FDA Seeks Less Radiation for Kids Getting X-Rays, CT Scans

WEDNESDAY, May 9 (HealthDay News) — In an effort to make sure
children are not exposed to any more radiation than necessary when they
get X-rays or CT scans, the U.S. Food and Drug Administration has asked
the makers of these devices to factor in the safety of pediatric patients
when using existing machines and designing new ones.

And if the manufacturers of these scanners can’t show their equipment
is safe for children, the FDA wants labels on the machines that say
so.

The agency released its recommendations on Wednesday, and there will be
a four-month period of public comment before the guidelines become
final.

X-ray imaging, such as CT scans, conventional X-rays and fluoroscopy,
are a valuable way of diagnosing problems and developing treatments, and
they can be essential before surgery, the agency noted in a statement.

However, the exposure to ionizing radiation can, over time, raise the
risk of cancer, and high doses of radiation may be problematic in
children.

“Imaging is very important. It saves lives,” said Dr. Marta
Hernanz-Schulman, chair of the American College of Radiology Pediatric
Imaging Commission and a professor of radiology and pediatrics at Monroe
Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tenn. “Like any
tool, it needs to be used judicially; like any other tool, it’s not a
panacea.”

“Children are not little adults,” Hernanz-Schulman added. “Their bodies
are more sensitive to radiation, because they are growing, so when the
cells are dividing they are more sensitive to the effects of
radiation.”

In addition, children actually absorb more radiation when they are
given adult doses, she added.

“Most of the effects of radiation are felt decades down the line,”
Hernanz-Schulman said.

The cancer risk of ionizing radiation is higher for children than
adults, and since the effects of radiation are cumulative children have a
longer time for the effects of radiation to show up, the FDA noted in its
statement.

Also, X-ray equipment settings designed for adults can cause a larger
radiation dose than needed to produce an image in children, the agency
added.

“The FDA is giving guidelines to manufacturers who are very interested
in doing the right thing and providing people with what we need,”
Hernanz-Schulman said.

Getting the manufacturers to make devices that can be easily adjusted
for children is a good thing. In addition, the manufacturers need to be
available to educate doctors on how to use the equipment for children,
Hernanz-Schulman said.

“The risk from a medically necessary imaging exam is quite small when
compared to the benefit of accurate diagnosis or intervention. There is no
reason for patients who need these exams to avoid them,” Dr. Jeffrey
Shuren, director of FDA’s Center for Devices and Radiological Health, said
in the statement. “Parents should engage in a discussion with their
child’s physician about benefits and risks of X-ray, computed tomography
(CT) and fluoroscopy exams.”

Parents should ask their doctor if the procedure is necessary or
whether there are different tests that can get the same information
without radiation, such as ultrasound or an MRI, Hernanz-Schulman
explained.

In addition, parents need to keep track of the tests done and the
radiation levels used so they can show doctors when tests are recommended
and when their child is seen at different facilities, she said.

The American College of Radiology recommends that parents ask their
pediatrician or other provider who orders a scan the following
questions:

  • How will the scan improve my child’s care?
  • Are there alternatives that don’t use radiation?
  • Is the facility accredited by the American College of Radiology?
  • Will the radiation dose be “child-sized”?

The Medical Imaging Technology Alliance (MITA) applauded the FDA
proposal.

“MITA is proud to be a long-time collaborative partner with the FDA on
initiatives to ensure the safe and effective use of medical imaging
equipment,” the association said in a statement Wednesday. “Our efforts
have included contributing to the development of pediatric radiation
safety training materials and convening stakeholders to explore ways to
prevent medical errors that involve radiation. MITA looks forward to
providing comments on the guidance released today to help reduce
unnecessary radiation exposure for children.”

More information

For more on imaging tests, visit the U.S. National Library of Medicine.

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