FDA issues emergency order as ventilator shortage looms during coronavirus pandemic
The FDA has issued an Emergency Use Authorization (EUA) order for various machines to be used as ventilators “in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings” during the coronavirus pandemic.
As described by the FDA, this allows anesthesia gas machines modified for ventilator use; and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors and ventilator accessories to be used for treating COVID-19 patients.
FDA Chief Scientist Denise Hinton said in a Tuesday letter to medical equipment manufacturers that this pandemic met the criteria for issuing this order because:
▪ COVID-19 can kill.
▪ The possible benefits of using the emergency equipment “outweigh the known and potential risks.”
▪ “There is no adequate, approved, and available alternative to the emergency use of the authorized ventilators, ventilator tubing connectors, and ventilator accessories for treating patients during the COVID-19 pandemic.”
The equipment brought into play by this EUA aren’t marketed in the U.S. or are marketed, but have a modification that requires a notification to the FDA.
This story was originally published March 26, 2020 at 1:40 PM.
