In the ever increasing interests of patient safety and efficient protection of public health, the FDA has adopted a rule for UDI in support of enhancing safety, with the aim of identifying errors involving medical devices and providing more rapid resolution of device problems.
The standardization of a common UDI mandate is designed to increase visibility and improve the quality of information in medical device adverse event reports, improve traceability and security within the supply chain. It will also reduce the potential for medical errors through consistent, unambiguous, harmonized data. Furthermore, UDI will facilitate the storage, exchange and integration of data and systems between suppliers and providers.
3 key questions for medical device manufacturers are; based on your current system capabilities:
- Are you able to properly control the elements and execution of your print jobs and then capture the data elements of every label printed?
- Will you be positioned to efficiently capture and submit the necessary UDI data to the Global UDI Database?
- Have you factored in the training of your staff and allocated sufficient time to integrate this additional labeling requirement to your current processes?
If you can’t give a definitive yes, then you need to think about how you will manage this in the future. By planning and implementing a label lifecycle management strategy with the right processes and right solution, you will guarantee UDI readiness for your organization without derailing your production.
This recent whitepaper from PRISYM ID and GS1 “UDI: Getting Ahead of the Game” walks you through the necessary steps and processes to keep you on track when implementing UDI.