Guidelines Help Steer Recall Issues
Final recommendations issued Sept. 28 from the Heart Rhythm Society are aimed at providing heart patients with clearer, timelier and more consistent information about the recall process and the performance of pacemakers and implantable cardioverter defibrillators (ICDs).
Offering specific guidance to physicians, Food and Drug Administration (FDA) officials and members of Congress about performance and advisory issues pertaining to implantable cardiac devices, the final recommendations report also addresses international principles related to device performance.
The guidelines have been officially endorsed by the American College of Cardiology Foundation, American Heart Association and an International Coalition of Pacing and Electrophysiology organizations, which includes the Asian-Pacific Cardiology Society, European Heart Rhythm Association, European Cardiac Arrhythmia Society and Latin American Society of Pacing and Electrophysiology.
The report will be published in the October issue of Heart Rhythm.
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