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<p>The implementation of Unique Device Identifiers (UDI) has reshaped medical device traceability by enhancing patient safety, regulatory oversight, and supply-chain transparency. This review synthesizes the evolution of smart and digitally enabled UDI models, examining how emerging technologies—including blockchain, artificial intelligence (AI), cloud infrastructures, and the Internet of Things (IoT)—are reconfiguring UDI lifecycle functions. Publications from 2010 to 2024 were identified through structured searches in PubMed, IEEE Xplore, Scopus, Web of Science, and Embase, supplemented by regulatory documents and pilot reports. Two reviewers independently screened all records, with consensus adjudication, and methodological quality was appraised using the Mixed Methods Appraisal Tool (MMAT) (κ = 0.81). A hybrid inductive–deductive thematic analysis in NVivo supported the derivation of key capability domains, risks, and research gaps. The review proposes a Smart-UDI Capability Framework, developed directly from thematic evidence across 67 included studies. The framework links stakeholder digital maturity to traceability objectives and is supported by thematic maps, coding structures, and illustrative excerpts. The analysis also identifies critical risks—including cybersecurity vulnerabilities, algorithmic bias, and data governance challenges—and expands on patient-centred considerations such as authenticity verification, transparency, and usability across care pathways. This framework is conceptual and requires independent empirical validation. The review outlines practical recommendations for regulators, manufacturers, and health systems to advance equitable and trustworthy digital UDI ecosystems. Overall, the findings provide a strategic foundation for ethically integrating emerging technologies into global device identification systems.</p>

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Smart UDI for Medical Devices: Global Harmonization, Cybersecurity, and Digital Convergence

  • 期刊论文

  • 发表日期：

    2026年1月13日

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  • Smita Kumbhar,
  • Alfej Tamboli

摘要

The implementation of Unique Device Identifiers (UDI) has reshaped medical device traceability by enhancing patient safety, regulatory oversight, and supply-chain transparency. This review synthesizes the evolution of smart and digitally enabled UDI models, examining how emerging technologies—including blockchain, artificial intelligence (AI), cloud infrastructures, and the Internet of Things (IoT)—are reconfiguring UDI lifecycle functions. Publications from 2010 to 2024 were identified through structured searches in PubMed, IEEE Xplore, Scopus, Web of Science, and Embase, supplemented by regulatory documents and pilot reports. Two reviewers independently screened all records, with consensus adjudication, and methodological quality was appraised using the Mixed Methods Appraisal Tool (MMAT) (κ = 0.81). A hybrid inductive–deductive thematic analysis in NVivo supported the derivation of key capability domains, risks, and research gaps. The review proposes a Smart-UDI Capability Framework, developed directly from thematic evidence across 67 included studies. The framework links stakeholder digital maturity to traceability objectives and is supported by thematic maps, coding structures, and illustrative excerpts. The analysis also identifies critical risks—including cybersecurity vulnerabilities, algorithmic bias, and data governance challenges—and expands on patient-centred considerations such as authenticity verification, transparency, and usability across care pathways. This framework is conceptual and requires independent empirical validation. The review outlines practical recommendations for regulators, manufacturers, and health systems to advance equitable and trustworthy digital UDI ecosystems. Overall, the findings provide a strategic foundation for ethically integrating emerging technologies into global device identification systems.