FDA and CDC Update Guidance:  Optimizing N95 Respirator Supplies

FDA and CDC Update Guidance:  Optimizing N95 Respirator Supplies

Both the FDA and CDC updated their strategies for optimizing N95 respirator supplies. As of April 9, CDC acknowledged that the supply and availability of NIOSH-approved respirators have increased significantly over the last several months.

In regard to conventional capacity strategies, CDC added language on extended use of N95 respirators as source control, as well as language on use of respirators with exhalation valves.

For contingency capacity strategies, CDC added a strategy to prioritize respirators for HCP who are using them as PPE over those HCP who are only using them for source control. They also clarified that for extended use of N95 respirators as PPE, N95 respirators should be discarded immediately after being removed.

For crisis capacity strategies, CDC removed the strategy of using non-NIOSH approved respirators developed by manufacturers who are not NIOSH-approval holders, removed decontamination of respirators as a strategy with limited re-use, and removed the table “Suggested well-fitting facemask or respirator use, based upon distance from a patient with suspected or confirmed SARS-CoV-2 infection and use of source control.” CDC highlighted that the number of reuses should be limited to no more than five uses (five donnings) per device by the same HCP to ensure an adequate respirator performance and emphasized that facemasks for caring for a patient with suspected or confirmed SARS-CoV-2 infection should only be used for certain scenarios as a last resort if respirators are severely limited.

 

Questions?

Contact:

Laura Hofmann, MSN, RN – Director of Clinical and Nursing Facility Regulatory Services
c: 425-231-4804

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April 14, 2021