January 26, 2021

FDA revises EUAs for N95 decontamination systems

By: Judy Mathias

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:

Sponsored Message

  • 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.


Sign Up For OR a.m.
Sign up for the free OR a.m. eLetter to get news like this in your inbox every morning!

OR Manager Jobs
Live chat by BoldChat