As part of its push to reduce children's exposure to radiation from medical tests, the FDA wants manufacturers to design scanners scalable to the youngest patients, AuntMinnie.com reports. Existing equipment that does not comply would be labeled with a warning that it is not for use on children.
A second article on the site notes that researchers from six U.S. children's hospitals are collaborating to build the first pediatric CT dose index registry based on patient size.
The FDA has been on an eight-year mission to reduce the exposure level of children, who are more sensitive to the negative effects of radiation and who, because of their age, will be exposed more often during their lifetimes.
At the same time, scans are becoming increasingly common. A study published last month in Radiology found that CT scans increasingly are emergency departments' diagnostic method of choice with appendicitis in children. In its recent update, the FDA urged parents to keep track of children's tests and to ask about approaches to reduce exposure.
In drafting this regulation, the FDA will take comments for four months on design of the new scanners, including CT and fluoroscopy devices, and bring medical staff and vendors together for a workshop July 16 to discuss guidance on the issue.
The research collaboration, called Quality Improvement Registry in CT Scans in Children, is designed to help users "child-size" their scanning protocols to produce quality images while reducing the child's exposure, according to AuntMinnie.com. It's starting with a study of abdominal scans. The researchers are determining typical dose settings through surveys then scaling them based on the child's size.
They want to improve the quality of CT scans nationally by setting a target dose range. Their study looks at levels between 25 percent and 75 percent of typical exposure levels, with the lower end being an image quality too poor for diagnosis and the upper end denoting excessive exposure. Their goals fall in line with the FDA's.
"Regardless if my child is imaged at a pediatric hospital or a local community hospital, they get the same basic care. Everybody should be able to do it," FDA biomedical engineer Jana Delfino told The Associated Press.
To learn more:
- read the AuntMinnie.com FDA story
- see the AuntMinnie.com article about the Quality Improvement Registry
- here's the Radiology study on CT scans
- see the FDA update
- check out the AP report