Cedars-Sinai Medical Center of Los Angeles said Monday that in reviewing the cases of patients who received eight times normal doses of radiation during CT brain perfusion scans, it appears some patients have an enhanced risk of developing cataracts.
In making that statement yesterday, Cedars-Sinai officials say they are offering to pay bills for future medical care if needed "should the CT brain perfusion scans cause any specific health problem."
Also, hospital officials acknowledged, "260 patients were affected, up from the initial finding of 206," over the course of an 18-month period that ended in August.
In letters sent yesterday, Cedars-Sinai officials told patients that approximately 20% of affected patients had exposure directly to the lens of their eyes from the radiation.
In a statement, Cedars-Sinai officials said that those letters "told those patients of the finding (of risk to the lens) and informed them that they may be at risk for developing cataracts sooner than they would have normally, had the scan delivered the appropriate amount of X-ray radiation."
The statement continued: "Cedars-Sinai said it will pay for treatment if there are cataracts caused by the unexpected X-ray levels of the scan."
The letter, signed by Cedars-Sinai Medical Center's chief operating officer and chief medical officer, apologized to the patients, and offered the medical center's "ongoing commitment" to being available to the patients "now and at any time in the future to answer any questions or concerns about your healthcare." It also noted the incident was "completely unacceptable to all of us."
It continued, "We have a responsibility to do right by our patients, so we are committed to addressing their needs by providing information and resources as we continue to investigate the scanning equipment issues," wrote Mark Gavens, Cedars-Sinai's COO.
The U.S. Food and Drug Administration and officials for the state Department of Public Health are investigating the incident. In October, the FDA issued an interim alert to hospitals throughout the country saying the overexposure "may not be isolated to this particular facility or this imaging procedure."
Cedars-Sinai has since changed its scanning procedures.
The overdose came to light after one patient who received an excessive dose of radiation during a 64-slice CT brain perfusion scan for a suspected stroke reported reddening of the skin and a loss of hair in August.
A later review of other patients who had undergone the scan determined that as many as 40% of the patients who received the scans reported experiencing symptoms, such as the loss of patches of hair, from the overexposure.
Since the incidents came to light on Oct. 11, an attorney representing one of the patients has filed a class action lawsuit against the hospital.
In turn, Cedars-Sinai CEO Tom Priselac sent a number of recommendations to the FDA suggesting changes in the scanner's design to prevent a recurrence.
The scanner was manufactured by General Electric, which issued this statement on Oct. 20: "Although GE Healthcare continues its internal investigation, we confirm that there were no malfunctions or defects in any of the GE Healthcare equipment involved."