STANDARD PRACTICES
UDI check up: Notes from the 2015 UDI Conference
by Karen Conway, Executive Director, Industry Relations, GHX
he theme of this summer’s UDI Conference was collaboration, a word I admit I use a lot, and yet I fear will reach the infamous status of words like “win-win” and “symbiotic” if it is overstat- ed and under explained. The good news is many of the formal presentations as well as sidebar discussions in the hallways and on the exhibit fl oor made a noble attempt to explore just what kind of collaboration is necessary to achieve value from the now nearly two-year-old regulation. Linda Sigg, Associate Director for In- formatics with the U.S. FDA Center for Devices and Radiological Health (CDRH), kicked off the conference, which was held in June in Baltimore. As lead of the UDI team, Sigg told the audience that UDI will only work if all the stakeholders, including FDA, utilize the unique device identifi ers (UDIs) as the way to unambiguously identify devices in different systems and for various purposes.
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In her opening session, titled “We’re on our Way,” Sigg proudly announced that since the last conference (held eight months earlier) the number of device records published to the Global UDI Da- tabase (GUDID) has more than doubled, from 33,000 to 75,000, with nearly that rate of growth for the number of “labeler” accounts. Labeler is the term the FDA uses for whoever is responsible for UDI, and in most cases, that is the manufac- turer. Sigg also announced that the beta site for AccessGUDID went live in early May; as discussed in the June edition of Standard Practices, AccessGUDID is the public website where users can search and download most of the information in the GUDID for free. Most of the data in the GUDID is for Class III devices, which are the only de- vices that to date must be in compliance with the UDI rule. But as Heather Valadez and Indira Konduri, also with the FDA UDI team, stated in their session on day two of the conference, the FDA is currently accepting records for the next round of
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compliance, this time for devices deemed to be “implantable, life-saving and life- sustaining.” Those devices need to be in compliance by September 24, 2015, and you can view a list of those devices, many of which are class II, on the FDA’s UDI website at
www.fda.gov/udi. Sigg said the FDA will begin accepting records for the remainder of Class II devices after the fi rst of the year.
While good progress, having the data in the GUDID and even being able to search and download the information is not enough if the data on the devices that are used in patient care cannot be captured. A panel from the Association for Auto- matic Identifi cation and Mobility (AIM) provided a demonstration of some of the technologies available to ensure proper labeling or marking of devices with UDIs, which must be both human and machine (think barcode) readable. That’s not always easy, when you consider the small size of some products and packaging and the need for barcodes and other auto ID car- rier technologies to meet certain standards for readability. For example, as the panel explained, just because a barcode reader beeps when scanning a barcode on a label, it does not mean the scanner was able to capture all of the right information or that the next scanner will be able to read it. The barcode needs to pass the test, but so do the barcode readers. And here’s where that collaboration word comes in again. Hospitals and other facilities where prod- ucts are being received and used need to make sure they not only have the proper technology in place (ideally barcode scan- ners that can read both linear and 2D data
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matrix barcodes) but also that the scanners are calibrated to manufacturer specifi cations. The use of UDIs in the hospital environ-
ment was discussed in several general sessions as well as the provider track on day two, sponsored by the Association for Healthcare Resource and Materials Man- agement (AHRMM). Many of the manu- facturers in the audience were particularly interested in how providers will use the UDIs, which is not an insignifi cant ques- tion given that UDI compliance for many manufacturers is an investment that can cost tens of millions of dollars if not more. Paul Helmering, Vice President of In- formation and Technology Solutions for ROI, the supply chain organization for St. Louis-based Mercy, added that UDI compliance is not an inexpensive propo- sition for hospitals, either. Costs include investing in quality barcode scanners and addressing challenges with moving data across technology systems with closed architectures. To determine the return on those investments, he says hospitals need to identify where process improvements can be realized through UDI adoption. As an example, he said Mercy created
fl ow charts around the capture and use of UDIs for inventory management. By changing processes, Mercy was able to sig- nifi cantly reduce the time spent by nurses on inventory management and give them more time for patient care. Admittedly, process change can be as challenging as some of the technology and fi nancial bar- riers, but with a willingness to give it a try (there’s that collaboration thing again), the nurses at Mercy were able to generate value for themselves as well as the hospital system. Helmering believes those benefi ts can also extend to manufacturers. He noted that before use of UDIs, the process improvement exercise uncovered that one supplier had more than $300,000 in expired consigned inventory on the shelf. With UDIs built into the system, Mercy hopes to help suppliers avoid that kind of scenario in the future. HPN
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