As the COVID-19 crisis unfolds, AAMI is providing this curated collection of resources to assist the health technology field. While AAMI finds these sources to be credible and has compiled this collection as a service to the field, these references are not endorsed by AAMI and the inclusion of any reference or resource should not be construed as endorsement, promotion, or support of any organization.
To request new or updated information, resources and links, please contact Bradley Schoener at firstname.lastname@example.org.
If you need guidance around standards, FDA’s Emergency Use Authorization (EUA) process, or other quality assurance and regulatory affairs issues, we would be happy to connect you with AAMI faculty who have indicated they would be willing to work with new clients, some on a pro bono basis. Please contact Bradley Schoener at, email@example.com for more information.
These guidance documents have been developed by the AAMI COVID-19 Response Team, made up of manufacturers, clinicians and FDA representatives, to respond to the ventilator shortage emergency.
Previous versions, for reference:
The ISO and IEC standards referenced in these guides have been made freely available by ANSI and can be obtained through this link.
National Association of Manufacturers and Business Roundtable launched a survey for businesses to identify specific ways they can provide or produce the supplies that are in high demand. They are working closely with federal agencies, including FEMA, to ensure that it captures the supply information they need. https://brt.nam.org/?_zs=TlDad1&_zl=suEe6