WASHINGTON--The Heart Rhythm Society today released the first comprehensive recommendations for the surveillance, analysis and performance reporting of pacemakers and implantable cardioverter defibrillators (ICDs). The draft guidelines offer detailed recommendations to physicians, the Food and Drug Administration (FDA), and Congress about performance issues and advisories for implanted cardiac devices.

The recommendations also provide heart patients with clearer, timelier and more consistent information about the recall and advisory process.

"As the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, we believe these suggested changes will ensure that patients continue to have access to these lifesaving treatments," said Anne B. Curtis, M.D., President of the Heart Rhythm Society. "We believe these draft guidelines are an important step towards strengthening patient and physician knowledge, confidence and trust."

The draft guidelines call for: 1.) greater transparency in the post-market surveillance, analysis, and reporting of information 2.) the establishment of new systems to identify malfunctioning devices more quickly and 3) 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.

Select highlights from the recommendations include the following:

Physicians:

• Should inform patients not only about the benefits and risks of devices, but also about the overall expected performance of devices, including potential malfunction rates.
• Should return all malfunctioning devices after explant to the manufacturer for analysis whether the replacement is routine or because of a malfunction. This will lead to more timely identification of potential malfunctions an
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Contact: Rachael Lille Moore
rmoore@HRSonline.org
202-464-3476
GYMR
26-Apr-2006


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