Summary: ECRI provided recommendations to the FDA’s Home as a Healthcare Hub initiative, emphasizing user-centered testing, cybersecurity, and support systems for home-use medical devices. The initiative aims to integrate healthcare into home settings using augmented and virtual reality. ECRI highlighted the importance of patient safety and ease of use in device design and support.

Key Takeaways

  • ECRI Recommendations: ECRI emphasized user-centered testing, cybersecurity, support systems, and simplified instructions for home-use medical devices.
  • FDA Initiative Goal: The initiative aims to create an AR/VR-enabled home prototype hub for better integration of healthcare at home, allowing patients to self-manage clinical needs.
  • Patient Safety Focus: ECRI stressed prioritizing patient safety, improving the recall process, and ensuring accessibility and ease of use for diverse patient needs.

ECRI Recommendations on FDA’s Home as a Healthcare Hub Initiative

In a July 25 public meeting, ECRI weighed in on the FDA’s new Home as a Healthcare Hub initiative with recommendations that aim to foster intentional design of housing spaces that allow people to more easily use medical devices and engage in healthcare at home.

FDA Initiative Overview

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.

Health Technology Hazard of 2024

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

Key Strategies for Improvement

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

ECRI’s Statement

“This initiative represents a laudable effort by the FDA with potential to improve health equity and accessibility for underserved populations,” said Scott Lucas, ECRI vice president for device safety. “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.”