Report: Emergency Use Authorization a Top Health Hazard for 2021

The U.S. Food and Drug Administration (FDA) has authorized hundreds of medical products in the past year for temporary use to help fight COVID-19. And while the agency’s Emergency Use Authorization (EUA) program has been crucial to battling the virus, it also could eventually become a health hazard to patients, clinicians, and hospitals.

“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,” explained Marcus Schabacker, M.D., Ph.D., president and CEO of ECRI, an an independent nonprofit organization that listed the complexity of managing devices authorized through the EUA process at the top of its recently-released 2021 Top 10 Health Technology Hazards report..

Through its EUA process, FDA can green-light previously unapproved products—or new indications for previously cleared products—as acceptable for use during an emergency. Hospitals need to watch for safety and performance issues, monitor the device’s authorization status daily, and know what to do with the device when the EUA ends.
 
“Failing to do so could create safety risks for patients and liability risks for the hospital,” added Schabacker, because once the EUA designation ends, the legal protections that support the use of EUA devices on new patients vanish.
 
EUAs can be ended at any time. For example, in August 2020, FDA revoked the EUA for a class of protective barrier enclosures after they were found to increase healthcare workers’ exposure to airborne particles, rather than limiting exposure.
 
“We’re concerned that hospitals might not have adequate processes in place to deal with this complex challenge,” said Schabacker. “Our new guidance can act as a roadmap for hospitals and health systems broadly. Additionally, through our alerts tracking reports, we are providing actionable advice. If more support is needed, ECRI is here to help.”
 
Now in its 14th year, ECRI’s Top 10 Health Technology Hazards identifies health technology concerns that warrant attention by healthcare leaders. ECRI’s team of biomedical engineers, clinicians, and healthcare management experts follows a rigorous review process to select topics for the annual list, drawing insight from incident investigations, reporting databases, and independent medical device testing.
 
“The coronavirus pandemic accelerated the adoption of some technologies and introduced risks we haven’t addressed before,” said Schabacker. “ECRI remains committed to building awareness about technology hazards to keep patients safe, especially for those technologies that have undergone shortened safety and effectiveness processes.”
 
ECRI’s full list of health technology hazards for 2021 includes:

1.  EUA device management | Complexity of managing medical devices with COVID-19 Emergency Use Authorization
2.  Drug name auto-display | Fatal medication errors can result when drug entry fields populate after only a few letters
3.  Telehealth adoption | Rapid adoption of telehealth technologies can leave patients and data at risk
4.  Imported N95-style masks | May fail to protect healthcare workers from infectious respiratory diseases
5.  Consumer-grade devices | Relying on consumer-grade products can lead to inappropriate healthcare decisions
6.  UV disinfection | Hasty deployment of UV disinfection devices can reduce effectiveness and increase exposure risks
7.  Software vulnerabilities | Vulnerabilities in third-party software components present cybersecurity challenges
8.  AI in diagnostic imaging | Artificial intelligence applications for diagnostic imaging may misrepresent certain patient populations
9.  Remote operation risks | Remote operation of medical devices designed for bedside use introduces insidious risks
10.  3D printing quality | Insufficient quality assurance of 3D-printed patient-specific medical devices may harm patients