U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Emergency Situations (Medical Devices)
  5. Coronavirus (COVID-19) and Medical Devices
  6. FAQs for Filtering Facepiece Respirator (FFR) Decontamination Systems
  1. Coronavirus (COVID-19) and Medical Devices

FAQs for Filtering Facepiece Respirator (FFR) Decontamination Systems

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 has issued emergency use authorizations (EUAs) for some decontamination systems to decontaminate certain types of FFRs, recognizing that new FFRs are not sufficiently available during the Coronavirus Disease 2019 (COVID-19) pandemic.

The FDA has issued EUAs for decontamination systems for decontaminating 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 help 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

Back to Top