Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines

September 2006

This report offers the first comprehensive recommendations for the surveillance, analysis and performance reporting of pacemakers and ICDs (Adobe PDF, 195K). These changes will help patients continue to have confidence and trust in these lifesaving treatments. View responses to FAQs on the recommendations. (Adobe PDF, 45K)

The overarching objectives of the recommendations include the following:

Greater transparency in the post-market surveillance, analysis and reporting of information;
The establishment of new systems to identify malfunctioning devices more quickly;
Standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified. Manufacturers, the FDA and physicians are encouraged to work together to prevent adverse events due to device malfunctions; and
The global scope of device performance issues; cooperation among industry, physicians, government authorities and national health care systems are necessary to reduce the risk of injuries and deaths due to device malfunctions.

Heart Rhythm Society plans 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.

The guidelines have been officially endorsed by the American College of Cardiology Foundation, American Heart Association and the International Coalition of Pacing and Electrophysiology Organizations (COPE), which includes the Asian-Pacific Cardiology Society, European Heart Rhythm Association, European Cardiac Arrhythmia Society and Latin American Society of Pacing and Electrophysiology.

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 Task Force recommendations are published in the October 2006 issue of Heart Rhythm.