FDA Meetings Explore the Role Registries Can Play in a Postmarket Surveillance System

Cardiology was well represented in Washington, D.C. last week. In addition to the more than 350 cardiologists in town for the ACC’s Legislative Conference, a number of other cardiologists met with the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services, the Agency for Health Care Research and Quality and others over the course of four days to discuss the need for a strong medical device postmarket surveillance system and to understand the role registries can play in this strengthened system.

Past President Ralph G. Brindis, MD, MPH, FACC, offered the College's strong support for the FDA's recently released postmarket surveillance strategy, Strengthening Our National System for Medical Device Postmarket Surveillance. "Today's postmarket surveillance system relies too heavily on a system of passive event reporting generated by busy clinicians who may not understand what to look for or how to complete and submit adverse event reports to industry or the FDA," Brindis stated. "We look forward to the day when this country has an envisioned postmarket device surveillance program that is fully inclusive of all designated implanted devices, offers ready patient and device identification that also meets HIPAA compliance, and functions in near 'real time' fashion  offering true protection for our patients while maximizing the opportunities for patient access to novel and innovative technologies."

This new strategy relies on four specific actions to implement a strengthened national medical device postmarket surveillance system:

  1. Establish a Unique Device Identification (UDI) System and promote its incorporation into electronic health information
  2. Promote the development of national and international device registries for selected products
  3. Modernize adverse event reporting and analysis
  4. Develop and use new methods for evidence generation, synthesis and appraisal

Throughout the week, cardiologists offered personal and professional experiences with postmarket surveillance. Brindis discussed efforts the National Cardiovascular Data Registry (NCDR®) has underway to integrate data collection with electronic health care records, models for registry sustainability and real world examples of the NCDR serving as a platform for post approval surveillance.  Massachusetts ACC Chapter Governor Fred Resnic, MD, FACC, spoke of his experiences with the DELTA project. ACC Trustee and NCDR Management Board Member Joseph Drozda, MD, FACC, shared his work developing the ability to add specificity to the UDI to allow for easier device identification and comparison, while Sharon-Lise Normand, PhD, FACC, highlighted the various issues around data collection, bias and analysis, and the value of state registries. Past President of The Society of Thoracic Surgeons (STS) Michael Mack, MD, FACC, and Fred Edwards, MD, FACC, discussed lessons learned from the STS registries and the STS/ACC TVT Registry™. Eric Peterson, MD, FACC, and J. Matthew Brennan, MD, FACC, shared views based on the experiences of the Duke Cardiovascular Research Institute with the STS and ACC registries, as well as past work conducted with the FDA. Mitchell Krucoff, MD, FACC, took the discussion from one that was U.S.-focused to one where the U.S. is one component of a global device surveillance system and learns from experiences in other countries, as well.

The ACC will submit written comments on the strategy and continue to work with the FDA and other stakeholders on implementation. Stay tuned to CardioSource.org and the ACC Advocate for updates.


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