When the U.S. Food and Drug Administration UDI rule was first published in 2013, the agency listed numerous benefits from the use of unique device identifiers (UDIs) to identify medical devices. As a reminder, the rule requires that UDIs be assigned to medical devices at each packaging level, that the identifiers be displayed in both machine and human readable form on the label (and in some cases the device itself), and that the UDIs and additional data be submitted to the FDA’s Global UDI database (GUDID). The published benefits focused primarily on improving post market surveillance and patient safety through:
- Fewer medical errors
- Improved ability to identify adverse events and respond to recalls
- Data on how products perform in routine clinical practice
The rule also spoke to how standard identifiers support the ability of the multiple IT systems used in healthcare to share and manage device data, which, the agency said, would help improve communications related to device safety with health systems and patients.
More recently, an open access, peer-reviewed paper1 documented additional clinical, financial and operational benefits realized by three hospitals in the Duke University Health System as the result of a “comprehensive implementation of UDI-based device and supply information management” in its cardiac catheterization (Cath) and electrophysiology (EP) laboratories. Specifically, Duke achieved:
- Greater supply chain efficiency
- Reduced clinician burden and documentation errors
- Better recall response
- Fewer rejected charges
- More effective inventory par level management
The paper outlines how other hospitals can follow suit and achieve similar benefits. Although a worthy pursuit and well documented by the authors who were personally involved in the effort at Duke, although in my opinion, the most important message is that achieving value from the UDI rule is highly dependent upon hospitals and healthcare systems incorporating UDIs across multiple clinical, operational and financial IT systems and processes, and that it can and should be done. Unfortunately, the UDI regulation only mandates action by suppliers, with only limited requirements from other government agencies for certified electronic health records (EHR) vendors and hospitals to capture and share UDIs related to devices implanted in patients.
Yet, the question remains: If these benefits can be achieved with a relatively quick return on investment (ROI) as demonstrated by the Duke team, why aren’t more hospitals and healthcare systems taking advantage of the UDIs?
The paper provides some answers to these questions through its successful use of approaches from the domain of implementation science, which studies methods to increase adoption of evidence-based practices in routine clinical care. The Duke team recognized that achieving value for multiple stakeholders, e.g., clinicians, supply chain, and finance, also requires open communication and intense engagement by those stakeholders in the process. Through their involvement, those stakeholders could see the interdependencies related to their respective use of UDIs. For example, by using scanners to capture UDIs at the point of care, Duke was able to record supply usage for multiple purposes, including procedure logs and reports, patient records, charge capture and billing, and inventory management. This not only reduced the documentation burden on clinicians, but it also enabled real time expired inventory alerts and faster response to recalls. More consistent charge capture and better par level management generated $600.000 in annual revenue recognition for the Duke System. Give inflationary pressures and staff shortages, these savings in both time and money can help support the ability of hospitals to allocate finite resources to where they are needed most, the delivery of value to patients. At the same time, value to individual stakeholders is critical to sustained adoption of change. Both clinical and inventory staff noted they would abandon the new workflows if they required more work or were deemed unreliable.
While Duke’s success is notable and exemplary, getting multiple stakeholders, processes, and systems aligned can be highly complex. The paper outlines the process from strategy and planning to technology build and deployment. Admittedly, the Cath and EP labs were chosen in part because the barcode scanning at the point of use is easier than in the operating room, although the steps followed provide a roadmap for successful change elsewhere. After gaining executive approval, Duke studied current work and data flows and identified the process changes and the interfaces required to support the capture and use of UDIs across core IT systems. Stakeholders were given the opportunity to express how they would like to interact with the system. In addition to extensive testing to make sure the system worked as intended and consistently, Duke ensured stakeholders had the training and education to support the transition.
Yes, it was a complex undertaking, but the process and ROI was not long (less than a year for Duke). True, Duke had some of the necessary pieces in place, including a robust enterprise resource planning system with a highly curated item master, both of which most hospitals and health systems recognize as foundational to effective supply chain operations. A single EHR and cardiovascular reporting system across all three hospitals was another important success factor, as well as something many health systems are also pursuing.
The move to a value-based healthcare system requires more integration across clinical, financial and operational domains, which is foundational to effective use of UDI2 and a clinically integrated supply chain.1 With more than $40 billion spent annually by hospitals on medical devices and supplies, understanding how these supplies and associated expenditures impact the quality and efficiency of care delivery and the financial impact on patients, hospitals and the healthcare system as a whole is critical. UDI provides the common language and source of truth to create that more holistic understanding and ability to deliver enhanced value.