FDA recommends not using decontaminated disposable respirators

April 12, 2021

The U.S. Food and Drug Administration (FDA) recommends that healthcare personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse, announced a letter to healthcare providers from the agency. 

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 said. 

The agency recommends that healthcare personnel and facilities: 

· Transition away from a crisis capacity strategy for respirators, such as decontamination of N95 and other filtering face-piece respirators.

· 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.

· 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. 

However, the FDA is not revoking the EUAs for decontamination and bioburden reduction systems. 

FDA has the letter