HME Recall Issues Top ECRI’s List of Health Hazards in 2023

HME Insights

PLYMOUTH MEETING, Pennsylvania—ECRI, a nonprofit organization focused on technology evaluation and safety in health care, said that the nation’s most pressing health technology safety issue for 2023 is gaps with recalls of home medical equipment (HME).

“Recall notices for home-use products often do not reach users, placing patients at serious risk of harm,” the organization said in its new report, “Top 10 Health Technology Hazards.”

As the trend toward care in the home accelerates, ECRI said, it is concerned about homecare patients not receiving safety notices that warn of problems with the medical devices they are using. Device manufacturers seldom have direct communication with homecare patients, and health care providers may not proactively contact patients about recalls. Patients with affected products may learn about a recall long after it was issued, and potentially from an unreliable source, the organization said in a news release. 

“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 ECRI President and CEO Marcus Schabacker. “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 cited in the report is the current recall of CPAP and BiPAP machines. The recall was initiated in June 2021 and affected 5.5 million devices; however, several months elapsed before some patients became aware of the recall. Moreover, because of the language used in the recall notice, patients were confused about whether to continue to use the device and what actions they needed to take.

The 10 topics on ECRI’s 2023 hazards list, ranked, are:

  1. Gaps in recalls for at-home medical devices 
  2. A growing number of defective single-use medical devices 
  3. Inappropriate use of automated dispensing cabinet overrides 
  4. Undetected venous needle dislodgement or access-bloodline separation during hemodialysis 
  5. Failure to manage cybersecurity risks associated with cloud-based clinical system
  6. Inflatable pressure infusers can deliver fatal air emboli from IV solution bags
  7. Confusion surrounding ventilator cleaning and disinfection requirements 
  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

For 2023, ECRI’s report challenges HME manufacturers to pursue improvements that could mitigate or even eliminate some of the hazards included on the list. With health care facilities understaffed and health care workers overstressed, it’s more important than ever that technologies be designed in ways that ensure their safe use, ECRI said. 

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

Download the executive brief for free at www.ecri.org/2023hazards.

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