BUILDing the UDI Roadmap

Jan. 23, 2020

The road to adoption of unique device identifiers (UDIs) remains a bumpy one for many hospitals and healthcare systems, even those who have been among the most ardent supporters of the U.S. Food and Drug Administration (FDA) regulation. Some of the biggest obstacles include internal resistance to change, limited resources, and lack of engagement and collaboration with manufacturers who are now inundated with additional UDI regulations from Europe to China and beyond. But bumps in the road are not necessarily bad, if the lessons learned by those willing to lead the way can clear the path for those who follow. That’s why it’s important to take notice of the work of the Building UDI into Longitudinal Data for Medical Device Evaluation (BUILD) Initiative, which just published a roadmap for point of care capture of UDIs for implantable devices.

The BUILD journey began in 2015, at the Medical Device Epidemiological Network (MDEpiNet) SMART Informatics Think Tank. I had the pleasure of co-facilitating the think tank with Mitch Krucoff, MD and former FDA Senior Advisor for UDI Adoption Terrie Reed, both of whom were at the Duke Clinical Research Institute at the time. The goal of the Think Tank was to gather a diverse group of stakeholders who were actively engaged in work around structured product and patient data, in hopes that they would identify opportunities to collaboratively advance the capture and sharing of such data to improve medical device safety and effectiveness. To be honest, as we were planning the Think Tank, we were unsure if we would meet our objective. The formation of the BUILD Initiative, along with several other FDA-funded initiatives, allayed those fears.

The roadmap is publicly available on the BUILD section of the MDEpiNet website (http://mdepinet.org/build/) and is worth a visit by anyone interested in the history, value and implementation of UDI. The roadmap itself, and the associated research, has generated a wealth of knowledge about how and why providers can and should implement UDIs for both clinical and operational purposes. In compiling the report, the BUILD research team studied provider organizations ranging in size from less than five hospitals to more than 100, and with revenue from less than $5 billion to more than $50 billion. Twenty-four clinical, supply chain and IT leaders were interviewed about their experience capturing UDIs for implantable devices in Cath labs and/or operating suites. The focus on implantables is important given regulations from the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid Services (CMS), respectively, requiring certified electronic health records (EHRs) to be able to parse and store UDIs and associated data from the FDA Global UDI Database (GUDID) and for providers to be able to share that data as part of the U.S. Core Data Set (the proposed new name for the Common Clinical Data Set). Both requirements have reimbursement implications for providers.

Beyond protecting compliance-dependent reimbursement, the roadmap outlines multiple uses for UDIs to improve clinical practice, analytics and research, and operational performance. Lead researcher Natalia Wilson, MD noted that UDI adoption and use is far more robust at the operational level compared to clinical applications. That may be because supply chain professionals, especially those involved in the Healthcare Transformation Group, were among the first to recognize the value of GS1 Global Trade Item Numbers (GTINs), one of the UDI-compliant codes, for contracting, procurement, inventory and recall management, and clinical supply documentation at the point of care.

While supply chain may be the first to move, Dr. Wilson stresses that supply chain cannot do this alone. Clinicians are critical to UDI adoption. Capturing UDIs at the point of care often falls to nurses, while physicians are key to utilizing UDI-related data when making decisions about how best to treat specific patients. Garnering clinician support takes a concerted effort, which the report says must be led by other clinicians, not supply chain management, although supply chain can help provide data to support the business and clinical case for UDI.

For busy physicians, Dr. Wilson says, it’s often just a matter of getting their attention. “Once they understand how UDIs can enhance clinical practice, they become supportive and want to share their perspective with their peers.”

For nurses, it’s another story. Dr. Wilson was the lead author for another paper studying nursing acceptance of a new implant barcode scanning system. The study found that nurses are often not told why such systems are being implemented, the anticipated impacts on workflow and patient care and the importance of data quality. One nurse was quoted as saying the system “just showed up one day,” while another “didn’t really know what it was all about or what it was for.” On the other hand, nurses had positive perceptions of how scanning vs. manually capturing implant data improves accuracy and their ability to focus on the patient. The roadmap emphasizes meeting with stakeholders to “discuss the ‘why,’ the benefit add and how it will be done.”

At nearly 70 pages, the final report and roadmap contains far more information than can be covered in just one column. In subsequent issues of Standard Practices we will delve deeper into the work of the BUILD Initiative, including recommended next steps to address challenges faced by early adopters.

As we explore the path to realizing the full array of benefits of UDI for multiple stakeholders (patients, clinicians, hospital administrators, regulators and manufacturers, among others), it’s important to remember that a transformation of this magnitude does not happen overnight. I applaud the BUILD Initiative for focusing on where the greatest value can be achieved, at the point of care and around implantable devices that have the greatest potential to enhance, if not save, lives, but also by their very nature pose the greatest risk.

Let’s take the journey together. Let me know if you have started down the UDI path, and if so, how’s the trip going? If not, let me know why not. Your input can help inform ongoing research, while making a difference for your peers and your patients. 

About the Author

Karen Conway | CEO, Value Works

Karen Conway applies her knowledge of supply chain operations and systems thinking to align data and processes to improve health outcomes and the performance of organizations upon which an effective healthcare system depends.  After retiring in 2024 from GHX, where she served as Vice President of Healthcare Value, Conway established ValueWorks to advance the role of supply chain to achieve a value-based healthcare system that optimizes the cost and quality of care, while improving both equity and sustainability in care delivery. Conway is former national chair of AHRMM, the supply chain association for the American Hospital Association, and an honorary member of the Health Care Supplies Association in the UK.