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FDA proposes measures to reduce radiation overexposure from brain scans
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An investigation into the reports of overexposure to radiation via CT brain perfusion scans has prompted the FDA to send a letter to the Medical Imaging and Technology Alliance suggesting possible CT equipment enhancements that could improve patient safety.
According to a press release, the FDA began its investigation in 2009 by reviewing information from states and facilities where radiation overdoses occurred from 2008 to Oct. 26, 2010, as well as inspecting manufacturers of CT scanner equipment. Results from the analysis indicated that when properly used, CT scanners did not malfunction; however, improper use of scanners was likely the cause for overexposure to radiation. Since the investigation began, the FDA has reported at least 385 patients who received excessive radiation from CT brain perfusion scans.
The steps being proposed in the FDA release to reduce the likelihood of overexposure include:
- A console notification to alert the operator of a high radiation dose.
- Providing particular information and training on brain-perfusion protocols to all facilities that receive base CT equipment, whether or not the facilities purchase the related software enabling quantitative analysis of cerebral hemodynamics.
- Clarification of parameters affecting dose, along with clear instructions on how to appropriately set those parameters.
- Organization of all dose-related information into one section of each user manual, in a dedicated dose manual or indexed comprehensively in a concordance covering all manuals.
Upcoming for the FDA will be follow-up discussions with manufacturers on the suggested changes.