Here's the latest info shared by WHO's Adriana Velázquez & Alejandra Vélez regarding Medical Devices and the World Health Organization (April 2020 Edition).
“Today, more than ever, medical devices are indispensable to save lives”
Once confirming good quality, we should make every effort to ensure medical devices for COVID are: available, accessible, appropriate and affordable to those that need them the most, and to deliver training for safe use!
Dear colleagues, as professionals in this area, you know the medical resources are being challenged, please disseminate prevention measures, like stay home, stay safe and raise awareness.
In this issue, only information related to the COVID-19 Pandemic is presented.
1. Coronavirus COVID-19 general information
1.1 Technical guidance: an overview of all technical topics: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance
1.2 Disease commodity package includes the list of all medical devices (including medical equipment, PPE) along with their technical specifications. This list will be updated again soon (link remains the same): https://www.who.int/publications-detail/disease-commodity-package---novel-coronavirus-(ncov)
1.3 Critical items for clinical management of COVID-19. This lists the medical devices and it also has a link to a calculator table, to help you quantify the needs for these technologies: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/covid-19-critical-items
2. On Personal Protective Equipment
Rational use of personal protective equipment: https://apps.who.int/iris/bitstream/handle/10665/331498/WHO-2019-nCoV-IPCPPE_use-2020.2-eng.pdf
3. On In Vitro Diagnostics and Laboratory
3.1 Coronavirus disease (COVID-19) outbreak – WHO Emergency Use Listing (EUL) for in vitro diagnostics.
Information on the call for diagnostics for emergency use, the tests that have been prequalified by WHO, (the first one was yesterday) and many more in the evaluation pipeline, as well as links to lists of IVDs approved by IMDRF members. https://www.who.int/diagnostics_laboratory/EUL/en/
3.2 Guidance for national laboratories
Particularly on laboratory testing: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance
4. On Medical Equipment for Clinical Management
4.1 Please find attached, a draft list of Priority Medical Devices for COVID management, version 3 April 2020, for consultation
4.2 Please find attached draft tables of technical specifications for invasive and noninvasive ventilators, version 4 April 2020.
4.3 Survey for manufacturers of COVID related equipment:
WHO is conducting a high-level market and risk assessment for respiratory equipment. Below is the link to participate in the survey. https://extranet.who.int/dataformv3/index.php/754894?lang=en. Please share it with ALL manufacturers globally!
The items listed in the survey aligns with the Disease Commodity Packages COVID19 and clinical management guidelines of WHO. https://www.who.int/emergencies/what-we-do/prevention-readiness/disease-commodity-packages/en/
The Pandemic Supply Chain Network (PSCN), a public-private collaboration, is a market network led by the WHO to facilitate a functioning supply chain during a pandemic.
The objective of this survey is gain insight on three key areas; i) the capacity of the market to supply oxygen therapy equipment to support the COVID19 response efforts around the world, ii) the capacity of organizations to increase its manufacturing capacity, and iii) the risks the sector will face in manufacturing and distributing the necessary equipment to meet the world’s demand.
5. On Innovation
Other sites of interest:
- Bill and Melinda Gates Foundation information https://www.gatesfoundation.org/TheOptimist/coronavirus
- Unitaid’s Executive Board today approved up to US$ 30 million for work against COVID-19, authorizing Unitaid to contribute its expertise in innovative treatment, diagnostics and respiratory triage tools to a global pandemic response.
- Global innovations exchange https://covid19innovations.org/
- Grand Challenges Canada https://www.grandchallenges.ca/
- UN Innovation network https://www.uninnovation.network/
6. WHO Requires Expert Consultants to Support COVID-19 Actions
Requirements: Biomedical/Clinical engineer, with postgraduate studies and with more than 7 years expertise on selection, procurement, evaluation, regulation, use of medical equipment used in ICU, and hospital areas.
Please mark with following checklist. Please, do not send CV if you do not comply with all requirements, please
Required studies: Biomedical or clinical engineer or similar, with postgraduate degree.
- More than 7 years of expertise in clinical settings, managing medical devices. Including selection, description, procurement, maintenance, training and safe use of medical equipment in health facilities.
- Knowledge of public procurement process
- Knowledge of review of technical specifications, standards,
- To have worked in a Ministry of Health, Nongovernmental organization for support to low and middle-income countries, UN agencies, or public hospitals.
Terms of Reference:
- Compile and integrate the technical specifications for the medical devices used for COVID for external consultation or review with experts.
- Compile, analyze and integrate the information from other UN agencies, Nongovernmental organizations, regulatory agencies and funding partners related to medical devices for COVID
- Consolidate information on users' training, maintenance, decommissioning and re-use for essential medical devices for COVID.
- Organize the information on technical specifications, assessments, reviews, analysis, to be discussed with OSL and other WHO departments,
- Compile evidence and collate reviews from external experts and integrate input on innovative technologies to support the clinical management of COVID
7. Information from Other Intergovernmental Organizations, In Reference to the Trade of Medical Devices for COVID-19
- World Trade Organization https://www.wto.org/english/news_e/news20_e/covid_25mar20_e.htm
- World Customs Organization, placed the Harmonized codes for medical devices to facilitate customs clearance, http://www.wcoomd.org/en/topics/facilitation/activities-and-programmes/natural-disaster/coronavirus.aspx
- UNICEF solidarity response funds https://www.unicef.org/press-releases/who-and-unicef-partner-pandemic-response-through-covid-19-solidarity-response-fund
8. COVID-19 Information from Non-Governmental Organizations with Official Relations with WHO
- IFMBE Clinical Engineering Division, resources for clinical engineers. https://ced.ifmbe.org/
- ISR, Resources for radiologists http://www.isradiology.org/blog/post/isr-covid-19-resources-radiologists
- IOMP, Medical physicists. https://www.iomp.org/covid-19-information-resource/
- ISRRT, Radiographers: https://www.isrrt.org/blog/who-announcements
9. Subscribe to WHO Newsletter
In this link, you can register to the WHO general news: https://www.who.int/news-room/newsletters
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
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