FDA: ‘Improper use’ of CT scanners led to perfusion overdoses

AuntMinnie.com | November 9 – The U.S. Food and Drug Administration (FDA) today released the results of its investigation into a series of radiation overdose incidents in CT brain perfusion exams. The agency said that, most likely, the incidents were not due to scanner malfunction, but rather were caused by “improper use” of the systems.

In October 2009, reports of a series of CT radiation overdoses at Cedars-Sinai Medical Center in Los Angeles prompted the FDA to begin looking into the issue of medical radiation. In addition to Cedars-Sinai, a number of other hospitals in the U.S. reported that patients had received radiation overdoses. In many cases, imaging facilities were unaware of the incidents until after patients had been sent home and began experiencing side effects from radiation.

The agency held a series of hearings in March 2010 to discuss ways to make CT brain perfusion scans safer, in particular by requiring scanner manufacturers to incorporate design changes into their products that enable radiology professionals to see how much dose has been delivered during a procedure.

In today’s announcement, the FDA said that its investigation indicated that scanner malfunction was probably not the cause of radiation overdoses in the CT brain perfusion cases. “Instead, it is likely that the improper use of the scanners resulted in these overdoses,” the FDA statement said.

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