Pediatric X-Ray Imaging
The US Food and Drug Administration (FDA) recently published final guidance entitled “Pediatric Information for X-ray Imaging Device Premarket Notifications,” encouraging manufacturers to consider child safety when designing X-ray imaging devices. In the guidance, which applies to new devices and modifications requiring the submission of a new 510(k), the FDA recommends manufacturers design these devices with protocols and instructions that address use on pediatric patients. It encourages the inclusion of pediatric indications and provides recommendations for labeling and instructions for use for X-ray imaging devices likely to be used on children.
Although this new guidance is intended for device manufacturers it is an excellent reminder of the unique requirements of the pediatric populations, especially with regards to x-ray imaging. The Federal Food, Drug and Cosmetic Act (FD&C) 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). However, 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.
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 adverse events to the FDA.
Included with today’s notice is an example policy addressing pediatric patient preparation and considerations for radiology procedures.
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