VALUE. DELIVERED.
Duke documents the value of UDI
by Karen Conway, Vice President, Healthcare Value, GHX W
hen the U.S. Food and Drug Administration UDI rule was fi rst published in 2013, the agency
listed numerous benefi ts from the use of unique device identifi ers (UDIs) to identify medical devices. As a reminder, the rule requires that UDIs be assigned to medical devices at each packaging level, that the identifi ers 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 benefi ts 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 identifi ers 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, fi nancial and operational benefi ts 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) laborato- ries. Specifi cally, Duke achieved: • Greater supply chain effi ciency • Reduced clinician burden and documen- tation errors
• Better recall response • Fewer rejected charges • More effective inventory par level man- agement The paper outlines how other hospitals
can follow suit and achieve similar benefi ts. Although a worthy pursuit and well docu- mented 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 fi nancial 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 certi- fi ed electronic health records (EHR) vendors and hospitals to capture and share UDIs related to devices implanted in patients. Yet, the question remains: If these benefi ts
can be achieved with a relatively quick return on investment (ROI) as demon- strated 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 imple- mentation 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, sup- ply chain, and fi nance, 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 sup- ply 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 infl ationary pressures and staff shortages, these savings in both time and money can help support the ability of hospitals to allocate fi nite resources to where they are needed most, the delivery of value to patients. At the same time, value to individual stakeholders is critical to sus- tained adoption of change. Both clinical and inventory staff noted they would abandon the new workfl ows if they required more work or were deemed unreliable.
60 June 2022 • HEALTHCARE PURCHASING NEWS •
hpnonline.com 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 tech- nology 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 road- map for successful change elsewhere. After gaining executive approval, Duke studied current work and data fl ows and identi- fi ed 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 sup- ply 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, fi nancial and operational domains, which is foundational to effective use of UDI2
chain.1
and a clinically integrated supply With more than $40 billion spent
annually by hospitals on medical devices and supplies, understanding how these sup- plies and associated expenditures impact the quality and effi ciency 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. HPN Visit
https://hpnonline.com/21267467 for references
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64
