2021-07-27-世界卫生组织-WHO_Medical_Devices_July_2021_Newsletter_8页_748kb

Summary of WHO Medical Devices July 2021 Newsletter

Global COVID-19 Data

• Confirmed cases: 188,655,968 as of 16 July 2021.
• Deaths: 4,067,517 as of the same date.
• Vaccine doses administered: 3,402,275,866 by 15 July 2021.

Focus on Medical Devices for COVID-19

• Oxygen is emphasized as critical for treatment, with initiatives like the ACT-A framework and oxygen task force to improve access.
• Key resources include guidelines for medicinal oxygen generation (e.g., PSI 93% and 99%), good manufacturing practices for medical gases, and efforts to repair PSA plants.
• NGOs and partners such as Every Breath Counts, PATH, and the Clinton Health Access Initiative are actively supporting oxygen availability.

WHO Priority Medical Devices and MeDevIS

• New publication on priority devices for cardiovascular diseases and diabetes includes over 500 devices, covering clinical interventions and settings.
• MeDevIS e-platform beta version released, integrating devices from WHO publications (cancer, COVID, cardiovascular, reproductive health), with an upcoming webinar.

Medical Device Nomenclature Standardization

• Discussions held during WHA74 focused on standardizing device naming, with consultation sessions involving stakeholders like regional regulators, biomedical engineers, and member states.
• Timeline includes upcoming information sessions, reporting to EB150, and IMDRF meetings.

Calls to Action

• Submit comments on draft oxygen standards by specified dates for WHO guidelines.
• Engage with resources like the Clinical management course on OpenWHO and C-TAP for technology access.
• Support WHO, UNICEF, and partners in increasing device availability and global collaboration.