When we talk about UDI in our industry, we always refer to the classes, Class 3, Class 2 and Class 1 UDI and we always reference the due dates. What gets lost in this discussion is the actual benefits that accompany UDI.
When UDI is fully implemented there are benefits to multiple organizations: the organization implementing UDI now has a more comprehensive and accurate labeling process for their products, the FDA benefits by insuring the public trust, healthcare providers can stand behind their products and tools with assurance and the consumer has a renewed confidence in the products and services that are a part of their healthcare treatment.
UDI Benefits include:
- Accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reduction of medical errors due to improper packaging
- Standard and clear document device identification
- Standards for identification that provide a more efficient method to manage recalls
- Address counterfeit product distribution
Adoption in Health Care Systems
The UDI ruling and implementation guidelines provide the ruling, fully realized benefits will only come with the complete adoption and use of these compliance standards by all members in the supply chain. Manufacturers, distributors and providers ultimately having a significant role to play in the successful adoption and deployment of UDI with continued focus on delivering the highest standards of products and services to the healthcare patient.