FDA says 50 more patients exposed to dangerous radiation at Los Angeles hospital

FDA: more dangerous brain scans at LA hospital

WASHINGTON — Federal health regulators have identified 50 more patients exposed to dangerous radiation levels from brain scans at a hospital in Los Angeles.

The Food and Drug Administration said Monday more than 250 patients at Cedars-Sinai Medical Center have received dangerous CT scans in the last 18 months. The brain scans are used to diagnose strokes.

The agency reported in October that more than 200 patients at the hospital had received up to eight times the level of radiation expected during their scans.

FDA officials say it’s unclear whether the problems are being caused by human error or a problem with CT equipment.

A spokeswoman for the hospital had no immediate comment Monday afternoon.

Cedars-Sinai uses a scanner from General Electric. But FDA officials have reported problems at other hospitals using different brands of scanners, including models from Toshiba.

GE spokesman Arevind Gopalratnam said Monday that “there were no malfunctions or defects in any of the GE Healthcare equipment involved.” He added that the company is cooperating with the FDA’s investigation.

FDA officials told reporters they also are investigating 14 reports of excess radiation at Glendale Adventist Medical Center and an unspecified number of problems at St. Joseph Medical Center in Burbank, Calif.

Spokesmen for both hospitals had no immediate comment.

The agency also is investigating similar reports from other states.

The FDA urged all hospitals and medical facilities to review radiation dosing guidelines to make sure procedures are followed for each scan. Officials also have advised manufacturers to review their training for CT scanner operators.

“While we do not know yet the full scope of concern, the facilities should take reasonable steps to double-check their approach to CT perfusion studies and take special care with these imaging tests,” said Dr. Jeffrey Shuren, acting director of FDA’s Center for Devices and Radiological Health.

The average American’s total radiation exposure has nearly doubled since 1980, largely because of CT scans, according to recent studies. Medical radiation now accounts for more than half of the population’s total exposure; it used to be just one-sixth.

CT scans became popular because they offer a quick, relatively cheap and painless way to get three-dimensional pictures so detailed they give an almost surgical view into the body. Doctors use them to evaluate trauma, belly pain, seizures, chronic headaches and other woes.