Here's the latest info shared by WHO's Adriana Velázquez regarding Medical Devices and the World Health Organization (December 2020 Edition).
Dear colleagues, 2020, an unprecedented year of public health relevance, is about to end.
The medical devices played a key role in protection, diagnosis, and treatment!
Thank you to all that ensured the quality of the products and make them accessible to all those that needed them, but still much more needs to be done, so we look forward to continue working together to ensure medical devices are available, affordable, of good quality and used appropriately and safely by everybody, everywhere, to increase the wellbeing of all. Hereby wishing you a healthier, safer, and happier 2021 for all.
Please find the following 3 sections of this last newsletter of 2020:
1. Annual WHO communication; 2. Interim guidance, publications, and training material; 3. Ongoing projects on medical devices, November-December 2020 ;
1. Annual WHO Communication - December 2020 WHO News
1.1 WHO’S COVID-19 response: https://www.who.int/news-room/spotlight/a-year-without-precedent-who-s-covid-19-response/
1.2 COVID-19: One year later – WHO Director-General’s new year message: https://www.who.int/news/item/30-12-2020-covid-19-anniversary-and-looking-forward-to-2021
1.3 10 Global health issues to track in 2021: https://www.who.int/news-room/spotlight/10-global-health-issues-to-track-in-2021
2. Interim Guidance, Publications, Consultations, and Training MMaterial for COVID-19
2.1 Interim guidance
1. On Medical devices:
- Priority medical devices for COVID-19 and associated technical specifications (20 Nov 2020): https://www.who.int/publications/i/item/WHO-2019-nCoV-MedDev-TS-O2T.V2
2. On the Personal protective equipment:
- Technical Specifications (13 Nov 2020) https://www.who.int/publications/i/item/WHO-2019-nCoV-PPE_specifications-2020.1
- On the use of masks: https://www.who.int/publications/i/item/advice-on-the-use-of-masks-in-the-community-during-home-care-and-in-healthcare-settings-in-the-context-of-the-novel-coronavirus-(2019-ncov)-outbreak
- Use of masks for children: https://www.who.int/publications/i/item/WHO-2019-nCoV-IPC_Masks-Children-2020.1
- Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages (23 December 2020) https://www.who.int/publications/i/item/rational-use-of-personal-protective-equipment-for-coronavirus-disease-(covid-19)-and-considerations-during-severe-shortages
- Mask use in the context of COVID-19, (1 December 2020) https://www.who.int/publications/i/item/advice-on-the-use-of-masks-in-the-community-during-home-care-and-in-healthcare-settings-in-the-context-of-the-novel-coronavirus-(2019-ncov)-outbreak
3. On in-vitro diagnostics:
- Information about emergency use listing, https://extranet.who.int/pqweb/vitro-diagnostics/coronavirus-disease-covid-19-pandemic-%E2%80%94-emergency-use-listing-procedure-eul-open (new website)
- Laboratory assessment https://www.who.int/publications/i/item/laboratory-assessment-tool-for-laboratories-implementing-covid-19-virus-testing (23 October 2020)
- Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays (11 September 2020) https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays
4. On the role of imaging diagnostics:
- You can find the role of ultrasound, chest X rays and CT scanners, here. https://www.who.int/publications/i/item/use-of-chest-imaging-in-covid-19
- And you can review chapter 8 of the Priority medical devices for COVID for the technical specifications https://www.who.int/publications/i/item/WHO-2019-nCoV-MedDev-TS-O2T.V2
5. The Emergency Global Supply catalogue. Updated 11 November 2020.
2.2 Training and learning. Check for new courses.
"OpenWHO is WHO’s interactive, web-based, knowledge-transfer platform offering online courses to improve the response to health emergencies. OpenWHO enables the Organization and its key partners to transfer life-saving knowledge to large numbers of frontline responders.”
“With COVID-19 science now doubling every 20 days and new guidance being published daily by WHO, the WHO Academy continues to improve its COVID - 19 mobile learning app so that health workers can keep up with the constantly evolving knowledge related to this disease.”
“OXYGEN Draft proposal for revision in The International Pharmacopoeia”
We invite you to review the following draft working document which will be 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/working-documents-public-consultation
- Please use the attached form to provide your comments
- Deadline 26 February 2021
3. Ongoing Projects November-December 2020 and Vacancies
3.1 Consultants and experts are working on the following projects and plan to deliver publications or reports in the first quarter of 2021. The following table includes names, contacts and status of activities.
|Project||Objective||Status of Activity||Email Contact and Consultants|
|Nomenclature of medical devices||Follow up the 145/3 https://apps.who.int/gb/ebwha/pdf_files/EB145/B145_3-en.pdf||
Annotated agenda for Executive Board 148/11 in January 2021 https://apps.who.int/gb/ebwha/pdf_files/EB148/B148_1(annotated)-en.pdf
Member States briefing in January 2021. More information will be available. (to come)
|Innovative technologies for low resource setting||Assess innovative technologies: specifications, regulations, HTA, in the intended settings||
Compendium of Innovative Health Technologies for Low Resource Settings 2020.
Gabriela Jimenez Moyao
Cesar Burgi Vieira
Global Clinical Engineering Alliance
Kim Walker Consulting
|Update of Global Atlas of medical devices,
Updated of country data
|Support facility assessments of biomedical equipment including oxygen sources, (inventory survey listed above) support the provision of country information for any of the surveys mentioned section 2 above||
ALL Focal points of Global Atlas, have been contacted in November – December to provide updated information.
|Facility surveys||To assess the availability of health products, WHO has developed several tools, can be found||
https://o2therapy.surveycto.com/collect/who_covid_oxygen_therapy_scto_open?caseid= Username:biomedequipment Password: facilityoxygen20
Bill Gentles and Tobey Clark
|Prequalification model for medical devices and PPE||Develop a draft PQ model for medical devices including PPE||Stefano Bergamasco; Sasikala Thangavelu; Alison Syrett; Mohid Khan; Riad Farah; Dragana Milic; Laurence Matheron; Ilaria Sirotich|
|Country consultants||Assess innovations, support training material, facility assessment||Joshua Tim, Martha Mulerwa, Mulugeta Mideksa; Thierry Houngbo;|
|Medical devices page||Organization of material for the updated website||Daniela Rodriguez|
|Donations of medical devices||Consolidate information on donated equipment status, use of guidance documents, and how to improve donations||
Dinsie Williams and
|Local production and technology transfer of medical equipment, personal protective equipment, IVDs and other medical devices||Support C-TAP and Technology Access Partnership to increase access of essential and priority health products||
|MEDEVIS||Priority Medical Devices Information system
( to come )
Mario Forjas Secca
Laura Lopez Meneses
3.2 WHO Vacancies:
Applications can be submitted on WHO’s career website, Stellis. The deadline for applications is Jan 15, 2021, 11:59:00 PM.
Technical Officer (Health Innovation) - (2004951)
Grade: P4; Contractual Arrangement: Fixed-term appointment; Contract Duration (Years, Months, Days): 2 years; Closing Date: Jan 15, 2021, 11:59:00 PM; Primary Location: Switzerland-Geneva;
Organization: HQ/DHI Digital Health and Innovation; Schedule: Full-time
Wishing you a peaceful, healthy, joyful 2021 for all, everywhere.
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
Web: www.who.int www.who.int/medical_devices/en/ | Follow WHO on Facebook, Twitter, YouTube, and Instagram.