“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!
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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 COVID-19 Pandemic is presented.
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1. Coronavirus COVID-19 general information
1.1 Technical guidance: overview on 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)
1.2 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.
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:
4. On medical equipment for clinical management
4.1 Please find attached, draft list of Priority Medical Devices for COVID management, version 3 April 2020, for consultation
Please note it expands from the Disease Commodity Package and includes all devices used in ICU caring for COVID patients. It will soon be posted as a final publication in WHO COVID site.
If you have any comments, please send via mail to medicaldevices@who.int on 6th April, please
4.2 Please find attached draft tables of technical specifications for invasive and noninvasive ventilators, version 4 April, 2020.
Please note it expands from the descriptions of the Disease Commodity Package. It will soon be posted as a final publication in WHO COVID site.
If you have any comments, please send via mail to medicaldevices@who.int on 6th April, please.
WHO is thankful for all input from advisors and experts groups
4.3 Survey for manufacturers of COVID related equipment:
WHO is conducting an 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 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.
With greater visibility combined with the need to match global and country-based demand, the PSCN can facilitate the global supply chain to provide the necessary supplies to those at most risk. More information, contact: griffinm@who.int and medicaldevices@who.int
5. On Innovation
If you have Innovative product that might help COVID, please be sent to techinnovation only via email to techinnovation@who.int, a format will be set to receive detailed information at: https://www.who.int/medical_devices/innovation/en/
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.
Consultants might be hired by different WHO offices ( HQ, Euro or countries)
ONLY IF you comply with requirements, are interested and available for 3 months, as full time consultant, please send 1 page CV by Monday 6 April,2020 to medicaldevices@who.int. along with the check list below and 2 references.
Please mark with following check list. 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.
Required Expertise:
More than 7 years 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,
Desirable:
To have worked in Ministry of Health, Non governmental 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, Non governmental 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
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 Information from Non-Governmental organizations in official relations with WHO
IFMBE, 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
8. Subscribe to WHO Newsletter,
In the link below you can register to the WHO general news
https://www.who.int/news-room/newsletters
Please stay home, wash your hands and take care!!
L. 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, WHO
Geneva, Switzerland
Office: +41 (0)22 791 1239
Mobile: +41 (0)79 634 0095
Web: www.who.int www.who.int/medical_devices/en/
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