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Area of Science:

  • Health Informatics
  • Medical Device Regulation
  • Real-World Evidence (RWE) Generation

Background:

  • The Unique Device Identifier (UDI) system aims to improve medical device safety and regulatory oversight.
  • Health systems are key stakeholders in the implementation and utilization of UDI data.
  • Real-world evidence (RWE) generation for medical devices relies on accurate and accessible device identification.

Purpose of the Study:

  • To assess the current status of UDI implementation in US health systems.
  • To identify barriers and facilitators impacting UDI adoption and utilization.
  • To understand the role of UDI in enabling RWE studies for medical devices.

Main Methods:

  • A mixed-methods approach was employed, combining structured surveys and semistructured interviews.
  • Eight health systems within the National Evaluation System for health Technology (NEST) research network participated.
  • Participants included individuals knowledgeable about UDI implementation from supply chain, IT, and procedural areas.

Main Results:

  • Only three of the eight participating health systems reported full UDI implementation.
  • Key barriers included lack of decision-maker awareness, insufficient organizational support, and external policy factors.
  • Limited UDI availability significantly hindered the generation of RWE for medical devices.

Conclusions:

  • Successful UDI adoption necessitates clear understanding of operational and clinical benefits among stakeholders.
  • Health systems need robust organizational systems and supportive culture for effective UDI implementation.
  • Enhanced UDI availability is critical for advancing medical device safety, effectiveness evaluation, and RWE studies.