The medtech industry appears to have a flaking wires issue-and the main answer to it may involve more stringent fundamentals around a gold-standard coating substance that has lost some of its luster. by Chris Newmarker as seen in Qmed The importance of fundamentals is the main lesson that Chicago-based Surface Solutions Group has learned over the…

Watch as Bruce Nesbitt explains the mandatory removal of PFOA from the presently specified PTFE coatings and the EPA’s position on the new regulations. Then, he covers the range of new coatings that are being developed and tested that comply with the EPA regulations and the pros and cons of each new type of coating….

Micron-accurate Coating Equal to Medical Device Tolerances With most biomedical procedures, success is measured in fractions of an inch–more commonly, microns. Exact friction-free insertion of guidewires, hypotubes, catheters, cannulas, stents, balloons, drug-delivery catheters, cameras, and tissue samplers is critical to the success and safety of every procedure. PTFE-coated guidewires are often used in the first…

Recall is the last word a biomedical business wants to hear. But that is what struck the guidewire industry last year after a voluntary recall – that the FDA classified as Class 1– for stainless steel guidewires going back to April 2013. The problem was poor adhesion of an aqueous PFOA-free PTFE coating that resulted in flakes…

Why the Solution to PTFE Adhesion to Guidewires is Not a Material Swap As seen in Q-Med The demand by the EPA that manufacturers eliminate PFOA from their PTFE formulations by 2015 appears related to a series of crises for some medical manufacturers due to loss of coating adhesion on guidewires. A recent FDA Class I recall notice states: “There…