The Association for the Advancement of Medical Instrumentation (AAMI) released four guidelines yesterday (4/14) from their COVID-19 response team about medical device such as respirators and ventilators to help combat the viral outbreak. The team is made up of manufacturers, clinicians, and FDA representatives, and gives instructions on the development and use of emergency ventilators and respirators to treat patients with respiratory failure due to COVID-19. They are as follows:
- Emergency Use Ventilator
(EUV) Design Guidance
- End User Disclosures for
Emergency Use Ventilators (EUVs)
- Emergency Use Resuscitator
Systems Design Guidance
- End User Disclosures for Emergency Use Resuscitator Systems
The American National Standards Institute (ANSI) has also worked to make the ISO and IEC standards referenced in these guidelines freely available for developers.
You may find more information here.
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