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.
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