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

Research Topic(s): Systems Engineering / Information Science

Lead Investigators: Joseph P. Drozda, Jr. (Mercy) and James E. Tcheng (Duke)

Sub-Project Principal Investigators: Natalia Wilson, MD, MPH (Arizona State, Jove Graham (Geisinger), J. Brent Muhlestein (Intermountain), David Slotwiner (Weill Cornell)

Community Partners: Mercy, Duke University, Intermountain Healthcare, Geisinger Health System, Weill Cornell Medicine

Description: BUILD focuses on leveraging unique device identification (UDI) as the index to connect data sources and move information on devices to clinicians for patient care, to researchers to assess device effectiveness and safety, and to support innovation. BUILD has three complementary components. In Extension of the UDI Implementation Pilot the Mercy Health coronary stent UDI model will be extended to two additional health systems. In Medical Device Data Capture and Exchange: Leading Practices and Future Directions a multi-stakeholder consortium of hospital system and manufacturer leaders in UDI will be formed, and key informant interviews will be performed in hospital systems implementing UDI for implantable devices to assess leading practices and gaps. In Electrophysiology structured reporting Providing UDI for Leads and devices using industry Standards to Electronic Health Records and CVIS systems (ePulse) capture of UDI will be demonstrated for pacemakers, cardioverter defibrillators, and leads.

Website: http://mdepinet.org/build/

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