FDA warns intravascular device coatings can peel during surgery

Accreditation Insider, December 1, 2015

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FDA recently issued a safety communication on intravascular medical devices (IMD), stating that their hydrophilic and/or hydrophobic coatings may peel off. Since 2014, the FDA has received 500 medical device reports about IMDs having their coating separate and there’s also been 11 recalls of IMDs by multiple manufacturers since 2010.
Use of a peeling IMD can result in embolic stroke, myocardial embolism, myocardial infarction, pulmonary embolism, pulmonary infarction, tissue necrosis, or death. Extra surgery is also required when pieces of hydrophilic and/or hydrophobic coatings break off inside a patient.
Although no particular brand or manufacturer was singled out, the FDA noted several factors that cause coating separation such as improper preconditioning or storage, procedure difficulty, complication’s with the patient’s anatomy, user technique, defective device design or manufacturing, and using the wrong device for a procedure.
However, the FDA said the benefits of IMDs still outweigh the dangers of their peeling coats. The agency urged medical personnel to follow the manufacturer’s specific instructions for each type of device, rather than taking a one-size-fits-all approach to maintenance and storage. This includes:
•    Washing each IMD with its recommended solution, rather than using solutions interchangeably. Avoid using alcohol, antiseptic solutions or other solvents to pretreat the device because this may cause unpredictable changes in the coating that could affect the device safety and performance. Avoid presoaking devices for longer than instructed or wiping the device with dry gauze because this may damage the coating.
•    Using the IMD for the purpose it was designed for. For example, the coating and performance of a device meant to be used in the peripheral vasculature may be different than those of a device meant to be used in the cerebral vasculature.
•    Ensuring there is sufficient room when using two devices together, such as catheter and introducer sheath, for one to pass safely within the other. Sometimes coatings will swell during use, so review the device labeling or consult the device manufacturer for further information.
•    Following manufacturer's instructions for proper IMD storage (e.g., shelf life, temperature, exposure to light) because improper storage can affect the integrity of the coating.
•    Not attempting to alter the shape of IMDs by bending, twisting, or similar methods which may damage the coating integrity in ways not always noticeable to the naked eye.
•    Using caution when manipulating, advancing, and/or withdrawing IMDs through needles, metal cannulas, stents, or other devices with sharp edges, or through tortuous or calcified blood vessels. Manipulation, advancement, or withdrawal past sharp or beveled edges may result in destruction and/or separation of the outer coating, which may lead to clinical adverse events.
•    Replacing a device if it does not move freely, is visibly kinked or otherwise damaged, or does not perform as expected.
•    Calling the manufacturer if you have any additional questions.

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