With Manufacturer mandatory compliance by September, 2016 and Meaningful Use Stage 3 coming in 2018, now is the best time to prepare for the upcoming mandatory enforcements. As the final interface with the patient, hospitals and ASCs provide the ideal landscape for supporting implant tracking and patient safety.

Ensure the most accurate patient record

Know which products are used and in what quantities. Non-sterile products such as orthopedic implant sets used in various types of spine, trauma, cranio-maxillofacial, or extremity surgeries often contain many individual components that have been separated from their original packaging. The FDA’s UDI Rule states that Class II and III medical implants must be direct part marked. By scanning and documenting UDI information in the sterile field, from a direct marked part, the most accurate device information is documented in the hospitals’ clinical documentation system. This eliminates the need for manual documentation of implant UDI data.


Track the Success of Implants

Product tracking throughout the entire life cycle enhances patient safety and post market surveillance actives. By keeping track of implants and how well they work for a large group of patients, it’s easier for health teams to determine which implant is right for each patient. Collecting and analyzing this information for all patients nationwide, can better answer questions, address concerns, and give the latest information on surgery and implants. We keep registries for patients with many chronic conditions and who have received implanted devices. And we are developing additional tools that will enable our clinicians to use these powerful techniques across the spectrum of medical care.

Increase Patient Safety

In rare cases when implantable products are recalled, the Tractus registry allows medical facilities to identify instantly all the patients who may be affected. This lets us connect the surgeon and hospital with the implant company and the FDA quickly and accurately to determine corrective action. When a recall occurs, having a national registry is a huge step forward in how fast you can reach your patients before their recalled devices fail.

Increase Charge Capture and Reimbursement

By ensuring that the invoice for a clinical product matches the product used for patient care, and that it is available immediately for processing, you are able to greatly reduce the time it takes and ensure complete accuracy to generate the appropriate documentation needed for reimbursement.


Improve the Quality of Care

Because all implant data are stored in Tractus’ cloud-based database of products, chain of custody for all implants start with the implant manufacturer and continue through implantation. Product tracking throughout the entire life cycle enhances patient safety and post market surveillance activities. Data from the implant registry, coupled with Tractus utilization provides detailed information that is valuable in reducing cost and improving outcomes. Further, Tractus development will provide information that may become helpful to predict risk for complications, such as infection and pain after surgery. By understanding risks, we’re better able to manage care before and after surgery to decrease the chance of complications. Our internal registries will extend our knowledge from published medical studies to how these implanted medical products perform in patients.

Key Benefits
  • Save time in the OR
  • Accurately and efficient document implant UDI and usage
  • Used in the sterile field. Therefore, there’s no error-prone pre or post-op manual entry of information to input the device information into the system software.
  • Analyze device and implementation trends, giving your team a clear picture of device and surgeon performance
  • Analyze and compare cost and performance by device, surgeon, implantation time, defective units, wasted units, and many other variables.
  • Ensure accurate device utilization and billing.
  • Improved tracking of recalled and expired devices
  • Tiered Access – 7 levels of user access to control data security.
  • Track Across All Departments – Implant tracking (all devices) across all hospital departments. Any item with a lot/serial/UDI number can be tracked.
  • UDI can be used to accurately identify the device through its distribution and use.
  • Visualizes image of final implant locations inside of patient
  • Clinical Care Benefits
    • Alerts patients and caregivers of device management schedules
    • Enables building of meaningful quality and performance measures and clinical decision support tools
    • Improves recall patient identification and effectiveness
    • Increases ability to conduct active surveillance
    • Links device to Diagnosis and other elements of Patient Care
    • Makes device available for summary views of patient
    • Provides rapid access to accurate, standardized device information
    • Supports care coordination and future patient care programs