Advanced Sterilization Products has won FDA emergency use authorization (EUA) for hospitals to use its Sterrad Sterilization Cycles systems to decontaminate N95 or N95-equivalent respirators for reuse by healthcare workers treating COVID-19 patients.
The EUA will enable decontamination of approximately 4 million respirators per day, according to the FDA. It covers the Sterrad 100S cycle, Sterrad NX standard cycle and Sterrad 100NX express cycle, which use vaporized hydrogen peroxide gas plasma sterilization. The agency estimates there are 9,930 Sterrad sterilization systems in approximately 6,300 hospitals across the U.S. Reprocessing times range from 55 minutes to 24 minutes and each can reprocess approximately 480 respirators per day.
This is the third EUA the FDA has granted for vaporized hydrogen peroxide systems to decontaminate the type of respirators healthcare workers are wearing to protect themselves from the COVID-19 virus. The agency authorized use of the Steris (NYSE:STE) V-PRO 1 Plus, maX and maX2 low-temperature sterilization systems on Friday and of the Battelle Critical Care decontamination system in March. Hospitals using each system can reprocess tens of thousands of respirator masks per day so that health personnel can reuse them, according to the agency.
“Our nation’s health care 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 Hahn in a news release. “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 health care workers on the front lines can be better protected and provide the best care to patients with COVID-19.”