New FDA Guidance on Paediatric Information for X-Ray Device Premarket Notifications

  • By: Staff Editor
  • Date: June 08, 2012
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On May 10 2012, the FDA released new draft guidance on "Paediatric Information for X-ray Imaging Device Premarket Notifications". This new guidance provides health professionals with guidelines enabling them to use the imaging equipment already in use at their facilities safely on paediatric patients. This guidance applies only to complete x-ray imaging devices that could be used on paediatric patients.
FDA encourages manufacturers to consider the safety of children in the design of new X-ray imaging devices, so as to reduce unnecessary radiation exposure from medical imaging in paediatric populations as:
  • they are more sensitive to radiation exposure than adults
  • have prolonged lifetime to realize the various serious effects of radiation exposure
  • excess radiation exposure can result by using similar equipment and settings designed for adults
Currently, X-ray equipment is marketed for general use with labelling that does not address paediatric concerns; radiological devices are sold without appropriate design features that would help users optimize benefits in comparison to risk of exposure. New draft guidance outlines information that should be provided in premarket notifications / 510(k) submissions for x-ray imaging devices with indications for use so as to minimize uncertainty during the premarket review process.
The 510(k) submission should include:
  • valid information of devices like the uncertainty of measurement, accuracy, trade name, other characteristics etc.
  • a statement of the intended use of the device ,a detailed summary of the results of the tests, control settings for evaluating imaging performance, a summary of any supporting literature used in protocol design, if any
  • relevant documentation of design features and specific risk mitigation strategies
  • labelling details, specific instructions, educational materials, training materials
  • means of communication by which individual facilities can contact the sponsor for guidance regarding dose reduction protocols and procedures.
FDA in collaboration with manufacturers and imaging experts aims to improve x-ray imaging devices by incorporating radiation protection principles into facility quality assurance, personnel credentialing and training requirements for improvements in device design and instructions for use.
Recommendations by the FDA
  • Manufacturers should design new X-ray imaging devices with user manuals which address indications for use, contraindications, warnings, precautions, device descriptions, instructions, quality control testing and additional information in paediatric populations in the 510(k) submission and in the labelling.
  • Manufacturers who do not adequately demonstrate that their new X-ray imaging devices are safe and effective may  include a label that cautions against use in paediatric populations else they may provide relevant data supporting safety and efficacy
  • Manufacturers should focus on protocols and control settings, quality assurance tools and make available targeted instructions, software interfaces and education materials for paediatric dose reduction, management and information.
  • Manufacturers should provide technical assistance to health care professionals on usage of currently marketed X-ray imaging devices and healthcare administrators should make radiation safety of paediatric patients a priority by promoting the use of such equipment.
Summary of requirements:
  • Typical paediatric-protocols for common procedures customized according to the patient's size and weight should be made available.
  • Pre-configured, default paediatric protocols list (with information regarding protocol name, brief description of exam purpose, anatomical region, intended size of patient, and the acquisition parameters used ) should be provided in the 510(k) submission.
Risk Assessment
  • Manufacturers should focus on risk assessment so as to include hazards and means of mitigation typical to paediatric use like control settings, protocols and design features etc.
  • According to FDA, medical imaging exams should be performed only after careful consideration and evaluation (clinical benefit of a medically appropriate X-ray imaging exam should outweigh the small radiation risk) of the patient's health needs by the child's physician and efforts should be made minimize radiation exposure.
(a)   Indications for use
Submitter of 510(K) application should provide a statement of the intended use and in case the imaging device has specific indications for use, a detailed explanation so as to prove that the differences do not affect the safety and effectiveness of the device should be provided. Any performance characteristics expected to change based on the size of the object being imaged should be tested in prior.
(b)   Contraindications, warnings, and precautions
Contraindications, warnings, and precautions should clearly address the potential risks and their association with the age, size, and condition of the paediatric subject and alert the end-user to specific hazards associated with the use of the device in the target population.
(c)    Instructions for use
Instructions for use should outline the technological features, proper configuration and how the device is to be used on patients and should address radiation dose reduction strategies for paediatric populations while considering the likely educational background of the end-user.
(d)   Quality control testing recommendations
Quality control recommendations should include information about specific tests conducted at periodic intervals which ensure the efficiency of the device when used on paediatric populations and instructions or guidelines to the user on how to ensure its continued proper operation.
Paediatric device features
The imaging device description should describe specific features related to typical paediatric populations after consultation with professionals in the field in order to ensure the device is suitable for paediatric use.
Laboratory image quality and dose assessment
Premarket notifications should include a rationale for the selected size/age subgroups for image quality or dose measurements that involve discrete measurements in phantoms and testing procedures. Any device features that are expected to vary depending on patient size should be evaluated for acceptable outcomes.
Clinical image quality assessment
Clinical images should be accompanied with corresponding information when there is insufficient evidence to demonstrate substantial equivalence.
Training and testing materials for users and manufacturers' personnel
Training program materials, user manuals should be provided to the end user and the 510(k) submission should include a description of the training materials for the device.

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