FDA OKs use of certain devices as ventilators amid COVID-19 pandemic

In an attempt to mitigate ventilator shortages during the COVID-19 pandemic, the FDA has issued an emergency use authorization to allow the emergency use, in health care settings, of certain ventilators, anesthesia gas machines modified for use as ventilators, ventilator tubing connectors and ventilator accessories that the agency determines meet specified criteria for safety, performance and labeling, according to statement from the FDA.

Ventilator tubing connectors are used for multiplexing certain continuous ventilators intended for use in a health care facility, which means one ventilator may be used for multiple patients simultaneously. Devices eligible for inclusion under this emergency use authorization include those that are not currently marketed in the U.S. or those that are currently marketed in the U.S. but the device is modified such that a manufacturer would be required to submit a new premarket notification to the FDA, according to the statement.

An emergency use authorization was also issued for certain imported respirators, which have not been approved by National Institute for Occupational Safety and Health (NIOSH), that have been designed, evaluated and validated to meet a performance standard specified in the emergency use authorization and/or that have a marketing authorization in certain specified jurisdictions, subject to the conditions of authorization in certain specified jurisdictions, according to the statement. Respirators authorized for emergency use are for use in health care settings by health care personnel in accordance with CDC recommendations to prevent exposure to airborne particulates.

The statement notes that this new emergency use authorization on respirators does not affect the previous emergency use authorization from March 2, which authorizes, in part, the emergency use of certain respirators approved by NIOSH, for use in health care settings by health care providers.

“This emergency use authorization demonstrates our ability to react and adapt quickly during this pandemic by providing maximum regulatory flexibility and helping to increase the U.S. ventilator inventory so that very ill patients have access to lifesaving devices they need while still providing appropriate FDA oversight,” the statement reads.