News | July 15, 2008

FDA Issues Warning on CT Scans

July 16, 2008 - Earlier this week, the FDA released a notification that the X-rays used during a CT examination may cause some implanted and external electronic medical devices to malfunction.

The devices include cardiac pacemakers, defibrillators, neurostimulators, external drug infusion pumps, cochlear implants and retinal implants.

According to the FDA statement, this type of interference might be reported more frequently because of the increased utilization of CT, the higher dose-rate capability of newer CT machines, an increase in the number of patients with implanted and externally worn electronic medical devices and better reporting systems.

Among the adverse events reported include unintended “shocks” (i.e., stimuli) from neurostimulators, malfunctions of insulin infusion pumps and transient changes in pacemaker output pulse rate.

The FDA recommends that before a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range.

For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should:

-Determine the device type

-Try to move external devices out of the scan range, if practical

-Ask patients with neurostimulators to shut off the device temporarily while the scan is performed

-Minimize X-ray exposure to the implanted or externally worn electronic medical device by: using the lowest possible X-ray tube current consistent with obtaining the required image quality; and making sure that the X-ray beam does not dwell over the device for more than a few seconds.

The FDA requested clinicians submit reports of any adverse events related to the CT and implanted or external electronic devices via www.fda.gov/MedWatch/report.htm or by calling 1-800-FDA-1088.

For more information: www.fda.gov/cdrh/safety.html.

Related Content

Hospital for Special Surgery Invests in Sectra Orthopedic 3-D Planning Software
News | Orthopedic Imaging | January 18, 2018
January 18, 2018 – International medical imaging IT and cybersecurity company Sectra announces that Hospital for Spec
Philips Introduces Technology Maximizer Program for Imaging Equipment Upgrades
Technology | Imaging | January 17, 2018
January 17, 2018 — Philips recently announced the launch of Technology Maximizer, a cross-modality program designed t
Fat Distribution in Women and Men Provides Clues to Heart Attack Risk
News | Women's Health | January 11, 2018
January 11, 2018 – It’s not the amount of fat in your body but where it is stored that may increase your risk for hea
Minimally Invasive Treatment Provides Relief from Back Pain

Lumbar spine MRI showing disc herniation and nerve root at baseline and one month after treatment

News | Interventional Radiology | January 11, 2018
The majority of patients were pain free after receiving a new image-guided pulsed radiofrequency treatment for low back...
Emergency Radiologists See Inner Toll of Opioid Use Disorders

Rates of Imaging Positivity for IV-SUDs Complications. Image courtesy of Efren J. Flores, M.D.

News | Clinical Study | January 11, 2018
January 11, 2018 – Emergency radiologists are seeing a high prevalence of patients with complications related to opio
CT Shows Enlarged Aortas in Former Pro Football Players

3-D rendering from a cardiac CT dataset demonstrating mild dilation of the ascending aorta.

News | Computed Tomography (CT) | January 11, 2018
Former National Football League (NFL) players are more likely to have enlarged aortas, a condition that may put them at...

Size comparison between 3-D printed prosthesis implant and a penny.

News | 3-D Printing | January 11, 2018
January 11, 2018 — Researchers using...
BlueCross BlueShield Companies in Eight States Issue Positive Medical Policies for HeartFlow FFRct Analysis
News | CT Angiography (CTA) | December 28, 2017
HeartFlow Inc. announced that Health Care Service Corp. (HCSC), which operates Blue Cross and Blue Shield plans in five...
Artificial intelligence was the number one topic in radiology in 2017.

Artificial intelligence was the number one topic of interest in radiology in 2017, based on the most popular articles and videos on ITN in 2017.

Feature | Imaging | December 28, 2017
The Imaging Technology News (ITN) website had another record year with more than 1.25 million page views in 2017.
Median Technologies Collaborating With Chinese Hospital for Lung Cancer Screening Programs. Dave Fornell
News | Lung Cancer | December 22, 2017
Median Technologies recently announced a research collaboration agreement with Xingtai People's Hospital, Xingtai City...
Overlay Init