FDA warns about coatings separating from medical devices, sometimes with lethal results

Coatings are applied to medical devices used in minimally invasive procedures to improve lubricity. Polytetrafluoroethylene (PTFE), polyvinylpyrrolidone (PVP) and silicone, among other materials, improve device maneuverability for the surgeon and minimize patient trauma and the formation of blood clots. Unfortunately, the materials also may detach from the substrate, causing serious injury and, in a handful of cases, death. This week, FDA issued a safety communication related to these coatings to make healthcare providers aware of the risks and suggest prevention techniques. Tagging Options Domain:  All Sites Keywords:  Materials and Additives read more

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FDA warns about coatings separating from medical devices, sometimes with lethal results

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