The agency released a draft proposal recommending that new imaging devices, such as CT, fluroscopy, and X-ray, include protocols and instructions for pediatric patients. This would be required on premarket approval notifications.
The FDA wants manufacturers to consider the safety of children when designing new imaging equipment, including computed tomography, fluoroscopy, and X-ray.
In a draft proposal released today, the agency outlines information that should be provided on premarket notifications for imaging devices for use in pediatric populations. The FDA recommends that manufacturers develop new devices protocols and instructions for pediatric patients, and add a caution label urging against pediatric use for devices not shown to be safe for children.
“One of the challenges is our patients range from 2 pounds to 350 pounds,” said Marilyn Goske, MD, chair of the Alliance for Radiation Safety in Pediatric Imaging (ARSPI), which runs the Image Gently campaign aimed at promoting radiation protection in the imaging of children.
Because a vast majority of patients at a general hospital are adults, manufacturers have focused equipment development on that population without indications for pediatric use. Pediatric patients are more sensitive to radiation and have longer lifetimes for exposure effects to manifest, so this guidance is particularly important, said Goske, a radiologist at Cincinnati Children's Hospital.
There are steps manufactures can take to help improve safety for pediatric patients, such as standardized dose displays and automated components, she said. “We have found the manufacturing community really wanting to hear this.”
The guidance is a result of FDA’s initiative launched two years ago to reduce unnecessary medical imaging radiation exposure. The agency is working with the ARSPI and the Medical Imaging and Technology Alliance (MITA) to develop pediatric imaging radiation safety training materials. The FDA also launched a pediatric X-ray site to provide information on the benefits and risks of imaging, recommendations for parents and providers, and information for manufacturers.
“MITA looks forward to providing comments on the guidance released today to help reduce unnecessary radiation exposure for children,” the group said in a statement. MITA advocates for physician-developed appropriateness criteria, mandatory accreditation of imaging facilities, and a national dose registry. “Our members are also leaders in the development of hardware and software innovations to reduce exposure, including dose alert features on CT technology to help minimize radiation dose and medical errors.”
A workshop is scheduled for July 16 to bring together industry, physicians, radiologic technologists, physicists, and patient advocates to discuss FDA’s draft guidance.