BUILD Report on Implementation of UDI for Implantable Devices at the Point of Care

This report is designed to serve as a practical and usable guidance on implementation of unique device identification (UDI) for implantable devices at the point of clinical care. Included is an Implementation Roadmap as well as gaps and challenges commonly faced in UDI implementation with strategies currently being used by hospital systems in response. Also included are detailed recommendations on needed next steps to improve adoption of UDI, consisting of pilot projects, topics for workgroup initiatives, further stakeholder engagement and areas of policy focus.

This project was undertaken to address a gap in development of a comprehensive UDI system in U.S. health care. This gap occurs at the point of care where electronic capture and documentation of UDI for implantable devices in patient electronic health records is not routinely being done throughout the U.S. health care system. Information presented in this report is based on interviews of UDI leaders from hospital systems that have implemented a UDI system for implantable devices at the point of care; a survey of these participating hospital systems; evaluation and discussion of project findings by the Building UDI into Longitudinal Data for Medical Device Evaluation (BUILD) Consortium leadership group; and input by the BUILD research team.

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Implementation Roadmap for Point of Care Capture of UDI for Implantable Devices

The Implementation Roadmap is designed to serve as a stand-alone section and was pulled out of the full BUILD report. The Roadmap, which was informed by the leadership interviews, delineates four key areas in UDI implementation for implantable devices at the point of care: Foundational Themes, Key Components, Key Steps and UDI Use. It is designed to serve as a guidance for hospital systems to develop their own organization-specific roadmaps.

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Gaps, Challenges & Strategies

The Gaps, Challenges & Strategies is designed to serve as a stand-alone section and was pulled out of the full BUILD report. The document presents six reported gap and challenge areas: Clinical, Information Technology, the Global Unique Device Identification Database (GUDID), Manufacturers, Support and the Overall UDI System. Included is a table of Challenge Areas & Strategies Utilized by Hospital Systems (Table 6).

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