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10 Health technologies safety risks, including weak AI governance, damaged infusion pumps, and defective orthopedic implants.
February 13, 2024
By: Rachel Klemovitch
Assistant Editor
ECRI, one of the nation’s largest nonprofit patient safety organizations, has released a report outlining challenges for patients and caregivers using medical devices at home. The report reflects industry trends and includes multiple concerns related to artificial intelligence and data security. ECRI follows a rigorous review process to select topics, report databases, draw insights from incident investigations, and independent medical device testing. ECRI researchers explain that most medical devices are designed to be used by healthcare professionals in a controlled clinical environment and may be too complex for people to use safely and effectively at home. According to studies, as the US population ages and the number of adults living with chronic conditions increases, more people are receiving medical care at home. This results in the use of medical devices, infusion pumps, and ventilators at home by caregivers and patients who may not have received sufficient training. “Severe harm can result from the misuse or malfunction of medical devices in the home,” said President and CEO of ECRI, Marcus Schabacker. “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 found numerous examples of patient harm from house-use devices. Skin injuries can occur when electrodes from cardiac monitors are applied incorrectly. Improperly changing infusion pumps can result in medication errors. Fatalities can occur if home ventilator alarms go unheard, fail to activate, or if the venous needle becomes dislodged when using a hemodialysis machine. Schabacker continued, “When a medical device is designed, it’s critical that human factors and the end user be considered. 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.” ECRI is now in its 17th year of Top 10 Health Technology Hazards Reports in identifying critical healthcare technology issues. ECRI supports hospitals, ambulatory surgery centers, health systems, and manufacturers in lowering risks.
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