FDA Issues Interim Recommendations on CT Scans

In a statement this week, Cedars-Sinai said it has already implemented many of the FDA's recommendations following an investigation at the medical center. "The FDA's recommendations are similar to the policy and procedure changes that Cedars-Sinai implemented in September after it identified that brain perfusion CT scans were unexpectedly producing higher than expected levels of X-ray radiation," the medical center said in a media release. "Last month, the California Department of Public Health accepted Cedars-Sinai's policy changes as the medical center's plan of correction in response to the department's investigation of the brain perfusion CT scan equipment issue."

It is still not clear who is to blame for the mishap at Cedars-Sinai. Hospital officials previously said they did not want to shift responsibility for the incident to the CT scanner's manufacturer, General Electric. But in its statement last month, Cedars-Sinai officials said the incident "has raised considerable questions about why the manufacturer-set ‘auto' mA setting for the brain perfusion CT scan delivered a higher than expected level of X-ray radiation, since ‘auto' mA settings in CT and other imaging scanners are generally designed to provide the lowest appropriate level of X-ray radiation."

Cedars-Sinai said that nearby Glendale Adventist Medical Center also "reported a similar problem with GE brain perfusion CT scan equipment where patients received higher than expected levels of X-ray radiation."

GE has denied culpability, saying: "Due to pending litigation, we cannot comment on that, but again, there were no malfunctions or defects in any of the GE Healthcare equipment involved in the Cedars incident."

The state's classification of the event as one involving "immediate jeopardy" means that Cedars-Sinai may be subjected to fines of $25,000 to $50,000. Hospital officials have said that about 40% of 206 patients who received doses of radiation either had patches of hair fall out or redness of skin.

Medical center officials also have said that the additional radiation exposure may have made patients more susceptible to cataracts. The hospital has volunteered to pay for any medical expenses caused by conditions related to their overexposures.