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Improving Patient Safety with Unique Device Identification

The proposed ruling for Unique Device Identification (UDI) should be welcomed by medical device manufacturers but being compliant by the effective date (based on classification) may be a worry for some organizations.

 

UDI aims to identify errors involving medical devices and provide more rapid resolution of device problems. The standardization of a common UDI mandate will increase visibility and improve the quality of information in medical device adverse event reports, improve traceability and security within the supply chain and reduce potential medical errors through consistent, unambiguous, harmonized data. Furthermore, UDI will facilitate the storage, exchange and integration of data and systems between suppliers and providers.


While all of this is good for anyone who may need to use a medical device to improve health outcomes; on the other hand, on the “manufacturing and labeling side”, this can be a daunting task. 


Organizations should already be seeking best practices in managing labeling lifecycle processes. Where paper-based methods and outdated labeling systems are being used it will be a struggle to manage the increased amount of data and information that will be generated. Organizations should be carefully planning their future labeling operations strategy now and consider implementing a validated, secure label lifecycle management solution. These systems will manage the design, approval, print, inspection, re-print, reconciliation and audit log of these labels making it much simpler to become UDI compliant.


In the industry it is common knowledge that labels and label data live in a state of change for multiple reasons, and it’s how we manage these changes which impacts our ability to achieve success, and further, it is also how we manage these changes which will impact the ability to ensure UDI compliance.
So the real questions for medical device manufacturers are; based on your current system capabilities a) are you able to properly control the elements and execution of your print jobs and then capture the data elements of every label printed? And b), will you be positioned to efficiently capture and submit the necessary UDI data to the Global UDI Database?


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.