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● Viewpoint

A challenge for IT, healthcare gets unique identifi ers


have been a member of the HIMSS Special Interest Group (SIG) for Supply Chain for many years. At an annual HIMSS meeting about 10 years ago, we heard a presentation about how the Defense Supply Center Philadelphia’s

(DSCP’s) lack of data congruence may result in receiving the wrong healthcare item, the wrong quantity, or an inferior item at a higher price. Additionally, on the chance a product supplier and a Department of Defense (DoD) healthcare facility refer to the same item with diff erent nomenclatures or diff erent item numbers, unnecessary ordering might occur. T e crux of the problem: no standards in healthcare product identifi cation. T e DoD had created its own data synchronization system, one that included

its own bar coding system of products for identifi cation. Meanwhile, there were well-known examples of the use of data synchroniza- tion to facilitate e-commerce, RFID and other supply chain effi ciencies with companies such as Wal-Mart, Lowes, Kimberly Clark, Proctor and Gamble, Sara Lee, Staples and many others. Data synchronization is “the process of establishing consistency among data

from a source to a target data storage and vice versa. It is fundamental to a wide variety of applications.” Imagine Wal-Mart being able to track a jar of tainted peanut butter in min- utes because it had a unique barcode, and a database to access for the tracking information. But in our healthcare facilities, we are barely able to know what products are on our shelves, let alone which patients they were being used on. Our HIMSS group, as well as many others, have continued to work on es- tablishing the standard for unique device identifi cation (UDI) so that we could synchronize our data. T e FDA has been part of that initiative since 2007. T e day has fi nally arrived, and the UDI ruling is here. At the annual UDI-FDA Conference in September, Jay Crowley, Sr. Advisor

for Patient Safety with the FDA’s Center for Devices and Radiological Health (CDRH), said as he announced the fi nal ruling, “T is is not about just being able to identify devices. We are talking about a holistic approach to integrating medical device identifi cation throughout the entire healthcare system. UDI will be a fundamental piece of everything we do going forward.” T e fi nal UDI rule was published in the Federal Register on Sept. 24, 2013.

It mandates a standardized plan for product identifi cation. (See page 6 for the ruling announcement.) In addition, this sets the stage for healthcare IT systems to capture and store this data in their inventory systems, their patient EMR/EHR records as well as their fi nancial billing systems. Of course, knowing all this, also means that IT professionals need to get acquainted with these standards and fi nd the solutions that will help get this important data into their data systems currently in operation or new ones that they shop for. T e rewards are priceless. To name a few: increase patient safety due to

properly identifi ed products and medication dosages; pull data from an EMR that proves the right solution was used for proper care; mine that data for future comparative eff ectiveness studies; quickly identify a patient that may have received a recalled device as well as recalled inventory in the hospital; accurately invoice a patient, their payors, or Medicare/Medicaid and speed up reimbursement; and, of course, to make sure the right product is available in inventory when needed. Now that the U.S. FDA has issued the fi nal UDI rule, work can get underway in earnest to realize the industry-wide benefi ts of better visibility around the products produced, purchased and used in the delivery of patient care – but only if we’re able to gather and use the data. At our HIMSS SIG group meeting this year, there will be a full pre-conference day on UDI implementa- tion. More on that later.



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