UDI: Turning the promise into the reality of quality data

Unique Device Identification (UDI) regulation is being increasingly leveraged by hospitals with the aim of maintaining quality data throughout their processes.

With the availability of supplier-provided product data, hospitals are now working to ensure that the promise of quality data becomes a reality for the benefit of their operations, caregivers and patients.

The U.S. Food and Drug Administration continues to focus on UDI data quality, working closely with manufacturers to identify issues and make corrections to UDI data in AccessGUDID (US FDA UDI Database). The agency is taking a patient-centred approach, considering the real-world evidence of UDI’s impact on patient care and safety.

At B. Braun U.S., data quality requires consistent effort and management. This leading manufacturer has put in place a centralised master data team and best practices focused on roles and responsibilities, data governance, enterprise-wide data management, and data quality. Tools include use of GS1’s Global Data Synchronisation Network® (GDSN), auditing, verification, and a validated process flow.

As users of product data, Geisinger and Franciscan Missionaries of Our Lady Health System (FMOLHS) in the U.S. are experiencing the benefits of quality data in automating processes, collaborating with regulators, suppliers and other providers. They are calling for the use of the Global Data Synchronisation Network® as the single source of complete and accurate product data for all stakeholders.
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