PTFE delamination plagues medical device manufacturers

Change isn't always good. That's what some medical device manufacturers are learning, as they face recalls because of PTFE adhesion issues.

When the U.S. Environmental Protection Agency required manufacturers to eliminate perfluorooctanoic acid (PFOA) from their PTFE formulations by 2015, because of PFOA's potential carcinogenic properties, many companies switched to a new PTFE formulation. PTFE is used to coat guidewires and other devices to enhance lubricity. The problem, however, is that the new formulation does not adhere as well to the substrate as the former product did and can flake off the device, which can create a life-threatening event. Qmed and MPMN Senior Editor Chris Newmarker spoke with Surface Solutions Group (Chicago), which claims to have developed a proprietary coating process that eliminates the potential for delamination. The article is published on qmed.com.

The newer PTFE simply isn't sticking to stainless steel wires the way it used to, Bruce Nesbitt of Surface Solutions Group told Newmarker. That hasn't stopped device manufacturers from using it, however, as PTFE "has the lowest coefficient of friction of anything out there," Surface Solutions Group President George Osterhout explained to Newmarker. Some large medtech manufacturers reportedly are even seeking unused inventory of the old PTFE, but that is a short-term fix, at best. A better solution is sourcing a coating process that solves the flaking issue, and that is bringing a lot of business to Surface Solutions Group, says Nesbitt.

The company is understandably mum about the processes it has developed, but it does provide some insights into what companies wrestling with coating delamination should do. You can read about them in Newmarker's article, "How to Prevent Guidewire Coatings from Flaking."