Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration

Journal Journal of the American Medical Informatics Association
Authors Drozda, Joseph P.; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E.
Year Published 2017
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OBJECTIVE: The US Food and Drug Administration (FDA) has recognized the need to improve the tracking of medical device safety and performance, with implementation of Unique Device Identifiers (UDIs) in electronic health information as a key strategy. The FDA funded a demonstration by Mercy Health wherein prototype UDIs were incorporated into its electronic information systems. This report describes the demonstration’s informatics architecture.

METHODS: Prototype UDIs for coronary stents were created and implemented across a series of information systems, resulting in UDI-associated data flow from manufacture through point of use to long-term follow-up, with barcode scanning linking clinical data with UDI-associated device attributes. A reference database containing device attributes and the UDI Research and Surveillance Database (UDIR) containing the linked clinical and device information were created, enabling longitudinal assessment of device performance. The demonstration included many stakeholders: multiple Mercy departments, manufacturers, health system partners, the FDA, professional societies, the National Cardiovascular Data Registry, and information system vendors.

RESULTS: The resulting system of systems is described in detail, including entities, functions, linkage between the UDIR and proprietary systems using UDIs as the index key, data flow, roles and responsibilities of actors, and the UDIR data model.

CONCLUSION: The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model.

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
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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.


National and International Postmarket Research and Surveillance Implementation: Achievements of the International Consortium of Orthopaedic Registries Initiative

Journal The Journal of Bone and Joint Surgery
Authors Sedrakyan, Art; Paxton, Elizabeth; Graves, Stephen; Love, Rebecca; Marinac-Dabic, Danica
Year Published 2014
Link to publication

Nearly every American will be exposed to a medical device during his or her life, and tens of millions of people will be treated with an implantable device. However, regulatory and public health systems in the United States and internationally have critical gaps. The U.S. Food and Drug Administration (FDA) has released a national medical device postmarket surveillance plan, in which the agency identifies as a main priority the goal of promoting the development of national and international medical device registries for selected products. Another top priority of the FDA is the creation of a unique device identification (UDI) system for medical devices in response to a 2007 federal law.

Journal of Bone and Joint Surgery, Vol 96, Issue Supplement 1

Journal Journal of Bone & Joint Surgery, Vol 96. Supplement 1 – International Consortium of Orthopedic Registries
Authors Multiple
Year Published 2014
Link to Publication

List of 14 Articles

  • National and International Postmarket Research and Surveillance Implementation: Achievements of the International Consortium of Orthopaedic Registries Initiative
  • A Distributed Health Data Network Analysis of Survival Outcomes: The International Consortium of Orthopaedic Registries Perspective
  • Effect of Femoral Head Size on Metal-on-HXLPE Hip Arthroplasty Outcome in a Combined Analysis of Six National and Regional Registries
  • Risk of Revision Following Total Hip Arthroplasty: Metal-on-Conventional Polyethylene Compared with Metal-on-Highly Cross-Linked Polyethylene Bearing Surfaces: International Results from Six Registries
  • Distributed Analysis of Hip Implants Using Six National and Regional Registries: Comparing Metal-on-Metal with Metal-on-Highly Cross-Linked Polyethylene Bearings in Cementless Total Hip Arthroplasty in Young Patients
  • Comparative Effectiveness of Ceramic-on-Ceramic Implants in Stemmed Hip Replacement: A Multinational Study of Six National and Regional Registries
  • Multinational Comprehensive Evaluation of the Fixation Method Used in Hip Replacement: Interaction with Age in Context
  • International Comparative Evaluation of Knee Replacement with Fixed or Mobile Non-Posterior-Stabilized Implants
  • International Comparative Evaluation of Knee Replacement with Fixed or Mobile-Bearing Posterior-Stabilized Prostheses
  • International Comparative Evaluation of Fixed-Bearing Non-Posterior-Stabilized and Posterior-Stabilized Total Knee Replacements
  • Survivorship of Hip and Knee Implants in Pediatric and Young Adult Populations
  • Which Implant Should We Use for Primary Total Hip Replacement?: A Systematic Review and Meta-Analysis
  • Review of Clinical Outcomes-Based Anchors of Minimum Clinically Important Differences in Hip and Knee Registry-Based Reports and Publications
  • Implementation of Patient-Reported Outcome Measures in U.S. Total Joint Replacement Registries: Rationale, Status, and Plans