FDA Issues Safety Warning about Separating Coatings on Medical DevicesNov 24, 2015
The Food and Drug Administration (FDA) has issued a safety communication alerting health care providers of the possibility hydrophilic and/or hydrophobic coatings on medical devices may separate—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 the practitioner's technique or use of the wrong device for the procedure. Improper preconditioning of the device and improper storage conditions can also cause the problem, as well as issues with the device's design or manufacturing processes.
Since January 2010, there have been 11 device recalls associated with these coatings peeling or flaking off of medical devices. The majority of the recalls were associated with guidewires, but there have also been recalls for other types of devices including sheaths, retrieval devices and embolization device delivery wires used in the blood vessels. Since January 2014, the FDA has received approximately 500 Medical Device Reports (MDRs) describing separation of coatings on medical devices such as guidewires, catheters, and introducers that had been used for cerebrovascular, cardiovascular and peripheral vascular procedures. The majority of the reports were submitted for vascular guidewires and over 75 percent of the reports describe device malfunctions.
Serious adverse events reported in these MDRs and in the scientific literature include pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, and death. Serious injuries associated with the peeling of coatings reported in MDRs included the persistence of coating fragments in patients that require surgical intervention to mitigate the consequences, adverse tissue reactions, and thrombosis.
The FDA believes the overall benefits of the devices continue to outweigh the risks, but health care providers should be aware of potential problems and consider certain actions prior to use. No specific manufacturer or brand of these devices is associated with higher risks than others. FDA analysis suggests that use-related issues may be mitigated through proper device selection, preparation, and other considerations noted below.
Health care providers should be aware that many devices are designed, labeled and indicated for specific uses and the right device should be chosen for the procedure.
Facilities should follow the manufacturer's instructions for proper device storage, considering shelf life, temperature, exposure to light, and so on. Improper storage can affect the integrity of the coating.
When two devices are used together (e.g., catheter and introducer sheath), the user should ensure there is sufficient room for one to pass safely within the other, taking into consideration the features of the device (e.g., curved tip), and that some coatings may swell during use. Users should follow the manufacturer's recommended preconditioning steps (if applicable), to properly activate the slippery properties of some device coatings. Use only the recommended solution because solutions may not be interchangeable and may affect coatings differently. Alcohol, antiseptic solutions, or other solvents may cause unpredictable changes in the coating, which could affect the device safety and performance. Avoid pre-soaking devices for longer than instructed, and do not wipe the device with dry gauze, which may damage the device coating.
To avoid patient injury, the FDA says, practitioners should consider replacing a device if it does not move freely, is visibly kinked or otherwise damaged, or does not perform as expected.