Officials at the Food and Drug Administration's Center for Devices and Radiological Health have concluded that a series of radiation overdoses in patients who received CT brain perfusion scans between 2008 and October 2010 were likely the result of improper use of the scanners, not equipment malfunction.
Excess radiation tied to equipment misuse: FDA
CDRH officials have published their conclusions in a just-released update of the agency's investigation into 385 reported cases of radiation overdose among patients at six hospitals across the country.
But while the findings have cleared questions of potential equipment malfunction, CDRH Director Jeffrey Shuren is urging manufacturers to put in place several safety mechanisms aimed at preventing user mistakes that could lead to future case of excess radiation exposure in patients.
In a letter sent to Medical Imaging Technology Association, Shuren asked CT machine manufacturers to provide equipment purchasers with information and training on brain-perfusion protocols; clarify dose parameters and instruct users on how to set those parameters; equip the machines with pop-up notifications that alert equipment operators when a dosing level is set higher than necessary; organize all dose-related material into one section of a user manual; and provide facilities with PDF files or hard copies of dose parameters for particular clinical applications.
MITA expressed support for the FDA's efforts. “As part of our commitment to patient safety, MITA and its members are committed to working with the FDA on MITA's Dose Check Initiative and the FDA's recommendations,” according to a statement from Executive Director Dave Fisher.
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