An international consortium of governments, not-for-profits and corporations (Matrix IT Medical Tracking Systems, Fingerprint, B.Braun, etc.) focused on improving medical device traceability kicked off a multi-country study at Wickenburg Community Hospital in Arizona. Unique Device Identification, (UDI) is a global initiative designed to provide information to reduce medical device related deaths and injuries. Each implant must be identified with a unique code that provides important information such as product, lot, serial and expiration date. One of the key technologies being tested was the sterile field scanning hardware and software, TRACTUS by Matrix IT Medical Tracking Systems Inc.

Named “Blueberry Castle,” the study will assess the current manual methods of operating room implant documentation versus documenting via scanning technologies. As hospitals continue to digitize Medical Health Records, it is as important to convert manual recording methods to automated barcode scanning methods thus minimizing the chances for human error.

Much like scanning in the grocery store checkout, Wickenburg Community Hospital is the first hospital in the world to use Matrix IT’s Tractus Platform to document medical implants, instruments and supplies used during surgery in the operating room. “We are pleased to be involved with this important study,” said Richard Wedig, Chief Officer of Surgical Services. “Sterile field scanning will allow us to document medical implants with improved accuracy. The accurate data will lead to improved patient care and safety. In addition, the data collected will allow us to analyze implant performance globally which will lead to better implant/patient outcomes,” he said.

“Given the clinical and financial importance of Unique Device Identification (UDI), a coalition was formed to observe and report on the results of using GS1 standards-based barcode scanning to help ensure regulatory compliance and increase patient safety,” said Alan Gormley, Head of Industry Engagement and Solutions for GS1 Ireland. “The coalition includes some of the world’s top UDI stakeholders,” said Gormley, “such as GS1 Ireland, American Hospital Association’s AHRMM, Association of Peri-operative Registered Nurses (AORN), U.S. and European government agencies and others who have demonstrated a commitment to ensure the success of a global UDI rollout.”

The study will help realize international medical device data collection objectives, such as the U.S. FDA’s National Evaluation System for Health Technology (NEST) and the European Union’s Medical Device Regulation (MDR) programs. These initiatives are designed to use the data collected to identify opportunities to reduce healthcare costs while identifying methods to improve patient outcomes.

Wickenburg Community Hospital CEO, Jim Tavary said, “We are thrilled to be a part of this innovative international consortium that is blazing a virtual path to improved patient safety. This study is a wonderful example of harnessing information technology to trace medical devices from the point of implantation in the surgical suite through their journey with each patient in the healing process,” he said.

Matrix IT CEO, Larry Donnelly said, “Documentation methods in the operating room vary widely and are prone to potential error. By isolating each documentation method, we can begin to understand the impact that these manual methods have on patient safety and cost,” he said.

“The Tractus system allows clinicians the ability to collect UDI information on all medical devices; whether hospital sterilized or sterile packaged by the manufacturer.” Donnelly added, “The device information is collected electronically via scanners, which can be shared for accurate data analysis designed to support programs such as the FDA’s NEST initiative.”