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The Food and Drug Administration said it will require manufacturers of certain medical imaging equipment to redesign machines to incorporate safeguards aimed at reducing patients' exposure to radiation.

Companies that would be affected included General Electric Co. (GE), Siemens AG (SI) and Toshiba Corp. (6502.TO), which make equipment for computed tomography, or CT, nuclear medicine and fluoroscopy medical imaging procedures.

Such procedures use ionizing radiation to produce an image of various tissues and organs inside the body. The doses of radiation are several times higher than standard x-rays, dental x-rays and mammography. The FDA said, for example, that the radiation dose associated with a CT abdomen scan is the same as the dose from approximately 400 chest X-rays.

The move comes after recent reports of accidental overdoses of radiation and is part of a broader effort the FDA is undertaking to limit excess radiation exposure.

Last October, Cedars Sinai Medical Center in Los Angeles disclosed that more than 200 patients had received excess radiation during CT scans used to determine if a person had suffered a stroke. The FDA later said patients were exposed to eight times the amount of radiation typically used during the exam. Since then, the agency said it is investigating similar reports in other states. The agency has also said more than one type of machine was used.

Exposure to ionizing radiation can raise a person's risk of developing cancer, although it's not clear how much the risk if raised. The FDA said accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts.

The FDA said it is considering requiring manufacturers to make sure devices can display, record and report equipment settings and radiation dose. The agency also said an alert could be provided for users when the dose exceeds a levels typically needed to obtain an image.

Source: FDA

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