Navigation Links
FDA Working to Prevent Radiation Overdoses During CT Scans
Date:11/9/2010

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.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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, dick.thompson@fda.hhs.gov

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. PositiveFriends.com 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:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... , May 26, 2016 ... Associated With Both Cost Savings and Overall ... plc (LSE: BTG), an international specialist healthcare company, ... at the 21st Annual Meeting of ISPOR (International ... treatment of hepatocellular carcinoma (HCC) using yttrium-90 glass ...
(Date:5/25/2016)... FDA 510(k) clearance covers ... for urological and surgical applications Mauna ... Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, ... US with the 12 th 510(k) clearance ... This new FDA clearance covers Confocal Miniprobes indicated ...
(Date:5/25/2016)... GERMANTOWN, Maryland , May 25, 2016 /PRNewswire/ ... Frankfurt Prime Standard: QIA) today announced that the company has ... GmbH to develop and commercialize predictive assays in oncology. An ... a marker to predict effectiveness of anthracycline treatment in triple ... are pleased to partner with Therawis, which developed the PITX2 ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... ... The Lung Institute has partnered with the Gulfcoast North Area ... at their clinic in downtown Tampa. The class is complimentary for the public. Register ... a free downloadable 4 Week Smoking Cessation Guide for those who are ...
(Date:5/26/2016)... ... 26, 2016 , ... American orthopedic surgeon and internationally recognized ... Horizon International (BHI), Brian Mehling, M.D., spoke at an International Conference and Expo ... in Chicago, IL, USA. Dr. Mehling’s presentation was focused on stem cell therapy ...
(Date:5/26/2016)... TN (PRWEB) , ... May 26, 2016 , ... ... fitness education and products recently hosted the first PowerWave Instructor Certification Course in ... who lead a group of fitness professional through the 8 hour interactive course ...
(Date:5/26/2016)... ... 2016 , ... On May 23rd during the National Eye Institute’s “Healthy Vision ... advocate, was honored by Ashram, Inc. as the world’s foremost water visionary. , “Sharon ... banks of the Nile to fill their red clay pots with life-sustaining water.” Said ...
(Date:5/26/2016)... ... May 26, 2016 , ... Workrite Ergonomics ... leadership and to further develop their rapidly expanding portfolio of customer and end ... a concentration in Marketing and an M.B.A. with concentration in management from Bryant ...
Breaking Medicine News(10 mins):