Background In 2009, the American Food and Drug Administration (FDA) issued an alert that transdermal patches containing metallic components can overheat during MRI or defibrillation procedures and can cause skin burns. In Europe, the information concerning metal content in transdermal patches is limited and not easily accessible.
Purpose -To review the presence of metallic components in commercialised transdermal patches and available recommendations as to whether they should be removed before an MRI or defibrillation procedure.
-To update institutional safe practice guidelines accordingly.
Summaries of Product Characteristics (SPCs) for all transdermal patches that were commercialised in August 2015 were reviewed. The presence of any metallic component and specific warnings on the risk of burnings during MRI or defibrillation procedures were recorded. When this information was not available, the manufacturers were contacted to provide such information.
Results 52 transdermal patches containing 14 different active ingredients were commercialised at the time of study. Only 23.1% (n = 12) of the SPCs included information concerning metal content: presence of metallic components was acknowledged in 8 patches and their absence was specified in 4. As far as patch placement during MRI or defibrillation procedures was concerned, less than a quarter of the SPCs (21.2%, n = 11) included this information: 7 of those patches must be removed and 4 can remain in place. After the manufacturers were contacted, we obtained the following information on the remaining 40 patches: 21 patches had no metallic components (3 can remain in place, 2 should preferably be removed and no further information was provided for the remaining 16) and 6 patches contain metals (4 must specifically be removed). We were not able to obtain information for 13 patches. After this information was gathered, a list of metal containing patches that should be removed as well as those metal free patches that can remain in place was made and incorporated into the Institutional Safe Practice Guidelines. For the remaining transdermal patches, removal was recommended to avoid any potential risks.
Conclusion Patients and healthcare professionals should be aware of the precautions regarding transdermal patch placement during MRI and defibrillation procedures, and information on any metallic components should be included in their SPCs. To include this information in our Institutional Safe Practice Guidelines was considered useful to lessen the risk of burns during these procedures.
No conflict of interest.
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