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
