Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc...

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.