FDA Reissues Respirators EUA with New Decontamination-for-Reuse Instructions

June 9, 2020

On June 7, the Food and Drug Administration (FDA) reissued emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination and reuse in a health care setting. Citing a response to public health concerns, the FDA guidance clarifies that the following respirators should not be decontaminated for reuse:

  • Respirators manufactured in China
  • Respirators with exhalation valves

The guidance notes that previously authorized respirators are no longer included on the list of respirators suitable for decontamination. Thus, GNYHA advises hospitals to ensure they review the revised list of authorized respirators and decontamination systems.

The FDA is only authorizing decontamination systems’ use on non-cellulose compatible N95 respirators and advises health care personnel to avoid reuse of respirators that are incompatible with authorized decontamination systems, even if they have been decontaminated.

For more details on the list of approved respirators and additional information on approved decontamination systems, please refer to the FDA guidance and reissued EUAs. GNYHA previously provided guidance from the Centers for Disease Control and Prevention and the Occupational Safety and Health Administration on decontaminating respirators.