miércoles, 25 de julio de 2012

Public Workshop Focuses on New Guidelines for Pediatric Imaging Devices ►NCI Cancer Bulletin for July 24, 2012 - National Cancer Institute

NCI Cancer Bulletin for July 24, 2012 - National Cancer Institute


Public Workshop Focuses on New Guidelines for Pediatric Imaging Devices

On July 16, the Food and Drug Administration (FDA) held a public workshop to gather comments on a draft guidance that encourages manufacturers to consider the safety of children in the design of new x-ray imaging devices. The draft guidance addresses the development, marketing, and use of imaging devices, including design features, labeling information, and testing in children.
Children are more sensitive than adults to radiation, including the low levels of radiation delivered by imaging machines such as computed tomography (CT) scanners and fluoroscopy devices, which use x-rays to see inside the body. A recent study showed that radiation exposure from CT scans in childhood results in very small but increased risks of leukemia and brain tumors in the first decade after exposure.
The FDA developed the new draft guidance as part of its Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. The agency launched the initiative in 2010 in response to rising concern about the contribution of medical radiation to exposures in the general population and after several reports of patients receiving accidental radiation overdoses during routine imaging.
The new draft guidance includes recommendations from a March 2010 public meeting on how to improve safety for pediatric patients undergoing medical imaging. Participants at that meeting recommended the development of tailored pediatric protocols and control settings by device manufacturers, better instructions and educational materials for device operators, an overall emphasis on reducing pediatric doses, and better tools for quality assurance and for the collection and storage of information on individual patients’ doses.
Participants at the workshop included members of the Alliance for Radiation Safety in Pediatric Imaging, professional organizations such as the American Association of Physicists in Medicine, industry representatives of the Medical Imaging and Technology Alliance, and members of the general public.
The participants discussed a number of issues, including
  • the need to use patient size rather than age to guide the development of pediatric imaging protocols;
  • the need for better training, since the majority of pediatric imaging scans are not performed in dedicated children’s facilities;
  • questions about whether simulation alone is sufficient to test new devices and protocols, or whether clinical data from children are needed;
  • the need for better communication between manufacturers and the medical staff who use the machines; and
  • concerns about whether restrictive product labeling would lead to the off-label use of machines with no safety or efficacy data available for children.
The FDA will accept comments on the draft guidance until September 7. Instructions on how to submit comments by mail or through regulations.gov can be found on the FDA’s draft guidance webpage. The draft guidance docket number is FDA-2012-D-0384.
An archived webcast of the public workshop is available, and full transcripts of all sessions will be made available, on the workshop webpage.

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