FDA issues Emergency Use Authorizations to ASP and STERIS to decontaminate millions of N95 respirators
The U.S. Food and Drug Administration (FDA) has issued emergency use authorizations (EUA) that have the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for reuse by healthcare workers in hospital settings.
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. 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.
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 low temperature sterilization process that utilizes hydrogen peroxide vapor. The vapor fills the sterilization chamber, penetrates the device and sterilizes exposed surfaces. The STERIS V-PRO Decontamination Cycle is capable of processing 10 respirators at one time through a process that takes approximately 28 minutes to complete. Each respirator can be processed up to 10 times for single-user reuse.
The FDA continues to work around the clock to help mitigate this pandemic as swiftly as possible. The agency will continue to help find solutions to increase the supply of certain essential medical devices needed for health care personnel to protect against COVID-19 and to provide the best care to patients with COVID-19.
