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  4. Electronic Medical Devices, X-ray Imaging and Radiation Therapy: What to Know and How to Prevent Damage
  5. Preventing Damage to Wearable Diabetes Devices During Imaging and Radiation Procedures
  1. Electronic Medical Devices, X-ray Imaging and Radiation Therapy: What to Know and How to Prevent Damage

Preventing Damage to Wearable Diabetes Devices During Imaging and Radiation Procedures

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Wearable diabetes devices and diagnostic X-ray imaging and radiation therapy

People wear medical devices on the body to treat diabetes. This page refers to wearable diabetes devices such as insulin pumps, continuous glucose monitoring (CGM) devices, and others. 

The FDA continues to receive reports of wearable device malfunctions following diagnostic X-ray imaging, such as X-rays, CT scans, fluoroscopy, and angiograms, as well as following radiation therapy such as for cancer treatment. Interference can occur when the radiation and the device electronics are incompatible, and the resulting damage causes the device to fail to work normally.

Doctors may recommend X-ray imaging or radiation therapy for medical reasons. Except for certain high strength radiation therapy, the chances of a problem happening during these procedures are extremely low. For people with CGM or insulin pumps, most device manufacturers recommend to remove the device and leave it outside of the room before diagnostic X-ray imaging or radiation therapy. The FDA supports these recommendations when it is safe and practical to do so. 

It is important to note that pausing one of these devices may be a greater risk than wearing the device during the imaging or radiation therapy, which is very low risk. This should be part of shared decision making between doctor and patient.

In situations where a device should not be removed during imaging or radiation therapy, the FDA provides the recommendations on this page to help prevent damage to those devices from these procedures. The following recommendations for wearable devices apply to any medical procedure that involves ionizing radiation.

Recommendations for people with wearable diabetes devices

For some high-energy radiation procedures, you should plan to remove your wearable diabetes device before the procedure. Talk to your doctor to see if this situation applies to you. 

Your doctor may recommend X-ray imaging or radiation therapy for medical reasons. Except for certain high strength radiation therapy, the chances of a problem happening during these procedures are extremely low. If you have a CGM or insulin pump, most device manufacturers recommend to remove the device and leave it outside of the room before diagnostic X-ray imaging or radiation therapy. The FDA supports these recommendations when it is safe and practical to do so. 

It is important to note that pausing one of these devices may be a greater risk than wearing the device during the imaging or radiation therapy, which is very low risk. This should be part of shared decision making between you and your doctor.

In situations where a device should not be removed during imaging or radiation therapy, you can help reduce the risk by doing the following:

Before the procedure

  • Tell your doctor that you use a wearable diabetes device. This will help them plan a procedure that minimizes the risks of problems.
  • Bring any components or accessories you need to manage your device (remote controller, display device). Make sure to bring backup therapy options such as your glucose meter and back-up insulin and insulin syringe that you use in case of device problems.
  • Contact your doctor managing your diabetes to make a plan for the day of your scan.
    • Your doctor can help you determine if it is possible to attach the device to an alternative location so that it will be outside the direct path of the imaging or therapy beam.
    • If the device is located inside the area to be imaged or treated and cannot be safely moved, work with your doctor to determine if your device can be safely turned off and for how long. You may not be able to remove the device if the device is stuck to your skin or when the insulin delivery tubing is not long enough.
    • If your doctor decides that the device should be turned off, it will reduce the likelihood of the procedure causing harm to the device. In this case you should follow the advice from your doctor for when to turn off the device before the procedure, and when to turn it back on afterwards. 
    • Before you turn off your device for the duration of the procedure, check your blood glucose level to make sure that it is within the expected range.
    • Follow your doctor’s recommendations for what to do prior to turning off the device.

During the procedure

  • Follow the plan you developed with your doctor.
  • If the device can be safely moved outside the direct beam of radiation without disconnecting it, work with the radiology tech to move the device so it will not be exposed directly to the beam during the procedure.
  • If the device cannot be moved but your doctor has determined that it can be turned off:
    • Follow your doctor’s instructions for turning off the device.
    • Communicate with the radiology tech to minimize the time the device is off; let the tech know the maximum time that your doctor has recommended the device can be turned off.
    • Remember to turn your device back on after the procedure. Follow your doctor’s instructions for restarting the device after a pause in using it.
  • If the device cannot be turned off safely, let the radiology tech know so they can plan imaging that will minimize the risk of damage to the device.
  • If your doctor has made other recommendations, follow those instructions.
  • Tell the radiology tech if you experience symptoms such as lightheadedness or fainting, or if you hear alarm or alert sounds from the device during or right after the procedure.
  • Contact your doctor as soon as possible if you had seizures or passed out during or after the procedure or if you heard alarm or alert sounds from the device.

After the procedure

  • Confirm your device is working correctly. Ensure that it is turned on and it has the correct settings, correct time and date, and other information. Look for any alarms or alerts or error codes.
  • Check your blood glucose level to make sure it is within the recommended range. Follow your doctor’s recommendations for what to do after restarting the device.

Recommendations for doctors ordering a radiation procedure

If a patient has a wearable diabetes device, it should NOT stop you from performing an appropriate, medically indicated procedure. Except for certain high strength radiation therapy, the chances of a problem happening during these procedures are extremely low. If you are treating a patient with a CGM or insulin pump, most device manufacturers recommend to remove the device and leave it outside of the room before diagnostic X-ray imaging or radiation therapy. The FDA supports these recommendations when it is safe and practical to do so.

It is important to note that pausing one of these devices may be a greater risk than wearing the device during the imaging or radiation therapy, which is very low risk. This should be part of shared decision making between you and your patient. 

In situations where a device should not be removed during imaging or radiation therapy, the recommendations below can help reduce risk. For imaging procedures specifically, CT continues to be the preferred tomographic imaging technology for patients with implantable or wearable medical devices. CT is safer than magnetic resonance imaging (MRI) for patients with devices of unknown MRI safety status. 

You should be aware that an MR Conditional device is only safe within the MR environment that matches its conditions of safe use. Any device with an unknown MRI safety status should be assumed to be MR Unsafe.

  • For therapeutic procedures involving photon energies of 10 MV or greater, wearable devices should be removed and left outside of the procedure room.
  • If the radiation exposure from the procedure will cover the area over the wearable device, discuss with the patient whether the device can be safely moved, attached at a different location, turned off and for how long, or if alternative diabetes management is required.
  • Communicate this information to the imaging facility that will be performing the procedure to help them plan for a procedure that will minimize the risk of adverse effects on the function of the device.

Recommendations for radiologists, radiation oncologists, and radiologic technologists

If a patient has a wearable device, it should NOT stop you from performing an appropriate, medically indicated procedure. A doctor may recommend X-ray imaging or radiation therapy for medical reasons. Except for certain high strength radiation therapy, the chances of a problem happening during these procedures are extremely low. If your patient has a CGM or insulin pump, most device manufacturers recommend to remove the device and leave it outside of the room before diagnostic X-ray imaging or radiation therapy. The FDA supports these recommendations when it is safe and practical to do so. 

It is important to note that pausing one of these devices may be a greater risk than wearing the device during the imaging or radiation therapy, which is very low risk. This should be part of shared decision making between doctor and patient. 

In situations where a device should not be removed during imaging or radiation therapy,  the recommendations below can help reduce risk. 

For imaging procedures specifically, CT continues to be the preferred tomographic imaging technology for patients with implantable or wearable medical devices. CT is safer than Magnetic Resonance Imaging (MRI) for patients with devices of unknown MRI safety status. 

You should be aware that an MR Conditional device is only safe with the MR environment that matches its conditions of safe use. Any device with an unknown MRI safety status should be assumed to be MR Unsafe.

Facilities administering a procedure that involves ionizing radiation can use the following recommendations to develop protocols for planned and for urgently needed procedures.

  • For therapeutic procedures involving photon energies of 10 MV or greater, wearable devices should be removed and left outside of the procedure room.
  • If the device can be safely moved during the procedure, work with the patient to move the device so it will not be directly exposed to the primary imaging area and will remain outside of the imaging area throughout the procedure. Note that only the electronics of the device could be affected by ionizing radiation.
  • If the device cannot be safely moved:
    • Ask the patient if it can be safely turned off during the procedure and for how long.
    • Set a timer and remind the patient to turn their device back on after the procedure and to check it for proper function.
  • If you cannot determine that a device can be safely moved or turned off, use the following recommendations to reduce risk of potential problems between the radiation source and the device:
    • While setting up CT scans and other prolonged imaging procedures (for example: angiograms, fluoroscopy), identify the device location relative to the planned imaging range using radiograph images (for example: scout or localizer views). Note: radiograph scans have not been associated with X-ray interference with electronic medical devices.
    • If possible, avoid including the device inside the region to be imaged or treated. For imaging procedures, it is important to ensure that the prescribed anatomy is imaged so that the necessary diagnostic information is obtained. Confirm the required anatomic range with the supervising radiologist.
    • For procedures where the device is located within the programmed scan range and cannot be safely moved or turned off, minimize direct radiation exposure to the electronics of the device by using:
      • the lowest dose needed for an imaging procedure, or consistent with the needed level of diagnostic image quality and
      • a lower dose delivery rate, as consistent with the As Low As Reasonably Achievable (ALARA) principle. For CT scans this can be accomplished by using a longer rotation time or lower pitch value, if appropriate for the ordered CT exam.
      • Medical procedures that would involve direct irradiation of the electronics of the device for more than several seconds require additional care and should not be performed unless the device can be safely relocated or turned off. Examples of these scans are CT perfusion exams or interventional procedures such as CT fluoroscopy. If moving or turning the device off is not possible and the scan is urgently needed, careful monitoring of the device during and after the procedure is required. 
  • Be mindful that interference is possible and be ready to terminate the scan if the patient experiences adverse symptoms. Although adverse symptoms are rare, they could include alarm sounds from the device, lightheadedness, fainting, seizures and loss of consciousness.

Recommendations for doctors managing the patient’s diabetes and insulin pump use

If a patient has a wearable device, it should NOT stop you from performing an appropriate, medically indicated procedure. Except for certain high strength radiation therapy, the chances of a problem happening during these procedures are extremely low. If you are treating a patient with a CGM or insulin pump, most device manufacturers recommend to remove the device and leave it outside of the room before diagnostic X-ray imaging or radiation therapy. The FDA supports these recommendations when it is safe and practical to do so. 

It is important to note that pausing one of these devices may be a greater risk than wearing the device during the imaging or radiation therapy, which is very low risk. This should be part of shared decision making between you and your patient.

In situations where a device should not be removed during imaging or radiation therapy, the recommendations below can help reduce risk. 

For imaging procedures specifically, CT continues to be the preferred tomographic imaging technology for patients with implantable or wearable medical devices. CT is safer than magnetic resonance imaging (MRI) for patients with devices of unknown MRI safety status. 

You should be aware that an MR Conditional device is only safe within the MR environment that matches its conditions of safe use. Any device with an unknown MRI safety status should be assumed to be MR Unsafe.

  • If a patient is scheduled for a therapeutic procedure that will use photon energies of 10 MV or greater, they should not wear their device during the procedure. Work with them to develop a plan to safely manage their diabetes without this device during the procedure. 
  • If a patient is scheduled for a procedure that will expose them to ionizing radiation, work with them to determine a location to attach the device so that it will be outside the direct path of the radiation beam.
  • If the device cannot be moved or attached to a location outside the direct path of the radiation beam, determine whether it can be safely turned off and for how long. Communicate this information to the facility that will be performing the procedure so that staff can work with the patient to minimize the probability of an adverse effect related to the device. If the device will be turned off, work with the patient to develop a plan to safely manage their diabetes without this device during the procedure.
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