FDA to health care facilities: OK to ‘transition away’ from reusing disposable respirators

Washington — Prompted by an “increased domestic supply” of NIOSH-approved respirators, the Food and Drug Administration is recommending health care facilities transition away from strategies intended to conserve supplies of disposable respirators amid the COVID-19 pandemic.

According to an April 9 statement from FDA, the agency and the Centers for Disease Control and Prevention “believe there is adequate supply of respirators to transition away from the use of decontamination and bioburden reduction systems.”

FDA recommends health care facilities and workers:

• Use decontaminated respirators or those that have undergone bioburden reduction only when supplies of new respirators are insufficient or when unable to acquire new respirators.
• Transition away from a crisis capacity strategy for respirators, such as decontamination of N95 and other filtering facepiece respirators.
• Increase inventory of various types of available NIOSH-approved respirators.
• Try to acquire elastomeric respirators and powered air-purifying respirators, which are designed to be reused, before reusable respirators.

FDA notes that NIOSH approved more than 875 respirator models or configurations between January 2020 and this past April. Some of those were manufactured by 20 or so new domestic NIOSH approval holders. Additionally, more than 6,400 approved respirator models or configurations are on NIOSH’s certified equipment list.

NIOSH and CDC also have updated their online guidance document Strategies for Optimizing the Supply of N95 Respirators.