Last month, AIM North America held a masterclass on the evolution of UDI. Despite having worked on UDI for nearly 15 years, I learned even more about not only the challenges, but also how and why we must continue to work together for its adoption.
I would like to recap some of the key messages from the two-hour program and offer some commentary on where we go from here. For those not yet familiar with UDI, regulators around the world, beginning with the U.S. FDA, are issuing regulations requiring manufacturers to assign and label their devices with unique device identifiers (UDIs) and to publish data about those products in designated databases. The UDI itself contains two parts: the UDI-DI that identifies a product, e.g., a manufacturer labelled suture or implant, at a particular packaging level, while the second part, the UDI-PI includes the production data, such as lot or serial number, expiration date, for specific products.
A primary regulatory driver has been to “identify devices through distribution and use,” which the first speaker, Steven Luxenberg, MD, with the U.S. FDA said includes documenting UDIs in “electronic health records, clinical information systems, claims data sources and registries.” The International Medical Device Regulators Forum, which provides guidelines on UDI regulation to support more global harmonization, recently added materials management systems as another key place where UDI should be documented to maximize its value.
Progress and problems on the regulatory front
In his comments, Dr. Luxenberg noted that more than 3.1 million UDI records have now been published by more than 6300 companies in the U.S. FDA’s Global UDI Database (GUDID). That data has broad interest, with an average of 4600 daily log ins to AccessGUDID (https://accessgudid.nlm.nih.gov/), where most of the GUDID data is publicly available for search and download.
Dr. Luxenberg said that new forms used for X12 administrative (claims) transactions enables the inclusion of the UDI-PI, although it is not yet required. X12 plans to recommend these new forms supporting UDI information exchange be federally mandated, which would then initiate a multi-year federal process to make the recommendation a requirement. Even without a mandate, many have argued for voluntary use, noting that the inability to specifically identify in claims data the brand of a device used in patient care increases healthcare costs while jeopardizing patient care in the event of recalls.
Other speakers spoke to some of the regulatory challenges to both compliance and use of UDI. Jay Crowley, who wrote much of the U.S. UDI regulation and now serves as vice president, medical device solutions and services for USDM Life Sciences, says despite the IMDRF’s call for harmonization, there is increasing variation in the requirements published or proposed in different countries. BD UDI program lead Dennis Black added that such variation increases the compliance cost and complexity for medical device manufacturers. This, in turn, can create challenges for providers. For example, manufacturers may publish different “clinically relevant” information about the same products given the variation in requirements across countries. Different regulatory triggers as to when a product’s UDI needs to change could also lead to a proliferation of multiple UDI-DIs for the same product globally. The IMDRF notes how this proliferation of different device identifiers and the lack of harmonization makes it difficult to ensure access to products during emergencies such as the recent pandemic.
UDI and the clinically integrated supply chain
James Tcheng, MD, a practicing interventional cardiologist at Duke Health, shared both the challenges and benefits of UDI adoption in the healthcare delivery environment. Dr. Tcheng noted the importance of integration of UDI into clinical and supply chain processes to enable the “clinically integrated supply chain,” in which clinicians, supply chain and other healthcare leaders collaborate on decisions to improve both the cost and quality of patient care. As he put it simply: “it’s about getting everyone working in concert vs. doing their own thing independently.”
Data, like UDI, according to Dr. Tcheng is key to collaborative decision-making. Dr. Tcheng outlined the steps that Duke Health has taken to incorporate UDI in the Cardiac Cath and electrophysiology labs, including use of the standard identifiers for procurement and inventory, clinical supply documentation at the point of use, and charge capture and billing. The results have been impressive, reducing manual documentation and associated errors, shortening procedural time, and improving both inventory and recall management, all of which he says have contributed more than half a million dollars in financial benefits.
Such improvements and savings did not come easy, says Dr. Tcheng, noting that it took more than 300 hours just to enable the various technology systems to be able to share UDIs. But he added the ongoing benefits are worth it. Just because it is hard, doesn’t mean it won’t work, said Dr. Tcheng, citing a similar journey taken by the aviation industry. In the late 1990s, following a series of mass casualty plane crashes, representatives from regulatory authorities, pilot unions, air carriers, and eventually air traffic controllers began a quest to create a unified, data-driven approach to aviation safety. It wasn’t easy, with many initially fearing that sharing information on safety incidents, even near misses, would result in retaliation. Advocates of the new, and notably voluntary, approach did not give up, ultimately leading to a new era of data capture, sharing and analysis, and resulting in zero fatal crashes among U.S. commercial airlines since 2009. It gives cause to question those who insist that UDIs will only be fully adopted across healthcare if they are mandated. My question is: If we can collectively improve the cost and quality of care, while reducing the clerical burden for clinicians and healthcare workers, why aren’t we rallying together to make it happen?
