Building UDI Into Longitudinal Data for Medical Device Evaluation (BUILD)

Description
BUILD combines into one initiative 3 of the 6 projects developed by the 2015 MDEpiNet SMART Informatics Think Tank.  The 3 projects leverage the unique device identifiers (UDIs) as the index for connecting data sources and moving information about devices to clinicians and researchers to enable the evaluation of device effectiveness and safety and to support innovation.  The pilots are 1) Extension of UDI Implementation Pilot; 2) Medical Device Data Capture and Exchange: Leading Practices and Future Directions; and 3) Electrophysiology structured reporting Providing UDI for Leads and devices using industry Standards to Electronic Health Records and CVIS systems (ePulse).  

The Extension Pilot builds on the Mercy FDA demonstration whereby coronary stent UDIs were incorporated in Mercy’s electronic information systems resulting in integration of clinical and device data, coupled with creation of a database useable for surveillance and research.  This process will be extended to Intermountain and Geisinger, and a distributed data network of the 3 systems will be developed with NCDR CathPCI Registry as the hub. The project includes linking with AccessGUDID at the National Library of Medicine.  The Leading Practices project builds a consortium of hospital organization, manufacturer and other stakeholder leaders that will work to outline the current environment of UDI use and conceptualize innovative solutions for capture, exchange, and use of implantable device data elucidating best practices for leveraging UDI from supply chain to the point of care.  The ePulse project focuses on the aggregation of data at the point of care, leveraging UDI as the information index. These granular data will be communicated to EHRs in C-CDA format.    
Start Date
01/01/2016
Projected End Date
08/31/2018
Project Tags
  • Clinical Research
  • Common data elements
  • EHR
  • GUDID
  • interoperability
  • Medical Device Surveillance
  • Patient Registry
  • Unique Device Identifiers
  • Distributed Research Network
  • Coronary Artery Stents
Project Point of Contact: rebecca.wilgusremove@removeduke.edu
Project Results
None