Advancing patient safety surrounding medical devices: Barriers, strategies, and next steps in health system implementation of Unique Device Identifiers (1 March 2022)

Summary

This study in the journal Medical Devices: Evidence and Research aimed to assess health system experiences of implementing Unique Device Identifier (UDI) systems for medical devices. Although the US Food and Drug Administration (FDA formalised the Unique Device Identification System Rule in 2013, parallel regulatory requirement for US health systems to use UDIs is lacking. Through semi-structured interviews, the authors identified barriers to implementing UDI systems and strategies to overcome them.

Content

The authors identified a range of internal and external barriers to UDI implementation in health systems, including:

• lack of organizational support
• information technology gaps
• clinical resistance
• information technology vendor resistance
• limitations in manufacturer support
• gaps in reference data
• lack of an overall UDI system).

They also identified strategies for overcoming these barriers, including:

• relationship building
• education
• engagement
• communication.

They concluded that next steps to advance UDI adoption need to focus on education, research, support and policy.