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  6. FAQs for Filtering Facepiece Respirator (FFR) Decontamination and Bioburden Reduction Systems
  1. Coronavirus (COVID-19) and Medical Devices

FAQs for Filtering Facepiece Respirator (FFR) Decontamination and Bioburden Reduction Systems

UPDATE: FDA Recommends Transition from Use of Decontaminated Disposable Respirators

The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. Based on the 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) currently available to facilitate this transition, the FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems. For more information, see FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities.

Decontamination systems are devices intended to decontaminate certain medical devices, such as filtering facepiece respirators (FFRs), so that they can be reused by healthcare personnel. The FDA issued emergency use authorizations (EUAs) for some decontamination systems to decontaminate certain types of FFRs, recognizing  there was insufficient availability to meet the needs of the U.S. healthcare system as a result of the Coronavirus Disease 2019 (COVID-19) pandemic. Also see Considerations for Selecting Respirators for Your Health Care Facility.

The FDA has issued EUAs for decontamination and bioburden reduction systems for decontaminating or reducing the bioburden of FFRs for reuse by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of FFRs resulting from the COVID-19 pandemic. In addition to authorizing some decontamination systems for emergency use, the FDA has also issued guidance to provide recommendations for sponsors requesting EUAs for decontamination and bioburden reduction systems for surgical masks and respirators.  

This page does not cover:

  • Reprocessing, decontamination, or reuse of:
    • Face masks, surgical masks, or face shields
    • Respirators for non-medical use intended to limit industrial or general exposure to non-infectious particles, such as during construction or other industrial use
    • Powered respirators such as powered air purifying respirators (PAPRs)
    • Elastomeric respirators

The information provided may be useful to manufacturers of decontamination systems and healthcare facilities (HCFs) providing personal protective equipment (PPE) to HCP.

On this page:

The Basics on Decontamination Systems for FFRs

Developing Respirator Decontamination Systems

Using FFR Decontamination Systems

Using Decontaminated FFRs

The Emergency Use Authorizations for FFR Decontamination Systems

Bioburden Reduction Systems

This section provides answers to frequently asked questions about the FDA guidance, Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. These questions and answers provide additional clarity on existing policies and do not introduce any new or modify any existing policies. For general information on respirators and masks, please see the FDA's page on N95 Respirators, Surgical Masks, and Face Masks.

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