FDA MedWatch - Interference between Computed Tomography (CT) and Electronic Medical Devices: Notification – Current Understanding of Potential Risk

Interference between Computed Tomography (CT) and Electronic Medical Devices: Notification – Current Understanding of Potential Risk

AUDIENCE: Radiology, Cardiology

ISSUE: FDA has received a small number of reports of adverse events that are believed to be associated with CT imaging of some implantable and wearable electronic devices (eg. insulin pumps, cardiac implantable electronic devices and neurostimulators).

FDAs current understanding is that when a CT scanner directly irradiates the circuitry of certain implantable or wearable electronic medical devices (i.e. when the device is visible in the resulting CT image), it can cause sufficient electronic interference to affect the function and operation of the medical device.

The probability that this interference can cause clinically significant adverse events is extremely low. Furthermore, the probability of x-ray electronic interference is lower when the radiation dose and the radiation dose rate are reduced. Interference is completely avoided when the medical device is outside of the primary x-ray beam of the CT scanner.

BACKGROUND: This information updates and replaces a 2008 Preliminary Public Health Notification.

RECOMMENDATION: The presence of insulin pumps, cardiac implantable electronic devices, and neurostimulators should NOT preclude the performance of an appropriate, medically indicated CT scan. The probability of an adverse event being caused by exposing these devices to CT irradiation is extremely low, and it is greatly outweighed by the clinical benefit of a medically indicated CT examination. See the FDA Notificationfor specific recommendations for Physicians, Radiologic Technologists, and Patients to reduce risk of interference.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the current FDA Notification and previous Preliminary Public Health Notification, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm493739.htm