Emergency use authorization revoked for some respirators

The U.S. Food and Drug Administration announced Wednesday that effective July 6 it is revoking the emergency use authorization for certain disposable respirators in health care settings.

The decision covers disposable respirators not approved by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health. The FDA cited the “increased domestic supply of respirators” for its decision.

The substitute face masks were approved for use during the pandemic due to dwindling supplies of approved N95 masks, which filter 95% of particles and are a preferred line of defense for medical staff treating COVID-19 patients.

The FDA is also revoking the emergency use authorizations for reusing decontaminated and bioburden-reduced disposable respirators.

In its announcement, the FDA said that “health care facilities should not use crisis capacity strategies any longer.”

It recommends that health care personnel and facilities use only FDA-cleared or NIOSH-approved respirators, including N95s, and that workers transition from wearing disposable respirators for respiratory protection “for an extended time to conventional capacity strategies that include wearing a disposable respirator for each patient contact.”

The FDA also said that “while there is an increase in domestic supply of respirators for health care personnel” it will continue to monitor the supply and demand.

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