The FDA issued a briefing confirming the revoking of emergency use authorizations (EUAs) for certain respirators and decontamination systems.
EUAs for all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, including disposable respirators like KN95s, along with decontamination and bioburden reduction systems, were all revoked, having been issued amid the COVID-19 pandemic.
According to an FDA release, the actions were consistent with the updated CDC recommendations for healthcare facilities to not use crisis capacity strategies and promptly return to conventional practices. Manufacturers of decontamination and bioburden reduction systems requested — and the FDA agreed to — the revocation of their EUAs, effective June 30.
NIOSH approved more than 875 respirator models or configurations since the beginning of the pandemic. The EUA revocations apply to all non-NIOSH approved, disposable facepiece respirator models, while the FDA withdrew two related decontamination and bioburden reduction guidance documents.
“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,” said Dr. Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health Dr. Suzanne Schwartz.
“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,” Schwartz said in the news release.
Schwartz went on to note that, early in the public health emergency, the need for such EUAs was evident, regardless of NIOSH approval. Those conditions no longer exist, she said, as the national supply of NIOSH-approved N95s is more accessible to healthcare workers.
“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,” Schwartz said. “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.”