Over the past several years, ECRI’s annual list of top hazards has included cybersecurity, false alarms, dirty endoscopes and a variety of issues that plague the misuse of medical devices. On this year’s list, COVID-19 has completely dominated the top 10, with the pandemic directly impacting seven out of the 10 named technology hazards. Topping the list are devices that have been temporarily cleared via the FDA’s emergency use authorization (EUA) process.
“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 Marcus Schabacker, M.D., Ph.D., president and CEO of ECRI in a press release. Among the challenges related to products in use as a result of an EUA are the fact that hospital staff must continually monitor these devices for safety and effectiveness, and their authorization status (because an EUA is a temporary approval that can be revoked at any time). “We’re concerned that hospitals might not have adequate processes in place to deal with this complex challenge,” added Schabacker. “The coronavirus pandemic accelerated the adoption of some technologies and introduced risks we haven’t addressed before.”
ECRI’s top 10 health technology hazards for 2021 are the following:
- Managing devices that have received COVID-19 EUA.
- Drug name auto display: Deadly medication errors as a result of drug entry fields populating after only a few letters are inputted.
- Rapid telehealth adoption can put patients and data at risk.
- Imported N-95-style masks: A high percentage of imported masks do not protect healthcare workers from infection respiratory diseases such as COVID-19.
- Consumer-grade devices: A reliance on these types of devices can result in inappropriate healthcare decisions.
- UV disinfection: Hasty deployment of UV disinfection devices can lead to a reduced effectiveness while also increasing exposure risks.
- Software vulnerabilities: Cybersecurity challenges due to vulnerabilities in third-party software components.
- AI in diagnostic imaging applications can misrepresent certain patient populations. Some “AI applications have been used to distinguish COVID-19 related lesions from other lung-related pathologies,” states ECRI.
- Remote operation risks related to medical devices designed for the bedside, which can introduce risks. This especially took off during the pandemic as methods to remotely operate ventilators, infusion pumps and other medical devices was employed.
- Insufficient quality assurance of patient-specific, 3-D printed medical devices—such devices may be “created without appropriate clinical verification of the design, quality control of the manufacturing process, and validation of the end product, the resulting object may not accurately represent key patient anatomy or may not perform as intended.” This can lead to surgical complications, injury or infection.