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Catheter Validation with Advanced X-ray

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Catheters are among the most widely used medical devices.  They are also among the most common subjects of FDA recalls, to the tune of hundreds of thousands of catheters recalled in a typical year.  Such recalls are costly in so many ways, for the patients they effect, as well as reputationally and financially for device manufacturers.  Ensuring catheter quality requires rigorous inspection, which is why we see more and more catheter manufacturers turning to automated X-ray inspection for these critical devices.

Inspect Inside and Out

Depending on their design and intended use, catheters may be inspected for tip defects, tube or punch hole errors, or to verify wire braid integration.  Such inspections can be tedious, costly and inaccurate when performed by humans, not to mention the huge bottlenecks they can cause.  Automated X-ray inspection can be tailored to support or replace human inspection, with integrated material handling and even artificial intelligence.  These systems are highly accurate, extremely efficient, and are remarkably cost effective.  Unlike machine vision tools, X-ray inspection isn’t limited to the exterior of the device.

Wire Consistency is Critical

Wire braiding in a catheter, for example, can enhance many characteristics, including torque transmission and column strength while maintaining the necessary flexibility.  Only with consistency in the braiding pattern, can a catheter perform predictably as part of a medical device.  Wire braided catheters are often an integral tool in heart procedures, and it is critical that the tubing behave reliably, consistently, and precisely as designed.  Consistency in the braiding provides for the most accurate and reliable placement of valves, and of course, variations in the braided structure could result in errors that might be life-threatening.

Powerful AI and Automation

These complex catheter designs demand inspection at multiple points along the tubing.  In addition, thorough inspection requires viewing from various angles.  Because of the size of the features, manually evaluating X-ray images is just not practical, particularly for meeting production demands. In order to rapidly analyzing images, custom algorithms are developed that are capable of counting peaks and valleys to validate precise per-inch crosses of the wire braid.  Such algorithms, combined with automated X-ray inspection systems can integrate seamlessly into manufacturing lines.  The inline design, fitted with a rotation device is able to provide automated inspection of all areas of interest at multiple angles.  By adding 3D laser scanning, the system can simultaneously inspect the outside of the tube as well.

Use of automated X-ray inspection in catheter production results in the most accurate and efficient validation, and ensures the highest possible quality.  If your quality assurance challenge demands a Creative solution, please reach out to our team today. We look forward to working with you.

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