PTFE coatings are widely used in a variety of industries and a myriad of applications. In the medical field, PTFE is commonly used to coat surgical instruments as well as medical components such as catheters, guidewires, and implantables. Recently the material garnered attention due to changes put forth by federal EPA protocols as well as medical product recalls.
PTFE (PolyTetraFluoroEthylene) is a fluorocarbon-based polymer and, over the years, has proven itself an essential coating used in almost all industries. Best-known for its non-stick qualities, it can be used on a vast array of materials such as carbon steel, stainless steel, steel alloys, aluminum, brass, and magnesium, as well as non-metallic surfaces such as glass, and some rubber materials.
Hereâs the problem: PFOA (Perfluorooctanoic acid), a non-natural occurring substance used in the manufacture of PTFE and other manufacturing applications, was persistently showing up at low levels in the environment. The EPA began investigations into the chemical, and, ultimately, issued a request to eliminate PFOA by 2015.
In the case of PTFE, there remained some of the PFOA used for manufacturing PTFE dispersions. That meant that all U.S. companies would have to develop new formulations of products that would not use PFOA in their manufacturing. EPA set up the transition into two phases: The first was a 95% reduction which was completed in 2010 and the second to be completed by 2015. (It should be noted that while the industry refers to the current materials as Zero PFOA PTFE for convenience, there is still the possibility of “trace” quantities of PFOA. The proper technical term is “manufactured free of PFOA”). After more than nine months of successful product testing and non-critical real-world applications in the field, our company announced last year, that it offered a fully-validated, Zero PFOA PTFE coating and application process for use on medical guidewires and devices having as good as or better performance characteristics as legacy (pre 2006) and low PFOA (phase 1) material.
While the new formulation of Zero PFOA PTFE successfully coated medical guidewires and devices, others were not so successful. One coater used possibly substandard replacement ingredients in its new formulation, and then mistakenly decided not to undergo the testing necessary to qualify the product for use within the human body. As a result, the FDA had some manufacturers recall their guidewires. This created doubt in the industry.
Following the recall of two OEM’s guidewire products, some in the medical device industry expressed concern and cast aspersions indiscriminately towards Zero PFOA PTFE. The medical PTFE coating industry suffered a loss of confidence. In fact, some manufacturers of medical guidewires considered coating their products with something other than PTFE.
The medical PTFE adhesion failure discovered on certain guidewires within the industry is the result of poor planning and due diligence and is no reflection on true viability of this advanced coating. Medical device OEMs should neither overreact, nor cast aspersion on all applicators or the PTFE coating itself. PTFE is still the Gold Standard for coating medical guidewires, and the zero PFOA material remains tested and FDA qualified.