FDA Issues Emergency Use Authorization to decontaminate millions of N95 respirators

April 13, 2020

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) that has the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for reuse by health care workers in hospital settings.

“Our nation’s healthcare workers are among the many heroes of this pandemic, and we need to do everything we can to increase the availability of the critical medical devices they need, like N95 respirators,” said FDA Commissioner Stephen M. Hahn, MD. “FDA staff continue to work around the clock, across government and with the private sector to find solutions. This authorization will help provide access to millions of respirators so our healthcare workers on the front lines can be better protected and provide the best care to patients with COVID-19.”

The FDA granted the EUA to Advanced Sterilization Products (ASP) for the STERRAD Sterilization Cycles (STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle), which uses vaporized hydrogen peroxide gas plasma sterilization. There are approximately 9,930 STERRAD sterilization systems in approximately 6,300 hospitals across the U.S. The STERRAD 100S Cycle, STERRAD NX Standard Cycle and STERRAD 100NX Express Cycle vary in reprocessing times from 55 minutes, to 28 minutes and 24 minutes. Each can reprocess approximately 480 respirators per day.

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