Imaging and kids: FDA recommends using X-ray systems with the lowest radiation exposure needed for child X-rays

X-ray assists in the diagnosis and treatment of various medical conditions in pediatric patients. Because younger patients are more sensitive to radiation, these imaging exams must be carefully and properly used, especially with X-rays that use ionizing radiation, a form of energy, which can present risks to young patients. Pediatric patients require less radiation than adults to obtain a quality image from an X-ray exam, so healthcare professionals must take extra care to “child size” the radiation dose. The FDA recommends that medical x-ray imaging exams use the lowest radiation dose necessary, taking into account the size and age of the patient.

According to the FDA, this is important because:

  • Pediatric patients are more radiosensitive than adults (i.e., the cancer risk per unit dose of ionizing radiation is higher)
  • Use of equipment and exposure settings designed for adults may result in excessive radiation exposure if used on smaller patients
  • Pediatric patients have a longer expected lifetime, putting them at higher risk of cancer from the effects of radiation exposure

Therefore, X-ray exams should be performed for children only when the child's physician believes they are necessary to answer the clinical question or to guide treatment.

Recommendations for Manufacturers:
Manufacturers of x-ray imaging devices are encouraged to promote dose optimization by designing their devices for optimal safe use and including dose-optimization information to end users in the labeling. This guidance focuses on recommendations to manufacturers for device features and instructions that would help medical professionals optimize radiation dose in x-ray imaging exams for pediatric patients.

FDA recommends that in order to minimize the risk of unnecessary exposure of radiation to children, manufacturers of x-ray imaging devices should, as part of their device design, perform a risk assessment that considers specific risks and mitigations arising from the use of their device in pediatric populations.
Additionally, an X-ray system with customizable settings for exposure duration and intensity and optimal for achieving the best X-ray image quality with lowest radiation exposure.
The UC-5000 from Source Ray is an example of this type of system. This system is also mobile and doesn’t require any additional X-ray room set-up like lead-lining or electrical upgrades that traditional fixed-rail systems do.

Tips about x-ray imaging for parents and caregivers:
It is important to keep a record of your child's x-ray imaging to provide inform your discussion with the referring physician when a new X-ray is requested. Be informed. Ask the referring doctor about the benefits and risks of imaging procedures.

Ask the imaging facility:

  • Does the facility use reduced radiation for children x-ray imaging?
  • Is there any preparation necessary to perform the x-ray (e.g., administration of a contrast agent, sedation, or advanced preparation)?
  • Advised to Report any adverse events to the FDA

The FDA also encourages manufacturers to consider how their device can be better configured for pediatric use, and to provide that more specific information to the end user.

What is the Role Healthcare Professionals?
Purchase equipment that is designed for use with pediatric patients, if possible, and request information from the manufacturer on how to properly configure the equipment for small patients.

Healthcare professionals are ensuring there is justification for all X-ray imaging exams performed on pediatric patients. They should also consider whether another type of imaging exam that does not expose the pediatric patient to ionizing radiation.

For more information, you can visit www.fda.gov.

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