Source: New York Times National Ed., 3/6/2011; US Food & Drug Administration
We previously reported on radiation errors with CT brain perfusion scans when they were widely reported in the summer of 2009 at Cedars-Sinai. Following reports at several other hospitals, the Food and Drug Administration conducted an investigation into why patients tested with this complex (and sparsely regulated) technology were being overradiated.
The Food and Drug Administration’s final report, issued Nov. 9, 2010, cited user error and recommended that manufacturers (including G.E.’s medical division) should do a better job of training and educating users and also the institution of controls to better warn technicians and operators when radiation levels are accidentally set too high.
The errors have continued to surface. A large West Virginia hospital, Cabell Huntington, overradiated patients suspected of having strokes with CT scans for more than a year after the FDA’s investigation.
A spokesman for G.E., who made the scanner, said a hospital technician had “manually increased” the radiation output to obtain a clearer picture, though that additional clarity was not necessary for diagnosis. G.E. said its machine did not malfunction, but it also said that technicians had subsequently received “refresher training.”A similar episode had happened the previous March.
Federal records indicate that Cabell knew of some of the overdoses for three months, but it did not disclose them publicly until The New York Times called the hospital for comment late last week. Within hours, the hospital issued a news release that was picked up by the local media. Charles Shumaker, a hospital spokesman, declined to say how many patients were overdosed, why the mistakes occurred or whether any hospital employees were disciplined as a result.
But Dr. Rebecca Smith-Bindman, a radiology professor who has testified before Congress about the need for more controls over CT scans, called the dosage report for one Huntington patient — provided to her by The Times — “grossly and unacceptably abnormal.”
One of those patients, a 36-year-old mother of two teenagers, lost large patches of hair in a band around her head. Her patient records indicate that she received at least 10x times the radiation she should have, according to her attorney.
David J. Brenner, who directs the Center for Radiological Research at Columbia University Medical Center, agrees that more needs to be done. “An underlying problem here,” he said, “is that there are almost no federal regulations controlling radiation exposure from medical X-ray scans, and it seems high time that we consider national legislation.”
Post: Gayle R. Lewis, Esquire