Brookfield, WI (PRWEB) October 09, 2015
Matrix IT Medical Tracking Systems LLC, a privately held Wisconsin-based company, has announced the final product specifications for TRACTUS, the world’s first sterile field scanner.
The TRACTUS platform was developed, manufactured and produced in the United States in response to the FDA’s recent Unique Device Identifier (UDI) Final Rule, which will require manufacturers to directly mark their products with a data matrix or barcode beginning in September 2016.
While in the operating room, surgeons and hospital staff can rely on the TRACTUS platform to quickly and accurately scan, track and document surgical implants, removing human data entry error. From a device’s point of manufacturing to the corresponding patient’s procedure, the fully integrated hardware and software communicate with the hospital’s clinical documentation and inventory management systems in real time.
TRACTUS intelligently captures individual codes and uploads the implant data to the patient’s electronic health record (EHR). In addition to satisfying the FDA’s documentation requirement, this also provides all stakeholders with the relevant data, including the device identification (DI) and product identification (PI).
TRACTUS comes equipped with a sterile scanner, non-sterile scanner, and software, each interacting wirelessly with one another. The battery-powered platform is rated for 18-24 hours of continuous use, and incorporates Bluetooth 4.1 for wireless data communication.
Further ensuring top quality patient care, the device also allows hospitals to run reports checking the implanted inventory for active FDA recalls.
Additional TRACTUS platform technical capabilities include:
1. Data matrix codes as small as 0.25mm^2* can be scanned from medical devices if they’re a “B” grade or better (adhering to GS1 standards). Codes as large as 125mm^2 have been scanned.
2. The TRACTUS system is capable of scanning all major code formats, including but not limited to EAN-13, EAN-8, UPC-A, UPC-E, data matrix codes, GS1-128, and linear stacked.
3. TRACTUS has a fully functional API and data communication protocol allowing for integration with existing supply chain management platforms. The data can be sent to any upstream or downstream providers.
4. TRACTUS is fully integrated with the GDSN and GUDID, allowing for a real-time ability to scan all medical implants, adhering to the FDA’s guidance.
5. Surgeon, part, and staff performance and preference can also be tracked through TRACTUS.
6. For dental and human tissue products, TRACTUS has the capability to validate and establish a verifiable chain of custody and tissue pedigree.
To watch video from Matrix IT’s presentation at the 2015 AIM Conference, including a demo of the software in action, visit http://www.goo.gl/bD8JXr.
About Matrix IT Medical Tracking Systems LLC and TRACTUS:
Matrix IT Medical Tracking Systems LLC holds 28 worldwide patents for sterile field scanning. TRACTUS is currently entering the final stages of hospital testing and 510k approval. To learn more about TRACTUS, visit the website at http://www.matrixmedical.co.