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Jamie Sheller
Jamie Sheller
Attorney • (800) 883-2299

New Guidelines Recommended For Heart Device Industry

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The Heart Rhythm Society, a group of electrophysiologists, has drafted some guidelines regarding pacemakers and implantable defibrillators. The guidelines were drafted after the society, FDA representatives and industry representatives participated in a two-day meeting last September.

Included in the guidelines are recommendations for independent watchdog committees to monitor manufacturing and regulation of pacemakers and defibrillators. Another recommendation was for the establishment of an FDA committee to analyze post-marketing device performance. However, the society also recommended that all heart devices removed from a patient be returned to the manufacturer. In a context such as the Guidant recall, where the manufacturer is reported to have deliberately withheld information about product defects, this recommendation could have negative effects on patients seeking to hold manufacturers accountable for injuries or death caused by their defective pacemakers or defibrillators. If all devices are returned to the manufacturer under such circumstances, the patient would lose the ability to have independent testing of their heart device. Further, crucial evidence would be in the defendant’s hands, with no guarantee of adequate and neutral analysis.