WASHINGTON, September 28, 2006 -- The Heart Rhythm Society today issued final recommendations to provide heart patients with clearer, timelier and more consistent information about the recall process and the performance of pacemakers and implantable cardioverter defibrillators (ICDs). The recommendations also offer specific guidance to physicians, Food and Drug Administration (FDA) officials and members of Congress about performance issues and advisories for implantable cardiac devices. In addition, the final recommendations report also addresses international principles related to device performance.
The report will be published in the October issue of Heart Rhythm.
"This report offers the first comprehensive recommendations for the surveillance, analysis and performance reporting of pacemakers and ICDs," said Dwight Reynolds, MD, FHRS President of the Heart Rhythm Society. "These changes will help patients continue to have confidence and trust in these lifesaving treatments."
The overarching objectives of the recommendations include the following:
"The next step is for the Heart Rhythm Society to work with Congress, regulators, industry, patients and other stakeholders to ensure that these recommendations will guide key policy decisions that will help heart patients," said Mark D. Carlson, MD, FHRS, Chairman of the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines.
Specific recommendations for each of the key audiences include:
A 15-member task force of leading cardiac care providers and experts developed the guidelines with feedback from regulators at the FDA, representatives from industry and patient advocacy groups. Additional feedback was received from a public comment period that ended May 30, 2006.
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 final guidelines are available online at http://www.hrsonline.org.
About the Heart Rhythm Society
The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of over 4,500 heart rhythm professionals in over 74 countries around the world.
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