January 26, 2021

FDA revises EUAs for N95 decontamination systems

By: Judy Mathias
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Editor's Note

The Food and Drug Administration on January 21 reissued emergency use authorizations (EUAs) for 10 systems used to decontaminate N95 respirators used by healthcare personnel .

The 10 systems are:


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  • Michigan State University Decontamination System
  • Technical Safety Services VHP Decontamination System
  • Stryker Sustainability Solutions VHP Decontamination System
  • STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers
  • Duke Decontamination System
  • Sterilucent, Inc Sterilization System
  • Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle
  • Advanced Sterilization Products (ASP) STERRAD Steriliztion System
  • STERIS Sterilization Systems for Decontamination of N95 Respirators
  • Battelle Decontamination System.

The EUAs also included approvals for systems to decontaminate N95 respirators 4 or fewer times, depending on the system.

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