The U.S. Food and Drug Administration (FDA) announced new efforts to increase the availability of ventilators and accessories and other respiratory devices during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing, the administration announced on Monday.
“With this boost from the FDA, medical device makers can more easily make changes to existing products, such as changes to suppliers or materials, to help address current manufacturing limitations or supply shortages. Other manufacturers, such as automakers, can more easily repurpose production lines to help increase supply,” said Health and Human Services Secretary Alex Azar.
First, the guidance has outlined the agency’s intention to exercise enforcement discretion for certain modifications to these FDA-cleared devices. The guidance will expedite manufacturing by adding production lines or alternative sites, for instance, using non-medical device manufacturers such as automobile manufacturers, to start manufacturing ventilator parts.
Second, the FDA will support hospitals and health care professionals by providing ventilators intended for other environments, including repurposing ventilators normally used for transporting patients in an ambulance into the hospital setting for long-term use. The FDA has also provided recommendations for other alternatives that should be considered such as devices for treating sleep apnea, continuous positive airway pressure (CPAP) devices.
Finally, the agency has encouraged manufacturers to communicate with the FDA about pursuing an emergency use authorization (EUA), which would allow them to distribute their ventilators in the United States. This includes U.S.-based manufacturers that were previously engaged in making medical devices, but have capabilities to increase the supply of these devices.
“The FDA is doing everything we can to support patients, health care professionals, hospitals, medical product manufacturers and the public during this pandemic. One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” said FDA Commissioner Stephen Hahn, M.D.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.