Coordinated registry network could improve device surveillance

October 29, 2015 – The DCRI’s Mitchell Krucoff, MD, and his colleagues discussed the benefits of a linked network in a recent JAMA editorial.

The creation of a coordinated registry network (CRN) is a key element in building a national medical device evaluation system, according to a new editorial by the DCRI’s Mitchell Krucoff, MD.

The article, co-authored with Art Sedrakyan, MD, PhD, of Weill Cornell Medical College and Sharon-Lise T. Normand, PhD, of Harvard Medical School, appears in this week’s issue of JAMA.

mitchkrucoffLast year, the Medical Device Epidemiology Network (MDEpiNet) convened the Medical Device Registries Task Force (MDRTF) to strengthen the medical device postmarket surveillance system using existing resources and develop an integrated system to facilitate premarket device clearance and approval.

The MDRTF recognized that most existing resources for postmarket device surveillance are unlinked and do not contain all the necessary elements. These elements include device and procedural details, patient descriptors, and long-term outcomes. The task force suggested that such limitations could be addressed by strategically linking complementary registries and data sources to create a CRN that provided most or all of the needed information.

The task force also identified five essential elements of a CRN:

  • The ability to uniquely identify medical devices
  • Implementation of standardized clinical vocabularies and dictionaries
  • Reusable interoperability solutions linking diverse, strategically complementary data sources
  • Partnered, inclusive governance
  • Value-based, incentivized sustainability

“The success and sustainability of the national system will depend on active transformation of the contemporary medical device landscape of fragmentation, skepticism, and distrust into a culture of good will and partnering,” Krucoff and his colleagues wrote.

“It will require a concerted effort to move toward shared data elements and standards-based practices, but doing so could allow more effective, low-cost, real-time, rich safety and research opportunities.”