WHO Medical Devices Newsletter, August 2021

Here's the latest info shared by WHO's Adriana Velázquez regarding Medical Devices and the World Health Organization (August 2021).

Dear colleagues: this month we share with you 3 new publications, webinars. Medical devices are indispensable for health care provision, please continue to support in every way you can, stay safe!

WHO August News:

Globally, as of 5:33 pm CEST, 27 August 2021, there have been 214,468,601 confirmed cases of COVID-19, including 4,470,969 deaths, reported to WHO. As of 25 August 2021, a total of 4,953,887,422 vaccine doses have been administered.

 

Find below the following information and please disseminate in your networks 

  1. Technologies for COVID-19
  2. WHO List of Essential in vitro diagnostics and guidance for the implementation at country level
  3. Other WHO webinars

 

 

Medical Technologies for COVID-19 and Other Health Priorities

 

1.1. Consultations

International pharmacopeia, open for open consultation for GMP medical gases and Oxygen 93%

We invite you to review the following draft working document which is posted on the WHO Medicines website under “Monographs and general texts under review/revision for inclusion in The International Pharmacopoeia”: https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/pharmaceuticals/current-projects 

 

Medicinal Oxygen

Draft proposal for revision in The International Pharmacopoeia” qas20_867_rev2_medicinal_oxygen.pdf (who.int)

 

It is intended to revise the monograph on Oxygen in The International Pharmacopoeia:

  • to clarify that the WHO Member States, considering options for increasing the supply of medicinal oxygen to treat COVID-19 and other patients, can safely apply oxygen generated by:
    • Oxygen Generation Plants and concentrators, which use Pressure Swing Adsorption (PSA) or Vacuum Swing Adsorption (VSA) technologies to generate 90 to 96% pure oxygen, referred to in the draft revision as  “Oxygen 93%; and/or
    • Air Separation Units, which use cryogenic technology to generate 99%  pure oxygen, are referred to in the draft revision as “Oxygen 99%;
  • to define quality requirements for these products.

 

Please comment and send the format to This email address is being protected from spambots. You need JavaScript enabled to view it. by September 10th 2021

 

WHO Good Manufacturing Practices for Medicinal Gases

qas21_875_gmp_for_medical_gases.pdf (who.int)

Arising from increased demand for medicinal gases, in particular the use of oxygen in the treatment of patients with Coronavirus disease 2019 (COVID-19), the World Health Organization (WHO) Health Products Policy and Standards Department and other departments involved in the supply of oxygen and the inspection of production sites of medicinal gases, raised the urgency for the preparation of the WHO good manufacturing practices for medicinal gases guidance text.

Please send your comments to Dr. Steve Estevao Cordeiro, Technical Officer, Norms and Standards for Pharmaceuticals, Technical Standards and Specifications (This email address is being protected from spambots. You need JavaScript enabled to view it.), with a copy to Ms. Sinéad Jones (This email address is being protected from spambots. You need JavaScript enabled to view it.before 31 August 2021.

 

Webinar: 2021 Compendium of Innovative Technologies for Low-Resource Settings

When: 31 August 2021, 16:00 TO 17:30 hrs CEST. This event will launch a new WHO publication:

Registration and more information: https://www.who.int/news-room/events/detail/2021/08/31/default-calendar/webinar-2021-compendium-of-innovative-health-technologies-for-low-resource-settings 

 

Medical Technologies for COVID

  • PSA Plants and oxygen concentrators that need repair: Please add your PSA plant that needs maintenance to Every Breath Counts LMIC Oxygen Plant "FIX LIST" - Google Sheets | https://fdunn8.wixsite.com/website 
  • Maintenance Challenge: https://drive.google.com/file/d/18URm59O_12t6ymjNqQ4pqxMvm0_YGv3I/view Email to connect: This email address is being protected from spambots. You need JavaScript enabled to view it. 
  • WHO, UNICEF, and other partners are working to support the repair of PSA plants, and increase the availability of oxygen at the country level. Consultants available to support regional WHO offices on oxygen related equipment, that have more than 5 years of expertise, please send CV to This email address is being protected from spambots. You need JavaScript enabled to view it.

 

NGOs are very active on oxygen and medical equipment support

 

C-TAP

The medical devices industry, academia, innovators are invited to share knowledge, IP, or data, join C-TAP: The technology access pool, to increase access to COVID technologies globally. Consultants interested to support C-TAP, that will have knowledge of technology transfer, local production, IP, innovation with more than 5 years of experience,  please send CV to This email address is being protected from spambots. You need JavaScript enabled to view it. 

 

Clinical Management Course

The Clinical management course is now live on OpenWHO: https://openwho.org/courses/clinical-management-COVID-19-mild-mod-severe  More information: https://www.who.int/emergencies/diseases/novel-coronavirus-2019 

 

 

WHO List of Essential In Vitro Diagnostics and Guidance for the Implementation at a Country Level

The EDL Secretariat is pleased to share with you the link for WHO's new guidance document:  “Selection of essential in vitro diagnostics at country level using the WHO Model List of Essential In Vitro Diagnostics to develop and update a national list of essential in vitro diagnostics”. It can be downloaded at: https://www.who.int/publications/i/item/9789240030923 

This document is intended to provide guidance to countries on methods for developing and updating national lists of essential in vitro diagnostics (NEDL). It describes the best practices for selecting categories of in vitro diagnostic tests for a NEDL, consistent with the evidence-based methods used to update the WHO EDL.

The document guides the identification of the most relevant categories of IVDs listed in the WHO EDL for inclusion in the NEDL according to the country’s context and needs. It includes an overview of the use of a NEDL for enabling and improving access to clinical laboratory services. 

Visit the new IVD pages which provide EDL advocacy materials, the link to the eEDL, the report of last SAGE IVD meeting including EDL3, and information on SAGE IVD. Your support for disseminating these materials and publications will be most welcome. https://www.who.int/health-topics/in-vitro-diagnostics#tab=tab_1 & https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/selection-access-and-use-in-vitro 

 

 

Other Webinars

Innovations in X-ray and Artificial Intelligence CAD Software for TB response

 
When: August 31st, from 12.00 to 13.30 CEST/Geneva time | Register using the following link: https://primetime.bluejeans.com/a2m/live-event/zeyszvct

The aim of the webinar is to highlight the addition and the use of ultra-portable X-ray devices and computer-aided detection (CAD) software in the Stop TB’s GDF catalog and the release of Stop TB’s ultra-portable X-ray and CAD implementation guide and in the context of the Global Fund’s  COVID-19 Response Mechanism (C19RM) which supports interventions to mitigate the impact of COVID-19 on TB services.

 

Objectives include:

  • Providing the most up-to-date WHO policy on when, where, and how X-ray machines can be used in TB programs for screening and triage, as well as insight on how new tools such as CAD solutions fit into these recommendations.
  • Discussing the new ultra-portable digital X-ray systems and CAD software available in the Stop TB GDF’s catalog for procurement and highlighting the newly released implementation guide as a resource for country programs and implementing partners for further learning and discussion.
  • Presenting the latest technical landscape of stationary, mobile and portable X-ray systems and the use of CAD software on analog-converted digital radiographs.
  • Spotlighting the experience of an early TB REACH implementer, including their advice and learnings from piloting these solutions.

The event will launch the latest WHO-IAEA technical specifications:

 

WHO COVID-19 Case Management Webinar Series

When:  31st August 13:30 to 15:30 CET

Topic: Optimizing Care for Patients with Severe COVID-19 Disease.
More information and registration: https://www.who.int/news-room/events/detail/2021/08/31/default-calendar/who-covid-19-case-management-webinar-series-optimising-care-for-patients-with-severe-covid-19-disease 

 

 

Global Atlas of Medical Devices 2021 open for consultation during 4 weeks

The latest edition of the Global Atlas of Medical Devices was published 5th August 2017: https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/global-atlas-of-medical-devices 

After many months of surveys, more than 1,000 email communications, and desk reviews, WHO presents the Draft 2021 Global Atlas of medical devices for final consultation.

WHO welcomes and is very thankful to all that collaborated in providing the information. This PDF document will be posted for consultation for 4 weeks,  from today to 24th September 2021.

Please note, this is a DRAFT PUBLICATION, still pending publication approval.  It includes country profiles: i.e.

The PDF file for consultation and a word file template can be used to send to WHO the comments or changes required, to This email address is being protected from spambots. You need JavaScript enabled to view it..  Please note that the edits can ONLY be submitted by governmental representatives of the Ministry of Health, regulatory authorities, or public institutions.


 

Many thanks, best regards & stay safe!

Sincerely,

 

Adriana Velazquez Berumen, MSc. | Biomedical Clinical Engineer | Team Lead Medical Devices and In Vitro Diagnostics, MDD | Health Product Policy and Standards Department, HPS | Access to Medicines and Health Products Division, MHP | World Health Organization, WHO | Geneva, Switzerland

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it.   

Web: www.who.int | www.who.int/medical_devices/en/ | Follow WHO on Facebook, Twitter, YouTube, and Instagram.

 

 

 

 

 

 

 


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