As medical device manufacturers and labelers mark their products with unique device identifiers to address the requirements of the U.S. FDA’s Unique Device Identification (UDI) Rule, these identifiers can also be scanned at the point of care. Healthcare providers can improve patient safety and, at the same time, realize operational efficiencies by scanning UDI bar codes as products are checked in and out of inventory and as they are used in the course of patient care.
For manufacturers that have chosen to use the GS1 System of Standards, the GS1 Global Trade Item Number (GTIN) is used as the unique device identifier (DI) and GS1 Application Identifiers (AIs) are used to represent production identifiers (i.e., batch/lot, serial number, expiration date, and/or production date). This information is encoded into a GS1 bar code, such as a linear GS1-128 bar code or a two-dimensional (2D) GS1 DataMatrix bar code and, as such, is available for scanning.
The Veterans Affairs (VA) Medical Center in Miami, Florida is proving the benefits are significant. One of 170 VA hospitals in the United States, the Miami facility is a primary care and mini-trauma center for nearly 150,000 veterans in South Florida.
The hospital once spent countless hours each week manually entering product codes into systems for hundreds of medical implants and other products that were received, placed into inventory, and ultimately used in patient procedures and care. As hospital staff noticed bar codes on an increasing number of devices, they knew that capturing the data with a simple scan could be much more efficient and accurate.
For instance, the hospital performs multiple eye surgeries every day. Hospital technicians found that manually entering a single device code took an average of 70 seconds, whereas with a bar code scanner, the same data could be captured in just 20 seconds. Over the course of a week, this amounted to more than an hour of potential time savings for approximately 100 procedures. Accuracy is also greatly enhanced by reducing the human errors and inconsistencies inherent in manual data entry.
Now, as medical devices and implants are received, the technicians scan the bar codes to automatically capture product information. The data is then stored in the hospital’s Medical Device Management System (MDMS) called UDITracker, provided by Champion Healthcare Technologies, a GS1 US Solution Partner. This has enabled them to improve operational efficiency by easily and accurately keeping track of implants and other medical devices.
Champion helped the hospital cleanse its database of imprecise product names and non-unique manufacturer catalog numbers and use standardized, unique device identifiers (GS1 GTINs) instead so all product information is aligned and can easily be found. They are now working on integrating implant usage information into the hospital’s proprietary electronic health record (EHR) system.
Reducing Product Expirations and Expediting Recalls
With its new system, the Miami VA hospital is able to search products by expiration date, quickly find the products that are near their expiration date, and use them first—saving time, reducing waste, and saving money when compared with manually checking expiration dates on individual packages. In fact, the medical center estimates a savings of $5,000 to $10,000 each month as a result of using inventory that might otherwise have expired.
Most important, scanning bar codes has improved patient safety by helping to eliminate human error. Since capturing unique device identification information saves tracking time, it could be used in the event of a recall. UDITracker includes a recall feature that enables users to click on the item being recalled. The technology then shows every patient in which the device was used and where the remaining devices are stored. Aside from the time savings this represents, the patient safety aspects are profound.
The Miami VA Medical Center’s transition to GS1 Standards-based UDI bar code scanning yielded lessons for all healthcare providers. First, U.S. FDA UDI Rule implementation helps improve patient safety, most of all when the unique device identifiers are fully captured at the point of care. Secondly, scanning the bar codes benefits the healthcare providers as well by delivering operational efficiencies and improving their bottom lines.
For more information about the Miami Veterans Affairs Medical Center’s bar code scanning program and recommendations developed during its inception, please read the GS1 US case study, "Veterans Affairs Medical Center: Demonstrating the Benefits of Scanning UDI Barcodes on the Front Lines."