This focus group study explored what health professionals believe they need to know in order to be able to talk to their patients about the risks of implantable heart defibrillators and pacemakers. Four focus groups, two of doctors and two of allied health professionals, were gathered from attendees of the 2006 annual meeting of the Heart Rhythm Society. Participants said that a manufacturer's recall of a device typically meant serious possible consequences to their patient's health, possibly having to remove the device and return it to the manufacturer. Focus group members said that factors they considered when deciding whether to remove a recalled device included the patient's dependence on the device and whether the risks of removing it were greater than the risks of leaving it in. Often, recall information would first appear in popular media. The health professionals believed that this would undermine the patient's confidence in the doctor or cause them undue alarm. Some focus group participants felt that the Food and Drug Administration should regulate the process of the producers' communications about device recall. Some felt that written information explaining existing and potential problems was very important. However, it is a challenge to find simple and digestible language they could use with their patients. The participants reported that they preferred receiving information about recalls via e-mail, express mail, or fax.
Report Title: Physicians' and Allied Health Professionals' Perceptions about Communicating Implantable Cardiac Defibrillator and Pacemaker Risks to Patients: Focus Group Research http://aspe.hhs.gov/pic/fullreports/06/8311.pdf
Agency Sponsor: FDA, Food and Drug Administration
Federal Contact: Bobolis, Mary A., 301-827-5253
Performer: Olchak Market Research; Greenbelt, MD
PIC ID: 8311