FDA authorizes process it says could decontaminate 4 million masks daily
Amid widespread shortages of personal protective equipment and masks during the COVID-19 pandemic, the FDA has granted several emergency use authorizations, or EUAs, for the decontamination and reuse of N95 or N95-equivilent masks.
Most recently, the FDA issued an EUA for Advanced Sterilization Products’ STERRAD Sterilization Cycles, which use vaporized hydrogen peroxide gas plasma sterilization. According to the FDA, the process could potentially decontaminate 4 million N95 or N95-equivalent respirators per day in the United States for reuse by health care workers in hospital settings.
Currently, the FDA estimates that there are approximately 9,930 STERRAD Sterilization systems in 6,300 U.S. hospitals that can reprocess approximately 480 respirators per day.
“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,” FDA Commissioner Stephen M. Hahn, MD, said 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.”
The FDA previously granted EUAs to the Steris Corporation and Battelle Memorial Institute for decontamination systems that also use vaporized hydrogen peroxide.