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FDA Addresses Radiation Dangers

Posted by Jane Akre
Thursday, February 11, 2010 2:34 PM EST
Category: Major Medical
Tags: CT Scans, Radiation, Cedars-Sinai, General Electric, New Englanld Journal of Medicine, Breast Cancer

The FDA addresses CT scan safety and dangers by requiring some standards.



Cecelia Lucas, 37, of Marietta, Georgia was involved in a head-on car accident in March, 2009.

Rushed to the nearby hospital, Lucas had a CT scan before she was transferred to another hospital where she had at least one more CT scan to determine the extent of the injury.

CT or computed tomography, is a medical imaging procedure that uses ionizing radiation to allow doctors to see cross-sectional images or ‘slices’ of the areas of the body.

Doctors found Lucas had a fracture of the second vertebrae. Surgery was not an option so instead, she was fitted for a halo to allow her neck to stay in place while it healed.

During the three months she wore it, Lucas had multiple CT scans. One the day of the removal of the halo, she was given two CT scans of the affected area within 30 minutes of each other.

By December of 2009, Cecelia Lucas was diagnosed with invasive ductile carcinoma. Two weeks ago she had a double bilateral mastectomy.

Her husband John tells IB News that he believes his wife’s overexposure may have caused her breast cancer.

“She is 37, a non-smoker, with no documented cases of breast cancer on either side of her family. I know that it happens to plenty of women in the same situation, but there is no doubt that she was overexposed to radiation based on simple logic.”

Lucas believes that the lightweight metal used to hold the halo in place, may have served as strong conductors to deliver radiation to his wife's chest in the same area where the cancer was found.

Exposure to radiation from a CT scan is equal to 300 normal chest X-rays. Lucas says his wife had enough radiation to equal 600 chest X-rays within 30 minutes.

The FDA reports that medical imaging that exposes patients to ionizing radiation can increase a person’s lifetime cancer risk.

FDA Action On Radiation Safety

This week the Food and Drug Administration launched an initiative to impose new safety controls on imaging devices. The agency will promote a personal medical imaging history card that allows a patient to keep track of the number of images they receive and the amount of radiation received over time. Developing more precise dosing standards may reduce unnecessary exposure to radiation.

The push follows revelations from patients at Cedars-Sinai Medical Center in Los Angeles who began losing their hair after receiving radiation from CT brain scans. The Los Angeles Times reports that 260 patients were accidentally exposed to more than eight times the normal dose of radiation over 18 months.

Other Los Angeles area hospitals and one in Huntsville, Alabama reported similar possible overdoses to at least 104 people.

In those cases, it's believed operators manually overrode settings to deliver a clearer image. The FDA will consider requiring the identification of any operator who manually re-calibrates any machine as well as determining an automatic calibration for any given procedure.

FDA Doesn't Go Far Enough 

The FDA will hold public meetings March 30 and 31 to consider formulating a voluntary national database to pre-determine the recommended optimal dosage for any given procedure. Further suggestions will be solicited about training requirements for operators of the CT and fluoroscopic devices.

Critics believe the review doesn’t go far enough. Estimates are that up to one-third of the 70 million CT scans performed in the U.S. each year are unnecessary. While the use of CT scans has more than tripled since 1995.

A 2007 study published in the New England Journal of Medicine reports that the estimated use of CT scans from 1991 through 1996 likely contributed to 0.4% of all cancers in the United States. Adjusting the estimate to current CT use is estimated to put the risk of cancer in the range of 1.5 to 2.0%, depending on the dose delivered and absorbed.

Scans are frequently used by medical personnel in emergency rooms to diagnose a head injury or kidney stones then repeated as part of a routine follow-up when a patient is transferred.

Standards Now? Talk To Your Doctor

While an imaging history card in the hand of a patient could keep them safe from multiple, cumulative exposures, currently the FDA encourages patients to talk with their doctors about the “medical need and associated risks for each procedure.”

Lucas says, “With all of the technology out there, I would think there was some safety incorporated into the machines. Once the patient is entered and identified, there should be some sort of safety standard so the machine wouldn’t allow you to have another CT scan. Obviously it’s not there.”#

1 Comment

Anonymous User
Posted by dana
Saturday, February 13, 2010 2:54 PM EST

While there is reason to ensure that CT scans are medically necessary and that equipment does not deliver excess radiation, DCIS would not develop within months of exposure and was likely already present - there are other causes of cancer and for breast cancer an estrogen mimic in the environment would be a more likely cause

Comments for this article are closed.

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