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Pacemakers, Implantable Defibrillators Frequently Recalled


Prystowsky says that it is, therefore, unlikely that device alerts cost anywhere near $870 million, because "that figure is based on the assumption that all devices are replaced."

Most alerts require little more than more frequent office visits to better monitor the patient, says Prystowsky, who is a consultant to Guidant, a manufacturer of both ICDs and pacemakers.

Although Maisel's paper tracks the number of FDA-issued alerts, it doesn't provide any data on the health effects of those alerts and Maisel admits that he can only estimate the costs involved with the alerts. He explains that the FDA warnings are the only official records available. When an alert is issued a notice goes out to the doctor who implanted the device and the patient in whom it was implanted. It is then up to the doctor and patient to decide how to respond, says Maisel.

A better approach, according to one expert, would be some uniform recommendations -- not generated by the device industry or the FDA -- about how to handle and track potential malfunctions.

In an editorial that accompanies the study, Kim A. Eagle, MD, chief of clinical cardiology at the University of Michigan Medical Center in Ann Arbor, tells WebMD that tracking devices after they are implanted is actually "a lot more complicated than tracking side-effects of pills. It is much more challenging because the devices are more complex."

Eagle says it is time doctors themselves become involved in monitoring device safety, and he suggests that the American Heart Association, the American College of Cardiology, and Prystowsky's group join forces to produce a better tracking system.

Prystowsky says his group is already planning a conference aimed at addressing device safety concerns. "This is not a new issue for us and we are already well along in the planning process," he says.

However it is done, Eagle says its clear that better device safety monitoring is needed. "What is very clear is that the recall carries with it a certain amount of inconvenience and expense. It has a direct impact on patient safety, although the lion's share of the recalls are not life-and-death issues."


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