AAMI drafts emergency ventilator, resuscitator guidance for COVID-19

Regulatory NewsRegulatory News | 14 April 2020 |  By 

The medical instrumentation industry group AAMI on Tuesday released four guidances for the development and use of emergency ventilators and resuscitators to treat patients with respiratory failure due to coronavirus disease (COVID-19).
The consensus documents were developed with input from manufacturers, clinicians and US Food and Drug Administration (FDA) staff and include recommendations for design and end user disclosures for both devices.
“These [consensus reports] are an especially valuable roadmap for companies new to the health technology space who are stepping up to build emergency-use ventilators and resuscitators. While they have talented engineers, many do not have the foundational knowledge in this area, particularly when it comes to patient safety,” said Julian Goldman, co-chair of AAMI’s COVID-19 response team.
The consensus reports come as manufacturers, including automakers and aerospace companies, rush to build ventilators to meet the massive demand for the devices caused by COVID-19. FDA has also issued a guidance and an emergency use authorization (EUA) to increase the availability of ventilators and their accessories amid the pandemic. (RELATED: FDA, MHRA Seek to Boost Ventilator Supply, Regulatory Focus 23 March 2020).
The two sets of consensus reports provide an overview of the clinical, engineering and test requirements for the safe use of emergency ventilators and resuscitators and discuss which requirements and standards are necessary and which, while required for non-emergency use devices, may be skipped with “appropriate disclosures” laid out in the accompanying end user disclosure documents.
AAMI advises that emergency use devices following the recommendations in the guidances “need not provide a level of performance equivalent” of critical care and life-supporting homecare ventilators or ventilatory support equipment.
AAMI also notes that the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) standards referenced in the guidances are available for free by request.


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