UDI One Step Closer To Reality

The United States Food & Drug Administration (FDA) and its European equivalents are currently conducting a real-world pilot aimed at bringing unique device identifiers (UDIs) one step closer to reality. UDIs have been a long-term dream for many in healthcare, who view the ability to track and trace medical devices using unique item-level codes as a true game changer for patient safety and documentation quality.

The end result of the UDI implementation worldwide will be unique labels affixed to each medical device that will allow patients to know exactly what devices were used on them in case of recalls or other safety issues. Hospitals will also become more accurate with their documentation due to the ease of scanning a unique bar-code rather than keying in information manually or scanning multiple bar-codes to get the same information. This article from Greg Gillespie at Health Data Management provides further details on the current UDI test:

“The study, dubbed Blueberry Castle, is trying to simplify the byzantine processes used for labeling and tracking medical implants.

Wickenburg (Ariz.) Community Hospital, one of the sites where new tracking and scanning technologies are being tested, struggles with trying to document—and get reimbursed for—all the implants it uses, says Richard Wedig, chief officer of surgical services at Wickenburg, which has a 19-bed acute care unit and serves a vast rural area in Arizona northwest of Phoenix.

“When you’re documenting by hand every plate and screw that’s being used for a knee replacement, there’s a lot of documentation you’re trying to do right in the OR,” Wedig says. “It’s a two-fold problem: from a patient safety perspective, you want to ensure you know exactly is being implanted in case of product recalls and other safety issues that crop up. And in regards to reimbursement, we have had problems when our records don’t match up with the manufacturer reps, so we have problems with documentation and reimbursement. There’s too many chances for human error right now.”

…Wickenburg is one of 40 hospitals in seven countries participating in the study. GSI, which creates a the vast majority of barcodes worldwide, as well as device manufacturer B. Braun Melsungen, Matrix IT and a number of associations including the American Hospital Association and the Association of Peri-operative Registered Nurses, are contributing either technology or expertise.

In addition, Google is providing some expertise to the group, says Brandon Donnelly, chief technology officer at Matrix IT. Google hosted study participants in its Belgian offices to brainstorm about how to tie together products and services for the effort, he adds.

Donnelly, for one, believes the study will be the first step in a complete overhaul of how the medical device industry operates. “There are so many manual processes being used right now that are inaccurate, not to mention technologies, like clips added to implants, that can be dangerous to patients,” he says. “The technology exists to create an end-to-end tracking for each and every implant. At its heart, the study is aimed at breaking the manufacturers’ stranglehold on data about implants, and giving it to patients and providers.”

Read the entire article here: International UDI effort for implants gets real-world test

With data accuracy around implants and medical supplies a constant source of frustration for hospitals, the roll-out of UDIs will bring a sea change to the healthcare system. To make sure you’re ready for the UDI roll-out, consider a system like iRISupply that targets the procedural areas of a hospital, where hospitals spend and make 50% of their dollars. The system Is UDI-ready and gives all the anticipated benefits of UDI today by using RFID technology to track supplies down to the item-level. The software will arm your hospital with the data you need to make inventory optimization decisions that will provide a large and sustainable ROI to your hospital. iRISupply will not only provide you with data, but will take it one step further and provide actionable recommendations that will allow you to cut costs in your surgical supply chain. Mobile Aspects supply chain experts will also sit down with you quarterly as part of a best-in-class customer success program to discuss strategies to optimize your owned/consigned inventory mix and review the data behind those suggestions.