SILVER SPRING, Md., Nov. 9, 2010 /PRNewswire-USNewswire/ — The
U.S. Food and Drug Administration has been investigating reports
that patients undergoing computed tomography (CT) brain perfusion
scans were accidently exposed to excess radiation. The FDA found
that when properly used, the CT scanners did not malfunction.
Instead, it is likely that the improper use of the scanners
resulted in these overdoses. However, the FDA has identified a
series or promising steps to enhance the safety of these
procedures. These steps could reduce the likelihood of radiation
overexposure in the event of improper use of the CT scanners.
(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)
(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)
The FDA has sent a letter to the Medical Imaging and Technology
Alliance (link below), the major professional industry organization
for manufacturers of CT scanners and other radiological imaging
devices, reporting on the results of the investigation and
discussing possible CT equipment enhancements that could improve
patient safety. The agency will hold follow up discussions
with manufacturers on the changes.
Those changes 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 receiving 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; and - Organization of all dose-related information into one section
of each user manual, in a dedicated dose manual, or indexed
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