International UDI effort for implants gets real-world test
The effort to use unique device identifiers on medical implants is getting a real-world test via an international study pulling together hospitals, vendors and medical associations in an effort to track implants from manufacturers to patients and every step in between.
The Food and Drug Administration and its European counterparts are implementing a unique device identification system to identify medical devices from distribution and use. The goal is to produce labels for most devices to include a unique device identifier in human- and machine-readable form.
With this approach, manufacturers or device labelers will submit information about each device to FDA’s Global Unique Device Identification Database, which would enable all parties in the process, including patients, to access information about a specific device.
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 implementing the Tractus system from Matrix IT Medical Tracking Systems for sterile field scanning to enable all implants, instruments and supplies being used in the OR to be scanned and documentation sent immediately to the electronic records system. “The system will answer a whole lot of questions we have about implants while in the operating room,” Wedig says.
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.”