FDA is warning healthcare professionals and patients that medicated patches with metallic backings can cause skin burns during MRI exams. These patches include both prescription and OTC products, including nicotine patches. The metallic backings are not ferromagnetic, so they are not attracted to the MRI machine's magnetic field. But the metal does conduct heat, which is what can cause burns in the immediate area of the patch.
It can be difficult to determine whether a patch has metal in the backing, because the metallic component may not be visible. Also, at this point the labeling for some of these patches does not contain a warning about the possibility of burns if worn during an MRI. FDA is working with patch manufacturers to be sure that their labeling includes the warning.
In the meantime, FDA recommends that health care professionals note the presence of a patch when they refer patients for MRI exams, and advise patients about removing the patch before the exam and replacing it afterwards. MRI personnel should follow published safe practice recommendations for patients wearing patches.
There are precautions patients can take, too. They should tell the doctor who is referring them for an MRI exam that they are wearing a patch, and ask for instructions about how to remove and dispose of the patch before the exam, and how to replace it afterwards. It is also important that patients tell the MRI staff about the patch, both when they make the MRI appointment and when they arrive at the facility.
FDA Patient Safety News: May 2009
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=86#4
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