The FDA issued an emergency use authorization (EUA) late Sunday for the Sterrad Sterilization Cycles for the decontamination of N95 respirators.
The EUA covers the Sterrad 100S Cycle, Sterrad NX Standard Cycle, and Sterrad 100NX Express Cycle from Advanced Sterilization Products. These devices use vaporized hydrogen peroxide gas plasma sterilization to decontaminate masks with processing times of 55 minutes, 28 minutes, and 24 minutes, respectively.
The EUA allows for a maximum of 2 decontamination cycles per respirator.
According to the FDA there are approximately 9,930 Sterrad Sterilization systems in approximately 6,300 hospitals across the US. Each can reprocess approximately 480 respirators per day, meaning the EUA allows for the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the US.
“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.”