How can we improve communication about medical device recalls?

Challenge

The U.S. Food and Drug Administration (FDA) currently regulates nearly 200,000 different medical devices. While it is both the expectation and the hope that medical devices will bring benefits to consumers who use them, unfortunately, like all products, these devices are subject to manufacturer error, or new and unexpected risks, and may need to be recalled.

The FDA wants to make sure the communications the public receives about medical device recalls are patient-focused, timely, and action-oriented. Because the issues surrounding a recall can be complex, it is important for consumers to understand whether a recall impacts them, what they need to do to minimize risks related to recalled devices, and where to go if they have questions.

Solutions

Westat collaborated with the FDA to conduct a multiphase research study that examined FDA medical device recall communications. Informed by an environmental scan that assessed communication and media coverage of several recalls, and a literature review to learn understand the current state of research, Westat conducted 18 consumer focus groups and 36 interviews. These groups examined opinions and preferences about FDA recall communications, and included consumers of various types of medical devices, such as heating pads, breast implants, and insulin pumps, segmented by education level.

Results

The FDA provides critical information to the public when medical devices are recalled, and re-examining these communications periodically is necessary to make sure they still meet consumer needs. The findings from this study will help the FDA improve how it communicates with consumers when a medical device is recalled.