UDI gets real

Sept. 23, 2019

Advances in medical technology are credited with delivering lifesaving and life enhancing therapies to patients, but more sophisticated devices are also cited as a contributor to higher healthcare expenditures. With more than 8,000 new medical devices entering the market each year, the question for healthcare providers, practitioners, payors and patients is: Does a new medical device deliver value, i.e., outcomes that matter to patients relative to the costs to achieve those outcomes? Given that many new medical devices are approved for sale with little or no testing on humans, the answer requires understanding how those devices perform in routine clinical practice once on the market.

Healthcare has a new tool to help answer that question, thanks to the work of Mercy Technology Services (MTS), which recently launched a real-world evidence (RWE) network to provide insights into how different products perform on specific patient populations and the corresponding impact on the cost of care. MTS serves as the information backbone for the St. Louis-based Mercy health system, which has led much of the early research on the value of unique device identifiers (UDI) and the technological and process changes necessary to achieve that value.

Mercy has used UDIs to unambiguously determine medical devices in its research to identify which products work best and offer the best price point. By using real-world evidence, Mercy says it has already saved $33 million on implants and surgical supplies without sacrificing quality. Now Mercy wants to make its outcomes research and that of other providers more widely available. Through the RWE Network, participating providers can use the data to guide their own sourcing decisions, while providing subscribing manufacturers and regulatory bodies with insights at the clinical practice level on product performance. The RWE Network will focus first on products used in orthopedics, cardiology and oncology.

Delving into data

Mercy generates RWE by extracting unstructured data — using natural language processing — from clinical notes in electronic health records. The insights contained in that data are organized in an SAP Hana database by Mercy’s data scientists, who, along with clinicians, are available to answer questions from RWE subscribers. Johnson & Johnson, Medtronic and BD are among the early subscribers to the system. They were also among the first to provide data on their respective products to Mercy, with help from Mercy’s GDSN-certified data pool, Health ConneXion.

In creating the RWE Network, Mercy is continuing to demonstrate the value of UDIs to multiple stakeholders across the healthcare ecosystem. The Food and Drug Administration (FDA) has long touted how incorporation of UDIs into health IT, including EHRs and registries, would improve post market surveillance. But getting to value has required significant investment, first by manufacturers that must comply with UDI regulations and by providers who must invest in technology and process change to effectively capture UDIs for products used in patient care. Now, we have the opportunity to see UDIs in action and how they help advance our collective ability to provide the best patient care at the most affordable cost.

In this respect, it will be informative to monitor the adoption and success of the RWE Network. UDIs alone do not provide value; value only comes when UDIs are put to use, e.g., in supply chain processes, in clinical supply documentation, and in post market surveillance. UDIs provide the foundation to ensure that researchers are studying the same products, but it is incumbent upon the data scientists to ensure we are effectively accounting for the variables that can impact outcomes. It’s not an easy task, but after more than 10 years on the UDI journey, Mercy is well positioned to show us how to make it real.

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.