Dwight W. Reynolds, MD, FHRS, president of the Heart Rhythm Society, testified this week 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. The goal is for the U.S. to use this network to gain easy access to post-market medical device surveillance information which can be used by the FDA and by practicing physicians.
“We recommend that FDA partner with physician associations such as the HRS and the ACC to use this 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,” Reynolds said. “We suggest a physician advisory panel be established to help FDA interpret the data and provide recommendations on action and communication of such data.”
Here’s a summary of Reynolds’ recommendations:
1. The FDA should design and implement a more robust reporting system for device malfunctions that could overcome many of the MAUDE (Manufacturer and User Device Experience) shortcomings and strengthen the voluntary reporting system;
2. The FDA should consider using remote monitoring technologies when establishing the Sentinel Network to locate abnormal device behavior as early as possible; and
3. The FDA should strengthen its partnership with physician associations to develop a Sentinel Network that is linked to registries, such as the baseline Implantable Cardioverter Defibrillator (ICD) Registry. The Heart Rhythm Society further recommends that the NCDR ICD Registry be modified to collect device-specific longitudinal performance data including device performance.