Warnings have been issued for more than 500,000 devices in a decade, says the study. While the number is correct, the medical director of a leading manufacturer says "they could be misleading" because of the implication that every one of those devices was faulty.
The study, led by Dr. William H. Maisel, an associate physician in the cardiac arrhythmia section of Brigham and Women's Hospital in Boston, looked at all recalls and alerts issued between January 1990 and December 2000 by the Food and Drug Administration (FDA) for pacemakers, which keep the heart beating regularly, and defibrillators, which deliver an electric shock when heart rhythm becomes abnormal.They counted 52 warnings covering 408,000 pacemakers and 114,645 defibrillators. What's more, the warnings "appear to be increasing in number and rate. With the growing number of device implants and expanding indications for device therapy, the number of patients affected by device advisories will likely continue to increase," report the researchers in the Aug. 15 issue of the Journal of the American Medical Association,
Maisel says some 700,000 Americans now have either an implantable pacemaker or defibrillator, and the FDA warnings "certainly have a lot of psychological impact." They also have a direct physical effect on the patients who have to undergo procedures to replace a potentially malfunctioning device, he says.
Dr. Marshall Stanton, medical director of Medtronic, Inc, a company that says it has half the market for the devices, says not all devices in a recall are necessarily faulty. "We had a recall on a defibrillator a year ago that was being used by 1,500 patients. We determined that fewer than 50 could have the device replaced, but we did the recall on all 1,500," he says.
Stanton says, "Many times a recall can be about something that is not life-threatening at all. In our experience, when a recall involves a large number of devices, that is often the case."
Maisel estimates the cost for all the warnings has been $870 million.
Stanton and Maisel differ about the reason for the increase in warnings in the last few years. "What may be seen here is an industry that is getting better at self-policing and monitoring," Stanton says. "We are as careful if not more careful now than we have ever been."
Maisel says, "An alternate explanation is that these devices have become more complicated. That complexity may account for the increase."
True, says Stanton, but that's a good thing. Part of the increased complexity is a built-in ability for self-monitoring, so that a device can detect a problem early. Many times, the correction requires no more than reprogramming the device, he says.
In an accompanying editorial, Dr. Kim A. Eagle of the University of Michigan Medical Center says one way to reduce the number of warnings is to require more testing before the FDA approves a device, with more input by experts outside the industry. Eagle says a better tracking system run by outside groups, such as the American Heart Association, also could help, though that could raise the cost of the devices and slow the introduction of new technology.
What To Do
"A patient who is concerned about an advisory about a device should consult his or her physician but shouldn't panic," Maisel says. "Patients should have the regular, close follow-ups with the physician that they would be having anyway."