Communicating medical device recalls: A rapid review of the literature.

Abstract

The U.S. Food and Drug Administration (FDA) currently regulates more than 190,000 different medical devices. Like all products, these devices may be subject to manufacturing problems, flawed designs, or new and unexpected risks, which in some cases require devices to be recalled. In 2021, the FDA's Patient Engagement Advisory Committee (PEAC) recommended that the FDA consider changes to the communication approach used for medical device recalls to make them more patient-focused, timely, and action-oriented. To support this recommendation, we conducted a rapid review of literature published from 2008-2022 to capture and examine information on risk communication approaches, methods, and best practices for recall-related communications about medical products. We identified 23 articles to include in our review. Our review found a lack of research-based studies as well as gaps in understanding about consumer perspectives, comprehension, and communication preferences related to recalls. Despite these limitations, we identified current communication approaches, numerous challenges, and recommendations for communicating medical products recall information to consumers. Further research is needed to assess consumer attitudes, understanding, and preferences and to reach consensus on best practices for effectively communicating recall information to consumers of medical products.