FDA Leans On Device Makers To Cut X-Ray Doses For Kids

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The Food and Drug Administration has a proposition for the companies that make X-ray machines.

Make sure your new equipment has settings and instructions that minimize radiation hazards for kids, or the agency will look to slap a label on the machines that recommends they not be used for children at all.

The agency proposed the approach today (details in the Federal Register); it’s the latest move to curb radiation hazards from imaging equipment.

X-rays and CT scans can provide doctors with lots of useful information. But the radiation that creates the helpful images also increases a person’s risk for cancer. There’s been an explosion in the use of imaging tests. And rising radiation doses, particularly from CT scans, have drawn concern.

The cancer risk increases with the dose of X-rays received during a person’s lifetime, so kids’ exposure is particularly important. It’s also the case that children are more sensitive to X-ray damage.

The FDA is also telling parents to speak up. If a doctor orders a test or procedure that uses X-rays, parents shouldn’t be afraid to ask if it’s really necessary. Also, it doesn’t hurt to ask if there’s an acceptable alternative, such as ultrasound or MRI, that doesn’t rely on X-rays.

Even so, the agency doesn’t want people to forgo needed X-rays. “The risk from a medically necessary imaging exam is quite small when compared to the benefit of accurate diagnosis or intervention,” Dr. Jeffrey Shuren, head of FDA’s Center for Devices and Radiological Health, said in a statement. “There is no reason for patients who need these exams to avoid them.”

The agency scheduled a public meeting in July to talk about the proposal.

The Medical Imaging & Techonology Alliance, a trade group, said it looks forward to commenting on the FDA’s proposal and working with the agency.