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, 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

Researchers Awarded 2018 Canon Medical Systems USA/RSNA Research Grants
News | Radiology Imaging | November 13, 2018
The Radiological Society of North America (RSNA) Research & Education (R&E) Foundation recently announced the...
The Fujifilm FCT Embrace CT System displayed for the first time at ASTRO 2018.
360 Photos | 360 View Photos | November 07, 2018
Fujifilm's first FDA-cleared compu...
MaxQ AI Receives FDA Clearance for Accipio Ix Intracranial Hemorrhage Platform
Technology | Artificial Intelligence | November 07, 2018
MaxQ AI announced that its Accipio Ix intracranial hemorrhage (ICH) detection software has received 510(k) clearance...
GE Healthcare Discovery RF Gen 2 system displayed at ASTRO 2018. It is a dedicated computed tomography (CT) scanner for radiation oncology
360 Photos | 360 View Photos | November 07, 2018
This is the GE Healthcare Discovery RF Gen 2 system displayed at the ...
Results of the vertebrae-based analysis (383 vertebrae in 34 patients) for detection of BME.

Results of the vertebrae-based analysis (383 vertebrae in 34 patients) for detection of BME.

Sponsored Content | Case Study | Computed Tomography (CT) | November 06, 2018
The following is a summary of a study published in the
The NeuViz 16 Essence from Neusoft Medical Systems.

The NeuViz 16 Essence from Neusoft Medical Systems.

Feature | Computed Tomography (CT) | November 05, 2018 | By Melinda Taschetta-Millane
According to an industry mark...
Carestream Spotlights Healthcare IT and Imaging Systems at RSNA 2018
News | Information Technology | October 31, 2018
Carestream announced it will be displaying several imaging and healthcare information technology (IT) offerings at the...
IMRIS, Siemens Strengthen Collaboration in Hybrid OR Neurosurgical Market
News | Hybrid OR | October 24, 2018
IMRIS, Deerfield Imaging, in partnership with Siemens Healthineers, announced a strengthened collaboration to advance...
Fujifilm Unveils FCT Embrace CT System for Oncology
Technology | Computed Tomography (CT) | October 23, 2018
Fujifilm Medical Systems U.S.A. Inc. recently introduced the FCT Embrace computed tomography (CT) system. Powered by...
The Aquilion Precision CT system from Canon offers very high resolution imaging, which may aid in cancer detection and improved treatment planning in radiation oncology. #ASTRO2018 #ASTRO #ASTRO18

The Aquilion Precision CT system from Canon offers very high resolution imaging, which may aid in cancer detection and improved treatment planning in radiation oncology. 

News | Computed Tomography (CT) | October 19, 2018
October 19, 2018 – At the 2018 American Society of...