- X-ray Imaging for Pediatrics
- FDA Roles in X-ray Safety
- Information for Health Care Professionals
- Information for Industry: X-ray Imaging Device Manufacturers and Assemblers
- Information for Patients, Parents and Caregivers
Medical X-ray imaging has led to improvements in the diagnosis and treatment of numerous medical conditions in pediatric patients. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients as persons aged 21 or younger at the time of their diagnosis or treatment. Typically these are broken down into different groups based on age ranges (neonates, infants, children, and adolescents). For medical X-ray imaging, the pediatric patient's size is even more important to consider than age, because patient size determines how much radiation is needed to produce a quality medical image.
The individual risk from X-ray imaging is small when compared to the benefits that it can provide through helping with accurate diagnosis. Still, efforts should be made to minimize risk by reducing unnecessary exposure to ionizing radiation. 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.
The FDA recommends that medical x-ray imaging exams, which include computed tomography (CT), fluoroscopy, and conventional X-rays, use the lowest radiation dose necessary, taking into account the size and age of the patient. Whether grouped by age or by size, an x-ray image should always be adjusted to meet the needs of the specific type of pediatric patient receiving the exam.
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. Medical imaging professionals should use techniques that are adjusted to administer the lowest radiation dose that yields an image quality adequate for diagnosis or intervention (i.e., radiation doses should be "As Low as Reasonably Achievable"). The technique factors used should be chosen based on the clinical indication, patient size, and anatomical area scanned, and the equipment should be properly maintained and tested.
The FDA collaborates with stakeholders across the imaging community to protect children's health by helping prevent unnecessary radiation exposure from X-ray exams, which includes:
- Encouraging manufacturers to address pediatric safety issues in current X-ray imaging devices and consider radiation safety of pediatric populations in the design of new X-ray imaging devices
- Publishing guidelines and other tools and resources to help enable imaging professionals to safely use imaging equipment on pediatric patients
- Fostering and strengthening relationships between manufacturers and health care professionals to improve device design and instructions for use
- Engaging in broad outreach efforts to incorporate radiation protection principles into facility quality assurance and personnel credentialing and training requirements
Examples of FDA's medical radiation protection activities include:
- Publication of the Pediatric Information for X-ray Imaging Device Premarket Notifications - Final Guidance that encourages equipment design and instructions that help medical professionals more easily optimize equipment settings for patients of all sizes.
- The FDA's Center for Devices and Radiological Health (CDRH) and Critical Path Program funded two contracts awarded to the Image Gently Alliance. The contracts supported the development of educational tools for imaging practitioners to encourage reduction of radiation dose to pediatric patients.
- The FDA's Initiative to Reduce Unnecessary Ionizing Radiation Exposure from Medical Imaging has resulted in numerous dose reduction programs, national and international standards, and educational resources.
The individual risk from a necessary imaging exam is minimal when compared to the benefit of aiding accurate diagnosis or intervention. However, because of the increased risk of radiation exposure to younger patients, the FDA recommends that health care professionals and hospital administrators take special care in reducing radiation exposure to pediatric patients by following these steps:
- Discuss the rationale for the examination with the patient and/or parent to ensure a clear understanding of benefits and risks.
- Reduce the number of inappropriate referrals (i.e., justify X-ray imaging exams) by:
- Determining if the examination is needed to answer a clinical question
- Considering alternate exams that use less or no radiation exposure, such as ultrasound or MRI, if appropriate
- Checking the patient's medical imaging history to avoid duplicate exams
- 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.
- Use the pediatric protocols, technique charts and other dose mitigating resources included with the equipment. If pediatric protocols or technique charts are not available for the currently marketed X-ray imaging device, ask the manufacturer or a pediatric imaging expert for assistance on how to appropriately use the device on small patients. Monitor radiation doses for patients and check the facility doses against diagnostic reference levels, where available, for quality assurance and safety.
- Report any adverse events to the FDA
- American Academy of Pediatrics: What Pediatricians Should Know about Medical Radiation Safety
- American College of Radiology (ACR): Appropriateness Criteria® Guidelines
- The National Cancer Institute: Radiation Risks and Pediatric Computed Tomography (CT): A Guide for Health Care Providers
- The Image Gently Alliance has educational material available to professionals regarding the safe and effective imaging care of children on their website. These include materials directed at technologists , dental professionals , radiologists , medical physicists , and referring physicians .
- The International Atomic Energy Agency (IAEA) Radiation Protection of Patients has published FAQs specific to minimizing exposure in Children and free, downloadable Paediatric Radiology training material for specific types of exams.
- World Health Organization report "Communicating Radiation Risk in Paediatric Imaging": http://apps.who.int/iris/bitstream/10665/205033/1/9789241510349_eng.pdf
The final guidance "Pediatric Information for X-ray Imaging Premarket Notifications " has been published, with the goal of encouraging manufacturers to consider radiation safety of pediatric populations in the design of X-ray imaging devices. The final guidance:
- Focuses on dose optimization; i.e., ensuring that X-ray imaging equipment is capable of adequately imaging pediatric patients at the lowest radiation dose that still provides images adequate for the clinical purpose and the information necessary for the patient's care.
- Encourages equipment design and instructions that help medical professionals more easily optimize equipment settings for patients of all sizes, so that all children receive safe, quality imaging whether at a small community hospital, large research center, or dedicated pediatric hospital.
- Outlines expectations that will help minimize uncertainty during the pre-market review process while promoting the safe X-ray imaging of children.
- Applies to new devices. However, many currently marketed X-ray imaging devices have general indications for use that cover a broad range of clinical applications and populations; therefore, FDA encourages manufacturers to provide technical assistance to health care professionals on how to appropriately and safely use these older devices on pediatric patients.
- Includes input from professionals across the imaging community.
X-ray imaging exams are noninvasive tests that produce images of inside your body and provide valuable information to help with diagnosis of illnesses and injuries. X-rays use ionizing radiation, a form of energy, which can present risks to the patients. However, when used appropriately, the benefit of an X-ray imaging exam far outweighs any risk from ionizing radiation. Understanding the benefits and risks of X-ray imaging can help you make the best decision about your child's health. The FDA recommends that X-ray exams be performed when the child's physician determines the results would help in a diagnosis or treatment.
Tips about x-ray imaging for parents and caregivers:
- Keep a record of your child's x-ray imaging to help inform your discussion with the referring physician when a new X-ray is recommended (see the list of resources below that offer additional tools and information)
- Ask the referring physician about the benefits and risks of imaging procedures, such as:
- How will an X-ray improve my child's health?
- Are there other options we could consider that do not use ionizing radiation and are equally useful?
- 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)?
- Report any adverse events to the FDA
Additional Resources for Patients, Parents, and Caregivers
- FDA Consumer Update - Dose Matters: FDA's Guidance on Children's X-rays
- The Image Gently Alliance: What Can I do as Parent?
- My Child's Imaging Record card, available from the Image Gently Alliance website
- The American College of Radiology (ACR) and Radiological Society of North America (RSNA) resource, RadiologyInfo: The Radiology Information Resource for Patients
- The International Atomic Energy Agency (IAEA) Radiation Protection of Patients (RPOP): Patients and Public and Pregnancy and Children