ECRI Ranks HME Recall Gaps as 2023’s Top Health Hazard

Recall notices of medical devices often don’t reach patients, and when they do, they often use confusing language.

• By David Kopf
• Jan 26, 2023

Non-profit patient safety organization ECRI named communications gaps in recalls of home medical devices as the nation’s most significant health technology safety issue for 2023.

ECRI’s Top 10 Health Technology Hazards report said that recall notices for HME often do not reach users, which puts them at serious risk of harm.

The report also noted that equipment and device manufacturers rarely communicate directly with homecare patients, and healthcare providers might not proactively contact patients about recalls. In the end, patients with affected products might learn about a recall long after it was issued.

“Even if patients do receive notifications, the language may be jargon-heavy and perplexing, and patients may have difficulty determining whether their device is affected or what to do about it,” said Marcus Schabacker, MD, Ph.D., president and CEO of ECRI. “Without clear, understandable information about a product recall, patients cannot accurately assess the health risks and may harm themselves by continuing to use an unsafe device, or by inappropriately stopping use of a device.”

One example is the 2021 recall of CPAP and BiPAP machines, which affected 5.5 million devices. While initiated in June 2021, ECRI reported that several months elapsed before some patients became aware of the recall. The organization added that the recall’s language confused patients about whether they should continue using their devices and what actions they needed to take.

The 10 hazards on ECRI’s 2023 hazards list in rank order:

1. Gaps in recalls for at-home medical devices cause patient confusion and harm.
2. The growing number of defective single-use medical devices puts patients at risk.
3. Inappropriate use of automated dispensing cabinet overrides can result in medication errors.
4. Undetected venous needle dislodgement or access-bloodline separation during hemodialysis can lead to death.
5. Failure to manage cybersecurity risks associated with cloud-based clinical systems can result in care disruptions.
6. Inflatable pressure infusers can deliver fatal air emboli from IV solution bags.
7. Confusion surrounding ventilator cleaning and disinfection requirements can lead to cross-contamination.
8. Common misconceptions about electrosurgery can lead to serious burns.
9. Overuse of cardiac telemetry can lead to clinician cognitive overload and missed critical events.
10. Underreporting device-related issues might risk recurrence.

“Reducing preventable harm requires more than just vigilance on the part of technology managers and device users,” Schabacker said. “The medical device industry also has a role to play.”