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How manufacturers can slide into FDA validation of their medical tubing

Written by Hunter Brankamp

 Image above: Medical catheters used with a custom fixture

 

Any products used in the medical world to treat patients should be the safest, cleanest, and most comfortable for the patient, right? That’s something we can all agree on.

Medical tubing, used as catheters, is one such product that should surely fit those descriptions. Getting a catheter installed is very painful, as anyone who has can surely attest. The quality of adhesion of the coatings on these tubes greatly impacts patient comfort and success during installation.

So, how do we know that these critical tubes are manufactured and coated to the highest of quality specifications, essentially making patient procedures less painful? Furthermore, what is deemed a safe and acceptable level of surface quality, and how can this be achieved?

Prior to the Surface Analyst, defining the path towards FDA validation was difficult, and often times with no means at all, simply not possible.

The FDA requires manufacturers to achieve strict standards when it comes to validating medical products are of the highest quality of manufacturing and preparation. But, prior methods for obtaining FDA validation in manufacturing medical supplies was like fitting a round peg into a square hole...it just wasn’t happening!

So from a surface quality standpoint, what does this all look like?

Catheters are coated with a variety of coatings, a common one being a hydrophilic, lubricious coating that allows them to be inserted into  patients to give maximum comfort and safety.

The best way to measure the quality of this coating, and achieving those prior mentioned goals, is to quantify the surface energy on that round, smooth surface so that the surface uniformly accepts the coating.

For the first time, this is not only possible, but now made simple using the Surface Analyst!

Specifically, using this device in unison with a custom fixture, designed to allow for accurate and convenient measuring of a round surface, we give medical device manufacturers the ability to validate their coating or treating process to achieve the desired results.

Those results, while also being piece of mind for the manufacturer, mean so much more.

Watch how the Surface Analyst quickly and accurately measures across medical tubing in this video.

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