FDA Releases Statement on Increase of US Supply of Ventilators, Respirators for Health Care
The FDA has issued a statement regarding action to help increase the supply of ventilators, ventilator tubing connectors, and ventilator accessories during the COVID-19 pandemic.
The FDA has issued a statement regarding action to help increase the supply of ventilators, ventilator tubing connectors, and ventilator accessories, including filtering facepiece respirators (FFRs) due to shortages during the coronavirus disease 2019 (COVID-19) pandemic.
An Emergency Use Authorization (EUA) was issued by the FDA to allow for the emergency use in health care settings of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories. The supplies must meet specified criteria for safety, performance, and labeling.
One ventilator may be used for multiple patients simultaneously, since ventilator tubing connectors are used for multiplexing certain continuous ventilators intended for use in a health care facility, according to the FDA.
In addition, the FDA has issued an EUA for certain imported non-National Institute for Occupational Safety and Health (NIOSH)-approved respirators that have been designed, evaluated, and validated to meet a performance standard specified in the EUA. This new EUA does not affect the previous EUA that was issued on March 2, which authorizes the emergency use of certain respirators approved by NIOSH for use in health care settings by health care providers.
FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients [news release]. Silver Springs, MD; FDA: March 27, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-increase-us-supply-ventilators-and-respirators?utm_campaign=032720_PR_FDA%20takes%20action%20to%20help%20increase%20U.S.%20supply%20of%20ventilators%20and%20respirators&utm_medium=email&utm_source=Eloqua. Accessed March 27, 2020.