FDA Fears Patient Radiation Overexposure from CT Brain Perfusion Scans Widespread
The U.S. Food and Drug Administration (FDA) released a notification to hospitals, CT scan facilities and medical professionals on October 8, 2009 encouraging every facility performing CT imaging to review its CT protocols and be aware of the dose indices normally displayed on the control panel. Although not named specifically, the notification was prompted by the report of radiation overexposures during CT scans at Cedars-Sinai Medical Center.
After a stroke patient complained of hair loss after a CT scan in August 2009, Cedars-Sinai investigated and found that over an 18-month period from February 2008 until August 2009, 206 patients at the facility received radiation doses that were approximately eight times the expected level. The radiation overexposure caused temporary hair loss in about 40% of the patients and many experienced reddening of the skin. Radiation exposure is linked to cancer.
A Cedars-Sinai Medical Center statement says the incidents happened during CT brain perfusion scans used in urgent situations, such as suspected strokes, to identify the extent of possible blood flow problems in the brain. An iodine solution injected into the patient is visible in the CT scans, which are like a series of highly detailed x-rays, to track blood flow in the brain.
Cedars-Sinai officials said the radiation overexposures were the result of a 2008 error when the hospital reset the CT scanner to override the manufacturer’s pre-programmed instructions to use a new protocol. Doctors thought the new protocol would result in more useful data during the specialized type of scan used to detect strokes. Once the machine was reset, it used the new protocol for all consecutive scans of that type.
“While this event involved a single kind of diagnostic test at one facility, the magnitude of these overdoses and their impact on the affected patients were significant. This situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure (CT brain perfusion),” said the FDA notification. The FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices.
The manufacturer of the scanner, GE Healthcare, said in a statement, “There were no malfunctions or defects in any of the GE Healthcare equipment involved in the incident.” The statement also said, “GE Healthcare CT products require that: 1) users carefully evaluate user-defined scanning protocols against the validated protocols that are provided on the scanners during installation, 2) like dose recommendations for drugs, the recommended dose for a prescribed medical imaging scan is an important clinical decision that should be made by a licensed professional in the context of healthcare delivery.”
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