X-Ray Radiation Exposure for Children Should Be Reduced: FDA

Federal health regulators are putting forward new recommendations that are designed to protect children from unnecessary radiation exposure

The FDA released new guidance this week, calling for manufacturers to demonstrate that X-ray imaging devices are safe and effective for use on children before putting those devices on the market. The agency also proposes that any manufacturers who fail to do so will have to label the device as potentially hazardous to children.

The new recommendations were announced on May 9, and the FDA is seeking public comment on the draft guidance before finalization.

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The FDA has joined forces with the Alliance for Radiation Safety in Pediatric Imaging (ARSPI) and the Medical Imaging and Technology Alliance (MITA), as well as manufacturers. The FDA has also launched a pediatric X-ray imaging website that provides information on the health risks and benefits of X-ray imaging on children.

The efforts comes as a result of the FDA’s “Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging”, which was launched in February 2010 after the discovery of CT scan radiation over-exposure problems that may have affected more than 200 patients at Cedars-Sinai Medical Center in Los Angeles. In the course of the resulting investigation, the FDA found that at least 385 patients had received excessive radiation while undergoing CT brain perfusion scans at a number of hospitals in California and Alabama.

In November 2010, the FDA recommended that the radiation therapy industry make changes to equipment and training to lessen the risk of radiation overdose for patients. The recommendations came after a year-long investigation by the FDA which concluded that nearly all radiation exposure problems suffered by patients are due to operator error and are rarely contributed to by broken CT scanners.

CT scan procedures and other forms of radiation therapy across the country came under close scrutiny prior to the recommendations by the FDA after the discovery that a number of patients have suffered radiation overexposure from CT Scans performed incorrectly.


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