FDAnews Device Daily Bulletin

HEART RHYTHM SOCIETY ISSUES SWEEPING RECOMMENDATIONS FOR HEART DEVICE REGULATIONS

May 2, 2006
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The Heart Rhythm Society (HRS) has issued a series of recommendations for industry, the FDA and physicians to consider in revising the processes for postmarket surveillance and analysis of pacemakers and implantable cardioverter-defibrillators (ICDs).

The HRS proposal comes in the wake of newly publicized studies that look at pacemaker and ICD malfunctions in the U.S., as well as the risk factors associated with ICD replacement in Canadian patients. Both studies were published in the April 26 issue of the Journal of the American Medical Association (JAMA).

While pacemaker malfunctions have declined in recent years, implantable cardioverter-defibrillator (ICD) malfunctions have increased, according to one of the JAMA studies. Researchers analyzed postapproval annual reports submitted to the FDA by pacemaker and ICD manufacturers from 1990 to 2002 to determine the number of device malfunctions and assess performance trends.

During that time, 2.25 million pacemakers and 415,780 ICDs were implanted, representing a threefold increase in pacemaker implantations and a tenfold increase in ICD implantations. Of the total number of devices explanted, over half of those extractions resulted from battery or capacitor abnormalities and electrical issues, the article states.

The recommendations by the HRS focus on the need for transparency in postmarket surveillance, analysis and reporting of device-related information, new systems to more quickly identify malfunctioning devices, and the use of standardized formats and language by industry to notify physicians and patients of devices that could malfunction. ()a href="http://www.fdanews.com/ddl/33_18/" target=_blank>