Bridging Unmet Medical Device Ecosystem Needs With Strategically Coordinated Registries Networks

Journal Journal of the American Medical Association
Authors Mitchell W. Krucoff, MD; Art Sedrakyan, MD, PhD; Sharon-Lise T. Normand, PhD
Year Published 2015
Link to publication

Abstract
The Medical Device Registries Task Force (MDRTF) recommends strategic coordinated registries network (CRNs) as the foundational architectural construct for the national system that will augment national registry development and unique device identifier implementation rather than replace them.
The proposed CRN structure could provide novel, important attributes to the national system. Creation of CRNs could encourage efficient “dual-purpose” leveraging of existing registries, EHRs, administrative data resources, and lessons learned from existing linked-registry models such as the Transcatheter Valve Therapy registry administrative claims and the International Consortium of Orthopedic Registries (ICOR) distributed data networks. The proposed CRN structure could provide the national system with flexibility to accommodate various information needs of different devices, spur development of partnering and interoperability solutions and their reuse across device areas, and encourage implementation of standardized device/data dictionaries. The CRN structure could thus encourage the stepwise growth of the national system, provide resilience in the fast-moving world of electronic systems, and offer the flexibility to shift over time from registry infrastructure toward EHRs and even mobile systems as primary data sources. In addition, the CRN structure could afford opportunities for registry owners and other stakeholders to collaboratively create inclusive governance solutions, customized information outputs, and partnered approaches to challenging issues such as informed consent.