PLYMOUTH MEETING, PA — Patients and caregivers struggling with home-use medical devices have been identified as the most pressing health technology safety hazard for 2024, according to a report by the nonprofit patient safety organization, ECRI. The report also highlights several concerns related to artificial intelligence (AI) and data security.
As a leading authority in medical device evaluations, ECRI uses a meticulous review process to select topics for its reports. The organization draws from incident investigations, reporting databases, and independent medical device testing to provide a comprehensive overview of the current health tech landscape.
The U.S. is seeing a growing trend of people receiving medical care at home due to an aging population and an increase in adults living with chronic conditions. Consequently, medical devices such as infusion pumps and ventilators, which were designed for use by healthcare professionals in clinical settings, are now being operated at home, often by caregivers and patients who lack sufficient training.
ECRI researchers warn that these devices could be too complex for laypeople to use safely and effectively. Misinterpretation of device readings could lead to a false sense of security among users, and errors might go unnoticed or unreported, making it challenging to identify potential problems.
“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. “Errors may go undetected or unreported, making it difficult to identify problematic trends.”
Examples of patient harm from home-use devices include medication errors from changing infusion pumps, skin injuries from incorrect application of cardiac monitor electrodes, and even fatalities from failed home ventilator alarms or complications with hemodialysis machines.
The other health tech hazards listed in the report, ranked in order of concern, include insufficient cleaning instructions for medical devices, drug compounding without technology safeguards, environmental harm from patient care, insufficient governance of AI in medical technologies, ransomware threats to the healthcare sector, burns from single-foil electrosurgical electrodes, risks of medication errors from damaged infusion pumps, defects in implantable orthopedic products, and misuse of patient data by web analytics software.
Now in its 17th year, ECRI’s Top 10 Health Technology Hazards report serves as a valuable resource for hospitals, health systems, ambulatory surgery centers, and manufacturers in mitigating risks.
The executive brief of the latest Top 10 Health Technology Hazards report is available for download on ECRI’s website. The full report, which provides detailed steps that organizations and industry can take to reduce risk and improve patient safety, is accessible to ECRI members.
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