WHO Medical Devices Newsletter, May 2020

Here's the latest info shared by WHO's Adriana Velázquez & Alejandra Vélez regarding Medical Devices and the World Health Organization (May 2020 Edition).

Dear colleagues,

Please find below information on related to COVID-19 technical documents

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance

 

1. Priority Medical Devices for COVID Management

WHO has developed several tools, which can be found at https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/covid-19-critical-items

The List of  Priority Medical Devices for COVID,  describes the medical devices, the purpose, and the settings where it can be used.

 

 

2. Emergency Supply Catalogue

 

 

3. Recently Launched the COVID-19 Essential Supplies Forecasting Tool (May 1st, 2020)

 

 

4. For Personal Protective Equipment

Rational use of personal protective equipment for coronavirus disease (COVID-19)

This document summarizes WHO’s recommendations for the rational use of personal protective equipment (PPE) in health care and home care settings, as well as during the handling of cargo; it also assesses the current disruption of the global supply chain and considerations for decision making during severe shortages of PPE. This updated version includes a section on considerations for decision making processes and a summary of temporary measures in the context of severe PPE shortage.

-  Access the publication (6 April 2020)

Table with standards

Mask, medical          Healthcare worker

Medical mask, good breathability, internal and external faces should be clearly identified

• EN 14683 Type II, IIR
• ASTM F2100 minimum Level 1
or equivalent

 

Face shield

Made of clear plastic and provides good visibility to both the wearer and the patient,  Adjustable band to attach firmly around the head and fit snuggly against the forehead, Fog resistant (preferable), Completely cover the sides and length of the face, May be re-usable (made of robust material which can be cleaned and disinfected) or disposable.

• EU PPE Regulation 2016/425,

• EN 166, 
• ANSI/ISEA Z87.1,
or demonstrate equivalent set of standards

Particulate respirator, grade N95/FFP2 or higher

N95 or FFP2 respirator, or higher
Good breathability with design that does not collapse against the mouth (e.g. duckbill, cup-shaped)

•  Minimum "N95" respirator according to, under NIOSH 42 CFR 84,
• Minimum "FFP2" according to EN 149 or demonstrate equivalent set of standards


Please find attached latest guidance released by FDA on the types of masks, this supersedes the document released 25 of March,

https://www.fda.gov/media/136449/download

 

 

5. For In Vitro Diagnostics

Laboratory testing guidance:

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance

 

WHO Emergency Use Listing (EUL) for in vitro diagnostics.

Currently, the following IVDs are eligible for EUL submission:

  • Assays for the detection of SARS-CoV-2 nucleic acid; and
  • Rapid diagnostic tests for the detection of IgM/IgG to SARS-CoV-2
  • All information can be found:

https://www.who.int/diagnostics_laboratory/EUL/en/

The EUL procedure is developed to expedite the availability of IVDs needed in public health emergency situations.

It is intended to assist interested procurement agencies and the Member States on the suitability for use of a specific IVD, based on a minimum set of available quality, safety, and performance data. Up to 24 of April, the following products have been approved by WHO.

 

6. Clinical Management of Patients

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/patient-management

 

 

7. For SARI Treatment Centers

- Access the publication (28 March 2020)

 

 

8. For Manufacturers

WHO is conducting a high-level market and risk assessment for respiratory equipment. 

link to participate in the survey.

 

9. On Innovation

If you have an Innovative product (approved for emergency use, or commercially available) that might help during the COVID-19 pandemic, please complete the WHO SURVEY at: https://extranet.who.int/dataform/396376 so that your product could be assessed for COVID-19 compendia.

Please send your questions to This email address is being protected from spambots. You need JavaScript enabled to view it., related past compendia of innovative technologies can be found at https://www.who.int/medical_devices/innovation/en/

Other sites of interest for innovation, some will provide grants for development or:

 

10. Data Update by Country

For COVID

In the context of COVID-19, availability of essential equipment to provide oxygen and respiratory therapy to all countries, especially those that may have limitations in accessing global markets, is of utmost importance.

WHO has developed a COVID-19 Biomedical Equipment Inventory Tool (survey) whose aim is to collect facility data on the availability of biomedical equipment (oxygen, accessories and consumables) and ventilators at the country level.  These data can serve to inform planning and readiness, at facilities and in-country, as well as to inform WHO’s global COVID-19 Supply Chain System of existing capacity so that appropriate equipment gets sent to where it can be absorbed, and in an equitable manner.

WHO has a team assembled at HQ to support countries and willing participants to conduct the survey at facilities in-country, which can be completed electronically via the web or by using a free “app” (SurveyCTO platform), or using a paper survey with an excel spreadsheet “roll-up”.  We are encouraging countries to complete this survey in order help inform country-level planning, as well as to reduce the burden on incredibly stretched global supply chain systems, which are in a current shift towards a WHO-led consortium. 

The COVID-19 Biomedical Equipment Inventory Tool can be found attached.  Of note, WHO is in full support of initiatives already underway to this effect, and encourages data sharing to HQ to ensure appropriate allocation.

Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. for support in implementing the survey, including leveraging existing survey initiatives, as well as if you are willing to participate.

  

Update of Global Atlas country data: https://www.who.int/medical_devices/countries/en/

 

Update of the Global Atlas: The last version of the Global Atlas for medical devices was published in 2017, and the update of information for the next printed version is planned for 2020.

We kindly request your help to bring-up-to-date the figures for each country. Each request for edition needs to be sent to This email address is being protected from spambots. You need JavaScript enabled to view it..

 

 

11. On-Going Work of WHO with NGOs in Official Relations to Support COVID-19 Efforts

Register here: https://us02web.zoom.us/webinar/register/WN_MhkdUp9qQZClrpkbi5G_lw

 

Date

14:00-15:00 Geneva time

Topic

Tuesday, May 5

Oxygen Systems

Friday, May 8

Masks, Respirators, and Face Shields

Tuesday, May 12

CPAP/BIPAP

Friday, May 15

Pulse oximeters

Tuesday, May 19

Ventilators

Other topics will follow

 

 

 

  • Humatem, has agreed to translate to French  COVID documents and  disseminate to member
  • GMTA and DITTA have been providing information of  manufacturers to have discussions in WHO
  • IFHE and IFMBE are supporting the work on Respiratory care units

 

 

12. Severe Acute Respiratory Infections Treatment Centre

Practical manual to set up and manage a SARI treatment center and a SARI screening

- Access the publication (28 March 2020)

 

 

13. Global Accelerator to Increase Access to Diagnostics, Vaccines, and Treatment

WHO Access to COVID -19 Tools (act) Accelerator launch event transcript 

https://www.who.int/news-room/detail/24-04-2020-global-leaders-unite-to-ensure-everyone-everywhere-can-access-new-vaccines-tests-and-treatments-for-covid-19

 

The information presented above has been developed by various departments in WHO and integrated for your information in this newsletter. In case you want to join this list, please send an email to This email address is being protected from spambots. You need JavaScript enabled to view it.with the words: SUBSCRIBE WHOMEDICALDEVICES in the body of the message. You can access all past newsletters. Any questions please address to This email address is being protected from spambots. You need JavaScript enabled to view it.

 


 

Please stay home, wash your hands, and take care!!

Alejandra Velez | Consultant on Medical Devices | Operations Support and Logistic (OSL) | Emergency Operations Department | World Health Organization, Geneva, Switzerland

And 

Adriana Velazquez Berumen, MSc. | Biomedical Engineer | Group 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, Geneva, Switzerland


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