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Public Alert No.022/2021 – Update: FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities

July 8, 2021,

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that the U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities to transition away from crisis capacity conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s. This recommendation is in follow-up to the April 9, 2021, letter in which the FDA recommended a transition away from decontamination or bioburden-reduction systems for cleaning and disinfecting disposable respirators, which were being reused by health care personnel.

Based on the increased domestic supply of new respirators approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) and consistent with CDC’s updated recommendations, the FDA believes health care personnel and facilities can transition away from using non-NIOSH-approved respirators and from utilizing decontamination and bioburden reduction systems. These crisis capacity conservation strategies have been used to address respirator shortages during the COVID-19 outbreak.

Recommendations

The FDA recommends that health care personnel and facilities:

  • Limit decontamination of disposable respirators. Decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFRs) or when any new respirators are unavailable.
  • Limit use of all non-NIOSH-approved respirators, including imported respirators, to only when there are insufficient supplies of new NIOSH-approved FFRs or when any new respirators are unavailable.
  • Transition away from a crisis capacity strategy for respirators, such as use of non-NIOSH approved respirators and decontamination of N95 and other FFRs.
  • Increase inventory of available NIOSH-approved disposable respirators, including:
    • N95s and other FFRs
    • Elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in the operating room 
    • Powered air-purifying respirators (PAPRs). 

Even if health care personnel and facilities are unable to obtain the respirator model that they would prefer, the FDA recommends obtaining and using a new NIOSH-approved respirator before using a non-NIOSH-approved respirator or decontaminating or bioburden-reducing a preferred disposable respirator.

NAFDAC implores health care personnel to report any adverse events or suspected adverse events experienced with any medical devices, including decontamination systems, bioburden reduction systems, or respirators.

Health professionals and patients are encouraged to report adverse events or quality problems experienced with the use of the products to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via pharmacovigilance@nafdac.gov.ng or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety Application available for download on Android and IOS stores

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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