CT Scan Makers to Install Safety Controls

The Medical Imaging & Technology Alliance, a medical imaging trade group, just announced that <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">CT scanner manufacturers will initiate installation of safety controls to better ensure patients do not receive excess radiation, reported the Associated Press (AP).

In October, the Food & Drug Administration (FDA) announced it was investigating CT scan overdoses. The FDA probe was launched after Cedars-Sinai Medical Center in Los Angeles confirmed that 206 patients mistakenly received eight times the regular dose of radiation during CT brain scans. The machine at Cedars-Sinai had been set at the higher level since February 2008, but the mistake had not been detected for 18 months. According to the Medical Center, the overdoses were discovered in August, when a patient reported hair loss.

The dosing checks are scheduled to begin before year-end and are meant to let scan operators know when the devices exceed the recommended safety levels, said the AP, adding that facilities will also be able to set maximum levels. The Alliance announcement followed an FDA announcement that it would be looking into the issue with excessive scan radiation, said the AP, and came one day prior to a Congressional hearing on imaging scanner safety. The five CT scanner manufacturers—General Electric Co., Siemens, Toshiba Corp., Royal Philips Electronics, and Hitachi—will be implementing the changes, said the AP.

Three hospitals in California reported hundreds of “acute radiation overdoses” in 2009 that left patients with lost hair and redness of the skin as a result of CT scanning, according to the AP.

Recently we wrote that a woman who may have received a botched CT brain scan at a Huntsville, Alabama hospital filed suit against GE Healthcare, the maker of the scanner used in her procedure. The class action lawsuit, filed in U.S. District Court in Alabama, claims the GE Healthcare CT scanner lacked safety features to warn of radiation overdoses.

Just prior, the FDA released interim results of an investigation into the issue of CT scan radiation overdoses. Its investigation found, in addition to the cases at Cedars-Sinai, at least 50 additional patients exposed to excess radiation of up to eight times the expected level during their CT brain scans. According to a prior AP report, those incidents occurred at Glendale Adventist Medical Center and Providence St. Joseph Medical Center in Burbank, California. Some reports have also been received from Huntsville Hospital in Alabama.

To date, all the radiation overdose cases involve more than one manufacturer of CT scanners. The FDA has not yet determined if the overdoses were the result of human error or an equipment problem. One patient claimed to have lost her balance, had memory problems, and lost hair. Her lawsuit claims GE Healthcare “carelessly researched the design and failed to adequately test” its products, and that the scanners lacked safety features to warn of overdoses.

The AP pointed out that total radiation exposure had about doubled in the past 30 years, with much of the blame linked to next-generation imaging testing, according to the AP. Other scanners and nuclear imaging machines, are being looked at said the AP.

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