The FDA has issued a draft guidance outlining its current thinking regarding information that should be included in premarket notifications for x-ray imaging devices with indications for use in pediatric populations.
Although the nonbinding recommendations are not legally enforceable, the FDA outlined the case for concern, noting three points:
- Children are more radiosensitive than adults;
- Children have a longer expected lifetime to realize the effects of radiation exposure, including cancer; and
- Use of equipment and settings designed for adults can result in excess exposure for pediatric patients.
Currently, most x-ray equipment is marketed for general use with labeling that does not address pediatric concerns. In February 2010, the FDA launched its initiative to reduce unnecessary medical exposure and in March of that year held a meeting to solicit feedback on strategies to reduce exposure.
Imaging professionals can use existing imaging devices that are not designed or labeled for pediatric use by following recommendations provided by the Alliance for Radiation Safety in Pediatric Imaging and other organizations, FDA said. Additional strategies to curb pediatric exposure include making available pediatric protocols and control settings, targeted instructions and education materials focused on pediatric dose reduction, quality assurance tools for facilitating dose management and dose information related to pediatric patients.
However, new x-ray systems “should be demonstrated to be appropriate for pediatric use or use in pediatric patients should be cautioned against,” the FDA wrote.
The agency recommended vendors provide data supporting safety and efficacy in pediatric populations or label the device with a statement cautioning against use in specific pediatric subgroups. These subgroups should be based on patient size rather than age. Vendors should clearly define indications for use and intended pediatric populations in the 510(k) submission and in the labeling.
The 510(k) submission also should include laboratory tests for dosimetry and image quality addressing typical pediatric use.
The FDA recommended that vendors consult with pediatric specialists, including physicians, physicists and technologists, during the design phase. Vendors should consider pediatric features, such as:
- Specific pre-set pediatric control settings;
- Automatic exposure control designed and tested for pediatric sizes;
- Pediatric procedures, labeling and protocols designed to minimize radiation exposure while maintaining image quality;
- Display and recording of patient dose and dose index and ability to record patient size; and
- Software interfaces that alert the user to pediatric considerations.
Vendors also should expand the risk assessment to include hazards and means of mitigation specific to pediatric use, according to the FDA. The assessment should consider settings and protocols, design features and automatic controls as they relate to pediatric patients.
The FDA emphasized the importance of making available pediatric-appropriate protocols and pre-programming protocols in device software, as appropriate.
Finally, the user manual should include labels for pediatric use; contraindications, warnings and precautions; device descriptions and instructions; quality control testing recommendations and additional information.
The guidance covers x-rays, fluoroscopy, CT and dental-ray devices.
To read the full document, click here.