Revocation of EUA for non-NIOSH Disposable Respirators

Posted 23 days ago by Michelle Wade

Subject: C/SNA Essentials : Revocation of EUA for non-NIOSH Disposable Respirators
 

C/SNA Essentials

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Revocation of EUA for non-NIOSH Disposable Respirators
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Jul 1, 2021 1:01 PM
Tina McRae-Phelps

The U.S. Food and Drug Administration (FDA) is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems (revocation effective June 30, 2021). As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. Recommendations for health care personnel and facilities are as follows:

  • Use only FDA-cleared or NIOSH-approved respirators, including N95s and other respirators under the Emergency Use Authorization (EUA) for NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency.
  • 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, according to the CDC's strategies, as appropriate.
  • Consider redistributing current inventory of non-NIOSH-approved respirators, such as, to:
    • Non-health care settings for non-medical use (for example, construction)
    • Other countries in need (in accordance with the Federal Food, Drug, and Cosmetic Act export provisions)
    • While it is possible that non-NIOSH-approved respirators may be reconditioned for use as source control (see, for example as face masks in Import Alert 89-18), the FDA does not recommend that non-NIOSH-approved respirators undergo reconditioning at this time because there is currently sufficient supply of source control medical devices, among other things
  • Continue to increase inventory of available NIOSH-approved respirators, including:
    • N95s and other disposable filtering facepiece respirators (FFRs)
    • Elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in an operating room
    • Powered air-purifying respirators (PAPRs).

 

Letter to Health Care Personnel and Facilities: www.fda.gov/medical-devices/...

Revocation letters for China FFR EUA and Imports FFR EUA: www.fda.gov/medical-devices/...

Revocation letters for decontamination system EUAs: www.fda.gov/medical-devices/...

FDA In-Brief: FDA In Brief: FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide

 



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Tina McRae-Phelps
American Nurses Association
Silver Spring MD