When the Food and Drug Administration (FDA) published the UDI rule in 2013, it listed the ability to “provide for more rapid, more efficient resolution of device recalls” as a primary driver for the regulation. Meanwhile, the economic analysis published as part of the final rule noted the potential “to more effectively target and manage medical device recalls” as one of two benefits (the other being better adverse event identification and response). Given the rise in the number of medical device recalls, including those posing the greatest threat to public health, you would expect to see more use of UDIs in the recall process. Yet, despite many providers and manufacturers having incorporated unique device identifiers (UDIs) into their internal systems for inventory and recall management and adverse event reporting, the use of the identifiers for those purposes remains surprisingly low. In this month’s column, we will explore the issue in greater detail and consider some possible reasons why UDIs for recall management has not gained more traction.
Recall trends
The number of recalls issued in 2018 was the highest in five years, while the average number of Class I units recalled per quarter increased more than 64 percent from 2016 to 2017. In 2018, Class I units recalled were even higher — by nearly 10 fold — but that was due to an unusually large Class I recall in the first quarter. According to a 2017 McKinsey report, a major recall can have a negative impact on perceived shareholder value, not to mention the significant risk to patient safety if the devices in question are not removed from the market and patients treated with those devices, especially implantables, cannot be identified.
Provider response
In the final UDI rule, the FDA noted that it “anticipates that providers will include UDIs in electronic health records (EHRs)… to identify the specific devices implanted into patients, and will improve…adverse event reporting and recalls.” With nearly two million UDI device identifiers (UDI-DI) for medical devices now available to the public in the FDA’s Global UDI database (GUDID) and additional UDI rules already or soon to be published in Europe, the Middle East and Asia, there is considerably more information available to providers to use them to manage recalls. The Learning UDI Community (LUC), operated by the Association for Healthcare Resource and Materials Management (AHRMM), also identified increased labor savings and improved patient safety by incorporating UDIs into both systems and processes to manage recalls.
For example, if providers store the UDIs for products purchased in their enterprise resource planning (ERP) or materials management information systems and concurrently track product recalls, they can be alerted if they scan a product that has been recalled. If they also record the UDIs for products used in patient care in electronic health records (EHRs), they can more effectively match a recalled product to a specific patient.
Few UDIs in recall management
While there are still limitations in many materials management and EHR systems, there appears to be a bigger problem: the lack of UDI usage in the recall process by both manufacturers and the FDA. When I reviewed the 19 Class I medical device recalls for 2019 featured on an FDA recall page,1 only one company (Integra Life Sciences) included the UDI-DIs, along with the catalog numbers and descriptions. Other companies, including some of the most ardent proponents of GS1 product identifiers (one of the UDI compliant codes), only listed product codes or model numbers.
Another possible challenge to increased use of the UDIs for recall management may be the FDA itself. In its most recent (April 2019) publication on recall procedures, the agency only references UDI once, and as one of many ways to identify products in recall communications. Further, when searching for recalls in the FDA’s medical device recalls database, there is only a place to list a product code, which could be interpreted as many things, including model numbers, catalog numbers, and part numbers. The lack of a specific field for UDI undermines the goal of having all stakeholders across the healthcare ecosystem identify products the same way, using UDIs.
The path to value
From the beginning, the FDA has stated that the benefits of UDI “will only be fully realized with the adoption and use of UDIs by manufacturers, distributors, payers, providers, patients, healthcare systems and other stakeholders.” Even if manufacturers and the FDA only used the UDIs to manage recalls, it is still incumbent on providers to use the identifiers to not only record the UDIs for products used in patient care in EHRs but also to use the UDIs in purchasing and inventory systems. That way they can not only match patients to recalled products, but also determine if they purchased the products in question and if so, where those products are being stored. In this way, they prevent future usage of the products and resulting patient harm.
It’s no surprise, it will take a village to realize the full value of UDI, but it seems to me that the first ones to the starting line should be the FDA and manufacturers. After all, the FDA was the first to recognize the value, and the manufacturers have invested the most to comply with the regulation. Now is the time to take the steps to begin realizing the benefits, while creating the path forward for others to take full advantage of the UDI system.
