SummaryFDA passed the Final Rule for Unique Device Identification (UDI) on September 24, 2013 with the rollout of Class III devices one year later.
Since its implementation, FDA issued several additional UDI guidance documents; however, one critical component still lacking in FDA’s Global Unique Device Identification Database (GUDID) is the ability to follow a device through a Change of Ownership – tracking the device’s lineage, so to speak.
The current adverse event reporting form (MedWatch) provides a field for the UDI to be reported. Should a number of these reports indicate the same UDI, FDA will likely be signaled to investigate further. The data source most helpful to the post-market analysts who review the MedWatch reports, is the GUDID. With that said, if the device analysts cannot search for a previous device identifier (Previous DI) for the device (as is currently the situation), they may miss the fact that the same device had a previous life with another manufacturer name and brand name. The device could have experienced similar adverse events under its previous ownership, which is not tracked or investigated as part of the current issue. FDA intended UDI to be a powerful tool for post-market surveillance analysts to see the lineage of a device, yet their attempt has fallen short, and this feature is still not available.
So, why is this so important? The UDI contains the manufacturer name and the brand name. This portion of the identifier is called the Device Identifier (DI) and is what FDA stores in the GUDID. Should the device line be sold to another company, a new DI will be created and the device will be marketed under the new label.
Dr. Joseph Drozda of Mercy Health, also the head of the Healthcare Transformation Group’s (HTG) R&D team, states “You are certain to encounter significant bumps in the road when implementing a program as complex as the new unique device identifier system. Not being able to link new device identifiers to the original identifier is one of those bumps; it poses problems for both the patient safety surveillance and device research aims of the system and it needs to be addressed promptly.”
The recent spate of mergers and acquisitions in the medical device space makes fixing this problem much more urgent. If Company A manufactures drug coated balloon catheters and sells this line of devices to Company B, Company B will have to apply for a new DI for the device it now owns, and register the new DI in the GUDID. In the GUDID, there is currently no field where the Previous DI (under Company A) can be recorded, meaning there is no way to show past ownership of the same device. If additional information is needed by the FDA post-market surveillance group or recalls division in order to investigate the number of reported unsafe devices, the GUDID will not provide them with accurate device lineage.
Searches on medical devices need to show both DIs, to:
1. Provide a public view (once GUDID data is transparent and online for the general public) that will allow providers and patients to make informed health decisions;
2. Enable FDA to make better enforcement decisions because it will have a view of the device’s lineage through its entire life cycle;
3. Allow for more streamlined and comprehensive recalls; and
4. Help manufacturers mitigate risk of the new device (to know if adverse events are being reported with the original UDI).
“As with any new regulation, best practices will evolve as we learn from healthcare organizations working to comply with the rule,” said Siobhan O’Bara, Senior Vice President of Industry Engagement, GS1 US. “While the GUDID does not currently specify medical device lineage back to an original owner, it is unknown if the FDA will modify requirements. However, the current structure supports medical device traceability – GS1 Standards provide the foundation for healthcare organizations to have global unique identification and manage medical device lineage through every step of the product life cycle, from manufacture to patient deployment, while also addressing patient demand for information and improving supply chain visibility and patient safety.”
Until FDA provides step-by-step instructions to device companies (presumably via guidance documents), the GUDID will likely remain an insufficient source for providing comprehensive device lineage, for post-market safety, research and surveillance.
For more questions about UDI, reach out to Madris Tomes directly at MTomes@Avalere.com.