The following quote is attributed to Suzanne Schwartz, M.D., M.B.A., director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health
“Throughout the pandemic, the FDA has worked closely with our federal partners at the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA) and with manufacturers to protect our front-line workers by facilitating access to the medical supplies they require. As a result of these efforts, our country is now better positioned to provide health care workers with access to NIOSH-approved N95s rather than using non-NIOSH-approved respirators or reusing decontaminated disposable respirators.
Early in the public health emergency, there was a need to issue emergency use authorizations (EUAs) for non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems to disinfect disposable respirators. Today, those conditions no longer exist. Our national supply of NIOSH-approved N95s is more accessible to our health care workers every day.
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Today, the FDA is taking additional action by announcing the revocation of EUAs for imported, non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems because of an increase in domestically-manufactured NIOSH-approved N95s available throughout the country. As access to domestic supply of disposable respirators continues to significantly improve, health care organizations should transition away from crisis capacity conservation strategies that were implemented at the onset of the pandemic.”
Additional Information
The U.S. Food and Drug Administration announced it is revoking EUAs of all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, which includes imported disposable respirators such as KN95s, along with revoking EUAs for decontamination and bioburden reduction systems.
Today’s actions are consistent with the Centers for Disease Control and Prevention’s (CDC) updated recommendations that health care facilities not use crisis capacity strategies and should promptly return to conventional practices. They are also consistent with the Occupational Safety and Health Administration’s (OSHA) recently published Emergency Temporary Standard (ETS) to protect health care workers, which requires health care employers to provide NIOSH-approved or FDA-authorized respirators for workers potentially exposed to COVID-19.
