The U.S. Food and Drug Administration issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.
“Authorizing this sterilization system will make it easier for hospitals to ensure that heroic healthcare workers on the frontlines have the protection they need,” said HHS Secretary Alex Azar. “Thanks to rapid work by the men and women of the FDA and President Trump’s vision for an all-of-America response, innovators are giving our healthcare warriors new tools nearly every day to fight the COVID-19 pandemic.”
“This EUA is another game changer. 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,” said FDA Commissioner Stephen M. Hahn, M.D. “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.”
The FDA granted an emergency use authorization to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide. Hydrogen peroxide sterilization is a low temperature sterilization process that utilizes hydrogen peroxide vapor. The vapor fills the sterilization chamber, penetrates the device and sterilizes exposed surfaces. The STERIS V-PRO Decontamination Cycle is capable of processing 10 respirators at one time through a process that takes approximately 28 minutes to complete. Each respirator can be processed up to 10 times for single-user reuse.
The FDA continues to work around the clock to help mitigate this pandemic as swiftly as possible. The agency will continue to help find solutions to increase the supply of certain essential medical devices needed for health care personnel to protect against COVID-19 and to provide the best care to patients with COVID-19.
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.