FDA Recommends to Transition Away from Crisis Capacity Conservation Strategies

FDA issued a letter to healthcare personnel and facilities recommending that they transition away from crisis capacity conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s. This recommendation is in follow-up to the April 9, 2021, letter in which the FDA recommended a transition away from decontamination or bioburden-reduction systems for cleaning and disinfecting disposable respirators, which were being reused by health care personnel. Recommendations for health care personnel and facilities are as follows:

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). 

 Letter to Health Care Personnel and Facilities: www.fda.gov/medical-devices/...