FDA Recommends Transition from Use of Decontaminated Disposable Respirators

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

In a Letter to Health Care Personnel and Facilities on April 9, 2021, 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.”

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 FFRs or if you are unable to obtain any new respirators.
  • Transition away from a crisis capacity strategy for respirators, such as 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, and powered air-purifying respirators (PAPRs). Even if you are unable to obtain the respirator model that you would prefer, the FDA recommends that you obtain and use a new respirator before decontaminating or bioburden reducing a preferred disposable respirator.

“The FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems. However, the FDA is not revoking the EUAs for decontamination and bioburden reduction systems at this time. If there are insufficient supplies of FFRs resulting from the COVID-19 pandemic, health care personnel may continue to use currently-authorized decontamination and bioburden reduction systems, though such reuse of respirators should be limited to when no other respirators are available, including reusable respirators such as elastomeric respirators or PAPRs.

Of note, while there is an increase in domestic supply of respirators for healthcare personnel, the FDA will continue to monitor supply and demand to assess respirator availability as facilities systematically transition away from the most extreme measures of respirator conservation (that is, crisis capacity strategies) to contingency and eventually conventional use. Therefore, respirators, specifically surgical respirators, presently remain on the FDA’s device shortage list. The shortage list reflects the categories of devices the FDA has determined to be in shortage at this time and will be maintained and updated as the COVID-19 public health emergency evolves. The presence of a device type on this list does not necessarily indicate that patient care has been affected.

The FDA will continue to keep health care personnel and the public informed if new or additional information becomes available.”