The FDA has granted Steris (NYSE:STE) emergency use authorization (EUA) for a vaporized hydrogen peroxide system to decontaminate up to 750,000 N95 respirators and equivalent masks per day in hospitals treating COVID-19 patients.
The Steris V-PRO 1 Plus, maX and maX2 low-temperature sterilization systems use the Steris N95 non-lumen decontamination cycle. Hydrogen peroxide vapor fills the sterilization chamber, penetrates the device and sterilizes exposed surfaces. The Steris V-PRO can process 10 respirators at one time in a 28-minutes cycle, and each respirator can be processed up to 10 times for single-user reuse, according to the FDA.
FDA commissioner Stephen Hahn called this EUA a “game-changer.”