Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System...

Area of Science:

• Healthcare Informatics
• Medical Device Regulation
• Health System Management

Background:

• The US FDA mandated Unique Device Identifiers (UDIs) for medical devices in 2013.
• Regulatory requirements for health systems to electronically document UDIs during patient care are currently lacking.
• Despite no mandate, some health systems have proactively implemented UDI systems.

Purpose of the Study:

• To assess the current state of UDI implementation in US health systems.
• To identify barriers encountered during UDI adoption.
• To explore strategies used to overcome these barriers and inform future steps.

Main Methods:

• Conducted semi-structured interviews with health system personnel in cardiac catheterization labs and operating rooms.
• Utilized framework methodology for interview transcription and analysis.
• Engaged an expert panel to evaluate findings and define barriers, strategies, and next steps.

Main Results:

• Twenty-four interviews across ten health systems revealed internal barriers (e.g., lack of support, IT gaps, clinical resistance) and external barriers (e.g., vendor resistance, limited manufacturer support, data gaps).
• Successful strategies included relationship building, education, engagement, and communication.
• Next steps for advancing UDI adoption emphasize education, research, support, and policy.

Conclusions:

• Understanding UDI implementation barriers and strategies can guide health systems in adopting UDI standards for electronic documentation.
• Focusing on education, research, support, and policy is crucial for advancing UDI adoption.
• A comprehensive UDI system in healthcare is essential for enhancing patient care and safety.