3 things you probably aren’t accounting for with your Unique Device Identifiers

Unique Device Identifiers were the boogeyman a few years ago; a major mandate from the FDA to update all medical devices with a new, quite long and cumbersome, identification number. This regulatory mandate represented a major cost to the industry as it worked to create the data, modify and revalidate manufacturing processes, adjust labeling requirements, and create new systems to store and track this data – essentially forcing the industry to evolve. 

Now, years later, most companies have become compliant in one way or another, but has UDI become back-of-mind, something we set and forget and hope not to have issues with? While the UDI may seem static and unchanging, that does not mean it does not require attention. 

So what should you be thinking about? 

1. Product Changes: The UDI is built from the catalog number, lot number, expiration date, and other device information that were true at the time the product was built. If you decide to make changes to the product, like rework, those lot numbers must be updated and, as a result, the UDI must be updated as well. Are you changing the design of the product? You might need to change the catalog number of your device too to reflect this design change, which would not just require a new UDI, but entirely new Device IDs and GUDID entries. Did devices have to get resterilized? Hopefully you’re updating those UDIs and relabelling. 
2. GUDID Entries: If you work with UDIs,  then you might also be familiar with the FDA GUDID Database where your Device IDs are federally registered, along with additional identifying information about the device. However, GUDID records are not set-it-and-forget-it either. Since GUDID has been launched additional data has been added to GUDID records. Additionally, GMDN codes (Required information for GUDID entries) are periodically retired with new codes being released, and these may need to be updated for records to be considered current. Fundamentally it is a good idea to periodically audit GUDID information to ensure your registered DIs with the FDA are correct and current. With all things GUDID, make sure your regulatory team is staying up to date with the current requirements. 
3. Field Management: The last consideration is final mile management of the UDI. After all, the UDI doesn’t just need to be created for each device, it needs to be tracked and followed with the device throughout its lifecycle. Ideally the UDI is able to be found and scanned at any time during the device’s existence, no matter where the device is, all the way to the point of use. And after the device is used, it must be stored and tied to supply chain and medical records so it may be identified in the event of a recall. This is one of the biggest challenges for the industry due to the reliance on “trunk stock” sales modalities, difficult to track devices (non-sterile surgical trays, tiny un-markable devices, etc.), and the lack of end-to-end interoperable software throughout the value chain. It is imperative that manufacturers consider the tools and processes they have built to store and track the UDI through to the patient record, and access the data even years after the surgery was done. 

While UDI may no longer be your burden to unravel, even existing UDIs require attention and maintenance to remain in good standing. It’s also worth noting that as a result of implementing UDI, compliant companies now have a feasible tracking identifier throughout their value chain, which is a powerful data point to be leveraged with other data to drive business intelligence reporting. After all of that time and investment in UDI, how are you leveraging UDI to drive value for your business?