由 John R. Fischer
, Senior Reporter | February 01, 2021
Management of medical devices approved under the FDA’s Emergency Use Authorization (EUA) label during COVID-19 topped ECRI’s 2021 Top 10 Health Technology Hazards report.
EUA solutions are previously unapproved medical devices that the FDA allows for use in emergencies. The complexity involved with managing these devices requires hospitals to watch for safety and performance issues, monitor their authorization status daily and be aware of what to do with these solutions when their EUAs end.
“Failing to do so could create safety risks for patients and liability risks for the hospital,” adds Schabacker, because once the EUA designation ends, the legal protections that support the use of EUA devices on new patients vanish,” said Dr. Marcus Schabacker, president and chief executive officer of ECRI, in a statement. He adds that ECRI is “concerned that hospitals might not have adequate processes in place to deal with this complex challenge.”
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The pandemic has led the FDA to issue emergency use authorization for a number of solutions, including left-sided Impella heart pumps
for COVID-19 patients undergoing extracorporeal membrane oxygenation treatment; Ortho Clinical Diagnostics' antibody test
; and G Medical Innovations Holdings' Vital Signs Monitoring System ECG Patch
EUA is a lower standard for evaluating the safety and effectiveness of a device compared to the typical FDA approval process. It is only designated to solutions that may be effective for a specified use and when the benefits of the product outweigh the risks. It may not, however, be as safe or effective as devices approved under the normal FDA process and are only authorized for use during that EUA period. When the health emergency ends or the FDA revokes the EUA, which can happen at any time, the device becomes unapproved again and loses any legal protections it had as an EUA device.
Coming in at number two on the list was drug name auto-display, which can cause fatal medication errors when drug entry fields populate after only a few letters. Following it was telehealth adoption (patient and data risks), imported N95-style masks (may fail to protect healthcare workers from infectious respiratory diseases), consumer-grade devices, UV disinfection, software vulnerabilities, AI in diagnostic imaging, remote operation risks, and 3D printing quality.
The pandemic has shifted what ranks as top hazards from ECRI’s 2020 list, which included surgical staplers, point-of-care ultrasound, and general-purpose surgical robots.
The 2021 list was based on insights from incident investigations, reporting databases, and independent medical device testing.