Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device...

Area of Science:

• Health Informatics
• Medical Device Regulation
• Patient Safety

Background:

• The US FDA's Unique Device Identification (UDI) System Rule mandates UDIs for medical devices.
• Electronic documentation of UDIs during patient care is crucial for patient safety but not routinely performed.
• High-risk, moderate-risk, and implantable devices are increasingly equipped with UDIs.

Purpose of the Study:

• To investigate the implementation experiences of diverse health systems regarding UDI.
• To develop a practical roadmap for UDI implementation at the point of care.
• To facilitate the electronic documentation of UDIs in clinical settings.

Main Methods:

• Conducted semi-structured interviews with personnel at ten health systems.
• Analyzed interview data using framework methodology.
• Developed a UDI implementation roadmap based on findings, refined by an expert panel.

Main Results:

• Twenty-four interviews revealed implementation steps, influencing factors, and barriers.
• A comprehensive UDI implementation roadmap was developed.
• The roadmap includes foundational themes, key components, steps, usage, and outcomes.

Conclusions:

• The UDI implementation roadmap offers a framework for health systems.
• It addresses multilevel factors essential for point-of-care UDI implementation.
• The roadmap aims to advance routine electronic UDI documentation, enhancing medical device safety and patient outcomes.