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FDA Urges CT Scan Makers to Make Safety Changes

Nov 9, 2010 | Parker Waichman LLP

US health regulators are urging the manufacturers of CT scan machines to implement two recommendations to lessen the likelihood that patients undergoing the procedures could be exposed to radiation overdoses. According to The New York Times, the recommendations are included in two documents the Food & Drug Administration (FDA) will release today.

The risk of CT scan radiation overdoses was made apparent late last year, when the FDA issued an alert and announced it was investigating such cases at a half dozen hospitals around the country, including Cedar-Sinai Medical Center in Los Angeles, Providence Saint Joseph Medical Center in Burbank, Glendale Adventist Medical Center in California, and Alabama’s Huntsville Hospital. The agency found that at least 385 patients who received excessive radiation from CT brain perfusion scans, many undergoing the test to confirm the presence of a stroke, had received excess radiation. 

According to the FDA alerts, machines involved in the botched CT scans, made by General Electric and Toshiba, had been wrongly calibrated and subjected patients who underwent brain perfusion scans following a stroke to excessive doses of radiation. The CT scan machines had been set at the higher level for 18 months, but went undetected. It wasn’t until patients began complaining of hair loss and skin reddening that the error was found.

The FDA investigation found that equipment failure played no role in the overdoses. According to The New York Times, the agency has now concluded that manufacturers of CT scanners should do a better job of training and educating those who use their equipment, and that the machines themselves could be made safer by warning operators that a dangerously high radiation dose is about to be administered. The FDA sent a letter Monday to the Medical Imaging Technology Alliance, spelling out its recommendations, the Times said.

The agency said that it hoped to discuss its recommendations with CT scan machine manufacturers at the end of this month, and that it expected the companies to act on at least some of them, the Times said.


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