Heart of the Matter

When Is a Recall Not a Recall?


 

As part of its new Recommendations From the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines, the society, in conjunction with the device manufacturers, is proposing that device recalls should now be called an “advisory notice” or “safety alert.” HRS suggests that this change is meant to lessen the anxiety of patients and doctors about the implication of a recall.

The American public, and I presume much of the rest of the world, is not exactly unaccustomed to recalls. We have at least one recall a month by auto manufacturers, some by the manufacturers of the reputedly solid Japanese makes. Thanks to the watchful eyes of a variety of federal agencies, we have recalls of everything from baby food to spinach, jet airplanes to baby car seats, and Christmas toys to microwave ovens. We also have had recalls of biologic and medical items including antiarrhythmic drugs, aortic valves, and the painkiller rofecoxib (Vioxx).

Most of these recalls are taken in stride, but the recall of an electronic device implanted in your body does have some unique implications, particularly when many of the devices are there to save your life and when their removal is associated with some risk and discomfort.

The HRS is having difficulty getting this nomenclature change to come about. According to an article in this month's CARDIOLOGY NEWS (see p. 4), the Food and Drug Administration is reluctant to remove “recall” from its lexicon since it is rooted in legislation that mandates its safety responsibilities. In an uncharacteristic Washington response, the FDA is not prepared to “spin” its terminology, even when it is part of the problem.

These proposed changes are taking place in an atmosphere where the number of defibrillator devices implanted is falling short of the expectations of the physicians and manufacturers. Based on the current guidelines of the American College of Cardiology, American Heart Association, and HRS, many more of the devices should have been implanted, suggesting that quality standards are being compromised.

The concern of the HRS is that the media attention given to recalls has made both patients and physicians reluctant to follow the guidelines. It also has called attention to the risks of removing recalled devices, raising questions about which devices should be removed when they are identified as recalled. At the same, time many well-meaning physicians who treat patients at risk of sudden death are concerned about the “one size fits all” approach to the implantation guidelines and are looking for better risk stratification of the benefit that can accrue to their patients. Surely, among the millions of patients included in those guidelines, we should be able to determine in which patient individual implantation is imperative.

As a result of the flawed reporting of device failure in the past, there has been an outcry from physicians for more transparency in the reporting of malfunction of these devices. Unfortunately, increased transparency is certain to raise the level of anxiety of all those involved—patients and physicians—in the implantation of the devices. It is unlikely that the changes in nomenclature will lessen the concerns and increase the understanding of the risks and benefits of implantable devices.

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