaecology…

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

2. Curved needle, 3/8 circle General surgery, vascular sutures…

3. Straight needle To be avoided (more dangerous than the curved needles).

Needle body – point Round-bodied needles taper gradually to a point whereas triangular-bodied needles have cutting edges along three sides. Examples include:Taper point needle (needle body is round and tapers smoothly to a point) & reverse cutting needle (needle body is triangular and has the third cutting edge located on the outer convex curvature of the needle)

Box 3. Needle body – point

2014 144

1. Round-bodied – Taperpoint needle Sutures of soft tissues, mucous membranes and vessels.

2. Triangular bodied - Reverse cutting needle Sutures of muscles and skin.

6.5 References 1. WHO Emergency & Essential Surgical Care. (http://www.who.int/surgery/en/, accessed 22 May 2014). 2. D Vo, M N Cherian, S Bianchi, L Noël, G Lundeg, A Taqdeer, B T Jargo, M Okello-Nyeko, A Kahandaliyanage, O SentumbweMugisa, A Ochroch E, D Okello, J Abdoulie, O.Ayankogbe, O A Soyannwo, P Hoekman, P Bossyn, R Sani, M Thompson, S Mwinga, S Prasad, M Wekesa, O Toliva, P Kibatala and M McCunn, Anesthesia capacity in 22 Low and Middle Income Countries. (2012). J Anesth Clin Res. April;3(4):207. 3. Ologunde R, Vogel JP, Cherian MN, Sbaiti M, Merialdi M,Yeats J, et al Assessment of cesarean delivery availability in 26 low- and middle-income countries: a cross-sectional study. (2014). Am J Obstet Gynecol. 4. Belle J, Cohen H, Shindo N, Lim M, Velazquez-Berumen A, Ndihokubwayo JB, Cherian MN.Influenza preparedness in low-resource settings: a look at oxygen delivery in 12 African countries. J Infect Dev Ctries. 2010 August;4(7):419-424. 5. Aide memoire on surgical and emergency obstetrical care at first referral level. Geneva: World Health Organization; 2003 (http:// www.who.int/surgery/publications/en/Aide-Memoire_surgery.pdf, accessed 22 May 2014). 6. Integrated Management for Emergency and Essential Surgical Care (IMEESC) toolkit. Geneva: World Health Organization; 2009 (http://www.who.int/surgery/publications/imeesc/en/index.html, accessed 22 May 2014).

7. Infection prevention and control 7.1 Injection safety With an estimated 25 billion injections administered annually in developing and transitional countries alone, injections are among the most frequently used medical procedures. If delivered unsafely, injections have the potential to contribute to the transmission of bloodborne pathogens with devastating consequences such as disability and death. Unsafe practices and the overuse of injections can cause an estimated 32% of Hepatitis B virus, 40% of Hepatitis C virus and 5% of all new HIV (human immunodeficiency virus) infections every single year (1). The risk of an unsafe injection is not only associated with the patient but also the health care worker (HCW) administering the injection and the community following dangerous waste disposal practices. In 1999, the World Health Organization (WHO) launched the Safe Injection Global Network (SIGN), an international alliance hoping to achieve the safe and appropriate use of injections on a global scale. The Injection Safety programme comprises of three core technical strategies believed to be necessary to bring about an improvement in injection practice. These include; (2) 1. Behaviour change among patients and healthcare workers to decrease injection overuse and achieve injection safety 2. Availability of necessary and of good quality injection devices and supplies 3. Management of sharps waste Implementation of these strategies will facilitate

7. Infection prevention and control

• • •

improved patient safety by preventing the reuse of injection equipment or reducing unnecessary injections; health care worker safety through needle stick injury prevention, provision of Hepatitis B vaccine or post exposure prophylaxis and community safety via safe sharps waste management.

Despite the simple strategies to improve injection safety, many countries are still facing to address unsafe injections issue: (3)

• • • •

Poor practices are being targeted such as preventing the reuse of equipment through the introduction of reuse prevention syringes (RUPs) syringes, however many challenges still remain. Injection equipment availability, supply and quality are still key issues that need to be resolved to ensure safer injection practices. Patient preference or doctor over-prescription of injectable medications means unnecessary injections are still a major issue. It is estimated that over 70% of injections are unnecessary when oral formulation could have been used as an alternative therapy. To bring about behaviour change is a well-recognized challenge yet it is essential that these issues and gaps in interventions are addressed to ensure improved injection safety throughout the world. Recent evidence suggests that change is possible. Intervention strategies that target all three core components simultaneously have been shown to have the greatest positive effect on improved injection safety.

To ensure rational use of injections and avoid risks of transmission of bloodborne pathogens to patients, healthcare workers and the community at large, WHO recommends to implement the following key steps: (4, 5, 6, 7, 8) 1. Always use one single-use sterile needle and one single-use sterile syringe per patient and per injection, and to reconstitute each unit of injectable medication. 2. Promote oral treatment and limit the number of injections to only those strictly necessary. Use oral rehydration to limit the use of drips. 3. Single-use syringes with a reuse-prevention feature (RUPs) should be considered for therapeutic injections, and auto-disable syringes with attached needles ( Ads) for immunization activities. 4. Ensure adequate supply of good quality and safety injection devices and that all injectable medications are supplied with matching quantities of single-use safety syringes, appropriate diluents and safety boxes/sharp containers according to the bundle principle. 5. Use single-dose vials rather than multi-dose vials. If multi-dose vials must be used, always pierce the septum with a sterile needle and avoid leaving a needle in place in the vial stopper. 6. Collect used needles and syringes in a sharps container according to waste segregation rules.

145

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

7.2 Decontamination and Sterilization at healthcare facilities (9, 10, 11) Safe maternal childbirth is one of the Millennium Goals set by the WHO, however this goal cannot be achieved due to a lack of properly sterilized medical devices in health delivery areas resulting in transmission of infectious agents such as hepatitis B and C, HIV and bacterial pathogens. Antenatal care and management of sexually transmitted diseases are offered in primary health clinics and community units. Maternal obstetric units (MOU) provide facilities for both natural deliveries as well as assisted childbirth such as Caesarean section. Medical devices used for examination of women, which come in contact with mucous membranes and maternal birth canal must be either disposable or, if reused, sterilized using heat s. Disposal items available in such healthcare facilities include personal protective clothing (such as gloves and plastic aprons), disposable vaginal speculae, needles and syringes, suturing material, and laboratory collection tubes A separate designated area should be made available to reprocess medical devices. It must have running water preferably both hot and cold, electricity and good light and ventilation. Only trained staff should clean medical devices and prepare them for safe patient use. Protective equipment such as a visor, mask, apron and gloves and headgear must be provided during the cleaning and reprocessing of medical devices. The first step and most important step in reprocessing medical devices is thorough cleaning prior to any method of disinfection or sterilization. This can be done either manually in a sink or bowl, via an ultra sonic bath or an automated washer disinfector. Manual cleaning will require a pair of domestic gloves, water with detergent at the correct dilution and a soft nylon brush to clean the medical devices by holding them under the water level to avoid splashing. Automated systems should include a disinfection stage with temperatures of not less than 80°C for 10 minutes or 90°C for 1 minute. Medical devices reprocessed in a washer disinfector must emerge dry. Chemical disinfectants such as sodium hypochlorite must never be used to soak medical devices prior to cleaning- these destroy the integrity of the medical device coating, create crevices and increase the risk of contamination- they also give a false sense of security to the users. After cleaning, the medical devices are inspected for cleanliness especially the hinges, serrated edges and teeth, integrity and functionality. Those found to be unfit for use are replaced before sterilizing with heat. In the absence of heat, a high level disinfectant (such as glutaraldehyde or peracetic acid) will be considered but the chemicals must be rinsed off thoroughly and medical devices dried prior to use. There is a danger of carrying over chemicals which can cause injury to the vaginal mucosa and therefore great care must be taken when using chemicals for maternity units and primary health care. Boiling sterilizers: these require filling with water and boiling for 10 min. Some have temperature and pressure gauges (pressure cookers) fitted to them. The advantage is that these is that they are cheap and can be used anywhere where there is electricity or a source of heating up the water. The disadvantage is that the process cannot be controlled and the devices cannot be dried without contaminating them. Bench top sterilizers: There is wide range of bench top sterilizers ranging from those that require filling and have a heating element to sophisticated self steam generating sterilizers. The medical devices are loaded in open trays and placed in the sterilizer. Some have built in validation processes. The advantage is that the medical devices are exposed to high temperatures and the process is much safer. The cycle is short and therefore the devices are readily available. The disadvantages are that the medical devices are not wrapped and therefore can become contaminated, the devices emerge hot and have to be cooled down and each cycle has to be monitored manually.

2014 146

7. Infection prevention and control

Figure 3. Bench top front loading sterilizer

Figure 4. Pot sterilizer

Dry Heat or Hot Air Sterilizers: These consist of a simple chamber incorporating a heating element and a fan. The advantages of these are that they only require a source of electricity and do not need running water. The disadvantages are that they require a very long cycle time that exceeds 3 hours by the time heat up is included. As with bench top sterilizers, the medical devices are not wrapped and therefore can become contaminated, the devices emerge hot and have to be cooled down and each cycle has to be monitored manually.

Figure 5. Dry Heat sterilizer

Whatever type of sterilizer is used, it is important that the process is validated and that either biological indicators or chemical indicators are routinely used to prove the sterilizing performance. Documentation requires standard operating procedures (SOP) that everyone carrying out the procedure will follow easily. There must be a register or a logbook kept of medical devices processed and by which method, to ensure patient safety records- Traceability is essential.

Acknowledgement: Contribution on behalf of the Decontamination Working Group under WHO Patient Safety, Prof Shaheen Mehtar, Unit for IPC, Div Community Health, Fac Medicine and Health Sciences Stellenbosch Uni, Chair of the Decontamination Working Group under WHO Patient Safety. Mr Wayne Spencer, Hospital Engineer, Healthcare Facilities Consultants, member of Decontamination Working Group under the WHO Patient Safety.

147

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Box 4. Model 10 Point Manual Washing Procedure: 1. Fill the sink or other clean receptacle with potable water to a predetermined level at the specified temperature and with the appropriate detergent. Detergents used must be specifically designed to clean surgical instruments: washing-up liquid should not ideally be used. Detergent dilution and water temperature should be in accordance with the manufacturer’s instructions and local policy. Consideration should be given to the use of an enzymatic detergent to facilitate the cleaning of surgical instruments with channels or complex parts. 2. Dismantle or open the instrument to be cleaned and fully immerse in the solution to displace trapped air and, in the case of hollow instruments, to ensure penetration of channels. 3. Brush, wipe, agitate, irrigate, jet-wash or hand-spray the item to dislodge and remove all visible dirt, taking care to ensure the item remains under the surface of the water at all times to prevent the creation of aerosol (spray). Brushes should be made from nylon bristles and should be cleaned and sterilized daily, or preferably, should be single-use only. 4. If high-pressure-jet guns are used for cannulated instruments, they should be connected to the cold-water supply only. The gun is connected to the instrument and held under water during the irrigation process. 5. Remove the device from the sink or bowl and drain any excess cleaning solution before placing into a second sink or bowl for rinsing. 6. Change the rinse-water after every batch of instruments or when it becomes visibly soiled or cloudy.

2014 148

7. Rinse the item thoroughly with clean potable water using the water-jet gun when necessary (see point 5). 8. Remove and drain the item, and then dry using the preferred method: for example, by using a clean, nonlinting cloth or by mechanical drying. An alcohol wipe can be used to facilitate the drying process. 9. Cleaning materials should be safely disposed of in accordance with local waste policy. 10. Record the device that has been processed including the method and solutions used and details of the staff member who completed the procedure.

7.3 Sterilization equipment Processing of reusable medical devices must be done according to the risk of infections (critical, semi-critical and noncritical items) and the heat resistance of the materials (thermoresistant or thermosensitive devices). Thermoresistant critical items (such as surgical instruments and surgical drapes) must be sterilized by steam autoclave between each patient and kept sterile until use. Thermosensitive critical items (such as tubes and catheters) are for single use only and must not be resterilized or reused. Thermoresistant semi-critical items must be sterilized by steam autoclave between each patient but do not need to be kept sterile until use. Thermosensitive semi-critical items must be subjected to high-level disinfection between each patient. Noncritical items must be cleaned and disinfected regularly but not necessarily between each patient, unless they have been soiled by blood or other biological fluids or in case of infection requiring isolation. For more information, please see Section 5 (special note on decontamination and sterilization at health-care facilities).

Table 45. Basic sterilization equipment and other relevant equipment (12) Drum, sterilizing # sizes Indicator, TST control, spot & tape Masking tape, for sterilization pack Paper sheet, crepe, for sterilization pack Timer, 60 min, mechanical Sterilizer, steam, approx. # capacities, electric with accessories

7.4 Health care waste management Health-care waste is a by-product of health care that includes sharps, non-sharps, blood, body parts, chemicals, pharmaceuticals, medical devices and radioactive materials. In order to avoid air and water pollution and the possible transmission of infections by health-care waste, proper health-care waste management should be implemented and promoted in all situations. (13, 14) Health-care waste management includes the following steps: 1. Segregation of the various categories of waste; 2. Storage and collection; 3. Treatment and disposal; 4. Waste zone.

7. Infection prevention and control

Segregation The four major categories of health-care waste recommended for organizing segregation and separate storage, collection and disposal are (WHO 2005):

• • • •

sharps (needles, scalpels etc.), which may be infections or not; non-sharps infections waste (anatomical waste, pathological waste, dressings, used syringes, used single-use gloves); non-sharps non-infections (general) waste (paper, packaging etc.); hazardous waste (expired drugs, mercury-containing thermometers, laboratory reagents, radioactive waste, insecticides etc.).

Storage and collection Sharps should be places immediately after use in puncture resistant, fluid impermeable sharps containers which are placed at the site of use and regularly collected for disposal. Non-sharps infections waste contains (15-401 capacity, with lids) should be collected, emptied, cleaned, disinfected and replaces after each intervention (e.g. in an operating or maternity unite) or twice daily. Non-sharps non-infections waste (20-601 capacity) should be collected, emptied, cleaned and replaces daily; alternatively, plastic bags may be used inside the containers (MSF 2005). For the above categories of waste, it is recommended that waste containers are a maximum of 5m from the point of waste generation, in 2 sets for each location, for a minimum 3 types of waste. At least one set of waste containers should be provided per 20 beds in a ward (MSF 2005). Hazardous waste should be collected and stored in appropriate labelled containers places in a secure location. Radioactive waste should be stored in containers that prevent dispersion, behind lead shielding. (14)

Treatment and disposal Sharps should be disposed of in a sharps pit (buried drum in small centres or emergency structures, concretelined sealed pit in other settings) or autoclave followed by shredding after which they can be buried in a pit or landfill. Non-sharps infections waste should be buried in a pit fitted with a sealed cover and ventilation pipe, or hightemperature (850 degrees C) incineration. Special arrangements may be needed for disposing of placentas, according to local custom.

149

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Steam sterilization prior to disposal, if available, is a preferred option for specific infectious waste such as blood samples, plastic syringes and laboratory tests, prior to disposal, as this avoids environmental pollution from incineration (14). It is important to dedicate one specific autoclave for waste sterilization that is different from the one used for sterilization of medical devices within the laboratory. See WHO, 2013 and UNEP, 2012 for details of range of processes for treating infectious wastes. Non-sharps non-infectious waste should preferably be recycled or can be buried in a pit or a landfill site. If space is limited, it could be incinerated. If this is not possible, it may be burned in a drum burner. In both cases, ashes and residues should be buried in a pit. There are several kinds of hazardous waste and each requires specific treatment and disposal methods, which may include encapsulation, sterilization, burial, incineration and long-term storage. Some wastes, such as pharmaceutical wastes, cannot be disposed of safely in low-cost settings and should be sent to a large centre for storage and destruction or returned to the supplier. For guidance on treatment and disposal of hazardous wastes, see WHO Safe management of wasted from health-care activities, second edition, 2013 (14). In all cases, national legislation should be followed.

Waste zone Health-care waste is segregated at the point of generation according to its four types (sharps, non-sharps infectious waste, non-sharps non-infectious waste, hazardous waste) in colour-coded or labelled waste containers that are collected from all healthcare services and stored safely before treatment and/or disposal by safest feasible method available. Waste containers should be located a maximum of 5 metres from the point of waste generation. At least one set of waste containers should be provided per 20 beds. The health care facility should have a specific waste-disposal zone which is fenced off, has a water point with soap and/ or disinfectant The waste-disposal zone should also be located at least 30 metres from groundwater sources. Where an incinerator is used, it should be located to allow effective operation with minimal local air pollution in the health centre, nearby housing and crops, and it should be large enough for extension if new pits or other facilities have to be built. Wastewater drainage rainwater and surface run-off from health-care settings should be built and managed to avoid contamination of the health-care setting or the broader environment. Wastewater should be removed in standard waste drainage systems to off-site sewer or on-site disposal systems. All open wastewater drains should be covered. Small quantities of infectious liquid may be poured into sinks or toilets. Toxic wastes (e.g. from a laboratory) should be treated as health-care waste and not combined with wastewater. Where possible the health-care setting should be connected to properly built and functioning sewer system and treatment plant. Otherwise and on-site septic tank with effluent discharged into a soakaway pit or infiltration trench. Grey water may also be disposed in the septic tank or in soakaway pits or infiltration trenches equipped with grease traps. There should be at least 1.5 metres between the bottom of the infiltration system and the groundwater table (more in coarse sands, gravels and fissured formations), and the system should be at least 30 metres from any groundwater source to avoid contaminating groundwater. Septic tank sludges from healthcare settings should not be used for agricultural purposes, but should be buried following safe procedures.

2014 150

Further reading WHO Management of waste from injection activities at district level. Guidelines for District Health Managers. Geneva: World Health Organization; 2006 (http://www.who.int/water_sanitation_health/medicalwaste/ mwinjections.pdf, accessed 22 May 2014). Mercury and health, fact sheet no. 361. World Health Organization; 2013 (http://www.who.int/mediacentre/ factsheets/fs361/en/, accessed 22 May 2014). Replacement of mercury thermometers and sphygmomanometers in health care, Technical guidance. Geneva: World Health Organization; 2011 (http://whqlibdoc.who.int/publications/2011/9789241548182_eng. pdf, accessed 22 May 2014). Natural Ventilation for Infection Control in Health-Care Settings. Carnberra: World Health Organization; 2009 (http://whqlibdoc.who.int/publications/2009/9789241547857_eng.pdf, accessed: 22 May 2014). Sterilization manual for health centres. Washington D.C.: Pan American Health Organization; 2009 (http:// www2.paho.org/hq/dmdocuments/2009/sterilization_manual_2009.pdf, accessed 22 May 2014).

WHO guidelines on Hand Hygiene in Healthcare: First Global Patient Safety Challenge Clean Care is Safer Care. Geneva: World Health Organization; 2009 (http://whqlibdoc.who.int/ publications/2009/9789241597906_eng.pdf, accessed 22 May 2014). Standard precautions in Health care. Geneva: World Health Organization; 2007 (http://www.who.int/csr/ resources/publications/EPR_AM2_E7.pdf, accessed 22 May 2014). Mercury in health care, Policy paper. Geneva: World Health Organization; 2005 (http://www.who.int/water_ sanitation_health/medicalwaste/mercurypolpap230506.pdf, accessed 22 May 2014). Infection control. Geneva: World Health Organization; 2004 (http://www.who.int/injection_safety/AM_ InfectionControl_Final.pdf, accessed 22 May 2014). Safe health-care waste management, Policy paper. Geneva: World Health Organization; 2004 (http://www. who.int/water_sanitation_health/medicalwaste/en/hcwmpolicye.pdf, accessed 22 May 2014). Healthcare worker safety, aide-memoire. Geneva: World Health Organization; 2003 (http://www.who.int/ injection_safety/toolbox/docs/en/AM_HCW_Safety.pdf, accessed 22 May 2014). Safe health-care waste management, aide-memoire. Geneva: World Health Organization; 2003 (http://www. who.int/water_sanitation_health/medicalwaste/aidemem.pdf, accessed 22 May 2014). UNEP Compendium of technoloiges for the treatment or destruction of healthcare waste. Nairobi: United Nations Environment Programme; 2012. (http://www.unep.org/ietc/Portals/136/News/Publication%20of%20 Healthcare%20Waste%20compendium%20of%20technologies/Compendium_Technologies_for_Treatment_ Destruction_of_Healthcare_Waste_2012.pdf, accessed 22 May 2014).

7. Infection prevention and control

7.5 References 1. WHO Aide memoire on injection safety. Geneva: World Health Organization (http://www.who.int/injection_safety/ about/country/en/AMENG.pdf, accessed 22 May 2014). 2. WHO Best Practices for injections and Related Procedures Toolkit. Geneva: World Health Organization; 2010 (http:// www.who.int/injection_safety/toolbox/9789241599252/en/index.html, accessed 22 May 2014). 3. WHO Guiding principles to ensure injection device security. Geneva: World Health Organization; 2003 (http://www. who.int/entity/injection_safety/toolbox/docs/en/Guiding_Principle_Inj.pdf, accessed 22 May 2014). 4. WHO-UNICEF-UNFPA Joint statement on the use of auto-disable syringes in immunization services. Geneva: World Health Organization, United Nations Children’s Fund, United Nations Population Fund; 1999 (http://www.who.int/ entity/injection_safety/toolbox/en/Bundling.pdf, accessed 22 May 2014). 5. Safe Injection Global Network: Advocacy Booklet. Geneva: World Health Organization; 2011 (http://www.who.int/injection_safety/sign/advocacy_booklet/en/index.html, accessed 22 May 2014). 6. Safe Management of Wastes from Health-Care Activities. Geneva: World Health Organization; 1999 (http://www.who. int/entity/injection_safety/toolbox/docs/en/waste_management.pdf, accessed 22 May 2014) 7. A Guide for the Quality Assurance of Single Use Injection Equipment. Geneva: World Health Organization; 2003 (http://www.who.int/entity/injection_safety/toolbox/docs/en/InjEquQualityGuiden.pdf, accessed 22 May 2014).

8. Safety of Mass Immunization Campaigns. Geneva: World Health Organization; 2002 (http://www.who.int/entity/ injection_safety/toolbox/en/AM_SafetyCampaigns.pdf, accessed 22 May 2014). 9. Pan American Health Organization. Sterilization Manual for Health Centers. Washington, D.C.: PAHO; 2009. (http://pdf. usaid.gov/pdf_docs/PNADT378.pdf, accessed 22 May 2014). 10. Best Practice in D&S Canada Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities. BC Ministry of Health; 2011 (http://www.health.gov.bc.ca/library/publications/year/2011/Best-practice-guidelinescleaning.pdf, accessed 22 May 2014). 11. Health Estates. Decontamination in General Dental Practices DHSSPS General Dental Services Quality Improvement Scheme Technical Guidance. 2007. (http://www.dhsspsni.gov.uk/gdp_dg_2007_-_decontamination_guidance_ nov_2007.pdf, accessed 22 May 2014). 12. Interagency list of essential medical devices for reproductive health. Geneva: World Health Organization, John Snow Inc., PATH, Population Action International, United Nations Population Fund and World Bank; 2008 (http://apps.who. int/medicinedocs/documents/s16440e/s16440e.pdf, accessed 22 May 2014). 13. WHO health-care waste web site. (http://www.who.int/topics/medical_waste/en/, accessed 22 May 2014). 14. Safe management of wastes from health-care activities, second edition. Geneva: World Health Organization; 2013 (http://apps.who.int/iris/bitstream/10665/85349/1/9789241548564_eng.pdf , accessed 22 May 2014)

151

8. Technical notes regulation and management of medical devices Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

8.1 Regulations for Medical devices The regulations are established with each jurisdiction’s Culture, History, Religion and Philosophy, especially Modern Medical regulations have a long struggled history with Complementary and Alternative Medicine. Generally, many jurisdictions established Food and Pharmaceutical regulations in the first and tried to consider Medical Device regulations in the next. The pharmaceutical professionals look hard to understand the conceptual difference between Pharmaceutical/Vaccine and Medical Device, because of their professional knowledge as quality, safety and efficacy. For example, International Organization for Standardization (ISO) issues Device-specific standards for Quality and Risk (see box 5), does not pharmaceutical one. So they may not have any interest in the viewpoint of standards. We can recognize many kinds of medical devices as Active/Energy Supplies, Active Implants, Implants, Life Supporting/Monitoring Devices, Therapeutic Devices, Surgical Instruments, Diagnostic Imaging Devices, IVD, Contraceptive Devices, Healthcare Facilities, Hygiene Materials, Assistive Devices for Disabled Persons, Softwares… Legislators and regulatory authorities need to consider the appropriate regulations on these categorized devices for their (1) quality management system with risk management process and regulatory audit process, (2) pre-market evaluation of safety and performance, (3) post-market vigilance/surveillance throughout their life-cycle and (4) priority of procurement. As pointed above, the global regulatory harmonization and convergence for Medical Device looks hard. However we need them, fundamentally to protect the public health, promote the public safety, decrease the cost of procurement and regulatory compliance and allow the earlier access to new technologies and treatments. Global Harmonization Task Force (GHTF) encouraged medical device regulatory harmonization and convergence at the global level with many guidance documents in five areas; (1) Pre-market Evaluation, (2) The Global Harmonization Task Force Regulatory Model Post-market Surveillance/Vigilance, (3) Quality Systems, (4) Auditing and (5) Clinical Safety/Performance GHTF Ad Hoc Working Group 2011 GHTF/AHWG-GRM/N1R13:2011 (see Reference). Also GHTF showed the GHTF Regulatory Model (GRM) with the components of regulatory __________________________________________________________________________________________________ frameworks inalso a progressive which be based on a due comprehensive should be noted that the manner, possible effect on theshall availability medical devices to a burden of legislative and policy implemented regulations on manufacturers of medical devices is outside the scope of the GHTF. foundation. Figure 13. Progressive Regulatory Framework Figure 6. Progressive Regulatory Framework

2014

Highest

Medium Basic Foundation

Medium Foundation Basic Foundation

Basic

While the Basic Level Framework components is considered to be the minimum requirements for a regulatory • Statement of policy considerations in establishing a regulatory frame: least burdensome framework, additional elements from the medium and high level ones may be considered, based on the need approach, harmonization, transparency, political accountability, protection of the public, for regulatory oversight or resource availability. In efforts to establish the most robust framework possible, and administrative efficiency individual jurisdictions should consider the partnering with other jurisdictions. Similarly, all elements of the basic • Acceptance of risk-based approach and classification system level framework should be presumed to be incorporated in the medium and highest level ones (Figure 6). • Adoption of elemental definitions including manufacturer, importer, distributor, medical device • Establishment and maintenance of a “registry” listing of products being placed on the national/regional market with the contact information for the manufacturer (including regulatory contact) and recognized importers and distributers Establishment of a basic but active post-market surveillance system with incident reporting – possible involvement with NCAR

11.1 Basic level framework:

152

•

In the next, we need the conceptual understanding of key topics for medical devices.

8. Technical notes regulation and management of medical devices

Quality Assurance Traditionally, GMP (Good Manufacturing Practice) is using to ensure the product quality in the manufacturing and testing process for Pharmaceuticals and Medical Devices. For example, the importer of Pharmaceuticals needs to assure the product quality by Laboratory testing with the sampling of each batch. Now we should require QMS (Quality management System) as ISO 13485 instead of GMP for Medical Devices. Generally medical devices consist of many parts including lots of raw materials. We can recognize one lot of medical device as sterilization lot, however this lot can’t be recognized as a single quality product. The different concept is ‘Management System’ from ‘Good Practice’. ISO 13485 doesn’t show any practical procedure or criteria, because they shall be established by an organization throughout the lifecycle of a medical device including the design and development, production, storage and distribution, installation and servicing of medical devices, and the design, development, and provision of associated activities. So regulators need to trust a medical device manufacturer with their audit results.

‘Risk’-based concept for Essential Principles All kinds of regulation may be established with ‘Risk-based’ concept. GHTF founding members have 4 classes as Low, Low-Moderate, Moderate-High and High (Table 46).

Table 46. Risk-based Classifications for Medical Devices in Different Jurisdictions Risk Low Low-Mod Mod-High High GHTF A B C D USA I II II III Europe I IIa IIb III Japan I II III IV Canada I II III IV Australia I IIa IIb III

However ISO 14971 shows the definition of ‘Risk’ is ‘combination of the probability of occurrence of harm and the severity of that harm’. Customarily, a classification system of this type is referred to as a ‘risk-based classification scheme’ but this is a misnomer since the rules take account only of the hazard presented by a particular device and not the probability harm will occur. So GHTF guidance uses Class A, B, C, D instead of digits (1<2<3<4). This classification requires more and detailed (not higher) information in Essential Principles of medical devices from A to D with their hazard. For example, GHTF guidance Rule 17 shows class C on condoms, because the hazard associated with unwanted pregnancy if caused by mechanical failure of the device is significant. So the manufacturer of condom needs to comply with all kinds of technical standards for safety, performance and quality of their condom in R&D process. Regulator will audit and evaluate the manufacturer’s QMS and application for approval or certification. Also post-market regulations are established with ‘risk-based’ concept. However condom shall be distributed /spread easily in the standing point to safeguard the public health. This purpose doesn’t require Class C distribution practice. In the conclusion, Pre or Post-market may require different class for some medical devices.

153

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Nomenclature/Coding System Human being can identify something with acknowledge by description. The nomenclatures of medical devices are also described with Term and Definition. However here are lots of languages, for example EU has 23 official languages, so we have ‘Translation’ issue in the global communication. If a certain country had introduced a western medicine from Dutch, this country should call ‘Forceps’as ‘Pincet’. So the term of medical devices are following the import of medical treatment in each jurisdiction’s history. In order to identify the medical devices, many jurisdictions established their own nomenclature system traditionally, for example, Product Code in US-FDA, UMDNS (Universal Medical Device Nomenclature System) by the US-ECRI, CND (Classificazione Nazionale Dispositivi Medici) in Italy, NKKN (Norsk Klassifisering Koding & Nomenklatur, Norwegian Nomenclature) in Norway and so on. CEN and ISO issued ISO 15225 and CEN had continued to establish the harmonize medical device nomenclature from 1997 as GMDN (Global Medical Device Nomenclature) including six existing nomenclatures; 1. CNMD Classification Names for Medical Devices and in Vitro Diagnostic Products. Developed by Food and Drug Administration (FDA) USA 2. EDMA European Diagnostic Manufacturers Association in vitro diagnostic product classification 3. ISO 9999 Technical Aids for Disabled Persons Classification 4. JFMDA Japanese Medical Device Nomenclature

2014 154

5. NKKN Norsk Klassifisering Koding & Nomenklatur, Norwegian Nomenclature 6. UMDNS Universal Medical Device Nomenclature System Developed by ECRI The purpose of GMDN is basically the usage for Data Exchange in Post-market vigilance and Inventory Control in the user facilities. So the flat structure is established instead of hierarchy one. This flat structure is very useful for Registration and Listing System, e.g. UDI (Unique Device Identifier) of each medical device. On the other hand, the hierarchy structure is very useful for regulation system on the group of specific medical devices, e.g. Conformity Assessment with their Essential Principle. On the other hand, another nomenclature may be used for Reimbursement System, based on the medical treatment categories. We should recognize these different concepts of nomenclature systems. The ‘Translation’ issue should be solved by ‘Coding’ system. Each nomenclature system has their own coding system, as 5 digits, 8 digits and so on. We don’t need to use specific term with their own languages, we need to use just codes with the translation in our background, for example we can find the code;16209 as ‘Ophthalmic tissue forceps, reusable’ in GMDN and we can still identify it is ‘Reusable Ophthalmic Pincet’ in our own traditional terms. The coding system is also forwarded in the post-market vigilance, e.g. Adverse Event Codes. We need to understand the importance of Coding System in the Global Communication.

Box 5. ISO Standards (http://www.iso.org/iso/home/standards.htm) ISO 9000:2005 Quality management systems -- Fundamentals and vocabulary ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes ISO 14971:2007 Medical devices -- Application of risk management to medical devices ISO 15225:2010 Medical devices -- Quality management -- Medical device nomenclature data structure

8. Technical notes regulation and management of medical devices

Box 6. GHTF Documents All GHTF guidance is available in International Medical Device Regulators Forum (IMDRF) website (http://www.imdrf.org/documents/documents.asp) GHTF/SC/N4 Definition and Glossary of Terms Used in GHTF Documents The GHTF Regulatory Model Unique Device Identification (UDI) System for Medical Devices GHTF/AHWG-GRM/N1 GHTF/AHWG-UDI/N2

GHTF/SG1/N71 Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ GHTF/SG1/N55 Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer GHTF/SG1/N78 Principles of Conformity Assessment for Medical Devices GHTF/SG1/N77 Principles of Medical Devices Classification GHTF/SG1/N68 Essential Principles of Safety and Performance of Medical Devices GHTF/SG1/N63 Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices GHTF/SG1/N44 Role of Standards in the Assessment of Medical Devices GHTF/SG1/N70 Label and Instructions for Use for Medical Devices GHTF/SG1/N65 Registration of Manufacturers and other Parties and Listing of Medical Devices GHTF/SG2/N54 Global Guidance for Adverse Event Reporting for Medical Devices GHTF/SG2/N33 Timing of Adverse Event Reports GHTF/SG2/N32 Universal Data Set for Manufacturer Adverse Event Reports GHTF/SG2/N36 Manufacturer’s Trend Reporting of Adverse Events GHTF/SG2/N57 Content of Field Safety Notices GHTF/SG2/N31 Proposal for Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized Representative GHTF/SG2/N68 Summary of Current Requirements for Where to Send Adverse Event Reports GHTF/SG2/N09 Global Medical Devices Competent Authority Report GHTF/SG2/N79 National Competent Authority Report Exchange Criteria and Report Form GHTF/SG3/N15 Implementation of risk management principles and activities within a Quality Management System GHTF/SG3/N17 Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers GHTF/SG3/N18 Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N19 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange GHTF/SG3/N99 Quality Management Systems - Process Validation Guidance GHTF/SG4/N28 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 1: General Requirements GHTF/SG4/N30 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy GHTF/SG4/N33 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3: Regulatory Audit Reports GHTF/SG4/N83 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4: Multiple Site Auditing GHTF/SG4/N84 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 5: Audits of Manufacturer Control of Suppliers GHTF/SG5/N1 GHTF/SG5/N2 Clinical Evidence - Key Definitions and Concepts Clinical Evaluation

GHTF/SG5/N3 Clinical Investigations GHTF/SG5/N4 Post-Market Clinical Follow-Up Studies GHTF/SG5/N5 Reportable Events During Pre-Market Clinical Investigations GHTF/SG5/N6 Clinical Evidence for IVD medical devices - Key Definitions and Concepts GHTF/SG5/N7 Scientific Validity Determination and Performance Evaluation Clinical Evidence for IVD medical devices - Scientific Validity Determination and Performance Evaluation GHTF/SG5/N8 Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices

155

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Acknowledgments: This note was contributed by Mr Tom(omichi) NAKAZAKI, Visiting Professor, Department of Development Promotion, Clinical Research, Innovation and Education Center, Tohoku University Hospital (CRIETO).

8.2 Labels and instructions for use of medical devices The primary purpose of labelling is to identify the medical device and its manufacturer, and communicate safety and performance related information to the user, professional or lay, or other person, as appropriate. Such information may appear on the device itself, on packaging or as instructions for use. Definitions (1, 2) Information supplied by the manufacturer: means ‘Labelling’. Labelling: the label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents. Label: written, printed, or graphic information either appearing on the medical device itself, or on the packaging of each unit, or on the packaging of multiple devices. Instructions for use: information provided by the manufacturer to inform the device user of the medical device’s intended purpose and proper use and of any precautions to be taken. Intended use / purpose: The objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer. User: the person, either professional or lay, who uses a medical device. The patient may be the user. Lay person: individual that does not have formal training in a relevant field or discipline.

2014

ISO & EN Standards: Symbols used in Medical device label (3, 4) Selected ISO 15223 and EN 980 Medical Device Symbols

• ISO 15223, Medical Devices - Symbols to be used with medical devices label, labelling and information to be supplied

• EN 980, Graphical symbols for use in the labelling of medical devices The following chart displays the symbols with their definitions (Table 43).

156

Table 43. Medical devices - symbols with their definitions Symbol Used for Symbol Used for

8. Technical notes regulation and management of medical devices

Do not reuse

Use by YYYY-MM-DD or YYYY-MM

Batch code

Serial number

Date of manufacture

Sterile

Sterilized using ethylene oxide

Sterilized using irradiation

Sterilized using steam or dry heat

Catalog number

Caution, consult accompanying documents

Sterilized using aseptic processing technique

Manufacturer

Authorized representative in the European Community

Contains sufficient for < n > tests

For IVD Performance Evaluation only

In vitro diagnostic medical device

Upper limit of temperature

Lower limit of temperature

Temperature limitation

Consult instructions for use

Biological risks

Control

Negative control

Positive control

Graphic symbols

157

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

8.3 Units and biomaterials used for medical devices Systems used to specify the outside diameter for medical devices The Stubs Iron Wire Gauge system (also known as the Birmingham wire gauge) is used to specify thickness or diameter of metal wire, strip, and tube products. The Stubs system was the first wire gauge recognized as a standard in 1884. In medical, this wire gauge system is used to specify the outside diameter of hypodermic needles, catheters and suture wires. It is abbreviated as G, Ga, Gg or g. Another system; the French scale or French gauge system is commonly used to measure the outside diameter of catheters, tubes & drains. It is abbreviated as FG, Fr or F. It is also abbreviated as CH or Ch (for Charrière, its inventor) in French speaking countries.

Units The different units (symbols) used to express outside diameter (O.D.) in medical devices are listed below:

THE STUBS IRON WIRE GAUGE SYSTEM

2014 158

Gauge = G, Ga, Gg or g

Synonym: Birmingham wire gauge Definition: Unit which indicates the outside diameter (O.D.: Outer Ø) of the product, in a range, from 8G to 30G, corresponding respectively: 4 mm to 0.3 mm The higher is the gauge, the smaller is the outside diameter. The gauge gives the outside diameter, but does not take into account thickness of the wall, so it will not indicate the internal diameter. e.g.: 25G = 0.020 Inches - 0.514 mm e.g.: 21G = 0.032 Inches - 0.819 mm e.g.: 19G = 0.042 Inches – 1.067 mm

Field of use: IV short catheters, needles, scalp veins Note: The gauge/mm correspondence may vary, due to figures being rounded off in conversion from inches to millimetres (Reference made to conversion table between fractional and/or decimal inches and metric millimetres) Inch = In or ’’

Synonym: in French « pouce » Definition: Unit used to express the outside diameter (O.D.: Outer Ø) of guides for catheters 1 Inch = 25.4 mm 1 mm = 0.0394 Inch or 0.0394’’

Field of use: Guides for catheters

Table 47. Sterile single-use hypodermic needles: equivalence Gauge / mm and colour coding for identification (EN-ISO 6009) (3, 5, 6) Size in Gauge Nominal O.D. in mm Colour code

8. Technical notes regulation and management of medical devices

29 G 27 G 26 G 25 G 23 G 22 G 21 G 20 G 19 G 18 G 17 G 16 G 15 G 14 G 13 G

0.3 mm 0.4 mm 0.45 mm 0.5 mm 0.6 mm 0.7 mm 0.8 mm 0.9 mm 1.0 mm 1.2 mm 1.5 mm 1.6 mm 1.8 mm 2.1 mm 2.4 mm

Grey Brown Orange Blue Black Dark green Yellow Cream Pink Red-violet White Grey-blue Light green -

Table 48. Sterile, single-use intravascular catheters: equivalence Gauge / mm and colour coding for identification (EN ISO 10555) (3, 4, 5) Size in Gauge Nominal O.D. in mm Colour code

26 G 24 G 22 G 20 G 18 G 17 G 16 G 14 G

0.6 mm 0.7 mm 0.8;0.9 mm 1.0;1.1 mm 1.2;1.3 mm 1.4;1.5 mm 1.6;1.7;1.8 mm 1.9;2.0;2.1;2.2 mm

Violet Yellow Blue Pink Green White Grey Orange

159

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

THE FRENCH SCALE OR FRENCH GAUGE SYSTEM French gauge = FG, Fr or F

Synonym: French size, Charrière Definition: Unit which indicates the outside diameter (O.D.: Outer Ø) of the product, each unit corresponds to ⅓ mm The smaller is the French size, the larger is the outside diameter. The French size gives the outside diameter, but does not take into account thickness of the wall, so it will not indicate the internal diameter. 1FG = CH01 = ⅓ mm e.g.: 8 FG = CH08 = 2.7 mm (0.105 Inch) e.g.: 14 FG = CH14 = 4.7 mm (0.184 Inch)

Field of use: Exploratory catheters, tubes and drains Note: Some manufacturers offer catheters in Inches Charrière = CH or Ch

2014 160

Synonym: French gauge, French size Definition: Unit which indicates the outside diameter (O.D.: Outer Ø) of the product, each unit corresponds to ⅓ mm CH01 = 1FG = ⅓ mm e.g.: CH08 = 8 FG = 2.7 mm (0.105 Inch) e.g.: CH14 = 14 FG = 4.7 mm (0.184 Inch)

Field of use: Tubes and drains

GENERAL NOTE: An increasing French size corresponds to a larger outside diameter catheter. This is contrary to needle-gauge size, where an increasing gauge corresponds to a smaller diameter catheter. Figure 7. Equivalence Charrière / mm Endotracheal tubes Catheters and drains

8. Technical notes regulation and management of medical devices

NB: OD = Outer Ø, ID = Inner Ø

Biomaterials Biomaterials are materials (synthetic and natural; solid and sometimes liquid) that are used in medical devices or in contact with biological systems.

Polymers A polymer is a large molecule (macromolecule) composed of repeating structural units (building block of a polymer chain). These sub-units are typically connected by covalentchemical bonds*. Although the term polymer is sometimes taken to refer to plastics, it actually encompasses a large class of compounds comprising both natural and synthetic materials with a wide variety of properties. *A chemical bond is an attraction between atoms that allows the formation of chemical substances that contain two or more atoms. *A covalent bond is a form of chemical bonding that is characterized by the sharing of pairs of electrons between atoms. Major Polymer Classifications/Categories:

• • • •

Thermoplastic Thermoset Elastomer (or rubber) Thermoplastic elastomer (TEP)

161

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Polymer nomenclature: There are multiple conventions for naming polymer substances. Many commonly used polymers are referred to by a common or trivial name. The trivial name is assigned based on historical precedent or popular usage rather than a standardized naming convention. Both the American Chemical Society (ACS)(7) and the International Union of Pure and Applied Chemistry (IUPAC)(8) have proposed standardized naming conventions; the ACS and IUPAC conventions are similar but not identical.

Medical Devices Polymers A large range of polymer types are used in the field of Medical devices. Most of them are thermoplastic polymers. Medical devices polymers are subject to strict selection criteria and strong regulations from the raw material to the finish product as a lot of them are intended for implanting in the human body for a fairly extended period.

Table 49. Common Medical Devices Polymers – Glossary Acronym Polymer type

ABS EVA FEP PA 6/6 or Nylon 6/6 PC PES PE HDPE LDPE PET PGA PLA PMMA POM PP PSU PTFE PUR PVC TPU Latex NR SI

Acrylonitrile butadiene styrene Ethylene vinyl acetate Fluorinated ethyl polypropylene Polyamide 6/6 or Nylon 6/6 Polycarbonate Polyether sulfone Polyethylene High density polyethylene Low density polyethylene Poly(ethylene tetraphthalate) Polyglycolide or Polyglycolic acid Polylactic acid Poly(methyl methacrylate) Polyoxymethylene, Polyacetal Polypropylene Polysulfone Polytetrafluoroethylene Cross-linked Polyurethane Polyvinyl chloride Thermoplastic Polyurethane Natural latex rubber; particularly for non-vulcanized rubber Natural rubber (elastomer) (an elastic polymer) Silicone elastomer

2014 162

8.4 Textiles used for linen and clothing in health-care facilities Protection from infection and safety for patients and healthcare workers are major concerns. Occupational Safety and Health Administration (OSHA)(10) is a division of the Department of Labor and was established in 1971 to save lives, prevent injury, and protect workers’ health. OSHA recommends that appropriate *protectiveclothing must be worn to form an effective *barrier when an employee has a potential for exposure on the job (OSHA, 1989). The type of clothing and linen needed depends upon the occupational task and the degree of potential exposure. If the clothes are potentially soiled from blood or other potentially infectious materials, protective clothing must be worn to prevent the employees underlying clothing from contamination. Fluid-resistant clothing must be worn when workers could become contaminated through splashing or spraying of blood or other potentially infectious materials. Because a larger volume of blood and other potentially infectious materials are associated with the work of the healthcare workers, a specific protective type of barrier clothing is needed. * Personal Protective Equipment: “specialized clothing or equipment worn by an employee for protection against infectious materials”(OSHA)(11) * Barrier material: a material that minimizes or retards the penetration of microorganisms, particulates and fluids. (12, 13)

8. Technical notes regulation and management of medical devices

Linen and clothing for medical applications are subject to regulations, governed by a large range of norms/ standards (EN/ISO) (14, 15) according to level of expected protection. Linen and Clothing used in healthcare facilities: patient bed sheet, patient gowns, lab coats, surgical suits, surgical gowns, surgical drapes, isolation gowns, coveralls, caps, face masks, shoes covers, boots covers. Linen and clothing used for patients and healthcare workers can be manufactured from either single-use fabrics or multiple use fabrics The characteristics of single-use fabrics or multiple use fabrics are dependent on fiber type, and expected level of barrier performance bacteria and liquid barrier performances of the products Reusable fabrics can be used over 50 times after laundering and sterilization; whereas, single-use fabrics are used only once before being discarded. There are several factors to consider in determining the most appropriate textile to use in healthcare facilities. These will vary according to procedure and local priorities and are likely to include:

• • • • • •

The type of procedure and the assessed level of risk involved A priority of properties desired, for example: wet and dry bacterial barrier properties, fluid resistance, liquid absorption, strength etc. Disposable or reusable Processing requirements, for example: ability to be sterilized, rinse finishes in laundry Cost Expected life

Single-use nonwoven textiles Nonwovens are principally produced in three stages: web formation, bonding and finishing treatments. Nonwoven manufacturing starts by the arrangement of fibers in a sheet or web. The fibers can be staple fibers or filaments extruded from molten polymer granules. Basic methods are used to form a web, and nonwovens are usually referred to by one of these methods: drylaid; spunlaid; wetlaid. Nonwoven can be made of natural materials such as cotton, linen, wood pulp, and paper, or man-made materials such as polyester, polypropylene, polyimide, and polytetrafluoroethylene (PTFE). Spunbond nonwoven: fabric made of different fibers: polypropylene (PP), polyethylene (PE) etc.

• • •

Nonwoven textiles for basic protection Lightweight, breathable fabric, which consists of continuous filament, with good tensile strength and elongation. Standard fabric, low-cost solution for protecting workers

163

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Meltblown nonwoven:fabric made of very high density web of polypropylene fibers

• •

Nonwoven textiles for high protection Meltblowns often are used as high-degree filter media for air, liquid and particles.

Spunbonded Meltblown Spunbonded (SMS) nonwoven: fabric made of high density of polypropylene fibers, comprising layers of spunbond polypropylene, meltblown polypropylene, and spunbond polypropylene. Spunbond layer is with good tensile strength and elongation, meltblown layer consists of continuous micro fiber. Different types exist: SMMS – SMMMS according to expected level of protection.

• • • •

Nonwoven textiles for high protection Fluid and particulate barrier. Lightweight and resistant to tears and punctures Strong and durable, yet offer outstanding comfort, breathability, softness, and wearability

Reusable woven textiles Woven material: fabric constructed from yarns made of natural or synthetic fibers or filaments that are woven together to form a web in a repeated interlocking pattern. Reusable linen and clothing are often made of cotton, polyester, or cotton and polyester blend woven fabrics with a plain weave

2014 164

Cotton Cotton is a natural and staple length fiber. The polymer structure of cotton fiber is composed of over 90% cellulose polymers. Cotton is a durable fiber. The problem associated with cotton use for linen and clothing is its ineffectiveness in protection of healthcare workers against bacterial penetration and transmission. In addition, the hydrophilic nature of cotton allows for seepage and penetration when cotton linen and clothing are splashed with liquids (e.g., blood, body fluids). Note: Cotton fabrics can be treated by chemicals for antimicrobial finishing and by adding a water-repellent finish.

Polyester Polyester is a synthetic fiber, which is usually a transparent white or off-white color. Linen and clothing made of polyester are very durable due to the strength of the fibers. Polyester is a hydrophobic fiber, which means that it is non-polar and, therefore, does not attract water. The hydrophobicity of polyester can create a fabric environment that becomes uncomfortable if the wearer perspires. The polyester fibers would not be able to wick the perspiration or moisture away from the body, due to lack of hydrogen bonding in comparison to the structure and wicking properties of cotton. In addition, because of the hydrophobic characteristic of polyester, if the garment becomes contaminated, stains will become difficult to remove through laundering.

Polyester and cotton blend A fabric with a polyester and cotton blend fiber (65%-35%) content is the most common fabric type used for linen and clothing. One of the reasons is their combined properties of comfort from cotton fibers and durability from polyester fibers .Fabrics containing a polyester and cotton blend are stronger than fabrics made of 100% cotton and are more absorbent than fabrics made only of 100% polyester. Note: Polyester/cotton fabrics can be treated by chemicals for antimicrobial finishing and by adding a waterrepellent finish. As general overview, reusable woven surgical gowns and drapes are made of a cotton/polyester blend or 100% polyester.

New generation of woven fabrics Microfilament fabrics The yarn in microfilament fabrics is made of fine, continuous polyester filaments. Conductive carbon fibers are generally also woven into the material to guarantee permanent antistatic qualities. These fabrics are highly resistant to tearing and rubbing and release practically no particles when used. Because of the fluorocarbon component, the materials are fluid-repellent, which means that high-quality materials can be reprocessed up to 80 times.

8. Technical notes regulation and management of medical devices

Laminates A trilaminate (three-layer construction) is a membrane sandwiched between an upper and lower layer. Selecting suitable surface materials produces liquid-absorbing or repellent effects as desired. The membranes can be designed to prevent bacteria or viruses from penetrating together with liquids. The membrane is not a barrier for water vapor molecules. Human perspiration can therefore escape in the form of moisture vapor, thus maintaining natural thermoregulation. Furthermore, trilaminates are impervious to liquids even under high pressure and absorb high volumes of fluid on the surface and are therefore used in surgical areas (high performance)(16).

General note: The discussion continues about single-use, disposable materials versus reusable fabrics for linen and clothing in healthcare facility. Protection from infection and safety for patients and healthcare professionals are major concerns. Cost, regulations and the environment are also concerns for healthcare facility administrators. Multiple factors must be weighed when making a decision to purchase linen and clothing for healthcare professionals and patients including:

• • •

Required level of barrier protection from fluids, particulates and micro-organisms to reduce risk of infections. Material breathability and garment construction for physical comfort and ability to remain focused during medical/surgical procedures. Appropriate and safe disposal and proper waste management for minimal impact on the environment.

Over the last two decades, many studies have been conducted comparing the advantages and disadvantages of woven and non-woven materials used for linen and clothing in healthcare facility. The need for improving the level of protection has increased with the rise in infectious diseases. This need is greater in countries where economic factors come in to play and seriously inhibit good healthcare and infection control practices.

Useful links • • • • • • Association for the Advancement of Medical Instrumentation (AAMI). Arlington: Association for the Advancement of Medical Instrumentation (http://www.aami.org/, accessed 22 May 2014) American Society for Testing Materials (ASTM). West Conshohocken: American Society for Testing Materials (http:// www.astm.org/, accessed 22 May 2014) International Organization for Standardization (ISO). Geneva: International Organization for Standardization (http:// www.iso.org/iso/home/standards.htm, accessed 22 May 2014) Committee for European Normalisation (CEN). Brussels: Committee for European Normalisation (http://www.cen.eu/ cen/Sectors/Sectors/Healthcare/Pages/default.aspx, accessed 22 May 2014) American College of Surgeons (ACS) Committee on the Operating Room Environment (CORE). Chicago: American College of Surgeons (http://www.facs.org/, accessed 22 May 2014) Association of peri Operative Registered Nurses (AORN) . Denver: Association of peri Operative Registered Nurses (http://www.aorn.org/, accessed 22 May 2014)

165

2 Purpose Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health It is important to understand that maintaining an accurate inventory is not technology inventory for people working the end of the HTM process. Rather, the within the health-care ﬁeld and who wish inventory serves as an input to the many What is medical equipment? to understand the topic in greater detail. different activities within the HTM cycle The reader will benefit from learning (Figure 1). The role of an equipment Medical equipment is a subset devices that calibration, maintenance, about of the medical different types of inventory andrequire inventory in each step of the cycle is repair, user training, the data included in managed these inventories. discussed in order to emphasize the and decommissioning — activities usually by clinical engineers. Medical equipment is used for the Furthermore, the document is intended to it plays in all facets of HTM. specific purposes of diagnosis and treatment of disease or importance rehabilitation following disease or injury; it can be illustrate the role of an accurate, detailed used either alone or in combination with accessory, inventory in HTM andany the importance in consumable, or other piece of medical equipment. ensuring the inventory provides useful Medical equipment excludes implantable, disposable or single-use medical devices (17). information to support informed decisionmaking.

8.5 Health Technology provide an Management overview of health-care

The purpose of this document is to

What is medical equipment management?

Medical equipment management (MEM) encompasses all activities performed across the life cycle of the equipment to ensure it contributes most effectively to patient care: Figure 8: The Medical Equipment Management Life Cycle (18) Planning and assessment Decommissioning and disposal Budgeting and ﬁnancing Figure 1. Health-care technology management cycle

2014

Maintenance and repair

• Create awareness • Monitor and evaluate

Technology assessment and selection

Operation and safety

Procurement and logistics

Training and skill development Source: Lenel A et al. (2005) (1)

Installation and commissioning

This includes both engineering and managerial skills to:

WHO Medical device technical series

• • • • • • • • • • • • •

Assess the equipment needs and plan for them effectively Allocate appropriate funds to them Select appropriate models with the right accessories and consumables Select appropriate maintenance materials such as spare parts Negotiate the terms of the service contract, and for training for maintenance staff Procure the equipment and manage delivery logistics Oversee the incoming inspection, installation and commissioning of the equipment Train the equipment users to operate it safely and effectively Train the maintenance team to service it properly Support the safe and effective operation of the equipment Manage the equipment inventory program and information about the equipment Manage the maintenance program, including preventive and corrective maintenance Decommission the equipment and dispose of it properly

MEM activities require skills and expertise in medical equipment, financial management, purchasing and supply chain management, workshop management and staff development.

166

Why is medical equipment management important? Medical equipment management is essential to prolong the useful lifespan of the equipment and make good use of scarce resources. Without an effective MEM system in place, costly equipment expenditures have a very low return on investment. The Swiss Centre for International Health found that equipment lost 30% of its value before even being place in service when it was procured improperly, or more sophisticated than necessary. Once put in to service, improper use and inadequate maintenance (both preventive and corrective) devalued it even further – until it was worth only 10% of the initial financial investment (19).

8. Technical notes regulation and management of medical devices

Who is involved in medical equipment management? MEM activities are typically led by a medical engineer (sometimes called a clinical or biomedical engineer1), with support from a team of medical engineering professionals of varying skill levels. These professionals may be craftspeople, technicians or technologists who are responsible for medical equipment maintenance and support the MEM activities. Depending on the size of the health facility and the structure of the health system, this team may work within a larger department such as the ‘facilities’, ‘maintenance’ or ‘hospital engineering’ department, or they may exist as their own department called ‘medical’, ‘clinical’ or ‘biomedical’ engineering. Regardless of the structure, the team will need to interact with a variety of stakeholders, both within their health facility and external to it, to perform the MEM activities: Figure 9. Clinical Engineer Interactions with Stakeholders for MEM Activities (20)

Vendors

Nurses

Doctors

Hospital Administration

Allied Health Professionals

Third Party Payors

Cost and Economics

CLINICAL ENGINEER

Efficacy, Safety

Patient

Leasing Agencies

Pow e Mai r, Cabl nten ing a Safe nce, ty

Hospital Environment

Regulation Agencies

Clinical Research

Input from the medical engineering team is essential during the whole MEM process.

1 Biomedical engineers belong to Unit Group 2149 “Engineering Professionals Not Elsewhere Classified” under the International Standard Classification of Occupations produced by the International Labour Organization. From this classification: “It should be noted that, while they are appropriately classified in this unit group with other engineering professionals, biomedical engineers are considered to be an integral part of the health workforce alongside those occupations classified in Sub-major Group 22: Health Professionals, and others classified in a number of other unit groups in Major Group 2: Professionals.” The full classification can be found at http://www.ilo.org/wcmsp5/groups/public/--dgreports/---dcomm/---publ/documents/publication/wcms_172572.pdf (accessed 17 October 2013)

167

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

What resources are available for health technology management? The WHO’s Medical Device Technical Series provides guidance on MEM activities that can be used to develop and improve MEM systems to ensure the best use is made of medical equipment investment. These include resources for:

• • • • • •

Needs Assessment Procurement Process Resource Guide Donation Inventory Management Maintenance Computerized Maintenance Management System

The ‘How To Manage’ Series for Healthcare Technology Series provides guidance on setting up and running a healthcare technology management (which includes MEM) system for:

• • • • • •

How to Organize a System of Healthcare Technology Management How to Plan and Budget for Healthcare Technology How to Procure and Commission your Healthcare Technology How to Operate your Healthcare Technology Effectively and Safely How to Organize the Maintenance of your Healthcare Technology How to Manage the Finances of your Healthcare Technology Management Team

2014

Managing medical equipment donations can be particularly challenging for low-resource health facilities that may rely significantly on them. Further resources that complement the WHO Medical device donations: considerations for solicitation and provision include:

• • •

Resource centre (HUMATEM) MAKING IT WORK: A Toolkit for Medical Equipment Donations to Low-Resource Settings (THET) Medical Surplus Recovery – good practice resources (CHAUSA)

To join a global discussion on MEM, please visit the INFRATECH website (http://listserv.paho.org/scripts/ wa.exe?A0=INFRATECH) is the Internet Discussion group created by WHO, PAHO and American Colleage of Clinical Engineering (ACCE) providing a forum for global networking and exchange of information on various issues of common concern on clinical engineering and health technology management. To join further discussion groups topics related to medical devices, please visit the EHEALTH website (http://listserv.paho. org/scripts/wa.exe?A0=EHEALTH) on e-health, the MED-DEVICES website (http://listserv.paho.org/scripts/ wa.exe?A0=MED-DEVICES) on regulatory issues and the HTA website (http://listserv.paho.org/scripts/ wa.exe?A0=HTA) on Health Technology Assessment.

168

8.6 References 1. The International Medical Device Regulators Forum (IMDRF) (http://www.imdrf.org/, accessed 22 May 2014) 2. Label and Instructions for Use for Medical Devices. GHTF/SG1/N70:2011. Tokyo: Global Harmonization Task Force; 2011 (http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n70-2011-label-instruction-use-medicaldevices-110916.pdf, accessed 22 May 2014) 3. International Organization for Standardization (ISO). Geneva: International Organization for Standardization (http:// www.iso.org/iso/home/standards.htm, accessed 22 May 2014) 4. Medical devices. Directive 93/42/EEC. Brussels : European Commission - European standards (EN) ; 1993 (http:// ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm, accessed 22 May 2014) 5. Medical devices. Directive 93/42/EEC. Brussels : European Commission - European standards (EN) ; 1993 (http:// ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm, accessed 22 May 2014) 6. Committee for European Normalisation (CEN). Brussels: Committee for European Normalisation (http://www.cen.eu/ cen/Sectors/Sectors/Healthcare/Pages/default.aspx, accessed 22 May 2014) 7. American Chemical Society (ACS). Wachington, DC: American Chemical Society (http://www.acs.org/content/acs/ en.html, accessed 22 May 2014) 8. International Union of Pure and Applied Chemistry (IUPAC). Reseach Triangle Park: International Union of Pure and Applied CHemistry (http://www.iupac.org, accessed 22 May 2014) 10. Occupational Safety and Health Administration (OSHA). Washington, DC: United States Department of Labor (http:// www.osha.gov/, accessed 22 May 2014) 11. Personal Protective Equipment. Washington, DC: OSHA United States Department of Labor; 2003 (http://www.osha. gov/Publications/osha3151.pdf, accessed 22 May 2014) 12. Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. ANSI/AAMI PB70:2003. Arlington: Association for the Advancement of Medical Instrumentation; 2003 (http:// marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/pb700310preview.pdf, accessed 22 may 2014) 13. Selection and use of protective apparel and surgical drapes in Health Care Facilities AAMI TIR11. Arlington: Association for the Advancement of Medical Instrumentation; 2005 (http://marketplace.aami. org/eseries/scriptcontent/docs/Preview%20Files/TIR110511preview.pdf, accessed 22 May 2014) 14. Personal protective equipment. Directive 89/686/EEC. Brussels: European Commission - European standards (EN) ;1989 (http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/personal-protectiveequipment/index_en.htm, accessed 22 May 2014) 15. Guidelines on the application of Council Directive 89/686/EEC of 21 DECEMBER 1989 on the approximation of the laws of the member states relating to Personal Protective Equipment. Version12 April 2010. Brussels: European Commission - European standards (EN) ; 2010 (http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/ppeguidelines_en.pdf, accessed 22 May 2014) 16. EN 13795:2012 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels 17. WHO Medical Device Technical Series. Geneva: World Health Organization; 2011 (http://www.who.int/medical_devices/ management_use/en/, accessed 22 May 2014) 18. How To Manage Series for Healthcare Technology Guide 1: How to Organize a System of Healthcare Technology Management. East Sussex: Ziken International Ltd; 2005 (http://www.healthpartners-int.co.uk/our_expertise/ HCTGuide1.pdf, accessed 22 May 2014) 19. Technical discussions: The role of medical devices and equipment in contemporary health care systems and services. Cairo: Regional Office for Eastern Mediterranean, World Health Organization; 2007 (http://gis.emro.who. int/HealthSystemObservatory/PDF/TechnicalandDiscussionPapers/The%20role%20of%20medical%20devices%20 and%20equipment%20in.pdf, accessed 22 May 2014) 20. Dyro J. Clinical Engineering Handbook. Elsevier; 2004.

169

8. Technical notes regulation and management of medical devices

9. Other health products Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health If possible, health-care facilities should be equipped with sterilization and pathology facilities, a pharmacy and nutrition counselling to complement the reproductive, maternal, newborn and child health priority intervention services. Equipment guidelines should be reviewed before implementation of these additional services (1).

9.1 Building services equipment Optimal implementation of medical devices requires proper planning of the entire medical unit. Adequacy of sources of energy, water and medical gases for the optimal function of medical devices should be evaluated. Equipment for communication and emergency patient transportation to the referral level should also be considered. Some of the supplies in previous lists could be part of the immunization supply chain and logistics. The cold chain, however, should be designed around national programmes. Some general services have different supply specifications according to the level of health-care facility. For example, the cleaning area, laundry, clothing, security, waste management, stationary supplies and office furniture should be stocked continually for the proper functioning of the medical area (1).

2014

9.2 Health counselling, education and promotion Health counselling, education and promotion are very important issues across the continuum of care, and there must be a continuous effort to provide them in the health-care facility (see Boxes 2–6). WHO has published several guidelines for health counselling to optimize the clinical practice of health workers and the role of a patient’s relatives in situations with varying levels of complexity. Health counselling may involve, for example, continuous vocational training for health workers and professional help for the patient’s family. Education on standard precautions such as hand hygiene and the provision of supplies for implementing such programmes must be accomplished in the health-care facilities (2). Health products that are not classified as medical devices and not listed in the previous tables may be used in the proper practice of priority interventions; for example, bednets can be used to prevent malaria, thermal care of newborns may require the use of hats, towels and kangaroo care wraps, and neonatal resuscitation may require mannequins and other training equipment. Box 7. Topics for health counselling, education and promotion in family planning and reproductive health

• • • • • • • • • •

Information on contraceptive methods Sexual and reproductive education: prevention and follow-up of risk factors Nutritional management (undernutrition, obesity, micronutrient deficiencies) Prevention of sexually transmitted infections Management of mental health disorders Counselling for breast examination Counselling for gender-based violence Counselling for infertile couples Counselling for post-abortion Bereavement assessment

Further reading Family planning: a global handbook for providers 2011. Geneva: World Health Organization and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs; 2011 (http://www.who.int/ reproductivehealth/publications/family_planning/9780978856304/en/, accessed 22 May 2014). Reproductive choices and family planning for people living with HIV: counselling tool. Geneva: World Health Organization; 2006 (http://www.who.int/reproductivehealth/publications/family_planning/9241595132/en/index.html, accessed 22 May 2014).

170

Clinical management of rape survivors: developing protocols for use with refugees and internally displaced persons. Revised edition. Geneva: World Health Organization; 2004 (http://whqlibdoc.who.int/publications/2004/924159263X. pdf, accessed 22 May 2014). Counselling for maternal and newborn health care: a handbook for building skills. Geneva: World Health Organization; 2013 (http://apps.who.int/iris/bitstream/10665/44016/1/9789241547628_eng.pdf, accessed 22 May 2014).

9. Other health products

Box 8. Topics for health counselling, education and promotion in pregnancy

• • • • • • • •

Prevention of sexually transmitted infections Nutritional management (undernutrition, obesity, micronutrient deficiencies) Interventions for smoking cessation during pregnancy Counselling on birth and emergency preparedness Counselling on post-abortion Bereavement assessment Management of mental health disorders Counselling of gender-based violence

Box 9. Topics for health counselling, education and promotion in postnatal mothers

• • • • • • • • • •

Support for breastfeeding Advice in family planning Management of postpartum depression Prevention of sexually transmitted infections Nutritional management (undernutrition, obesity, micronutrient deficiencies) Counselling for gender-based violence Bereavement assessment Advice in family planning Sexual and reproductive education Management of mental health disorders

171

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

Box 10. Topics for health counselling, education and promotion for postnatal babies (newborns)

• • • • • •

Promotion and provision of thermal care (immediate drying, warming, skin-to-skin – kangaroo mother care, delayed bathing) promotion and support for early initiation of and exclusive breastfeeding Detection of abnormal state of nutrition (obesity, undernutrition) Promotion and provision of hygienic cord and skin care Newborn stimulation and play Birth registration

Further reading Counselling for maternal and newborn health care: a handbook for building skills. Geneva: World Health Organization; 2013 (http://apps.who.int/iris/bitstream/10665/44016/1/9789241547628_eng.pdf, accessed 22 May 2014). Caring for the newborn at home: a training course for community health workers. Geneva: World Health Organization; 2012 (http://www.who.int/maternal_child_adolescent/documents/caring_for_newborn/en/index.html, accessed 22 May 2014). Home visits for the newborn child: a strategy to improve survival. Geneva: World Health Organization; 2009 (http:// whqlibdoc.who.int/hq/2009/WHO_FCH_CAH_09.02_eng.pdf, accessed 22 May 2014).

2014

Box 11. Topics for health counselling, education and promotion in infancy and childhood

• • • • • • • • • •

Monitoring of early childhood development Detection of abnormal state of nutrition (obesity, undernutrition) Assessment of breastfeeding and supplementary feeding programme Teaching mother to give oral drugs at home Teaching mother to treat local infections at home Identification of emergency signs Advise of immunization status of mother and children Counselling on family planning and reproductive health Human immunodeficiency virus (HIV) counselling Toys and play therapy

Further reading Counselling for maternal and newborn health care: a handbook for building skills. Geneva: World Health Organization; 2013 (http://apps.who.int/iris/bitstream/10665/44016/1/9789241547628_eng.pdf, accessed 22 May 2014). Pocket book of hospital care for children: guidelines for the management of common illnesses, second edition 2013 (http://www.who.int/maternal_child_adolescent/documents/child_hospital_care/en/index.html, accessed 22 May 2014).

172

9.3 References 1. Lenel A, Temple-Bird C, Kawohl W, Kaur M. How to organize a system of healthcare technology management. Geneva: World Health Organization; 2005 (http://www.who.int/management/organize_system_%20healthcare.pdf, accessed 22 May 2014). 2. Standard precautions in health care. Geneva: World Health Organization; 2007 (http://www.who.int/csr/resources/ publications/EPR_AM2_E7.pdf, accessed 22 May 2014).

173

9. Other health products

2014

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

174

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

ISBN 978 92 4 156502 8

Основные сведения

Организация Всемирная организация здравоохранения (ВОЗ / WHO)

Тип документа Publications

Дата принятия 21 апреля 2016 г.

Источник Всемирная организация здравоохранения