The UDI rule published in 2013 was intended in part to both accelerate and provide a more efficient means of resolution to device recalls. In the final rule, the economic analysis specifically identified as one of the benefits the potential to “more effectively target and manage medical device recalls”. Yet now, even with a rise in medical device recalls, and the fact that many healthcare providers and manufacturers have incorporated UDIs into internal systems, the use of identifiers for the purpose of recall management remains low.
In a recent contribution to HPN, Karen Conway explores limitations on the provider side and the lack of UDIs in recall management as obstacles to generating value from UDIs. As an advocate of data standards, Karen has published extensively on the benefits, challenges, progress, and achievements in the industry to implement standards.
There are many opportunities for providers to use UDI device identifiers for recall management—proactively to prevent the use of a recalled device, and in the event of a recall, for patient identification where an existing device is in use. This can be enabled by incorporating UDIs into existing systems and expanding the use of technology for scanning at the point of use to capture products in the electronic health records (EHRs). In order to achieve this, providers will need the ability to store UDIs in their enterprise resource management (ERP) or materials management systems, concurrently track product recalls, and likely expand scanning technology. All of which require a meaningful investment of resources from providers.
For the industry to experience the broad array of potential benefits from UDI adoption, stakeholders must collectively engage and contribute on the path to value. In spite of the investments that manufacturers have made so far to comply with regulations, there are still apparent gaps challenging the use of UDIs for recall management. A recent review of the 19 Class l medical device recalls for 2019 revealed only one company had included the UDIs along with catalog numbers and descriptions. The rest of the companies only included product codes or model numbers. The lack of that data, however, could be attributed to the fact that the FDA hasn’t provided a specified field for UDIs, but rather only a field to list a product code and that could be misleading.
The FDA acknowledged from the start that adoption and use of UDIs by all healthcare stakeholders was the way to realize the broad potential benefits. There is a shared responsibility to derive the many advantages available from UDIs, but it would seem appropriate for the FDA and manufacturers that have invested the most to comply with regulations, to take the lead to enable expanded adoption.