Navigation Links
FDA Makes Interim Recommendations to Address Concern of Excess Radiation Exposure during CT Perfusion Imaging
Date:12/7/2009

SILVER SPRING, Md., Dec. 7 /PRNewswire-USNewswire/ -- As part of an ongoing investigation into cases of excess radiation during CT perfusion imaging of the brain, the U.S. Food and Drug Administration today provided imaging facilities and practitioners with interim recommendations to help prevent additional problems.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The FDA issued an initial safety notification in October after learning of 206 patients who had been exposed to excess radiation at Cedars-Sinai Medical Center in Los Angeles over an 18-month period.

Since then, the FDA, working with state and local health authorities, has identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans. These cases so far involve more than one manufacturer of CT scanners. The FDA has also received reports of possible excess radiation from other states. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer.

On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure. These recommendations apply to all CT perfusion images, including brain and heart, because they use similar procedures and protocols.

These recommendations include:

  1. Facilities assess whether patients who underwent CT perfusion scans received excess radiation.
  2. Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study.
  3. Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
  4. Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient.
  5. If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study.

The FDA continues to work with manufacturers, professional organizations, and state and local public health authorities to investigate the scope and causes of these excess exposures.

The agency is also advising manufacturers to review their training for users, reassess information provided to health care facilities, and put into place new surveillance systems to identify problems quickly.

"The FDA is making progress in the investigation of this problem," said Jeffrey Shuren, M.D., acting director of the FDA's Center for Devices and Radiological Health. "While we do not know yet the full scope of the concern, facilities should take reasonable steps to double-check their approach to CT perfusion studies and take special care with these imaging tests."

CT or CAT scanning refers to computed tomography, a form of medical imaging that uses X-rays to produce 3-dimensional images to help physicians diagnose and treat medical conditions. CT perfusion scans evaluate blood flow in various organs such as the brain and the heart.

Patients should follow their doctor's recommendations for receiving CT scans. Medically necessary CT scans, administered properly, can provide important health information to guide diagnosis and treatment. Patients who have undergone a CT perfusion scan and have questions regarding radiation exposure should speak with their doctor.

The FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If an adverse event is identified, health care professionals should follow the reporting procedures at their facility. Report these directly to the device manufacturer or to MedWatch, the FDA's voluntary reporting program. This can be done on-line by filing a voluntary report, by phone at 1-800-FDA-1088, or by obtaining the fillable form online, print it and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

CT Brain Perfusion Scans Safety Investigation: Initial Notification

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. RSV Researcher Makes Gains in Finding Treatments
2. Resveratrol Longevity Science Makes Dramatic U-Turn, But Resveratrol Supplements Remain Unchanged
3. Susan G. Komen for the Cure(R) Makes Unprecedented Research and Local Program Grants
4. Unexpected Side Effect: Makes You Happier
5. FDA Advisory Panel Makes Favorable Recommendation for GlaxoSmithKline and Genmabs ARZERRA(TM) (ofatumumab)
6. Brain Fitness Makes Boomers Age Younger
7. New Reconstruction Method Makes Speaking, Eating Possible After Tonsil Cancer Surgery, U-M Study Shows
8. West Physics Consulting Makes the 2009 Inc. 5000 List
9. FUJIFILMs DR-based FFDM System Makes US Debut at RSNA
10. FUJIFILMs DR Cassette Makes World Debut
11. BSGI Makes Significant Impact on Detection of Breast Cancer in Patients with Negative Mammographic Findings
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... Oct. 12, 2017 West Pharmaceutical Services, ... solutions for injectable drug administration, today announced that it ... opens on Thursday, October 26, 2017, and will follow ... business expectations at 9:00 a.m. Eastern Time. To participate ... (International). The conference ID is 94093362. ...
(Date:10/11/2017)... , Oct. 11, 2017  Hill-Rom Holdings, Inc. ("Hill-Rom") ... Surgical facility in Las Piedras, Puerto Rico ... and blades. ... the facility sustained minor structural damage, temporary loss of ... Repairs have been completed, manufacturing operations have resumed, and ...
(Date:10/5/2017)... ROSEMONT, Ill. , Oct. 5, 2017 /PRNewswire-USNewswire/ ... American Association of Oral and Maxillofacial Surgeons (AAOMS) ... than opioids – to be used as a ... post-surgical pain. ... relationship, the AAOMS White Paper "Opioid Prescribing: Acute ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... ... Asante, a nationally recognized health system in southern Oregon, ... health joint venture through an agreement, effective October 1, 2017, to create AccentCare ... company with Asante, delivering clinically integrated care, for the past eight years. This ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... Restoration, has recently contributed a medical article to the newly revamped Cosmetic ... Mohebi’s article spotlights the hair transplant procedure known as Follicular Unit Extraction ...
(Date:10/12/2017)... ... 12, 2017 , ... Leading pediatric oncology experts at Children’s National Health ... Congress of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired ... Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., Chief ...
(Date:10/12/2017)... GRAND RAPIDS, Mich. (PRWEB) , ... October 12, ... ... OnSite Wellness, has been named one of Michigan’s 2017 Best and Brightest in ... Best and Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 ...
(Date:10/12/2017)... BALTIMORE (PRWEB) , ... October 12, 2017 , ... ... average of $3,296 in property taxes a year. In some states—like New York, ... higher. , By contrast, many overseas retirement havens have extremely low property-tax rates, ...
Breaking Medicine News(10 mins):