FDA Revokes Use of Non-approved Disposable Respirators in Health Care Settings

  • Published
  • 2 July 2021
  • Category
  • News

The U.S. Food and Drug Administration (FDA) has revoked emergency use authorizations (EUAs) for non-approved disposable respirators in health care settings effective July 6.

The revocation is based on the increased domestic supply of respirators approved by the National Institute for Occupational Safety and Health (NIOSH), and it is consistent with an Emergency Temporary Standard issued by the Occupational Safety and Health Administration (OSHA) to protect health care workers. Crisis capacity conservation strategies, such as wearing non-approved masks or decontaminating and reusing respirators, were previously recommended due to respirator shortages earlier in the COVID-19 pandemic.

The FDA recommends that health care personnel and facilities:

The FDA does not recommend reconditioning of non-NIOSH-approved respirators. If a reusable respirator is needed, organizations should first try to acquire respirators such as elastomeric respirators and PAPRs, which are designed to be reusable.

In a related action, NIOSH has updated its Strategies for Optimizing the Supply of N95 Respirators to indicate health care facilities should not be using crisis capacity strategies and should promptly resume conventional practices.

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