FOR IMMEDIATE RELEASE
March 7, 2007

Contact: Charlie Jones
Heart Rhythm Society
202-464-3474
cjones@hrsonline.org

Heart Rhythm Society Addresses FDA Hearing On Post-Market Medical Device Surveillance Network

Dwight W. Reynolds, MD, FHRS, President of the Heart Rhythm Society, testified on March 7, 2007 at FDA’s public meeting about the Sentinel Network, an electronic network that would integrate existing and planned efforts to collect, analyze, and disseminate medical product safety information to health care practitioners and patients. Excerpts from Dr. Reynolds’ testimony include the following:

“As a practicing heart rhythm specialist for over 25 years, I know firsthand how important it is for the U.S. to establish a comprehensive ‘Sentinel Network’ of easily accessible and reliable post-market medical device surveillance information which can be used by the FDA and by practicing physicians caring for patients to enhance care and safety. In September, 2006, the Heart Rhythm Society published recommendations to improve the post-market surveillance system for implanted devices. The reason we are here today is to share these recommendations with a wider audience and to improve the nation’s post-market surveillance system for implanted medical devices.

“Today I will only focus on three of these recommendations:

1) The need to improve the current post market surveillance network, with an emphasis at highlighting enhancements needed to MAUDE.

We recommend that the FDA begin efforts to design and implement a more robust reporting system for observed device malfunctions that could overcome many of the MAUDE (Manufacturer and User Device Experience) shortcomings and strengthen the voluntary reporting system.

2) The important role of remote monitoring of implanted cardiac devices and its potential for inclusion in the “Sentinel Network.”

We recommend that cardiac rhythm management device manufacturers continue to develop and that the FDA consider using remote monitoring technologies when establishing the Sentinel Network. Such technologies would help identify abnormal device behavior as early as possible, automatically and accurately determine the status of certain implanted device functions, and reduce underreporting of device malfunctions by determining the functional status of an implanted device more frequently and more accurately.

3) The potential of the current ICD Registry to facilitate the collection of post-market surveillance data.

We recommend that the FDA strengthen its partnership with physician associations to develop a Sentinel Network that is linked to existing and future registries, such as the baseline Implantable Cardioverter Defibrillator (ICD) Registry. We further recommend that the NCDR ICD Registry be modified to collect detailed device-specific longitudinal performance data including a report of device performance at the time of device replacement or death.

“We recommend that FDA partner with physician associations such as the HRS and the ACC to use this aggregated data to speed public health action in the event of future device recalls. We also recommend that FDA utilize practicing clinicians as it further develops and integrates the Sentinel Network. We suggest a Physician Advisory Panel be established to help FDA interpret the data and provide recommendations on action and communication of such data.

“The Heart Rhythm Society looks forward to working with the FDA as it seeks to establish a national ‘Sentinel Network.’”

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View Testimony