It has been more than six years in the making, but in September 2013, the FDA—working with The Joint Commission—issued a final rule to establish a unique medical device identification and tracking system. To comply, medical device manufacturers will have to assign a unique numeric or alphanumeric code to most devices, and hospitals will be required to help track their distribution and use, just as they’re required to do now for human tissue grafts.
The purpose is to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety. Medical device manufacturers will have to start assigning UDIs to Class III devices in 2014. (See below for implementation deadlines.)
To help members prepare for compliance, HealthTrust has contracted with Champion Medical Technologies, a supplier that specializes in tissue, implant and device tracking solutions, including “UDITracker.” This secure, Web-based program for implantable device tracking—including human tissue grafts and hips, knees, cardio and plastic implants—can help hospitals meet new UDI requirements and also realize other benefits UDI tracking can provide.
Automated Inventory Control and Point-of-Use Entry
Champion’s UDITracker automates what was once a time-consuming and error-prone process for hospitals. In addition to barcode scanning, UDITracker offers one-click tissue or implant data entry through its QuickReceipt feature that accesses realtime shipment status to save supply chain managers time and improve data accuracy. And, since UDITracker can track any item with a lot/serial/UDI number, any hospital department’s inventory can be tracked and managed with the system.
Inventory Cost Savings
Between expiring and missing inventory, hospitals could lose thousands of dollars every year—an unnecessary cost UDITracker can help avoid.
“UDITracker has saved us so much time,” says Argenis Mendoza, business manager, operating room, Reston Hospital Center in Reston, Va., who has been using the system for more than two years. “It alerts us of upcoming expiration dates, and I can make sure that those products get used first to avoid waste.” Nikki Hawkins, business manager at Eastside Medical Center in Snellville, Ga., says just a few months of using UDITracker has resulted in fewer lost implants. “UDITracker offers a wide range of reports, stats and other information that improves our hospital’s documentation of implants, starting from the loading dock to patient entry.” Hawkins adds that’s due to UDITracker’s storage units, including secure “swipe, grab and go” RFID cabinets and freezers that automatically capture and process inventory transactions in real time. “All of our implantables are now stored in those two units,” she says. “That makes it easier to find out who took a graft out of the tracker.”
Faster Recall Management
When exposed to a product recall, most hospitals take weeks or more to investigate. But UDITracker can slash that response time to about 24 hours, thanks to its realtime FDA and manufacturer recall inventory matching system called RecallConnect. When a recall occurs, UDITracker scans current and historical hospital inventory for a match, as well as provides ongoing matching for future inventory activity. And when integrated with an electronic health record system, UDITracker can simultaneously pinpoint which individual patients were affected as well. This fast, efficient response to device recalls can help increase patient safety and decrease liability to an organization.
On-the-Spot Quality Assurance
In the case of implants that must be delivered by reps on the day of surgery, there’s little time for quality assurance oversight. But not doing the required due diligence can be a costly mistake. UDITracker features a mobile QuickCheck app that allows you, in one click, to check the device for recalls and verify contract pricing.
Compliant With UDI Rules
Although the FDA and Joint Commission hadn’t released UDI rules on tracking medical devices as of press time, UDITracker has been reviewed by the FDA, and Champion says it’s ready for UDI rule requirements.
The Joint Commission also is expected to require the tracking of all surgical implants in accordance with the UDI rule. That’s reason enough to look into UDITracker, according to Hawkins of Eastside Medical Center. “The Joint Commission has made this a priority in most of its surveys, so I think it will be the standard for the tracking of all implants very soon.”
UDITracker is an application service provider-deployed program with no software to install—only an Internet-connected computer is required. Implementation takes about two days to complete, and a product specialist will be on-site to help with inventory input and staff training.
Reprinted with Permission: “Getting Ready for UDI Compliance.” The Source, Q1 2014