Latest FDA Update on Respirators

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

On Thursday, May 27, 2021, the FDA issued this letter to healthcare facilities:  FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators.

The FDA recommends that health care personnel and facilities:

  • Limit decontamination of disposable respirators. Decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFRs) or when any new respirators are unavailable.
  • Limit use of all non-NIOSH-approved respirators, including imported respirators, to only when there are insufficient supplies of new NIOSH-approved FFRs or when any new respirators are unavailable.
  • Transition away from a crisis capacity strategy for respirators, such as use of non-NIOSH approved respirators and decontamination of N95 and other FFRs.
  • Increase inventory of available NIOSH-approved respirators, including:
    • N95s and other FFRs
    • Elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in the operating room 
    • Powered air-purifying respirators (PAPRs). 

Even if health care personnel and facilities are unable to obtain the respirator model that they would prefer, the FDA recommends obtaining and using a new NIOSH-approved respirator before using a non-NIOSH-approved respirator or decontaminating or bioburden-reducing a preferred disposable respirator.

 The letter contains previous FDA actions, information on reporting problems to the FDA and contact information.