2021-06-27-世界卫生组织-WHO_Medical_Devices_June_2021_Newsletter_7页_395kb
报告摘要
WHO Medical Devices June 2021 Newsletter Summary
Core Content
The June 2021 WHO Medical Devices Newsletter highlights ongoing efforts to improve global access to medical devices, particularly in the context of the ongoing COVID-19 pandemic and non-communicable diseases. It emphasizes the importance of collaboration, standardization, and innovation in addressing health challenges.
Main Points
1. WHO List of Priority Medical Devices and MeDevIS e-platform
- Launch: WHO has launched a list of priority medical devices for cardiovascular diseases and diabetes, along with the MeDevIS electronic-platform.
- Purpose: To improve access to essential medical technologies and support regulation, procurement, and health technology assessment.
- Features: The platform allows browsing by therapeutic areas, clinical areas, type of health product, and usage (capital, reusable, or single use).
- Date: The webinar on this topic is scheduled for June 30, 2021, at 14:00 (Geneva Time).
2. Seventy-fourth World Health Assembly (WHA74) Outcomes
- Virtual Assembly: Took place from May 24 to June 1, 2021.
- Key Discussion: Focused on the standardization of medical device nomenclature.
- Member State Requests:
- Emphasis on transparency, harmonization, and evidence-based systems.
- Request for WHO not to create a new nomenclature to avoid duplication.
- Call to map EMDN to GMDN to minimize impact.
- WHO Response:
- Confirmed not to create a new nomenclature.
- Planned to conduct information and consultation sessions in 2021, with a report to the Executive Board in February 2022.
- Encouraged Member States to support in finding agreements and mapping systems.
3. Medical Technologies for COVID-19
- Oxygen Access:
- Oxygen remains critical for treating both COVID-19 and other diseases.
- WHO, UNICEF, and other partners are working to repair PSA plants and increase oxygen availability at the country level.
- Global Fund Mechanism:
- The Global Fund has opened a mechanism to support countries in procuring in vitro diagnostics, personal protective equipment, treatments, and oxygen equipment.
- Technology Sharing:
- The medical devices industry, academia, and innovators are invited to share knowledge, IP, or data through C-TAP (COVID-19 Technology Access Pool) to increase global access.
- Clinical Management Course:
- WHO has launched a clinical management course on OpenWHO for mild, moderate, and severe cases of COVID-19.
Key Information
- WHO Initiatives:
- ACT Accelerator: Commits to 870 million vaccine doses and calls for increased investment in pandemic tools.
- IMDPR Teleconference: Scheduled for June 24, 2021, to brief on WHA74 outcomes and next steps.
- Consultancy Opportunity:
- WHO is seeking a full-time consultant to support nomenclature standardization efforts.
- Closing Date: July 5, 2021, at 9:00 CET.
- Requirements: More than 7 years of expertise in medical device nomenclature, coding, classification, regulations, or health technology management. Must have a postgraduate degree and excellent English writing skills.
- Duration: 4 months.
- Email: medicaldevices@who.int
Timeline of Events
| Date | Activity | Expected Outcome |
|---|---|---|
| 18–25 March | MDRP MS BAG Preparation | Update on MDRP status and development of DRC |
| 12 April | Information Session to Member States | Present updated analysis and listen to proposals |
| 23 April | Meeting with IFIMCI | Listen to clinical and biomedical engineers' use |
| 13 May | Meeting with NGOs | Share information and listen to NGO inputs |
| May–June | WHA74 and EB149 | - |
| 24 June | IMDPR Teleconference | Briefing on WHA outcomes and next steps |
| July (TBC) | WHO HQ, Regional Advisors | Status, plan, and input |
| July (TBC) | UN Agencies | Nomenclature and tech specs |
| July (TBC) | Nomenclature Agencies | Willingness to map WHO and agency systems |
| August (TBC) | Medical Devices Industry | QMTA, DITT.A |
| August (TBC) | Biomedical and Clinical Engineers | Use of nomenclature in healthcare facilities |
| August (TBC) | Regional Regulators Networks | Nomenclature usage and challenges |
| 7 September | Member States Information Session | Report on consultation sessions |
| Mid September | IMDRF Meeting | Briefing and next steps |
| October | Consultation and Report for EB150 | Discussion of the report |
| 1 February 2022 | EB150 | Presentation to the Executive Board |
Contact Information
- Email: medicaldevices@who.int
- Webinar Registration: Register here
- WHO Medical Devices Website: Access here
Additional Resources
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