FDAnews Device Daily Bulletin

NEW GUIDELINES RECOMMEND BETTER MONITORING PROCESSES FOR IMPLANTABLE HEART DEVICES

April 27, 2006
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While pacemakers and implantable cardioverter-defibrillators (ICDs) have been shown to save lives, recent events have raised questions about their effectiveness and safety, Heart Rhythm Society (HRS) officials said recently. The organization has issued a series of recommendations for industry, the FDA and physicians to consider in revising the processes for postmarket surveillance and analysis of the devices.

Malfunctions in pacemakers and ICDs in the U.S., as well as the risk factors associated with ICD replacement in Canadian patients, point to the need for a more careful monitoring of the devices, according to results from two studies published in the Journal of the American Medical Association.

The HRS draft guidelines call for greater transparency in the postmarket surveillance, analysis and reporting of information, new systems to more quickly identify malfunctioning devices, and standardized formats and language on the part of industry to notify physicians and patients when a malfunction is identified (Full story will appear in the April 30 issue of Devices & Diagnostics Letter (http://www.fdanews.com/wbi/newsletters/device.html)).