Suppliers face increasing legal risk as the Food and Drug Administration reduces emergency actions related to the novel coronavirus pandemic.
Beginning in February 2020, the FDA temporarily allows providers to use vaccines, diagnostic and antibody tests, personal protective equipment, ventilators, and antibody treatments under emergency use authorizations (US). Emergency use authorizations allow FDA to approve devices for uses that have not gone through the full approval process when the agency determines that the potential benefits of the product outweigh the 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 suppliers to wear unapproved respirators or reuse disinfected respirators after deciding that the nation had enough N95 masks to protect front-line workers.
That could spell trouble for providers who suddenly find themselves using unapproved devices and therapies, said William Garvin, an attorney for Buchanan Ingersoll & Rooney.
“There may be no protection for you if things go wrong and people want to sue for wearing something they think you shouldn’t have been wearing,” Garvin said.
The absence of emergency use authorizations can also make it difficult for providers to get paid when they use those devices for applications that are not fully FDA approved.
Healthcare providers should keep track of which therapies, devices and other products they use are allowed for emergency use only, said Dr. Marcus Schabacker, CEO of ECRI, a health security organization. Suppliers also need to be aware of changes in FDA designations and know what to do if the agency revokes a temporary approval. All affected devices and therapies must be accounted for and locked or tagged. These efforts are fully documented and communicated to health system personnel.
“It’s very similar to a recall,” Schabacker said. “It is basically the same process.”
Suppliers must also confirm that they understand why the FDA stopped allowing emergency use of a product because it may affect supplier contracts. Hospitals may or may not cancel the supply contracts allowed under the emergency use authorization if that status changes.
“You must ensure a smooth transition from these US products to non-US products in a way that does not affect your ability to provide services,” Garvin said.
Emergency authorizations for certain medical devices during the COVID-19 pandemic are this year’s top technological hazard, 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 authorization for emergency use, but do not have systems to monitor their impact on patient safety, how the devices are used and when the FDA removes the authorization, Schabacker said when ECRI released its report earlier this year. anus.