Yesterday we wrote that the Medical Imaging & Technology Alliance, a medical imaging trade group, announced that CT scanner manufacturers will initiate installation of safety controls to better ensure patients do not receive excess radiation, citing the Associated Press (AP). Now, the Wall Street Journal (WSJ) is writing that a movement is gaining speed across the country to lower CT scan radiation exposure in children.

Many are concerned about the cancer risks linked to the use of these devices, especially when children are involved, said the WSJ. About five-to-ten percent of all CT scans performed annually—about 70 million—are conducted on children, said the WSJ, a problem, given their smaller size and longer life span.

Now, the Society for Pediatric Radiology is sponsoring a campaign entitled “Image Gently” to urge use of the smallest necessary amount of radiation when administering a CT scan on children, as well as working with radiologists to cover reproductive organs and consider safer tests, such as ultrasound, among other alternatives, said the WSJ.

Meanwhile, we have written that in October, the U.S. Food & drug Administration (FDA) announced it was investigating CT scan overdoses. The FDA probe was launched after Cedars-Sinai Medical Center in Los Angeles confirmed that 206 patients mistakenly received eight times the regular dose of radiation during CT brain scans. The machine at Cedars-Sinai was set at the higher level since February 2008, but the mistake was not detected for 18 months. According to the Medical Center, the overdoses were discovered in August, when a patient reported hair loss.

The dosing checks are scheduled to begin before year-end and are meant to let scan operators know when the devices exceed the recommended safety levels, said the AP, adding that facilities will also be able to set maximum levels. The Alliance announcement followed an FDA announcement that it would be looking into the issue with excessive scan radiation, said the AP, and came one day prior to a Congressional hearing on imaging scanner safety. The five CT scanner manufacturers—General Electric Co., Siemens, Toshiba Corp., Royal Philips Electronics, and Hitachi—will be implementing the changes, said the AP.

According to Center of Disease Control and Prevention (CDC), about 435,000 children under the age of 14 are seen in emergency rooms annually for evaluation of traumatic brain injury (TBI); however, said the WSJ, not all head injuries result in TBI, which means that not all CT scans are needed and children are being put at unnecessary risk of cancer from radiation exposure. In response, University of California Davis Children’s Hospital emergency department doctors developed physician guidelines, said the WSJ.

The information was based on a study published in the Lancet last fall that looked at over 42,000 children from 25 medical centers and used information from the Pediatric Emergency Care Applied Research Network, reported the WSJ. The study found that one in five children over the age of two, and close to 25 percent of those children under the age of two, who did receive a CT scan following a head injury did not need the scan because they were at what was described as a “very low risk” of a serious injury of the brain when compared to the risk of cancer resulting from the radiation, said WSJ.

Now, a class action suit has been filed in the U.S. District Court in Alabama in which claims have been made that the GE Healthcare CT scanner lacked safety features to warn of radiation overdoses, among other issues. Another lawsuit claims GE Healthcare “carelessly researched the design and failed to adequately test” its products, and that the scanners lacked safety features to warn of overdoses.

This entry was posted on Tuesday, March 2nd, 2010 at 10:13 am and is filed under Defective Medical Devices, Health Concerns.