Report: Home medical devices pose risk

PLYMOUTH MEETING, Pa. – One of the nation’s largest nonprofit patient safety organizations has named challenges for patients and caregivers using medical devices at home as the most pressing health technology safety hazard for 2024.  

In a new report, ECRI, an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all health care settings worldwide, says that medical devices used in the home, such as infusion pumps and ventilators, may be too complex for lay people to use safely and effectively. 

“Severe harm can result from the misuse or malfunction of medical devices in the home,” said Marcus Schabacker, MD, PhD, president and CEO of ECRI. “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.” 

Among the examples of patient harm: Medication errors when changing infusion pumps; skin injuries from incorrectly applied electrodes from a cardiac monitor; and fatalities if a home ventilator alarm fails to activate or goes unheard. 

“When a medical device is designed, it’s critical that human factors and the end user be considered,” said Schabacker. “As more patients receive medical care outside hospitals and nursing homes, the reality of modern care settings should influence the design of devices and other supplies we need to keep patients healthy.” 

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