Contents of December 2021 Newsletter:

Section 1: Call for Essential in vitro diagnostics

Section 2: Nomenclature of medical devices to be discussed in Executive Board

Section 3: Consultants required for medical devices 2022 projects 

 

You can find all past newsletters here;  WHO medical devices information here; WHO in vitro diagnostics information here  and WHO oxygen-related here

 


 

WHO COVID-19 Dashboard

Globally, as of 4:42 pm CEST, January 20, 2022, there have been 336,790,193 confirmed cases of COVID-19, including 5,560,718 deaths, reported to WHO. As of January 19, 2022, a total of 9,571,502,663 vaccine doses have been administered. 

Globally, as of 4:48 pm CEST, December 10, 2021, there have been 267,865,289 confirmed cases of COVID-19, including 5,285,888 deaths, reported to WHO. As of December 9, 2021, a total of 8,158,815,265 vaccine doses have been administered.

  

Towards the 4th Edition of the WHO Model List of Essential In Vitro Diagnostics (EDL4):

The EDL Secretariat is pleased to announce the opening of the application period for EDL4.

The details of the call including deadlines, priorities, and the submission process can be found here or: https://www.who.int/news-room/articles-detail/call-for-submission---submissions-for-the-fourth-who-model-list-of-essential-in-vitro-diagnostics-(edl-4)

Additional information on the EDL can be found here.

 

Nomenclature of Medical Devices

2.1 Background

The topic of standardization of nomenclature of medical devices has been discussed in the WHO Executive Board EB145/3 (May 2019) and EB148/13 (January 2021) and the World Health Assembly (WHA74 May 2021).

As requested by the Member States, since July 2021, WHO has been working on this topic:

Country Surveys, more than 40 consultations with different stakeholders, including Ministries of Health, regulatory agencies, health care providers, non-governmental organizations, med-tech industry, UN agencies, and nomenclature agencies, among others.

A pilot project to map 4 of the most used nomenclatures was done and results were presented in December 2021, in:

 

The description of all activities can be found on the WHO Website for Nomenclature.

 

2.2 Executive Board 2022 (EB150/14)
The standardization of nomenclature will be discussed during the WHO Executive Board on 24-29 January 2022.

The documents related to the Executive Board 150 can be found here

The nomenclature of medical devices includes 3 documents:  

  • EB150/14 This report covers work done by WHO between June to September 2021: Standardization of medical devices nomenclature, International classification, coding, and nomenclature of medical devices.
  • EB150/14 Add.1 This report covers from September to December 2021: Standardization of medical devices nomenclature, International classification, coding, and nomenclature of medical devices.
  • EB150/14 Add.2 Financial and administrative implications for the Secretariat of decisions proposed for adoption by the Executive Board

 

 

 

Consultancy Open for 2022 Projects

WHO will be initiating new projects this year and continuing others and therefore is looking for consultants in the following areas listed below. 

Please send an expression of interest (EOI) to medicaldevices@who.int by 31 January attaching an updated CV and area of interest. Thank you!

 

Pricing of Medical Devices

  • Objective: support the development of the pricing model for medical devices, including single-use devices and capital equipment.
  • Requirements: 
    • Academics (Post-Graduate Degree) in Biomedical or Clinical Engineering or related fields. 
    • Professional Experience (>7 Years) in Health Economics, Health technology Management, Health Technology Assessment, Reimbursement Policies, Clinical Interventions Costs, Pricing, and Affordability of different types of medical devices, Elements of Price.
  • More Information here

 

Medical Devices Information System (MEDEVIS)

  • Objective: support the continuous development of MEDEVIS.
  • Requirements: 
    • Academics (Post-Graduate Degree) in Biomedical or Clinical Engineering or related fields. 
    • Professional Experience (>7 Years) in Data management, Expertise in Hospitals Managing Medical Equipment, and other Medical Devices, Policy Level Expertise of Development of National Lists
  • More Information here

 

Health Products for Universal Health Coverage Compendium (UHCC)

  • Objective: select the medical devices (including in-vitro diagnostics, medical equipment, single-use medical devices, imaging, assistive devices) required for health interventions.
  • Requirements: 
    • Academics (Post-Graduate Degree) in Biomedical or Clinical Engineer, Health Technology Manager.
    • Professional Experience (>7 Years) for in vitro diagnostics, laboratory management, and extensive expertise in health care systems.
  • More Information here

 


 

Please Stay safe, take care, get vaccinated when possible, and wear your PPE!

Best wishes for a safe and healthier 2022!

 

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: velazquezberumena@who.intmedicaldevices@who.int   

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