Implementing unique device identification in electronic health record systems: organizational, workflow, and...

Area of Science:

• Medical device regulation and health informatics.
• Health information technology implementation.
• Postmarket surveillance strategies.

Background:

• The U.S. Food and Drug Administration (FDA) proposed a unique device identification (UDI) system to enhance medical device postmarket surveillance and quality.
• While some institutions use electronic health records (EHRs) for similar data capture, resource-limited settings may face challenges implementing UDI.
• Existing literature on EHR and clinical research systems implementation informs the understanding of UDI system challenges.

Purpose of the Study:

• To identify and analyze the organizational, workflow, and technological challenges associated with implementing a UDI system.
• To draw parallels from the implementation of EHR and clinical research systems to inform UDI system integration.
• To provide recommendations for successful UDI system adoption.

Main Methods:

• Literature review on EHR and clinical research systems implementation.
• Analysis of organizational, workflow, and technological factors impacting UDI integration.
• Identification of stakeholder coordination, change management, and data reuse issues.

Main Results:

• Organizational challenges include stakeholder coordination, change management for UDI integration into EHRs, and data reuse.
• Workflow challenges involve data capture methods like keyboard entry and barcode scanning within EHRs.
• Technological challenges encompass system interfacing, data transformation for research, and application of data standards.

Conclusions:

• Recommendations focus on regulatory frameworks, organizational collaboration, and professional society engagement to address UDI implementation barriers.
• Successful UDI system implementation necessitates a holistic approach integrating people, processes, and technology.
• Achieving the FDA's envisioned benefits, such as improved postmarket surveillance and quality of care, depends on overcoming these multifaceted challenges.