Patient Education Key as Home Medical Devices Pose Patient Safety Threat

The move to hospital-at-home and home use of medical devices could be the biggest threat to patient safety this year, according to ECRI, prompting industry stakeholders to call for human-centered design on these devices and better patient and caregiver education for their use.

In its Top 10 Health Technology Hazards for 2024, ECRI called out usability and instructions as a threat to the proper use of at-home medical devices and, ultimately, patient safety.

Hospital-at-home models and other models promoting remote patient monitoring are making consumer use of medical devices more common, ECRI said. With more care being administered within the home—a trend fueled in large part by the nation’s aging population—more patients and family caregivers are in charge of using devices like infusion pumps and ventilators. Patients and their caregivers are taking the place of the clinicians and other medical personnel who would normally operate them in the hospital setting.

Although hospital-at-home has many benefits, like allowing patients to age in place or recuperate in their own homes, ECRI contended that layperson or consumer use of these devices could, in fact, lead to misuse and subsequent patient safety issues.

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

That’s putting “usability challenges with medical devices in the home” as the leading health technology hazard for 2024, a ranking of patient safety threats ECRI puts out each year. ECRI predicted that “insufficient cleaning instructions for medical devices” would be the second-biggest threat to patient safety this year.

To combat this threat, healthcare professionals should increase patient and caregiver education about using these tools. Educational efforts as part of hospital discharge plans have already proven to reduce complications when the patient transitions to home. Fortifying that patient and caregiver education with best practices for using medical devices in the home is a critical next step.

But efforts need to extend beyond providers delivering good caregiver and patient education, ECRI indicated. It’s also incumbent upon device developers and manufacturers to play their part, too, Schabacker said.

"When a medical device is designed, it's critical that human factors and the end user be considered," Schabacker explained. "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’s list of the top 10 health technology hazards for 2024 also includes:

• Drug compounding without technology safeguards
• Environmental harm from patient care
• Insufficient governance of AI in medical technologies
• Ransomware as a critical threat to the healthcare sector
• Burns from single-foil electrosurgical electrodes
• Damaged infusion pumps risk medication errors
• Defects in implantable orthopedic products
• Web analytics software and the misuse of patient data

This year’s leading health technology safety hazards are not dissimilar to last year’s, placing an emphasis on how poor regulation can lead to patient confusion and potential patient harm. In particular, the 2023 list of patient safety hazards listed gaps in recalls for home medical devices and how they can contribute to patient confusion as the leading health technology patient safety hazard.