• Thomas R Campion, Stephen B Johnson, Elizabeth W Paxton, Alvin I Mushlin, and Art Sedrakyan.
• Departments of *Public Health †Pediatrics ‡Center for Healthcare Informatics and Policy, Weill Cornell Medical College, New York, NY §Surgical Outcomes and Analysis, Kaiser Permanente, San Diego CA ∥Department of Medicine, Weill Cornell Medical College ¶New York-Presbyterian Hospital #Department of Surgery, Weill Cornell Medical College, New York, NY.
• Med Care. 2014 Jan 1; 52 (1): 26-31.

BackgroundThe United States Food and Drug Administration (FDA) has proposed creating a unique device identification (UDI) system for medical devices to facilitate postmarket surveillance, quality improvement, and other applications. Although a small number of health care institutions have implemented initiatives comparable with the proposed UDI system by capturing data in electronic health record (EHR) systems, it is unknown whether institutions with fewer resources will be able to similarly implement UDI.Objective And MethodsThis paper calls attention to organizational, workflow, and technological challenges in UDI system implementation by drawing from the literature on EHR and clinical research systems implementation.FindingsOrganizational challenges for UDI system implementation include coordinating multiple stakeholders to define UDI attributes and characteristics for use in EHRs, guiding organizational change within individual institutions for integrating UDI with EHRs, and guiding organizational change for reusing UDI data captured in EHRs. Workflow challenges include capturing UDI data in EHRs using keyboard entry and barcode scanning. Technological challenges involve interfacing UDI data between EHRs and surgical information systems, transforming UDI and related patient data from EHRs for research, and applying data standards to UDI within and beyond EHRs.Discussion And ConclusionsWe provide recommendations for regulations, organizational sharing, and professional society engagement to raise awareness of and overcome UDI system implementation challenges. Implementation of the UDI system will require integration of people, process, and technology to achieve benefits envisioned by FDA, including improved postmarket device surveillance and quality of care.

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