1. Managing medical devices under emergency use authorizations
To meet the unprecedented need for medical equipment and supplies during the COVID-19 public health emergency, the FDA temporarily authorized the use of hundreds of previously unapproved medical products. That includes 321 EUAs for diagnostics, 26 for PPE, 27 for medical devices, 105 for ventilators, tubing connectors and accessories, and 10 for drugs, including vaccines.
When the health emergency ends or the FDA revokes an EUA — which can happen at any time — the covered device reverts to unapproved status. At that time, the legal protections that support the use of EUA devices on new patients are terminated. Plus, EUA devices may not be as safe or effective as devices that have been through FDA’s normal clearance process, ECRI warns.
“Emergency use authorization is a lower standard than is used to assess safety and effectiveness through FDA’s normal clearance process, and it requires more work on the part of the hospital,” said ECRI president & CEO Dr. Marcus Schabacker in a news release.
Healthcare facilities must manage inventories of EUA devices and their documentation, monitor each device’s status daily to determine whether the EUA remains active and unchanged, and determine what to do with these devices once the EUA ends.
“Failing to do so could create safety risks for patients and liability risks for the hospital,” Schabacker said. “We’re concerned that hospitals might not have adequate processes in place to deal with this complex challenge.”