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Flawed Covid-19 Protective Barriers Lose FDA Authorization

Dec. 3, 2020, 3:52 PM

Protective barriers meant to act as a second shield for health-care providers against airborne Covid-19 particles aren’t effective and can actually damage the protective equipment they’re meant to supplement, the FDA said in a letter yanking their approval.

According to a letter published Thursday, the Food and Drug Administration in August revoked a blanket authorization for protective barrier enclosures after giving them the green light in May. The barriers are meant to provide “an extra layer of barrier protection” for providers treating Covid-19 patients. They’re typically plastic enclosures that go around a patient that allow providers to slip their arms in via holes.

Airborne particles can still reach providers because of those arm holes, making the barrier useless. They’ve also made intubating patients slower and arduous, the FDA said. Intubation is necessary for patients with severe Covid-19 symptoms who can’t breathe on their own. A provider puts a tube down a patient’s airway to connect them to a ventilator.

The barriers can also damage protective equipment, which is already scarce.

The FDA can authorize drugs or devices when there’s no other alternative and when manufacturers show the product “may be effective.” As the agency gets more data, it can revoke those authorizations, which it has done several times throughout the pandemic for various treatments or tests.

The letter to manufacturers was dated Aug. 20 but was officially published in the Federal Register Thursday.

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Andrew Childers at achilders@bloomberglaw.com

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