Hospitals must be attentive as FDA revokes more authorized devices

After authorizing a record number of products for emergency use during the Covid-19 pandemic, the Food and Drug Administration has since begun whittling down the pool. Hospitals should pay close attention as the agency revokes more authorizations, which could leave them liable if they continue to use those products, ECRI CEO Dr. Marcus Schabacker said.

“Physicians were desperate during the pandemic to get their hands on something,” he said. “If you take (that device) away, what are they going to use instead? Hospitals have to think through that.”

Just as the FDA gave emergency use authorizations (EUA) to hundreds of products, it now must go through the time-consuming process of deciding which ones to approve, and which ones to stop using. He expects the agency will consider four main questions as it goes through each of them:

  1. Is there an FDA approved alternative for this device?
  2. Do we really have a need for it anymore?
  3. Were there any adverse events associated with this device?
  4. What data has the company provided in terms of safety and efficacy?

For instance, devices were authorized last year to navigate widespread shortages of protective equipment, but are no longer needed. In June, the FDA revoked its authorization for decontamination systems that hospitals used to sterilize N95 masks for re-use. Now, the FDA recommends moving away from decontaminating disposable masks.

Similarly, the agency has revoked some products that are no longer in use. Last month, it revoked an authorization for a Covid-19 test developed by Curative. The startup’s test had been administered to hundreds of thousands of people in Los Angeles, until the FDA warned about false negatives. Now, it’s offering a test developed by Abbott instead.

“What they’re going through now is just to see which of these devices really had a benefit or were necessary,” Schabacker said in an interview with MedCity News.

For healthcare providers, it’s up to them to make sure they’re no longer using these revoked devices.

“People need to take that as seriously as they would have to take a recall,” he said. “If the FDA recalls a product, it is up to everybody to ensure it is removed and not used on a patient. You can’t take a laissez-faire approach here.”

He recommends that hospitals have a committee in place to keep track of all of the products they’re using that are under an EUA, including an inventory of where they are and how many have been supplied. He also recommends they start considering if there is an approved alternative available, and what their plan would be if that EUA gets revoked.

When that happens, Schabacker said hospitals should move it to a secure area and put a big label on it that says, “not for human use.” If a device is currently being used to treat a patient, such as a ventilator, they can finish the treatment first.

Physicians will also have to navigate changing regulations around drugs that were authorized to treat Covid-19 during the pandemic. For example, the FDA revoked its EUA for antimalarial drugs chloroquine and hydroxychloroquine in June, after determining that they were unlikely to be effective in treating Covid-19. Any prescription to use them to treat Covid-19 would be off-label, and come with the associated liability.

Photo credit: FDA, Flicker

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