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Food and Drug Administration and Compliance Issues
Friday, April 10, 2020
Coronavirus (COVID-19) Update: FDA Issues Second Emergency Use Authorization to Decontaminate N95 Respirators
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...