Second Edition
AIDS Medicines and diagnostics services
July 2015
WG Implementation Guidelines Tool 4
This document provides the specifications for major pesticide application equipment used for control of vectors of diseases. The specification guidelines contained herein are intended to assist national authorities and other public health users in selecting equipment of assured quality for applicati...on of pesticides for vector control.
The test methods described herein are intended to assess whether the equipment will function for a minimum of three years with appropriate routine maintenance according to the manufacturer’s label instructions. Manufacturers shall be requested to provide warranty against manufacturing defects with guaranteed after-sales service on the equipment, any certification required by national authorities regarding materials used in the construction of the equipment, and results of tests that have been carried out for compliance with national or international specifications.
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UNICEF provides a detailed update and list of Ebola virus disease personal protective equipment technical specifications for use in high- and low-risk settings. It includes barriers for full body protection, as well as the head, nose, mouth, eyes, hands and feet. In selecting the right PPE specifica...tions for frontline workers, the degree of contact with infectious material, and the potential for infected fluid penetration should be considered.
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Oxygen is an essential medicine required at all levels of the health care system; only high quality, medical-grade oxygen should be given to patients. Pressure swing adsorption (PSA) oxygen generating plants are a source of medical-grade oxygen. This document provides technical specifications as th...e minimum requirements that a PSA Oxygen Plant must meet for use for the administration of medical-grade oxygen.
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In December 2019 a novel coronavirus (2019-nCoV) was identified as the causative agent of a severe acute respiratory illness among people exposed in a seafood market in Wuhan, China; • Human-to-human transmission has been documented, including in healthcare workers, and aerosol-generating procedur...es (AGP)† may play a role in the spread of the disease; • There are uncertainties in the natural history of the 2019-nCoV, including source(s), transmissibility mechanisms, viral shedding, and persistence of the virus in the environment and on fomites; • As of 6 February 2020, the following precautions are recommended for the care of patients with suspected or confirmed cases of 2019-nCoV: o For any suspected or confirmed cases of 2019-nCoV: standard + contact + droplet precautions o For any suspected or confirmed cases of 2019-nCoV and AGP: standard + contact + airborne precautions • The use of personal protective equipment (PPE) by healthcare workers requires an evaluation of the risk related to healthcare-related activities;
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The document "Priority medical devices list for the COVID-19 response and associated technical specifications" complements this guideline.
This document provides interim guidance on the quality, performance characteristics and related standards of personal protective equipment (PPE) to be used i...n the context of COVID-19. This includes WHO Priority Medical Devices, specifically: surgical masks, non-surgical masks, gloves, googles, face shields, gowns and N95 masks. It is intended for procurement agencies, occupational health departments, infection prevention and control departments or focal points, health facility administrators, biomedical and materials engineering, PPE manufacturers and public health authorities at both national and facility levels.
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23 February 2021
This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the latest available evidence and interim guidelines. This includes: oxygen therapy, pulse oximeters, patient monitors, thermometers, infusion and suc...tion pumps, X-ray, ultrasound and CT scanners as well as personal protective equipment. In order to facilitate access to quality assured priority medical devices, the document also includes technical and performance characteristics, related standards, accessories and consumables. It is intended for policy-makers and planning officers in Ministries of Health, procurement and regulatory agencies, intergovernmental and international agencies as well as the medical device industry.
This document is an update to the List of priority medical devices for COVID-19 case management and Technical specifications for invasive and non-invasive ventilators for COVID-19.
This document complements the Technical specifications of personal protective equipment for COVID-19.
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Types of radiotherapy equipment covered by the guide include external beam radiotherapy machines (both Cobalt-60 and linear accelerators), brachytherapy devices that apply radiation sources directly to tumours and complementary imaging devices such as conventional or computed tomography (CT) simulat...ors, as well as other tools essential for safe operation and quality control. Depending on the type of radiotherapy machine, the need for specialized professionals and infrastructure, as well as quality assurance and maintenance, may vary.
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August 2020.
Essential diagnostic products areconsidered an integral part of UHC, they are an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a review of the UHC pilot in September 2019 es...tablished that whereas the Kenya Medical Supplies Authority (KEMSA) was able to fill up to 80% of pharmaceutical items, the order fill rate for diagnostic products was less than 50 percent for level 2 and 3 facilities and as low as 30 percent for level 4 and 5 facilities.
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August 2020.
In December 2018, the President launched the UHC pilot covering four strategically selected counties-Isiolo, Kisumu, Machakos and Nyeri. It isplanned that by the year 2022, all persons in Kenya will be able to use the essential services they need for their health... and wellbeing through a single unified benefit package, without the risk of financial catastrophe. Essential health products are considered an integral part of UHC andare an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a review of the UHC pilot in September 2019 established that whereas the Kenya Medical Supplies Authority (KEMSA) was able to fill up to 80% of pharmaceutical items, the order fill rate for medical supplies was less than 50%for level 2 and 3 facilities and as low as 30%for level 4 and 5 facilities.
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23 February 2021
This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the latest available evidence and interim guidelines. This includes: oxygen therapy, pulse oximeters, patient monitors, thermometers, infusion and suc...tion pumps, X-ray, ultrasound and CT scanners as well as personal protective equipment. In order to facilitate access to quality assured priority medical devices, the document also includes technical and performance characteristics, related standards, accessories and consumables. It is intended for policy-makers and planning officers in Ministries of Health, procurement and regulatory agencies, intergovernmental and international agencies as well as the medical device industry.
This document is an update to the List of priority medical devices for COVID-19 case management and Technical specifications for invasive and non-invasive ventilators for COVID-19.
This document complements the Technical specifications of personal protective equipment for COVID-19.
more
The document "Priority medical devices list for the COVID-19 response and associated technical specifications" complements this guideline.
This document provides interim guidance on the quality, performance characteristics and related standards of personal protective equipment (PPE) to be used i...n the context of COVID-19. This includes WHO Priority Medical Devices, specifically: surgical masks, non-surgical masks, gloves, googles, face shields, gowns and N95 masks. It is intended for procurement agencies, occupational health departments, infection prevention and control departments or focal points, health facility administrators, biomedical and materials engineering, PPE manufacturers and public health authorities at both national and facility levels.
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Ce document fournit des orientations provisoires sur la qualité, les caractéristiques de performance et les normes connexes des équipements de protection individuelle (EPI) à utiliser dans le contexte de COVID-19. Il s'agit notamment des dispositifs médicaux prioritaires de l'OMS, à savoir : l...es masques chirurgicaux, les masques non chirurgicaux, les gants, les lunettes de protection, les écrans faciaux, les blouses et les masques N95. Il est destiné aux organismes d'approvisionnement, aux services de santé au travail, aux services ou points focaux de prévention et de contrôle des infections, aux administrateurs d'établissements de santé, aux ingénieurs biomédicaux et des matériaux, aux fabricants d'EPI et aux autorités de santé publique, tant au niveau national qu'au niveau des établissements.
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Globally, 311,000 women die of cervical cancer every year, 85 percent of them
in resource limited regions of the world. To address this grave threat to women,
the WHO made a call to action in 2018, resulting in accelerated plans to improve
cervical cancer control under the elimination threshold w...ith respect to cervical
cancer incidence. As part of WHO’s approach to cervical cancer control, availability of high quality,
affordable medical devices for HPV screening, and treatment of precancerous
lesions in low resource settings is indispensable.
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This is a guidance document for countries and implementing partners on the technical requirements for developing digital information systems for issuing standards-based interoperable digital certificates for COVID-19 vaccination status, and considerations for implementation of such systems, for the ...purposes of continuity of care, and proof of vaccination.
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The portable diagnostic imaging technology covered by this document will serve not only the pressing demands for tuberculosis screening and triage but also other diseases. Therefore, the requirements, accessories, hardware and software packages listed in the following specifications are described in... detail in order to serve also other pathologies and conditions, like trauma and pneumonia.
Through the definition of "minimum technical requirements", this document is recommended to support decision-making regarding the selection, incorporation, allocation and use of portable X-ray systems and is intended for health care providers, managers of imaging departments, procurement and regulatory agencies, policymakers and planning officers in ministries of health, as well as biomedical engineering professionals, medical physicists, the private health sector, medical device industry and intergovernmental and international agencies.
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The United Nations Commission on Life-Saving Commodities (UNCLSC, 2012) defined 13 health products to end preventable deaths of woman and children. One of those 13 products is the neonatal resuscitator, is indispensable medical device to save newborns from asphyxia at birth. For the efficient use of... neonatal resuscitation, training of healthcare professionals using neonatal resuscitation manikins is the most effective approach. Critical lifesaving trainings calls for the need of neonatal resuscitation manikins with the right features.
The purpose of the WHO Neonatal resuscitation manikin: technical specifications is to provide a minimum standard baseline to meet the increasing demand to procure good quality, affordable, accessible, and appropriate neonatal resuscitation manikins. Towards the development of this baseline, this document includes compilation of available scientific evidence from technical literature, international publications, expert reviews, and an industry survey which was conducted by WHO medical devices team.
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