The Heart Rhythm Society actively participated in the U.S. Food and Drug Administration’s workshop on Best Practices for Pacemaker and ICD Lead Postmarket Surveillance on October 2-3, 2008. This postmarket lead surveillance workshop was developed by the FDA’s Center for Devices and Radiological Health (CDRH).

Participants included members from FDA, from industry, and electrophysiologists representing the Heart Rhythm Society:

• Clinical Diagnosis of ICD and Pacemaker Lead Problems — Andrew Krahn, MD, Associate Professor of Cardiology, University of Western Ontario, University Hospital
• Returned Product Analysis — Bruce Wilkoff, MD, FHRS, CCDS, Director of Cardiac Pacing, Cleveland Clinic
• Adverse Event Reporting and Post-Approval Studies, Registries, and Home Monitoring — William H. Maisel, MD, Director, Medical Device Safety Institute, Beth Israel Deaconess Medical Center CV Division

Society participants emphasized the following in their presentations:

• importance of post-market surveillance
• risk versus benefit of lead extraction for return product analysis
• importance of follow-up and communicating adverse events in a timely manner
• benefits of registries and home monitoring systems for reporting essential information

The Center plans to summarize and release the workshop outcomes later this month.The Heart Rhythm Society will report back when the FDA releases their final conclusions. The workshop’s agenda can be viewed on the FDA page.

If you have any questions, please contact Donna Goldberg, Clinical Documents Manager, Heart Rhythm Society.