FDA: X-rays during CT may cause device malfunction
The Food and Drug Administration (FDA) has sent an alert about X-rays used during CT examinations that might cause implanted and external electronic medical devices to malfunction.
The FDA has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. It is possible that this interference is being reported more frequently now because of the increased use of CT, the higher dose-rate capability of newer CT machines, an increase in patients with implanted and externally worn electronic medical devices, and better reporting systems, the FDA says.
"We are continuing to investigate this issue while working with device manufacturers and raising awareness in the health care community," the FDA said in a released statement. "To date, no patient deaths have been reported from CT scanning of implanted or externally worn electronic medical devices."
The FDA makes the following recommendations:
- Before beginning a CT scan, use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range.
- For CT procedures in which the medical device is in or immediately next to the programmed scan range, the operator should determine the device type; if practical, try to move external devices out of the scan range; ask patients with neurostimulators to shut off the device temporarily while the scan is performed.
- Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality, and making sure that the X-ray beam does not dwell over the device for more than a few seconds. (See tips for after the CT, below.)
After a CT Over Electronic • Have the patient turn the device back on if it had been turned off prior to scanning. Source: Food and Drug Administration. Web: www.fda.gov/cdrh/safety/071408-ctscanning.html. |
For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, be ready to take emergency measures to treat adverse reactions if they occur.
[Editor's note: For more information, contact Issues Management Staff, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, MD 20850. Voice mail: (240) 276-3357. Fax: (240) 276-3356. E-mail: [email protected].]
The Food and Drug Administration (FDA) has sent an alert about X-rays used during CT examinations that might cause implanted and external electronic medical devices to malfunction.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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