The crux of the problem: no standards in healthcare product identification.
The DoD had created its own data synchronization system, one that included its own bar coding system of products for identification.
Meanwhile, there were well-known examples of the use of data synchronization to facilitate e-commerce, RFID and other supply chain efficiencies 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 minutes 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 establishing the standard for unique device identification (UDI) so that we could synchronize our data. The FDA has been part of that initiative since 2007. The day has finally 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 final ruling, “This is not about just being able to identify devices. We are talking about a holistic approach to integrating medical device identification throughout the entire healthcare system. UDI will be a fundamental piece of everything we do going forward.”
The final UDI rule was published in the Federal Register on Sept. 24, 2013. It mandates a standardized plan for product identification. (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 financial billing systems.
Of course, knowing all this, also means that IT professionals need to get acquainted with these standards and find the solutions that will help get this important data into their data systems currently in operation or new ones that they shop for.
The rewards are priceless. To name a few: increase patient safety due to properly identified 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 effectiveness 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 final UDI rule, work can get underway in earnest to realize the industry-wide benefits 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 implementation. More on that later.
