FDA Preliminary Public Health Notification:
Possible Malfunction of Implantable Medical Devices Caused by CT Scanning

On July 14, 2008, the Food & Drug Administration (FDA) issued notice that the Agency has received a small number of reports of adverse events in which computed tomography (CT) scans may have interfered with pacemakers, ICDs, among other electronic medical devices. 
     » Read the FDA's full "Dear Healthcare Professional" notification

The FDA notes that while most patients with electronic medical devices undergo CT scans without any adverse consequences, a small number of adverse events have been reported in which CT scans may have interfered with electronic medical devices, including

• pacemakers
• defibrillators
• neurostimulators
• implanted or externally worn drug infusion pumps

To date, no patient deaths have been reported from CT scanning of implanted or externally worn electronic medical devices. In its letter, the FDA provides recommendations and requests that hospital continue to report adverse events to FDA.

The FDA is continuing to investigate this issue while working with device manufacturers and raising awareness in the healthcare community. The agency theorizes this interference is reported more frequently now because of the increased utilization of CT, the higher dose-rate capability of newer CT machines, an increase in the number of patients with implanted and externally worn electronic medical devices, and better reporting systems.

Visit the FDA website for background on this issue and how to report adverse events.

According to FDA, “MedSun is the FDA's Medical Product Safety Network of 350 hospitals spread throughout the United States. Information from 132 of these facilities indicated that they have not experienced any CT medical device interference, while 3 have had from 1 to 3 events that may have been CT scan induced. Fifteen MedSun facilities indicated they take some precautionary steps when CT scanning patients who have electronic medical devices.”