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|
|10/20/2020||Roxby Development Zoe-Ann Decontamination System|