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WHO Medical Devices Newsletter, July 2021

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

Dear colleagues:

Access, Availability, Affordability, and Appropriate use of medical devices for COVID-19 are essential: In-vitro diagnostics, Personal protective equipment, and Oxygen sources, delivery, and monitoring systems.

Please continue to support in every way you can!

 

WHO July news:

Globally, as of 7:21 pm CEST, 16 July 2021, there have been 188,655,968 confirmed cases of COVID-19, including 4,067,517 deaths, reported to WHO. As of 15 July 2021, a total of 3,402,275,866 vaccine doses have been administered.

 

 

Find below the following information and please disseminate in your networks 

1. Medical devices and other technologies for COVID-19
2. WHO List of Priority medical devices for cardiovascular diseases and diabetes and MeDevIS e-platform 
3. Nomenclature of medical devices

 

1. Medical Technologies for COVID-19

Oxygen, Oxygen, Oxygen,  continues to be the medicine most needed for COVID-19 and for other diseases and conditions, work by ACT-A: Access to COVID-19 Tools and many other organizations is ongoing.

 

Oxygen task force ACT-A Therapeutics

https://unitaid.org/news-blog/unprecedented-cooperation-global-oxygen-suppliers-june-2021/#en 

Unprecedented cooperation with global oxygen suppliers paves way to increase access for low- and middle-income countries to address COVID-19 crisis

 

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

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/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 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% 51 pure oxygen, referred to in the draft revision as “Oxygen 99%”; and 52
  • to define quality requirements for these products.

Send an email to This email address is being protected from spambots. You need JavaScript enabled to view it. by 10th September 2021.

 

WHO good manufacturing practices for medicinal gases

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.

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.

qas21_875_gmp_for_medical_gases.pdf (who.int)

 

PSA plants and oxygen concentrators that need repair list:

  • 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

 

NGOs are very active on oxygen support

 

Global Fund

The Global Fund has opened another window for sending funding proposals in September!

COVID-19 Response Mechanism to support countries to procure: in vitro Diagnostics, Personal Protective Equipment, Treatment, and Oxygen Equipment. They have authorized funds for 540 PSA plants.

 

C-TAP

Medical devices industry, academia, innovators are invited to share knowledge, IP or data, join C-TAP: The technology access pool, to increase access of technologies globally.

 

WHO 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 

 

2.1 New Publication: WHO List of Priority medical devices for cardiovascular diseases and diabetes

The book was launched on JUNE 30, you can download it here: WHO List of  Priority medical devices for management of cardiovascular diseases and diabetes

It includes more than 500 medical devices (listed by clinical interventions, clinical areas of the hospital, diabetes, and complications of diabetes, for cardiac disease and stroke).

 

2.2 WHO Priority Medical Devices Information System: MeDevIS

The beta version was released 30th of June.

It includes all the priority medical devices listed in 4 WHO publications:  for cancer management, for COVID, for cardiovascular and diabetes for reproductive, maternal, newborn, and child care.

An interactive session on MeDevIS will take place Wednesday 21 July 2021 14:00 CEST (Geneva time): https://www.who.int/news-room/events/detail/2021/07/21/default-calendar/webinar-an-interactive-session-on-medevis

 

3. Nomenclature of medical devices consultations.

The WHA74 took place virtually from 24 May to 1 June 2021, in light of the ongoing COVID-19 pandemic. You will be able to listen to all the discussions here.

Topic WHA74.7 Standardization of medical device nomenclature discussions took place 29 and 31 of May. 

WHO will be conducting information sessions and consultation with various stakeholders as indicated in the timeline of events here below.

More information can be found here

 

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

 


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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