On November 27, 2017, the US Food and Drug Administration (FDA) released final guidance encouraging manufacturers to consider radiation safety of pediatric populations in the design of x-ray imaging devices.
But pediatric X-ray imaging safety doesn’t rest solely on the shoulders of manufacturers. Medical professionals and caregivers also have an important role to play, Laurel Burk, PhD, from the FDA’s Center for Devices and Radiological Health, emphasized during a January 9 webinar in which she gave an overview of the final guidance.
Pediatric x-ray imaging safety is a “shared responsibility,” she told the more than 100 attendees. To minimize risks to children, imaging should be “justified and optimized.”
“Justification means performing x-ray exams only when needed to diagnose a disease or answer a medical question, and when the benefits are believed to outweigh the risks. Optimization means performing that necessary exam using techniques for the lowest radiation dose that still results in adequate image quality so that the image can be used for diagnosis,” Dr Burk said.
“Appropriate justification is the responsibility of medical professionals who order and perform x-ray imaging. Optimization, however, is an area where other experts and stakeholders like manufacturers can make significant contributions,” Dr Burk added.
Clear Instructions and Indications for Pediatric Use
Most x-ray imaging devices used today can be safely optimized for use in children, “but we’ve heard from health care providers that many of these devices lack clear instructions for pediatric use or instructions on how to optimize dose,” Dr Burk said.
Some expert organizations offer training materials and recommendations for dose optimization in pediatrics, but imaging professionals may have a hard time locating and applying these recommendations without some extra support from manufacturers, she added.
Manufacturers, she noted, are in the “best position to understand what specific features can be applied to their devices to enhance the safety of pediatric use and to mitigate pediatric-specific risks that occur from inappropriate use.”
The guidance document notes that patient size/weight matters more than age for x-ray imaging and radiation dose optimization. “Smaller patient thicknesses need less radiation to produce a good quality image. Children’s heads grow at a different rate than their bodies, so age groupings for head imaging may differ from body imaging. The new guidance suggests size/age ranges for pediatric groupings for body imaging and for head imaging, keeping in mind that patient size or thickness is the most important factor in imaging and dose optimization,” Dr Burk explained.
The guidance recommends that manufacturers optimize their devices for pediatric use “by default, or with an easy set up, providing instructions for optimization and including pediatric instructions for use,” Dr Burk noted. It also asks manufacturers to develop device-specific features that enhance safety and mitigate pediatric-specific risks.
Most general-use x-ray devices will have significant pediatric use, Dr Burk said. “Unless a device’s design explicitly excludes pediatric imaging, we know most devices will be used to image children,” she added. By one estimate, 10% of all computed tomography (CT) procedures (60 million annually) are for pediatric patients, she noted.
“We believe that if devices are designed, tested and labeled for safe and effective use in the pediatric population, they will be safe and effective for everyone,” said Dr Burk.
Cooperation Driving Innovation
The guidance advises manufacturers to include an indication for use (IFU) statement on all devices, which should specify all populations for whom the device is intended. If a pediatric population or subpopulation’s needs were specifically evaluated in the design and testing of the device, that population or subpopulation should be clearly stated in the IFU. If a device is intended only for adult use, that should also be clearly stated in the IFU, Dr Burk said.
Because most general-use x-ray devices can be used in pediatric populations, the language “not for pediatric use” in the IFU statement should be reserved for devices only when there are physical design safety limitations preventing safe use in children, she told attendees. “One example could be extremity-only cone beam CT which is designed for adults and adult-sized limbs and where pediatric-sized shielding isn’t included,” Dr Burk said.
Cooperation has driven innovation in pediatric safety features. – Laurel Burk
The guidance also recommends that performance testing of a device cover the full indicated patient size range (from neonate to adult) in situations that represent typical clinical use. 510(k) submissions should include a summary of the tests conducted and results. X-ray devices for which significant pediatric use is anticipated should include a pediatric summary section on labeling or in the user manual. Manufacturers are also advised to provide pediatric-appropriate protocols for common procedures, adjusted for the patient’s size/weight.
Dr Burk said parents and other caregivers have a responsibility to track the child’s medical imaging history, ask the doctor whether the exam will improve the child’s healthcare, and ask the imaging facility about safeguards and if the exam is “child-sized.”
She noted that since the draft guidance document was first published, “we’ve seen significant cooperation among industry, clinicians, physicists and regulators on this issue. This cooperation has driven innovation in pediatric safety features.”
Dr Burk emphasized that the FDA is not suggesting that facilities immediately replace their older imaging equipment. “Imaging professionals can safely use the equipment that they have right now even if they don’t have these instructions for use. But we really encourage health care professionals to refer to guidelines and advice provided on our pediatric x-ray imaging website for help in using their current equipment to optimize for pediatrics,” she said.
More information and resources are available on the FDA’s updated pediatric x-ray imaging website.
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