FDA authorizes decontamination, reuse N95 and equivalent respirators to combat COVID-19

In a second emergency use authorization (EUA), the United States Food and Drug Administration (FDA) has approved the decontamination of N95 and equivalent respirators for reuse by health care workers in hospitals working to contain COVID-19.

Such masks have been in short supply as hospitals strain to keep up with the demands of the pandemic. However, the FDA said this EUA would support decontamination of approximately 750,000 respirators per day, giving hospitals a potentially and significantly larger field to work with going forward.

“This EUA is another game changer,” FDA Commissioners Stephen Hahn said. “It will allow hospitals to decontaminate compatible N95 respirators using vaporized hydrogen peroxide sterilizers that are readily available in approximately 2,000 U.S. hospitals. It’s another important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by health care personnel on the front lines of the COVID-19 pandemic.”

To make this reuse possible, the FDA has granted an EUA to STERIS Corporation for its STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle, which uses vaporized hydrogen peroxide to do its work. The low temperature sterilization process uses said vapor to penetrate devices and sterilize exposed surfaces. The V-PRO Decontamination Cycle is capable of processing 10 respirators at a time, with an approximately 28 minute turnaround time. Each respirator can be processed up to 10 times for a single user.

“Authorizing this sterilization system will make it easier for hospitals to ensure that heroic healthcare workers on the frontlines have the protection they need,” HHS Secretary Alex Azar said.