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

Decontamination System EUAs for Personal Protective Equipment

UPDATE: FDA Recommends Transition from Use of Decontaminated Disposable Respirators

On April 9, 2021, the U.S. Food and Drug Administration (FDA) recommended health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. An increased domestic supply of new respirators approved by the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) and authorized for health care personnel use by the FDA are now currently available to facilitate this transition. For more information, see FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities

Decontamination and bioburden reduction systems are devices intended to decontaminate or reduce bioburden of certain medical devices (such as compatible respirators) so that they can be reused by healthcare personnel. The FDA has issued EUAs authorizing the emergency use of some decontamination systems to decontaminate certain respirators as well as a bioburden reduction system, 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 bioburden reduction and decontamination systems to decontaminate certain PPE devices during the COVID-19 public health emergency.

On April 30, 2021, the FDA revoked the emergency use authorization (EUA) of the Battelle CCDS Critical Care Decontamination System, which was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by healthcare personnel. The FDA revoked the EUA in response to Battelle's request for voluntary withdrawal of the authorization. In response to changing customer needs, as of March 31, 2021, Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities.

Date EUA Issued PPE (Letter of Authorization) Other Documents
04/15/2020 Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle (Reissued 01/21/2021)
04/11/2020 Advanced Sterilization Products (ASP) STERRAD Sterilization System (Reissued 01/21/2021)
04/09/2020 STERIS Sterilization Systems for Decontamination of N95 Respirators (Reissued 01/21/2021)
04/20/2020 Sterilucent, Inc. Sterilization System (Reissued 01/21/2021)
05/07/2020 Duke Decontamination System (Reissued 01/21/2021)
05/21/2020 STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers (Reissued 01/21/2021)
05/27/2020 Stryker Sustainability Solutions VHP Decontamination System (Reissued 01/21/2021)
06/13/2020 Technical Safety Services VHP Decontamination System (Reissued 01/21/2021)
07/24/2020 Michigan State University Decontamination System (Reissued 01/21/2021)
10/20/2020 Roxby Development Zoe-Ann Decontamination System
12/04/2020 Ecolab's Bioquell Technology System
12/03/2020 Lumin LM3000 Bioburden Reduction UV System
01/15/2021 Yale New Haven Health FFR Decontamination System

Additional Resource

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