Providers face growing legal risk as the Food and Drug Administration winds down emergency actions related to the novel coronavirus pandemic.
Starting in February 2020, the FDA temporarily let providers use vaccines, diagnostic and antibody tests, personal protective equipment, ventilators, and antibody treatments under emergency use authorizations (EUAs). Emergency use authorizations allow the FDA to approve devices for uses that haven’t gone through the full approval process when the agency determines that the potential benefits of the product outweigh potential risks.
The FDA began reversing course in recent months as new evidence emerges about the effectiveness of tests and treatments, and supply chain problems begin to subside. Last month, the FDA stopped allowing providers to use unapproved respirators or reuse disinfected respirators after it decided the nation had enough N95 masks to protect frontline workers.
That could spell trouble for providers who suddenly find themselves using unapproved devices and therapies, said William Garvin, an attorney at Buchanan Ingersoll & Rooney.
“There may be no protection for you if things go bad, and people want to sue for using something that they think you shouldn’t have been using,” Garvin said.
The absence of emergency use authorizations also can make it harder for providers to get paid when they use those devices for applications not fully FDA-approved.
Healthcare providers need to track what therapies, devices and other products that they use are allowed only for emergency use, said Dr. Marcus Schabacker, CEO of ECRI, a healthcare safety organization. Providers also need to be aware of changes in FDA designations, and know what to do if the agency rescinds a temporary approval. All affected devices and therapies must be accounted for and locked up or labeled. Those efforts are fully documented and communicated to the health system’s staff.
“It’s very similar to a recall,” Schabacker said. “It’s basically the exact same process.”
Providers should also confirm they understand why the FDA stopped allowing emergency use for a product because it can affect contracts with suppliers. Hospitals may or may not get out of contracts for supplies allowed under emergency use authorization if that status changes.
“You need to ensure a smooth transition from these EUA products to non-EUA products in a way that doesn’t affect your ability to provide services,” Garvin said.
Emergency authorizations of certain medical devices during the COVID-19 pandemic are the top technology hazard this year, according to ECRI. These temporary approvals present safety risks for patients, and liability challenges for providers because the FDA can revoke authorizations at any time. Providers are using devices under emergency use authorization but don’t have systems in place to monitor their impact on patient safety, how the devices are being used and when the FDA removes authorization, Schabacker said when ECRI published its report earlier this year.