FDA Home Page | CDRH Home Page | Search | A-Z Index

FDA > CDRH > FDA Patient Safety News > Show #60 > Cables and electrodes can burn patients during MRI

Cables and electrodes can burn patients during MRI

The following article was published in Nursing 2006, Volume 36, Issue 11 and is not an official FDA document.

BY SUSAN LANGE, ARRT, MPH, AND QUYNH NHU NGUYEN, BS

PATIENTS UNDERGOING magnetic resonance imaging (MRI) while wearing ECG electrodes attached to cables have received second- and third-degree burns on skin under the electrodes. These burns were discovered after the MRI, according to reports received by the Food and Drug Administration.

What went wrong?

The radiofrequency fields that occur during an MRI can heat ECG cables and electrodes, seriously burning skin under the electrodes. The burns can be severe enough to require plastic surgery.

What precautions can you take?

The number of MRI studies performed annually is consistently increasing. As the imaging technology advances, more patients require monitoring during study because of the type of study or their general condition. Patient monitoring requires the use of MRI-compatible equipment. To help reduce patient adverse events during an MRI, follow these steps:

• Coordinate with the MRI staff technologist before the imaging study to ensure that cables and electrodes are available that have been cleared for use in the MRI environment. Make sure electrodes used aren’t past their expiration date.
• Search the patient for any previously used electrodes and cables that may have been inadvertently left behind, either in clothing, in the sheets, or on the patient. Remove any electrodes and cables that are no longer being actively used for monitoring. This will prevent the possibility of burns from leftover electrodes.
• Be aware that, even though you’re using electrodes and cables that are approved for use during an MRI, a serious burn can still develop if the electrodes aren’t in complete contact with the skin surface (that is, if excess hair hasn’t been removed or there’s an air gap between the electrode and the skin). When there’s an air gap, the electrical pathway is broken and heat can build up at the center of the electrode as well as letting the current arc from the electrode to the skin, which can cause burns. Don’t let the cables form a loop and keep them off the patient’s skin by placing a blanket under them.
• After the MRI study is complete, patients (especially those who can’t verbalize), should be examined for possible burns or reddening of the skin under the electrodes.
• If your patient has a burn, make sure she gets appropriate treatment. Document all medically relevant information in the medical record and file an incident report. Notify your facility’s biomedical engineering department and quarantine the electrodes involved plus any remaining in the packet.

Although you need to support the adverse event-reporting policy of your health care facility, you may voluntarily report a medical device that doesn’t perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178) or online at http://www.fda.gov/medwatch/how.htm. The opinions and statements in this report are those of the authors and may not reflect the views of the Department of Health and Human Services. Beverly Albrecht Gallauresi, RN, BS, MPH, who coordinates Device Safety, is a nurse-consultant at the Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md.

Susan Lange is a medical imaging specialist and Quynh Nhu Nguyen is a biomedical engineer fellow at the Center for Devices and Radiological Health.

CDRH Home | CDER Home | CBER Home

Updated February 1, 2007

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH