When the U.S. Food and Drug Administration (FDA) was promoting the importance of the still unpublished UDI rule, the underlying value proposition was visibility. The rule requires manufacturers to assign unique device identifiers (UDIs) to the label of their products and to mark those products at each packaging level with the UDIs in both human and machine-readable formats. The FDA cautioned that the UDI on labels alone would not do the trick. It is a building block necessary to unambiguously identify products across organizations – both public and private sector – and in technology systems from electronic health records to claims databases. The FDA was also clear that the UDI rule was not a track and trace requirement; rather the UDIs would be a necessary element to make such a system possible for medical devices. While the FDA was focused on its regulatory responsibilities, supply chain professionals were quick to see additional benefits, including improved transactional efficiency, order fulfillment and inventory management.
When the UDI rule was published in 2013, it noted the potential to more effectively 1) identify adverse events and 2) target and manage medical device recalls. That same year, the FDA published an updated version of “Strengthening Our National System for Medical Device Postmarket Surveillance,”1 which clearly depicted the vision for UDI in electronic health records, claims data, registries and medical device reports, among others. Nearly eight years later, achieving the vision of UDI has been stifled in part due to regulatory delays and the reluctance of both providers and suppliers to do more with UDI than required by regulators. Even more disconcerting, some of those roadblocks exist within the FDA and other government agencies, as outlined in a recent perspective piece2 in the Journal of the American Medical Association Internal Medicine.
UDI in adverse event reporting and recalls
Perhaps most surprising is the lack of consistent use of UDIs for adverse events and recall management, given that both were noted in the Regulatory Impact Analysis published with the final rule. Less than 2 percent of the more than one million adverse event reports made in 2019 contained UDIs, while only one-tenth of medical device recalls include UDIs. The problem, in part, is that the UDI is just one of many identifiers the FDA will accept for recalls. With adverse events, the story is even stranger. The JAMA viewpoint piece says the Freedom of Information Act office at the FDA often redacts the UDI if it believes it could jeopardize protected patient information. Unfortunately, that risk could be addressed by redacting only the production identifier portion of the UDI, e.g., when it contains a serial number, as opposed to the full UDI, which includes the more generic device identifier.
UDI in claims
For years, the FDA has relied on national drug codes (NDC) in claims forms to identify and conduct post market surveillance on specific drugs used in patient care. The FDA had envisioned the UDI would serve that purpose for medical devices; without it, claims data only says a patient received a type of device, e.g., a coronary stent, but not the specific brand, model or serial number of the device. In 2017, after considerable debate, the standards organization that administers claims forms agreed to add a field for UDIs for implantable devices; three years later, the field is not yet in place, and the Centers for Medicare and Medicaid Services (CMS) would still have to mandate its consistent use.
UDI in electronic health records
Both CMS and the Office of the National Coordinator for Health IT require that EHRs be able to capture and store UDIs for devices implanted in patients in electronic patient records and be able to share that data. Many health systems still struggle with data management, point of use capture, and interoperability that would provide for greater visibility into device performance.
As mentioned earlier, UDI is a building block, but it takes a village (including hospitals, suppliers, payers, technology companies, and regulators, among others) to adopt and use the UDIs to achieve the value intended by the regulation.
UDI in COVID-19 response
The supply shortages experienced during COVID-19 may be the impetus to get UDI back on track. While UDIs could not have prevented the shortages resulting from the simultaneous unprecedented and extended global increase in demand and the constraint on global supply production and movement, the identifiers could have made it easier to optimize availability of supplies where they are needed most.
• UDI could be used by hospitals for better visibility into current inventory levels, utilization (burn) rates and anticipated needs based on patient volumes.
• Hospitals could use UDIs to share demand data with suppliers to help with more need driven allocation.
• The Strategic National Stockpile and other organizations managing safety stock could use UDIs, which include expiry dates, to rotate stock before it becomes unusable.
• Suppliers could let hospitals know about backorders or partial or delayed shipments using UDIs in electronic purchase order acknowledgements and advanced ship notices, allowing hospitals more time to take alternative action.
• Use of UDIs in conjunction with classification schemas and/or clinically relevant attributes for products can help hospitals identify alternative vendors or supplies.
• Global adoption of UDI could help manage products being used under emergency use authorizations to help minimize counterfeiting and to track potential adverse events or recalls.
For those of us who have been on the UDI journey, the road can seem impassable. On the other hand, if we think about why we headed in this direction in the first place, the investments we have made to date, and the benefits for a wide range of stakeholders, this is not the time to stop in our tracks or turn back now.
Refrences
2. Kinard M, McGiffert L. Medical Device Tracking—How It Is and How It Should Be. JAMA Intern Med. Published online December 16, 2020. doi:10.1001/jamainternmed.2020.7797
