The AAMI COVID-19 Response Team developed and released four AAMI Consensus Reports (CRs) which are emergency guidance documents regarding the safe and effective emergency use of resuscitators and ventilators, and enables their rapid development. The Response Team is composed of clinicians, manufacturers, and FDA representatives. The documents provide a “valuable roadmap” for companies that are new to the production of these devices, and save the manufacturers time by directing them toward the standards documents that apply to them. The four CRs are available for free at www.aami.org/COVID_CR and are the following:
· AAMI CR501:2020, Emergency Use Ventilator (EUV) Design Guidance
· AAMI CR502:2020, End User Disclosures for Emergency Use Ventilators (EUVs)
· AAMI CR503:2020, Emergency Use Resuscitator Systems Design Guidance
· AAMI CR504:2020, End User Disclosures for Emergency Use Resuscitator Systems
The documents will evolve, so it is encouraged to continue to check for updates.