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FDA shifts gears as mask shortages ease

May 28, 2021 By Nancy Crotti

KN95 mask FDA

KN95 mask (Image from the Oklahoma State Department of Health)

The FDA wants healthcare providers to move away from using certain imported disposable masks, such as KN95s.

The recommendation to ease off using non-NIOSH-approved masks comes less than two months after the agency said providers could transition away from reusing decontaminated masks.

An increase in the domestic supply of NIOSH-approved disposable masks, such as N95s, has reduced the need to use imported KN95s and similar masks that lack NIOSH approval, the agency said.

The FDA is also recommending that healthcare facilities increase their inventory of:

  • NIOSH-approved respirators, such as N95s and other filtering facepiece respirators (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,” the agency said.

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    • Mergers & Acquisitions
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  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
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    • Orthopedic
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