Performance Improvement 2008. How Do Patients and their Caregivers Regard Medical Device Recalls and Safety Information?


This qualitative focus group study with patients and caregivers of patients who used medical devices explored their perceptions and opinions about medical device recalls and safety information. The research explored: reactions to and perceptions of the term "recall" as it relates to medical devices; reactions to and perceptions of alternative signal words; personal real-world experiences with medical device recalls; and perceptions of the ideal recall communication process. Six focus groups met and included patients and caregivers of patients who had implantable cardioverter defibrillators (ICDs) and pacemakers, implanted devices other than ICDs and pacemakers, and non-implanted devices.

A key finding included the group´s reaction to the term "recall." The term elicited many different emotions --- from anxiety, anger, and distrust; to the more benign feelings of "cautious" and "need more information." The term conveyed to patients the need to call their doctor or manufacturer to find out how they were affected. Most equated recall with "replace." Emotional reaction to the word "recall" varied by device type. Participants with ICDs and pacemakers were relatively composed on the subject of recalls, because they are well informed about their device and well monitored by their physicians. Non-implant participants felt that consequences of a recall would not be as severe and that they could just stop using their devices. Those with devices that were more critical wanted to know what they should do. Participants with implanted devices other than ICDs/pacemakers were the most upset by the recall discussion. They were the least likely to know the manufacturers of their devices, and they were not uniformly confident their doctor would contact them about a recall. Another key finding from the study included reaction to alternative signal words. The terms "recall," "urgent product danger," "urgent product warning" and "urgent public safety warning" all indicated the need to call the doctor or manufacturer immediately. Other terms such as "safety alert" and "safety advisory" indicated a less urgent message. Most participants said that ideally, device recall information should be distributed through multiple channels: manufacturer, doctor, and media. Participants most wanted information about the severity and potential health risks, device model numbers, symptoms, next steps, contact information, and potential costs.

Report Title: Findings from Six Focus Groups on Medical Device Safety Communications, Report may be obtained from Federal Contact
Agency Sponsor: FDA, Food and Drug Administration
Federal Contact:
Paula Silberberg, 240-276-3234
Performer: House Market Research/Edge Research

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