Electronic Medical Devices, X-ray Imaging and Radiation Therapy: What to Know and How to Prevent Damage
On this page:
- Are medical imaging procedures such as X-rays and CT Scans safe for people with electronic medical devices?
- What should I know about interference between CT scans and electronic medical devices?
- What steps should I take to prevent interference during CT scans?
- What steps should I take to prevent interference during radiation therapy procedures?
- Reporting problems to the FDA
The FDA has received some reports of electronic medical devices being damaged during CT scans. Damage to the devices may be caused by interference from radiation during CT scans. Interference is when the radiation and the device electronics are incompatible, and the resulting damage causes the device to fail to work normally. For imaging procedures specifically, CT continues to be the preferred tomographic imaging technology for people with implantable or wearable medical devices. CT is safer than magnetic resonance imaging (MRI) for people with devices of unknown MRI safety status. The FDA is providing recommendations to patients and health care providers to help avoid interference. Most of the recommendations provided here are specific to CT, however they also apply to other imaging procedures.
Are medical imaging procedures such as X-rays and CT Scans safe for people with electronic medical devices ?
Yes, doctors recommend X-ray procedures, including CT scans, for people with electronic medical devices for medical reasons. The probability of any issues is extremely low.
If a person has a wearable electronic medical device, such as those discussed later on this page, it should NOT stop health care providers from performing an appropriate, medically necessary imaging procedure, such as a CT scan.
CT scans are useful for health care providers to diagnose medical conditions. CT scans continue to be the preferred imaging technology for people with implantable or wearable medical devices. CT is safer than magnetic resonance imaging (MRI) for people with devices of unknown MRI safety status.
Devices are labeled as unsafe, conditional, or safe for the magnetic resonance (MR) environment. If your device is labeled MR conditional, follow the conditions for safe use. If you do not know the MRI safety status of a device, assume it is not safe to use in the MRI.
The FDA is not aware of any confirmed interference from other imaging technologies such as X-ray, fluoroscopy, angiograms, or mammograms. Still, the recommended precautions on this page should be followed to avoid any potential damage from interference.
What should I know about interference between CT scans and electronic medical devices?
Computed Tomography (CT) is a valuable type of imaging used by health care providers to diagnose certain medical conditions. Most people can get a CT scan without any problems. However, the FDA continues to receive a limited number of reports of issues associated with CT imaging interfering with or damaging some electronic medical devices.
When a wearable electronic medical device is directly exposed to radiation during a CT scan, there may be electronic interference, and the wearable device may be damaged. The FDA’s current understanding is that the interference is caused only when the CT scanner radiation is direct. This means when the CT scanner is imaging the part of the body where the medical device is located. For example, if a CT scan is imaging the stomach, and a device is also on the stomach, interference may happen.
The probability that this interference could cause clinically significant issues is extremely low. The likelihood of damage occurring is lower when the radiation dose and the radiation dose rate are reduced.
What steps should I take to prevent interference during CT scans?
Based on the FDA’s review of available literature, interference is completely preventable when the medical device is outside of the primary imaging area of the CT scanner. Interference can occur when the CT scanner is imaging the part of the body where the medical device is located.
What steps should I take to prevent interference during radiation therapy procedures?
During certain high strength radiation therapy procedures, such as some gamma ray therapies, wearable devices should be removed and left outside of the room. Talk to your doctor about the FDA’s recommendations for wearable devices during high strength radiation therapy procedures.
FDA recommendations for types of electronic devices:
- Wearable diabetes devices (such as insulin pumps and continuous glucose monitors)
- Implantable electronic heart devices (such as pacemakers and implantable cardioverter defibrillators)
- Neurostimulators
Reporting problems to the FDA
If you suspect a problem with your device after using a medical imaging device such as a CT scanner or X-ray machine, please report the problem to the FDA. You can file a voluntary report at MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
- Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
- Medical device manufacturers, distributors, importers, and device user facilities (which include many health care facilities) must comply with the Medical Device Reporting (MDR) Regulations of 21 CFR Part 803.