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Documentation and tracking of supplies, equipment and medical devices is central to the operational, financial, and clinical delivery of safe, efficient, and effective patient care. The labeling of medical devices with a unique device identifier (UDI) creates the opportunity to tightly integrate device information across health information systems by using the UDI as the index "source of truth". While the FDA UDI Final Rule was published in 2013, implementation of UDI across healthcare is still nascent. This presentation will delineate the potential benefits of the UDI, use a people / process / technology paradigm to describe the approach to implementation of a UDI-based "clinically integrated supply chain" in the Duke cardiac catheterization and electrophysiology labs, and deliberate the path to accomplishing UDI implementation at scale.
James Tcheng, MD, is a Professor of Medicine (Cardiology) and a Professor of Family Medicine and Community Health (Informatics) at Duke University, Durham, NC. He is an interventional cardiologist and faculty of the Duke Clinical Research Institute and the Duke Center for Health Informatics. He serves as the Chief Medical Information Officer of the Duke Heart Network and Director of Information Technologies for the Duke Heart Center. He is the UDI physician champion for the Duke University Health System and is active across multiple national initiatives involving professional societies, academia, standards development organizations, government, and the life sciences industry in the realm of medical device documentation and tracking.