The Food and Drug Administration (FDA) this week granted an emergency use authorization (EUA) to allow healthcare personnel to use some industrial respirators during the COVID-19 outbreak in health care settings.
The FDA was responding to an EAU application from the Centers for Disease Control and Prevention (CDC) designed to maximize the number of respirators available to the U.S. healthcare system.
The majority of respirators on the market are used in industrial settings. However, the FDA’s EUA allows respirators approved by the National Institute for Occupational Safety and Health (NIOSH), which are not currently regulated by the FDA, to be used in a healthcare setting by healthcare personnel during the coronavirus (COVID-19) outbreak.
Respiratory protective devices are designed to achieve a very close facial fit and very efficient filtration of airborne particles, allowing them to filter more airborne particles than face masks, the FDA said in its statement. The FDA concluded that respirators approved by NIOSH, but not currently meeting the FDA’s requirements, may be effective in preventing healthcare personnel from airborne exposure to COVID-19.
“The FDA and CDC are aware that as the COVID-19 outbreak continues to expand globally, the supply chain for these devices will continue to be substantially stressed as demand exceeds available supplies. Under the circumstances of this emergency, nationwide shortages are anticipated,” the FDA said in a press statement.
