Heart Device Recalls

FOR IMMEDIATE RELEASE: May 23, 2008
Contact: Bill Seiler bseiler@umm.edu
Ellen Beth Levitt eblevitt@umm.edu 410-328-8919

BETTER STRATEGIES ARE NEEDED TO INFORM PATIENTS OF HEART DEVICE RECALLS

University of Maryland survey highlights the impact of recalls on affected patients

Despite extensive media coverage and information from their physicians, one in five patients with an implanted heart device was not aware of the recent defibrillator and pacemakers recalls. In addition, significant discrepancies exist between the patients’ preferred sources of recall information and how they actually learned of those recalls.

Those are the main findings of a survey conducted in Baltimore of patients with the devices, part of an ongoing effort to improve patient care, education and safety. Cardiologists at the University of Maryland Medical Center and the Baltimore VA Medical Center presented the results of their survey at the Heart Rhythm Society’s annual meeting in San Francisco, Calif., last week.

“We’ve concluded that we need to communicate about recalls with all patients who have heart devices, whether or not the recall applies specifically to their device,” says principal investigator Timm-Michael L. Dickfeld, M.D., Ph.D., a cardiologist at the University of Maryland Medical Center and director of electrophysiology at the Baltimore VA Medical Center. Dr. Dickfeld is also an assistant professor of medicine at the University of Maryland School of Medicine.

Recalls of defibrillators and pacemakers as well as the leads attached to them have increased since the 1990s, reflecting the increased complexity and number of implanted devices and leads. While the term “recall” may suggest that the device must be taken out of the patient, Dr. Dickfeld says recalls rarely mandate removal. An FDA recall is often a safety alert that may require only a change in the software controlling the device, or a different type of follow up for the patient. “The recalls are red flags indicating that something might be wrong,” says Dr. Dickfeld.

The survey included 61 randomly selected patients who were asked to participate in an 18-question quality-of-life questionnaire assessing the impact and perception of device recalls between October 2006 and April 2007. The patients’ average age was 66; nearly three-fourths were men. Eighteen percent said they were not aware of any recalls for pacemakers or defibrillators. Only 24 percent said they learned about the recall from their physician, while 51 percent said they received their recall information from TV, newspapers, the Internet and other media.

However, the survey found that a majority, 79 percent of those surveyed, preferred that their cardiologist be the main source of information, while only two percent wanted to be notified through the media and 14 percent preferred that the recall information come from the device manufacturer. There were differences among the patients over the threshold that would trigger their need for more information. Almost half (45 percent) wanted to be informed if a defect occurred as rarely as one in 100,000, while 12 percent asked for information only if the failure rate was above 10 percent.

During the course of the survey, the devices of eight of the 61 patients in the study were recalled. Those patients were given specific information about their recall. But the survey indicated that 24 percent of the entire group studied felt they had not received enough information about the recalls.

Despite the differences between where the information came from and how they wanted to find out, the emotional impact of recalls for patients appears to be limited and a large group of patients were upbeat about their devices. Eighty percent said they would recommend their device to others and 95 percent agreed that the device is still worth having.

As a result of the findings, Dr. Dickfeld believes physicians need to take a comprehensive approach to informing patients about recalls. “We have extended our informational efforts to all patients who have a defibrillator or pacemaker each time a recall is issued, whether or not their particular device has been recalled,” say Dr. Dickfeld. “The goal is to reassure all our patients during a recall, and to reduce any worries or concerns among those who are not directly affected by a given recall.”

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This page was last updated on: May 23, 2008.