The FDA has issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by healthcare workers in hospital settings.
The EUA was granted to Steris Corp 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.
The H2O2 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.
This EUA will support decontamination of approximately 750,000 N95 respirators per day in the US.
“This EUA is another game changer. It will allow hospitals to decontaminate compatible N95 respirators using vaporized hydrogen peroxide sterilizers that are readily available in approximately 2,000 US hospitals,” said FDA Commissioner Stephen M. Hahn, MD. “It’s another important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by health care personnel on the front lines of the COVID-19 pandemic.”