FDA Issues Warning For Patients With Medical Devices
The US Food and Drug Administration (FDA) made a preliminary announcement that computed tomography (CT) scans can cause some medical devices to malfunction. This announcement has direct implications for dystonia patients who have implanted devices such as deep brain stimulation and intrathecal baclofen hardware. CT scans deliver X-rays to the body, and the FDA found that external and some internal medical devices can be damaged by these X-rays.
There have been no deaths reported from CT exposure, but some patients have reported problems with their devices after having a CT scan. Patients have had problems with devices such as pacemakers, defibrillators, neurostimulators (used for deep brain stimulation), and internally and externally worn pumps that administer drugs (such as the pumps used to deliver intrathecal baclofen). Some of the problems that have been reported include changes in the rate that the pacemaker triggers the heart to beat and problems with insulin pumps. Also, CT exposure has caused neurostimulators to deliver a shock that was not intended.
The complications from CT scanning are different from the problems with magnetic resonant imaging (MRI), which we have been known for some time.The FDA is not sure if the increase in the number of malfunctions associated with CT scans is caused by more CT scans being done, more of these devices used by patients, newer machines delivering higher strength X-rays, or more people reporting the complications.
Until the cause is determined, the FDA recommends that individuals make sure that everyone involved in their care, including X-ray technicians, know about their implanted or external device. If you have a neurostimulator, be sure that your healthcare provider turns it off during the scan. Afterward, your device should be checked to make sure it works properly, even if you turned it off during the scan. Do not hesitate to talk to your healthcare provider if you have questions.
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The US Food and Drug Administration (FDA) made a preliminary announcement that computed tomography (CT) scans can cause some medical devices to malfunction. This announcement has direct implications for dystonia patients who have implanted devices such as deep brain stimulation and intrathecal baclofen hardware. CT scans deliver X-rays to the body, and the FDA found that external and some internal medical devices can be damaged by these X-rays.
There have been no deaths reported from CT exposure, but some patients have reported problems with their devices after having a CT scan. Patients have had problems with devices such as pacemakers, defibrillators, neurostimulators (used for deep brain stimulation), and internally and externally worn pumps that administer drugs (such as the pumps used to deliver intrathecal baclofen). Some of the problems that have been reported include changes in the rate that the pacemaker triggers the heart to beat and problems with insulin pumps. Also, CT exposure has caused neurostimulators to deliver a shock that was not intended.
The complications from CT scanning are different from the problems with magnetic resonant imaging (MRI), which we have been known for some time.The FDA is not sure if the increase in the number of malfunctions associated with CT scans is caused by more CT scans being done, more of these devices used by patients, newer machines delivering higher strength X-rays, or more people reporting the complications.
Until the cause is determined, the FDA recommends that individuals make sure that everyone involved in their care, including X-ray technicians, know about their implanted or external device. If you have a neurostimulator, be sure that your healthcare provider turns it off during the scan. Afterward, your device should be checked to make sure it works properly, even if you turned it off during the scan. Do not hesitate to talk to your healthcare provider if you have questions.
You can review the report from the FDA at http://go.reachmail.net/rmgo.asp?tid=775368&eid=4696&sb_id=268226,268226
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