Groundbreaking Global Operating Room UDI Data Collection Study Launched

7 countries, 40 hospitals, Matrix IT Medical Tracking Systems, B.Braun, GS1 IE, AIM, AHA, AORN team together for UDI documentation

Consortium Blueberry Caste Google CloudAn 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.

OR Medical Device UDI ScanningMuch 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, GS1 Ireland. "The coalition includes some of the world's top UDI stakeholders such as GS1 Ireland, American Hospital Association's AHRMM, Association of periOperative 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.

Wickbury Hospital Blueberry Castle TeamWickenburg 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."


For more information contact Brandon Donnelly at +1.206.550.5000

GS1 Ireland is a not for profit organisation dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally. The GS1 system of standards is the most widely used supply chain standards system in the world.

GS1 numbers and barcodes enable organisations of any size to order, track, trace, deliver and pay for goods across the supply chain, anywhere in the world. GS1 is recognised by the International Standards Organisation (ISO), the European Standardisation Committee (CEN) and the American National Standards Institute. Today, over two million-member companies in 145 countries use GS1 standards as part of their daily business communications, representing some five billion scanning transactions a day.

Matrix IT Medical Tracking Systems Inc. is the developer of the world's only universal operating room UDI collection platform capable of data capture of all surgical device information, regardless of how it is presented. The Tractus sterile field scanner captures UDI information from medical devices marked with data matrix codes containing the full UDI.

Wickenburg Community Hospital is a nonprofit organization. Established in 1926 and like the tenacious Western spirit that built Wickenburg, our rural Community Hospital and Clinics are committed to quality health and wellness services where the patient, family and community come first. The hospital is federally designated as a Critical Access Hospital and state designated as a Level IV Trauma Center supporting the needs of residents and surrounding rural communities within approximately 3,300 square miles.

The campus includes Specialized Emergency Medicine, Advanced Life Saving Technology, Critical Cardiac Care, Mayo Clinic Telestroke Partnership, Community Clinics, Surgical and Diagnostic Services, Licensed 19 Bed Acute Care Unit, Nuclear Medicine, Laboratory, Medical Resonance Imaging (MRI), Cardiopulmonary, Pharmacy, Rehabilitation Center, Infusion Center, Wound Care Center, Internal Medicine, Family Medicine, Sports Medicine, Allergy Program, Interventional Pain Management Program, Venous Insufficiency Program, and more.


Giving time back to patient care

The initiative provides traceability of items used during surgery and procedures, improving the standard of care provided to patients and the Hospital's efficiency.

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