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HRS ISSUES FINAL RECOMMENDATIONS ON HEART DEVICE OVERSIGHT

September 28, 2006

The Heart Rhythm Society (HRS) Sept. 28 issued its final recommendations on the device recall process and the performance of pacemakers and implantable cardioverter defibrillators.

The report addresses the group's "overriding objectives," which include:

Establishing greater transparency in the postmarket surveillance, analysis and reporting of device information;

Establishing new systems to identify malfunctioning devices more quickly;

Implementing standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified; and

Examining the global scope of device performance issues.

The report will be published in the October issue of Heart Rhythm.

The final guidelines can be viewed at www.hrsonline.org/uploadDocs/HRSTaskForceRecsFull.pdf (http://www.hrsonline.org/uploadDocs/HRSTaskForceRecsFull.pdf).