According to Boyd Coatings Research Co. Inc., the recent medical PTFE adhesion failure discovered on certain guidewires within the industry is the result of the poor planning and due diligence and is no reflection on true viability of this advanced coating.
HUDSON, Mass.--(BUSINESS WIRE)--PTFE coating on guidewires has become a hot topic following a recent adhesion failure and recall. Medical device OEMs should not overreact and cast aspersion on all coatings applicators nor the PTFE coating itself. PTFE is still the Gold Standard coating for medical guidewires says Don Garcia, Director, Research & Development at Boyd Coatings. All coatings applicators had to reformulate PTFE, following the new Zero PFOA federal mandate. Boyd Coatings began its development of the new PTFE in 2012 well ahead of the 2015 deadline. Companies working within the medical field must practice all of the due diligence demanded by an industry where a mistake could cost a human life. Boyd Coatings did its methodical due diligence and exhaustive rigorous testing (including saline soaks) and, after nearly two years, has not had any PTFE adhesion problems whatsoever.
But to be successful in this industry, one must be constantly aware of the law of unintended consequences. This means thorough planning using known tools such as FEMA and rigorous testing to assure that all of the problems have been anticipated and properly resolved
We are aware of the adhesion problem discovered on some guidewires within the industry, continues Garcia. But to be successful in this industry, one must be constantly aware of the law of unintended consequences. This means thorough planning using known tools such as FEMA and rigorous testing to assure that all of the problems have been anticipated and properly resolved . Companies who have been in the medical industry for many years know this and the recent recall should serve as a reminder to OEMs that they should work with experienced medical coatings applicators that understand medical requirements, apply appropriate science and are thorough in the pursuit of product quality.
Boyd Coatings Research Co., Inc. applies, high performance coatings, specializing in the medical, industrial and aerospace markets using either off-the-shelf or custom-developed coatings. The company is ISO 9001 registered and is a licensed applicator of all the major fluoropolymer manufacturers including DuPont Teflon, Whitford Xylan, 3M fluoropolymers as well as other popular coatings providing non-stick, heat resistant, conductive, insulative, hydrophobic and other desirable properties. For more information or samples for qualification, contact Boyd Coatings at email@example.com.
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