Recently the US FDA issued a safety notice on Lubricious Coating Separation from Intravascular Medical Devices.
The FDA wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients. Coating separation can be caused by a number of factors, ranging from the difficulty of the procedure and the patient’s anatomy to practitioner technique or using the wrong device for the procedure, to improper preconditioning of the device and improper storage conditions as well as issues with device design or manufacturing processes.
This highlights the need for intravascular medical device manufacturers to perform simulated use testing on these devices, specifically looking for particulate matter. Nelson Laboratories can assist customers with these tests.
FDA Safety Communication Date: 23 November 2015
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