Following the radiation overdoses that 260 patients received at Cedars-Sinai Medical Center last October, the U.S. Food and Drug Administration (FDA) released a series of proposals designed to address problems with CT scan machines.

The proposals stem from an FDA investigation into the CT scan machines used at Cedars-Sinai and other hospitals throughout the United States, and seek to clarify the procedures used for administering radiation during different types of CT scans. The patients at Cedars-Sinai received eight times the regular dosage of radiation during a procedure known as a brain perfusion scan. The overdoses occurred between February 2008 and last August, when a patient complained about patchy hair loss and redness of the skin that is not usually associated with CT scans.

The FDA is considering requiring manufacturers of CT scan machines to feature a display that would record and report radiation dosage settings, and alert technicians when a dosage exceeds the accepted dosage level for most patients. The FDA also recommended more training for technicians, and that the machines electronically submit radiation dosage levels to each individual’s medical record to keep track of the dosages.

In addition, the FDA is recommending that Medicare and Medicade adopt new requirements for hospital accreditation that would mandate that hospitals participate in regular surveys of their dosage protocols.

“The goal of the FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiologic Health. “Working together, the FDA and other organizations hope to help patients get the right imaging exam, at the right time, with the right radiation dosage.”

Simi Singer, a spokesperson for Cedars-Sinai, said the hospital is not releasing any new statements based on the FDA proposals, and referred to previous statements made by hospital administrators that outlined changes to the procedures for administering CT scans. According to a statement by Thomas M. Priselac, president and CEO of Cedars-Sinai Medical Center, the hospital instituted changes in four areas regarding CT scans.

“Protocol changes can only be initiated by Department of Imaging Section chiefs, and must be clearly documented. All changes will be reviewed by the radiation physicist to confirm they will not result in higher than appropriate doses. After review and approval by the radiation physicist, authority to change standard protocol settings can only be updated in the scanners by the supervisor, and their ability to make setting changes is password protected. In-service training for technologists on any changes to standard protocols and dose alerts will be expanded, and will be clearly documented,” Priselac said.

The California Department of Pubic Health (CDPH) issued a “deficiency” notice to Cedars-Sinai in November after its investigation determined there were errors in the protocol of administering CT scans at the hospital. The CDPH required the hospital to submit a plan of action to correct the problems, which was completed, according to CDPH spokesman Ralph Montano. A subsequent unscheduled inspection found that the hospital had taken steps to correct the action, Montano added. Any administrative fines or sanctions against the hospital will be determined later.

The investigation did not specifically determine who was at fault for the overdoses, and Montano declined to comment on whether they were caused by human error. It also came to light in November that patients at two other hospitals in Los Angeles — Providence Saint Joseph Medical Center in Burbank and Glendale Adventist Medical Center — had received radiation overdoses of approximately four times the normal doses during a 20-month period ending last October. The investigation and potential sanctions are still pending in those cases, according to Montano.

Forty-two patients who received radiation overdoses at Cedars-Sinai Medical Center have entered into a class action lawsuit filed against the hospital and General Electric, the manufacturer of the CT scan machines at Cedars-Sinai. The lawsuit alleges negligence on behalf of the staff at Cedars-Sinai and with General Electric. Attorney William Newkirk, who is representing the patients, said the FDA proposals verify his position that CT scan radiation overdoses are not just a local problem.

“It is really remarkable that the FDA has not adopted even more stringent standards,” Newkirk said. “Obviously, Cedars has made a lot of efforts to minimize the problems right now because a federal agency is looking into it. But the FDA isn’t doing this simply because 260 patients had this problem, it is because this problem is nationwide, and it could be a problem worldwide. It verifies that there could be a problem, and we need to address the risks.”

Newkirk said the risks to the patients who received the overdoses is significant, with a one in 600 chance of developing a tumor. Other patients may have a higher risk of developing cataracts.

Newkirk said so far, the patients involved in the lawsuit have not experienced any serious medical problems, but the potential has caused them much anxiety. He added that lawsuit is progressing, and a hearing will be held on February 26 in Central Civil West Court to determine how the case will proceed. Newkirk said there is a possibility that a judge may accept the class action lawsuit on behalf of all of the patients, or may require that they be handled as individual cases in what is known as mass tort litigation. Either way, Newkirk said he plans to continue vigorously pursuing the civil action.

Following the radiation overdoses that 260 patients received at Cedars-Sinai Medical Center last October, the U.S. Food and Drug Administration (FDA) released a series of proposals designed to address problems with CT scan machines.

The proposals stem from an FDA investigation into the CT scan machines used at Cedars-Sinai and other hospitals throughout the United States, and seek to clarify the procedures used for administering radiation during different types of CT scans. The patients at Cedars-Sinai received eight times the regular dosage of radiation during a procedure known as a brain perfusion scan. The overdoses occurred between February 2008 and last August, when a patient complained about patchy hair loss and redness of the skin that is not usually associated with CT scans.

The FDA is considering requiring manufacturers of CT scan machines to feature a display that would record and report radiation dosage settings, and alert technicians when a dosage exceeds the accepted dosage level for most patients. The FDA also recommended more training for technicians, and that the machines electronically submit radiation dosage levels to each individual’s medical record to keep track of the dosages.

In addition, the FDA is recommending that Medicare and Medicade adopt new requirements for hospital accreditation that would mandate that hospitals participate in regular surveys of their dosage protocols.

“The goal of the FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiologic Health. “Working together, the FDA and other organizations hope to help patients get the right imaging exam, at the right time, with the right radiation dosage.”

Simi Singer, a spokesperson for Cedars-Sinai, said the hospital is not releasing any new statements based on the FDA proposals, and referred to previous statements made by hospital administrators that outlined changes to the procedures for administering CT scans. According to a statement by Thomas M. Priselac, president and CEO of Cedars-Sinai Medical Center, the hospital instituted changes in four areas regarding CT scans.

“Protocol changes can only be initiated by Department of Imaging Section chiefs, and must be clearly documented. All changes will be reviewed by the radiation physicist to confirm they will not result in higher than appropriate doses. After review and approval by the radiation physicist, authority to change standard protocol settings can only be updated in the scanners by the supervisor, and their ability to make setting changes is password protected. In-service training for technologists on any changes to standard protocols and dose alerts will be expanded, and will be clearly documented,” Priselac said.

The California Department of Pubic Health (CDPH) issued a “deficiency” notice to Cedars-Sinai in November after its investigation determined there were errors in the protocol of administering CT scans at the hospital. The CDPH required the hospital to submit a plan of action to correct the problems, which was completed, according to CDPH spokesman Ralph Montano. A subsequent unscheduled inspection found that the hospital had taken steps to correct the action, Montano added. Any administrative fines or sanctions against the hospital will be determined later.

The investigation did not specifically determine who was at fault for the overdoses, and Montano declined to comment on whether they were caused by human error. It also came to light in November that patients at two other hospitals in Los Angeles — Providence Saint Joseph Medical Center in Burbank and Glendale Adventist Medical Center — had received radiation overdoses of approximately four times the normal doses during a 20-month period ending last October. The investigation and potential sanctions are still pending in those cases, according to Montano.

Forty-two patients who received radiation overdoses at Cedars-Sinai Medical Center have entered into a class action lawsuit filed against the hospital and General Electric, the manufacturer of the CT scan machines at Cedars-Sinai. The lawsuit alleges negligence on behalf of the staff at Cedars-Sinai and with General Electric. Attorney William Newkirk, who is representing the patients, said the FDA proposals verify his position that CT scan radiation overdoses are not just a local problem.

“It is really remarkable that the FDA has not adopted even more stringent standards,” Newkirk said. “Obviously, Cedars has made a lot of efforts to minimize the problems right now because a federal agency is looking into it. But the FDA isn’t doing this simply because 260 patients had this problem, it is because this problem is nationwide, and it could be a problem worldwide. It verifies that there could be a problem, and we need to address the risks.”

Newkirk said the risks to the patients who received the overdoses is significant, with a one in 600 chance of developing a tumor. Other patients may have a higher risk of developing cataracts.

Newkirk said so far, the patients involved in the lawsuit have not experienced any serious medical problems, but the potential has caused them much anxiety. He added that lawsuit is progressing, and a hearing will be held on February 26 in Central Civil West Court to determine how the case will proceed. Newkirk said there is a possibility that a judge may accept the class action lawsuit on behalf of all of the patients, or may require that they be handled as individual cases in what is known as mass tort litigation. Either way, Newkirk said he plans to continue vigorously pursuing the civil action.