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 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.
We are not the only team developing low-cost ventilator technology and here we list those that meet the following criteria:
- Have considered safety and system limitations
- Have a plan to produce at scale with established industrial groups
- Have received or are seeking regulatory approval
- Will share their designs
SEAT & Protofy.xyz, Catalonia, Spain
‘Basic’ ventilator breathes air into Spain’s choked ICUs
JMA Wireless, Syracuse, NY & Bologna, Italy
Coronavirus: Tech company in Clay designs emergency ventilator, gives away blueprints
PREVAIL NY by JMA Offers Free, Open-Source Emergency Mechanical Ventilation System Blueprints to All Manufacturers