Table 3.

Needed Next Steps to Address Barriers in Implementation of Unique Device Identifiers

Barrier	Next Steps
Internal Barrier
Lack of organizational support	● Create durable easily accessible UDI adoption presentation and education materials for organizational leaders, staff and clinicians. ● Perform comprehensive workflow analysis of UDI implementation. ● Create a job description for the UDI initiative leader. ● Include barcode training as a requirement for new staff on-boarding.
Information technology gaps	● Assess & map the optimal IT infrastructure for UDI implementation. ● Create a catalog of IT systems by vendor indicating functionality for UDI implementation including gaps.
Clinical resistance	● Create standard education materials on UDI adoption for clinicians and clinical staff. ● Map best practices for UDI integration into clinical workflows. ● Include barcode training as a requirement for new staff on-boarding.
External Barrier
Information technology vendor resistance	● Study health system-IT vendor relationships. ● Engage IT vendors in multi-stakeholder workgroups.
FDA GUDID gaps	● Study health system use, barriers, limitations ● Collaboratively work with manufacturers.
Manufacturer support	● Include UDI-focused requirements in contracting. ● Collaboratively work on requirement of “UDI” on the device label next to the barcode.
Lack of an overall UDI system	● Collaboratively work on policy drivers. ● Create durable easily accessible education materials for stakeholders. ● Broaden dissemination avenues. ● Study impact of UDI use on outcomes. ● Develop metrics. ● Delineate funding sources for UDI research and advancement.

Abbreviations: UDI, unique device identifier; IT, information technology; FDA, US Food and Drug Administration; GUDID, Global Unique Device Identification Database.