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  7. Decontamination Systems for Personal Protective Equipment EUAs
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Decontamination Systems for Personal Protective Equipment EUAs

Decontamination systems are devices intended to decontaminate certain medical devices (such as compatible respirators) so that they can be reused by healthcare personnel. FDA has issued EUAs authorizing the emergency use of some decontamination systems to decontaminate certain respirators, recognizing that availability of PPE is an integral part of routine patient care during the COVID-19 pandemic.

This table below includes authorization information for the use of decontamination systems to decontaminate certain PPE devices during the COVID-19 public health emergency.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.

Date EUA Issued PPE (Letter of Authorization) Other Documents
04/15/2020 Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle (Reissued 06/06/2020)
04/11/2020 Advanced Sterilization Products (ASP) STERRAD Sterilization System (Reissued 06/06/2020)
04/09/2020 STERIS Sterilization Systems for Decontamination of N95 Respirators (Reissued 06/06/2020)
03/29/2020 Battelle Decontamination System (Reissued 06/06/2020)
04/20/2020 Sterilucent, Inc. Sterilization System (Reissued 06/06/2020)
05/07/2020 Duke Decontamination System (Reissued 06/06/2020)
05/21/2020 STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers
05/27/2020 Stryker Sustainability Solutions VHP Decontamination System (Reissued 06/06/2020)
06/13/2020 Technical Safety Services VHP Decontamination System
07/24/2020 Michigan State University Decontamination System
08/20/2020 Nova2200

 

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