The Medical Device Unique Device Identifier as the Single Source of Truth in Healthcare Enterprises – Roadmap for Implementation of the Clinically Integrated Supply Chain

James E Tcheng,1 Miriam V Nguyen,1 Helen W Brann,1 Patricia A Clarke,1 Maureen Pfeiffer,1 Jane R Pleasants,2 Gregory W Shelton,1 Joseph F Kelly1 1Department of Medicine, Duke University Hospital and Health System, Durham, NC, USA; 2Strategic Marketplace Initiative, Westborough, MA, USACorrespondence: James E TchengDuke University Hospital and Health System, Hock Plaza Suite 403, 2424 Erwin Road, Durham, NC, 27705, USATel +1 919 668-8796Email tchen001@mc.duke.eduAbstract: Documentation and tracking of supplies, equipment and medical devices is central to operational, financial, and clinical aspects 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”. Across 3 hospitals of the Duke University Health System, we executed a comprehensive implementation of UDI-based device and supply information management in our cardiac catheterization and electrophysiology laboratories. Following are our key insights. Implementing a UDI-centric environment is a complex undertaking requiring integration of information systems, management processes, and clinical workflows involving leadership, inventory management, supply chain, clinical and billing teams. Implementation involves the domains of procedure documentation, electronic health records (EHRs), charge capture and billing, and interface and information technology systems, including information systems vendors. Replacing manual processes with electronic messages is not simply an exercise in programming information systems – successful execution requires orchestrated re-engineering of clinical and operational workflows. Our initiative resulted in a more efficient and effective supply chain, eliminated operational and clinical documentation errors, automated the posting of device implant data to the EHR, reduced clinician burden, improved charge capture, and produced a substantial financial benefit, with return on investment recognized in well under 1 year. We believe our stepwise approach to accomplishing a clinically integrated supply chain can serve as a roadmap for other healthcare enterprises to follow.Keywords: unique device identifier, medical devices, supply chain, clinical documentation, implementation roadmap, interoperability