FDA Warning: Possible Dangers of CT Scans for Patients with Pacemakers
A recent FDA report to health care providers, warned of potential "adverse events" due to computerized tomography (CT) scans of patients with electronic devices implanted. Though few incidents have been reported thus far, the FDA is taking all reports seriously. Possible adverse events include medical devices shocking patients, sending inaccurate signals due to the CT scans, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.
The Chicago Tribune noted this announcement came as a surprise to physicians, many of whom were aware of these dangers with MRI scans. Dr. Leonard Berlin, chairman of the radiology department at Rush North Shore Medical Center in Skokie says he was not aware of this. "We haven't seen any of these problems and I'm not aware of any of my colleagues having seen them either. But, of course, we'll abide by what the FDA is recommending," Dr. Berlin says.
So what devices are possibly affected?
Possibly affected devices include cardiac pacemakers, implantable cardiac defibrillators, neurostimulators, drug infusion and insulin pumps, cochlear implants, and retinal implants. Behind this news are six confirmed reports of devices malfunctioning after a CT scan and another nine reports of suspected problems, according to FDA spokeswoman Karen Riley. As of yet, no deaths have been reported.
FDA's suggests that patients with such devices:
- Discuss the risks and benefits of CT scans over other medical imaging
- If your device has external parts, your doctor may be able to safely turn off or temporarily move the device from the area to be scanned (though the device MUST be turned back on or moved back after)
- Remind the person performing the scan of your device
- Report any pain from CT scan; the scan should be painless
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