FDA says facilities should transition away from non-NIOSH-approved respirators

May 28, 2021

The U.S. Food and Drug Administration (FDA) recommends that healthcare facilities transition away from using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s.

Last month, the agency said healthcare facilities should transition away from decontamination or bioburden-reduction systems for cleaning and disinfecting disposable respirators, which were then reused by healthcare personnel.

“The FDA believes, consistent with CDC/NIOSH recommendations, that the increased supply and availability of NIOSH-approved respirators supports transition away from use of non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems,” the agency said.

From January 2020 through May 2021, NIOSH approved over 875 respirator models or configurations  manufactured by approximately 20 new, domestic organizations. There are now over 6,400 total respirator models or configurations on the NIOSH certified equipment list which have been authorized by the FDA.

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