News | Computed Tomography (CT) | April 13, 2016

FDA Warns of Interference Between CT Scans and Electronic Medical Devices

Agency says while device operation could be impacted, risk of clinically significant adverse events is extremely low

computed tomography, CT scans, electronic medical devices, interference, FDA

April 13, 2016 — The U.S. Food and Drug Administration (FDA) has received a small number of reports of adverse events that are believed to be associated with computed tomography (CT) imaging of some implantable and wearable electronic devices. These include insulin pumps, cardiac implantable electronic devices and neurostimulators.

The agency’s 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.

FDA said 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.

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.

For more information: www.fda.gov

Related Content

SCCT Releases New Guideline for CT Use During TAVR
News | Computed Tomography (CT) | January 08, 2019
The Society of Cardiovascular Computed Tomography (SCCT) has released a new expert consensus document for computed...
A CT calcium scoring image showing calcified plaques in coronary vessel segments. The higher the calcium content of the vessels, the high risk the patient is for a heart attack event. CAC exam

A CT calcium scoring image showing calcified plaques in coronary vessel segments. The higher the calcium content of the vessels, the higher risk the patient is for a heart attack event. Image courtesy of Canon Medical Systems.

Feature | Computed Tomography (CT) | October 17, 2018 | Dave Fornell, Editor
A picture is worth a thousand words, and to patients concerned about their health, detailed images of the coronary an
Abdominal Aortic Calcification May Signal Future Heart Attack

Image from computed tomography (CT) colonography shows segmented abdominal aortic calcification measured with semiautomated CT tool on coronal image. Within region of interest over aorta selected by user, tool automatically segments and quantifies aortic calcification (shown in blue). 

Image Credit: O’Connor S D, Graffy P M, Zea R, et al. Does nonenhanced CT-based quantification of abdominal aortic calcification outperform the Framingham Risk Score in predicting cardiovascular event sin asymptomatic adults? Radiology doi: 10.1148/radiol.2018180562. Published online Oct. 2, 2018. © RSNA.

News | Computed Tomography (CT) | October 12, 2018
Computed tomography (CT)-based measures of calcification in the abdominal aorta are strong predictors of heart attacks...
Siemens Healthineers Announces First U.S. Install of Somatom go.Top CT
News | Computed Tomography (CT) | September 17, 2018
September 17, 2018 — The Ohio State University Wexner Medical Center in Columbus recently became the first healthcare
Key Patient Preparations for a CT Scan
News | Computed Tomography (CT) | September 05, 2018
The Center for Diagnostic Imaging (CDI) in Miami recently released a list of important preparations patients should...
Videos | Computed Tomography (CT) | July 25, 2018
A discussion with Patricia Dickson, LRT(CT), director of imaging and outpatient services, Capital Cardiology Associat
Videos | Computed Tomography (CT) | July 23, 2018
Ed Nicol, M.D., FSCCT, MBA, head of cardiac CT, Royal Brompton Hospital, London, and chair of the Society of Cardiova
Videos | Computed Tomography (CT) | July 17, 2018
An interview with Patrick Serruys, M.D., Ph.D., Imperial College London, principal investigator of the SYNTAX III Tri
Overlay Init