Exploring Unique Device Identifier Implementation and Use for Real-World Evidence: A Mixed-Methods Study with NESTcc Health System Network Collaborators

Abstract

AbstractObjectivesTo examine the current state of Unique Device Identifier (UDI) implementation, including barriers and facilitators, among eight health systems participating in a research network committed to real-world evidence (RWE) generation for medical devices.DesignMixed methods, including a structured survey and semi-structured interviews.SettingEight health systems participating in the National Evaluation System for health Technology research network within the United States.ParticipantsIndividuals identified as being involved in or knowledgeable about UDI implementation or medical device identification from supply chain, information technology, and high-volume procedural area(s) in their health system.Main Outcomes MeasuresInterview topics were related to UDI implementation, including barriers and facilitators; UDI use; benefits of UDI adoption; and vision for UDI implementation. Data were analyzed using directed content analysis, drawing on prior conceptual models of UDI implementation and the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. A brief survey of health system characteristics and scope of UDI implementation was also conducted.ResultsThirty-five individuals completed interviews. Three of eight health systems reported having implemented UDI. Themes identified about barriers and facilitators to UDI implementation included knowledge of the UDI and its benefits among decision makers; organizational systems, culture, and networks that support technology and workflow changes; and external factors such as policy mandates and technology. A final theme focused on the availability of UDIs for RWE; lack of availability significantly hindered RWE studies on medical devices.ConclusionsUDI adoption within health systems requires knowledge of and impetus to achieve operational and clinical benefits. These are necessary to support UDI availability for medical device safety and effectiveness studies and RWE generation.Key MessagesWhat is already known on this topicRecent legislation and policy have placed increased emphasis on tracking medical device safety and effectiveness using real-world evidence (RWE).The unique device identifier (UDI), available on labels of most moderate- and high-risk medical devices, ensures accurate and reliable medical device identification and tracking.What this study addsEven among health systems committed to RWE generation, UDIs are often not available within their data sources to enable effective medical device identification for RWE studies.Knowledge by health system leaders about UDI benefits and buy-in about its operational and clinical benefits are necessary for UDI implementation and availability for RWE generation.How this study might affect research, practice or policyResults demonstrate the need to increase awareness and provide guidance about the value of UDI use to health system leadership.Policy mandates are necessary to drive greater UDI adoption in health systems and support real-world evidence generation.