Government officials reported on Monday that U.S. regulators are investigating more cases of patients exposed to up to eight times the normal amount of radiation during brain scans performed with General Electric and Toshiba equipment.
According to the Food and Drug Administration (FDA), some patients received excessive amounts of radiation, which in high doses can lead to cataracts and an increased risk of some forms of cancer.
The FDA said in October that it was looking into 206 cases of patients being overexposed to radiation during CT perfusion scans of the brain at Cedars-Sinai Medical Center in Los Angeles over an 18-month period.
On Monday, the FDA said it had confirmed at least 50 more cases at Cedars-Sinai and two other California hospitals. Officials said that such cases also have been reported in Alabama.
The agency said that some patients experienced skin redness and hair loss caused by the excessive levels of radiation.
The FDA has yet to determine whether the issue is the machines or the way they were being used, said Dr. Jeffrey Shuren, acting director of the FDA’s device center, during a conference call with reporters.
The FDA is providing interim recommendations in order to avoid future problems. The agency is continuing to work with manufacturers, professional organizations, and state and local public health authorities to investigate the excess exposures.
The agency is also recommending that manufacturers review their training for users, reassess information provided to health care facilities, and put into place new surveillance systems to quickly identify problems.
The computed tomography (CT) perfusion scans are used to evaluate blood flow in the brain to diagnose strokes, and are also used to examine the heart.
While GE continues to look into the problem, their healthcare spokesman Arvind Gopalratnam said, “we confirm that there were no malfunctions or defects in any of the GE Healthcare equipment involved.”
Toshiba said the FDA had alerted the company to a particular site where potential over-radiation occurred with the company’s equipment.
“We are cooperating fully with the FDA and working with them to investigate this matter,” said Paul Biggins, head of regulatory affairs for Toshiba America Medical Systems.
Cedars-Sinai spokeswoman Simi Singer said the hospital had documented 260 cases and had disclosed the total in November. In September, the hospital implemented policies similar to those issued by the FDA, she added.
“We continue to work with the FDA and other regulatory agencies to help identify the root causes of this issue,” Singer said.
The new FDA guidelines urge imaging centers to review protocols for CT perfusion scans of the brain and heart and advise technicians to check the display panel before using the equipment to ensure that they are delivering the correct levels of radiation.
“While we do not know yet the full scope of the concern, facilities should take reasonable steps to double-check their approach to CT perfusion studies and take special care with these imaging tests,” the FDA’s Shuren said in a statement.
Glendale Adventist Medical Center in California reported ten cases, FDA spokeswoman Karen Riley said. The hospital gave a statement on the 10 cases in November, claiming that the patients were exposed to about three to four times the usual level of radiation while undergoing tests with a GE machine, with “minimal” associated risk.
While the Glendale hospital is still using the machine, it did make procedural changes in order to avoid future problems, the statement said.
There were other cases found at California’s Providence Saint Joseph Medical Center with Toshiba equipment, but the FDA said the exact numbers are not yet known. Hospital spokeswoman Patricia Aidem said “we have had no reports of any ill effects to patients” from the scans.
At least one case was identified at a hospital in Huntsville, Alabama, the FDA’s Riley said.
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