Navigation Links
FDA Working to Prevent Radiation Overdoses During CT Scans

SILVER SPRING, Md., Nov. 9, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has been investigating reports that patients undergoing computed tomography (CT) brain perfusion scans were accidently exposed to excess radiation. The FDA found that when properly used, the CT scanners did not malfunction. Instead, it is likely that the improper use of the scanners resulted in these overdoses. However, the FDA has identified a series or promising steps to enhance the safety of these procedures. These steps could reduce the likelihood of radiation overexposure in the event of improper use of the CT scanners.



The FDA has sent a letter to the Medical Imaging and Technology Alliance (link below), the major professional industry organization for manufacturers of CT scanners and other radiological imaging devices, reporting on the results of the investigation and discussing possible CT equipment enhancements that could improve patient safety.  The agency will hold follow up discussions with manufacturers on the changes.

Those changes include:

  • A console notification to alert the operator of a high radiation dose;
  • Providing particular information and training on brain-perfusion protocols to all facilities that receiving base CT equipment, whether or not the facilities purchase the related software enabling quantitative analysis of cerebral hemodynamics;
  • Clarification of parameters affecting dose, along with clear instructions on how to appropriately set those parameters; and
  • Organization of all dose-related information into one section of each user manual, in a dedicated dose manual, or indexed comprehensively in a concordance covering all manuals.

CT brain perfusion scans produce cross-sectional images of the head that evaluate blood flow in the brain. In an update released today, the FDA discussed findings of a probe into radiation overdoses in patients who received CT brain perfusion scans in hospitals located in California and Alabama.

Begun in 2009, the FDA's investigation included information from the states and facilities where radiation overdoses occurred from 2008 to Oct. 26, 2010. The agency also inspected CT scanner equipment manufacturers.

The probe indicated that CT scanners, when properly used, did not result in overdoses. However, the investigation uncovered potential enhancements to CT equipment that could reduce the likelihood of radiation overexposure if improper use occurs –  a goal of the agency's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.  

"Improving patient safety is part of our public health mission," said Jeffrey Shuren, M.D., director of FDA's Center for Devices and Radiological Health. "Patients should not have to worry that a device designed to diagnose an illness exposes them to unnecessary risks."

Since the investigation began, the FDA is aware of at least 385 patients who received excessive radiation from CT brain perfusion scans, many undergoing the test to confirm the presence of a stroke, performed at five hospitals in California and one in Alabama.

While unnecessary radiation exposure should be avoided, a medically-needed CT scan has benefits that outweigh the radiation risks. Patients should follow their doctor's recommendations for receiving CT scans.

For more information:

Safety Investigation of CT Brain Profusion Scans: Update 12/8/2009

Letter to the Medical Imaging and Technology Alliance

Computed Tomography

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Visit the FDA on Facebook

RSS Feed for FDA News Releases [what is RSS?]

Media Inquiries: Dick Thompson, 301-796-7566,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Concentra Offers Flu Vaccines to Keep America Working
2. Launches STD Social Networking Site Balancing Dating with Online Support Features
3. Alseres Pharmaceuticals, Inc. to Address a Congressional Briefing on Paralysis Research and the Spinal Cord Injury Community at Working 2 Walk in Washington, DC, April 13-15, 2008
4. MTV and SpinVox Partner to Launch First Ever Integrated Voice Powered Cause-Related Social Networking Campaign Stand By What You Say
5. Foundation Venture Capital Group Invests in UMDNJ Company Working to Improve Leukemia Treatments
6. Striking Red Cross Workers Raise Public Awareness of Unsafe Working Conditions
7. North Carolina GlaxoSmithKline Foundation Working With Nonprofits to Promote Health, Science and Education Through Ribbon of Hope Grants
8. American Red Cross of Greater Los Angeles Working With Philips Lifeline Medical Alert Service to Help Seniors Stay Independent
9. Alexza Executes $15 million Working Capital Loan with Hercules Technology Growth Capital, Inc.
10. Data Presented at the European Working Group on Gaucher Disease Demonstrate Continuous Improvements in Bone Mineral Density for VPRIV(R) (Velaglucerase Alfa) Through 69 Months
11. Wound Management Technologies CellerateRX® Activated Collagen™ Debuts at the South African Diabetic Foot Working Group Congress in Cape Town
Post Your Comments:
(Date:11/24/2015)... 24, 2015 Teledyne DALSA , a Teledyne ... technology, will introduce its CMOS X-Ray detector for mammography ... 29 to December 3, at McCormick Place in ... diagnostic and interventional imaging will be on display in the ... of advanced CMOS X-Ray detectors is the industry benchmark for ...
(Date:11/24/2015)... , Nov. 24, 2015  Enova Illumination is ... of Helsinki, Finland to combine ... are at the cutting edge of medical visualization: Enova ... the United States and Novocam ... Together, they provide the world,s most powerful battery-operated LED ...
(Date:11/24/2015)... Nov. 24, 2015  Freudenberg Medical has developed specialty tubing ... outside of medical facilities. Africa ... care is sparse. Nevertheless, prompt diagnosis is important to treat ... the virus. With the help of a portable mini-lab or ... to village in affected areas and perform rapid testing for ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... November 24, 2015 , ... Dehydration, defined as a loss ... to perspiration in the hot sun, and heat stroke and death will quickly follow. ... radio host Sharon Kleyne. Every cell, system and structure requires water to function properly. ...
(Date:11/24/2015)... ... 2015 , ... “I am so thrilled, as a newbie here, to leave a mark for ... $7,500 School Lounge Makeover® from California Casualty . Stephanie is in her fifth year ... much longer tenure. , “This is such an amazing school and we deserve a space ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... and safety labels , has been featured in the American Feed ... exclusively to representing the business, legislative and regulatory interests of the U.S. animal ...
(Date:11/24/2015)... ... ... Add a fresh touch to this year’s holiday festivities with indoor plants ... style and cheer to any space. , Holiday plants are more than just festive ... all year long. , “Holiday plants make a room come alive,” says Justin Hancock, ...
(Date:11/24/2015)... ... , ... On the pleasant autumn morning of November 15, 2015, nearly 130 ... for Autism held at Steep Rock Preserve in Washington, Connecticut. The run, which offers ... triumph. , Created and hosted by The Glenholme School, a special needs boarding and ...
Breaking Medicine News(10 mins):