Ongoing Concerns with ICDs

Introduction by Michelle Bridenbaker
The news of the potential for device malfunction associated with implantable cardioverter defibrillators (ICDs) first surfaced in February of this year with reports of the potential for battery shortening in ICDs manufactured by Medtronic Inc. (Minneapolis, Minnesota), but quickly subsided from the media. In late May, however, the issue reemerged with another report of potential device concerns associated with ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured by Guidant Corporation (Indianapolis, Indiana). Since the report in late May, numerous reports regarding device concerns (affecting other device manufacturers) have continued to surface, with what may seem like alarming frequency.
In the time span of less than 2 weeks, Guidant issued several voluntary recall notices affecting more than 80,000 of its ICD and CRT-D devices. As of July 1, the US Food and Drug Administration (FDA) formerly classified these actions as Class I and Class II recalls, Class I designation being the most serious. The question now becomes: What should doctors do next?
Many in the medical community believe that the current situation has provoked unnecessary "mass hysteria" and advocate that physicians remain informed and communicate the situation, including the risks and benefits of treatment options with their affected patients. In addition, initiatives are under way to draft formal recommendations as to how (and when) manufacturers should appropriately disseminate information regarding potential device concerns to the medical community and how physicians should respond to such concerns, including the decision to explant a device based on degree of risk.
Because of the rapid pace at which the information was released, the majority of clinicians received the information in laymen's terms. The aim of this article is to provide the healthcare practitioner with a clinical summary of the recent events, as well as a description of the reactions to and initiatives taken by the medical community.

Michelle L. Bridenbaker, RN, BSN, CPhT, freelance medical writer, Indianapolis, Indiana.

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