Updated 23 April 2020

AAMI / FDA / NHS Guidance

The AAMI, in collaboration with the FDA, has released detailed guidance on emergency use ventilators and resuscitators. All design work should comply with this information.

Note: The EUA filings that we are tracking are for “resuscitators” not “emergency use ventilators.” This aligns with the philosophy of using these system as bridge devices. However, filings are aligning with the ventilator guidance.

The UK National Health Service has also released a wealth of information including revision 4 of a Rapidly Manufactured Ventilator System specification.

The FDA has just released specific guidance around an Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19).

FDA released information pertaining to ventilator supply and strategies for healthcare providers.