Home as a Healthcare Hub: ECRI Recommends FDA Prioritize Patient Safety

Recognizing that the home environment is an integral – although overlooked – component of the healthcare system, the U.S. Food and Drug Administration (FDA) recently announced its Home as a Healthcare Hub initiative. In a July 25 public meeting, ECRI weighed in with recommendations on the initiative, which aims to foster intentional design of housing spaces that allow people to more easily use medical devices and engage in healthcare at home.   

The FDA initiative involves creating an augmented reality/virtual reality-enabled home prototype hub. The goal is for device developers and other stakeholders to use the hub to visualize structural and design elements for more seamless integration of healthcare in the home setting, enabling patients to self-manage their clinical needs.

During the meeting, ECRI shared insights based on decades of experience conducting research, accident investigations, medical device testing, and evaluating ECRI’s database of patient harm incidents and “near misses” (the largest database of its kind) to identify alarming trends.

ECRI named challenges with home-use medical devices the number-one health technology hazard of 2024.

That, as well as the inherent complexity of many medical devices, led ECRI to stress to the FDA the importance of the following strategies in improving healthcare at home:

• Increase user-centered testing for home-use devices
• Prioritize cybersecurity in the connected home environment
• Establish a method for home health patients to report device issues and get support
• Focus on ease of use in the design of device user interfaces, considering the needs of patients with physical limitations, disabilities and varying levels of technology literacy
• Provide simple and concise instructions without medical jargon for home-use medical devices
• Plan for checkpoints in the medical device lifecycle that require a trained medical professional (e.g., equipment set-up, maintenance and repairs, ongoing training)
• Improve the device recall process so patients using home as their healthcare hub receive timely information

Watch this brief video featuring ECRI’s Vice President for Device Safety Scott Lucas for highlights of ECRI’s recommendations to the FDA.

 “This initiative represents a laudable effort by the FDA with potential to improve health equity and accessibility for underserved populations,” said ECRI Vice President for Device Safety, Scott Lucas. “In advancing the Home as a Healthcare Hub initiative, we call on the FDA and leaders across the healthcare ecosystem to prioritize patient safety and strive to achieve zero preventable harm in the delivery of care. That commitment is especially critical as we adopt and modify non-traditional environments to become places where patients can receive quality healthcare.”

About ECRI

ECRI is an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings. With a focus on technology evaluation and safety, ECRI is trusted by healthcare leaders and agencies worldwide. ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI and the Institute for Safe Medication Practices PSO is a federally certified Patient Safety Organization as designated by the U.S. Department of Health and Human Services. Visit www.ecri.org.