Home Medical Device Usability Tops ECRI Hazard List

Feb. 1, 2024
ECRI’s Top 10 list also includes concerns related to artificial intelligence and data security

Usability challenges with medical devices in the home tops the 2024 list of health technology hazards in a report from ECRI, a nonprofit patient safety organization. The Top 10 list also includes concerns related to artificial intelligence and data security.

The nonprofit ECRI says it follows a rigorous review process to select topics, drawing insight from incident investigations, reporting databases, and independent medical device testing.

As the number of adults living with chronic conditions increases, medical devices such as infusion pumps and ventilators are now being used in the home, sometimes by caregivers and patients who have not been sufficiently trained, ECRI says.

Most medical devices are designed for use by healthcare professionals in a controlled clinical environment and thus may be too complex for laypeople to use safely and effectively, ECRI researchers say.

“Severe harm can result from the misuse or malfunction of medical devices in the home,” said Marcus Schabacker, M.D., Ph.D., president and CEO of ECRI, in a statement. “Patients and caregivers who misinterpret device readings may feel a false sense of security. Errors may go undetected or unreported, making it difficult to identify problematic trends.”

ECRI researchers have encountered numerous examples of patient harm from home-use devices. Medication errors can occur when changing infusion pumps. Skin injuries can occur when the electrodes from a cardiac monitor are applied incorrectly. Fatalities can occur if a home ventilator alarm fails to activate or goes unheard, or if the venous needle becomes dislodged during use of a hemodialysis machine.

In ranked order, ECRI's Top 10 Health Technology Hazards for 2024 are:
1.     Usability challenges with medical devices in the home
2.     Insufficient cleaning instructions for medical devices
3.     Drug compounding without technology safeguards
4.     Environmental harm from patient care
5.     Insufficient governance of AI in medical technologies
6.     Ransomware as a critical threat to the healthcare sector
7.     Burns from single-foil electrosurgical electrodes
8.     Damaged infusion pumps risk medication errors
9.     Defects in implantable orthopedic products
10.   Web analytics software and the misuse of patient data

Regarding ransomware, ECRI researchers say that healthcare delivery organizations need more support to fend off attacks and recover. The report says policymakers should consider incentives for implementing strong security programs and law enforcement tools for disrupting criminal networks.

Now in its 17th year, ECRI’s Top 10 Health Technology Hazards report identifies critical healthcare technology issues. Since its creation in 2008, the list has supported hospitals, health systems, ambulatory surgery centers, and manufacturers in mitigating risks.


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