W. Virginia Hospital Overradiated Brain Scan Patients, Records Show

The patients, atCabell Huntington Hospitalin Huntington, W.Va., were overdosed with radiation until late November, records show, even after theFood and Drug Administrationhad publicly issued its final report on hundreds of overdoses involving brain scans at other hospitals and the errors had been discussed publicly in Congress and by state officials and professional organizations.

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.”

Richard A. Patterson, a Los Angeles lawyer who is representing patients who were overradiated at other hospitals, said he and his associates represent at least 20 patients at Cabell who were sent letters from the hospital saying they had received too much radiation.

One of those patients, Marcie Iseli, a 36-year-old mother of two teenagers, lost large patches of hair in a band around her head, a pattern ofhair lossthat matches dozens of other patients who were overradiated in 2008 and 2009 atCedars-Sinai Medical Centerin Los Angeles and atHuntsville Hospitalin Alabama.

Ms. Iseli had her CT procedure on Nov. 16 after experiencing nerve weakness on one side of her face. She said she immediately became nauseated.“The only thing I can remember is the weakness, being tired, my hair started coming out in clumps, my head was burning, my face was really hot,” she said.

Her patient records indicate that she received at least 10 times too much radiation, Dr. Smith-Bindman said.

“The events of the past year have certainly raised awareness of the issue,” said Karen Riley, a spokeswoman for the Food and Drug Administration.“However, we suspect that overexposures continue to occur and that incidents are underreported.”

Problems with the procedure, called a CT brain perfusion scan, first began to surface in the summer of 2009 at Cedars-Sinai, and then later at several other hospitals. These errors set off an investigation by the Food and Drug Administration into why patients tested with this complex yet lightly regulated technology were being overradiated.

The Food and Drug Administration’s final report, issued Nov. 9, 2010, said that most of the overdoses were a result of user error. However, it also said that manufacturers should do a better job of training and educating those who use their equipment and that their machines should have a more effective way of warning operators when radiation levels are too high.

Mr. Patterson, who is Ms. Iseli’s lawyer, said it was unfathomable that Cabell Huntington Hospital could make these mistakes“after the entire radiology world and the universe was aware of the problems.”

According to Food and Drug Administration records, G.E. Medical Systems, the company that made the CT scanner, filed a report in December 2010 about an error that occurred at Cabell in June. According to that report, the prescribed dose“was significantly greater”— or 5.6 times higher— than G.E.’s guidelines.

G.E. 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.”

G.E. filed a second report this January on a similar episode that had happened the previous March.

“It’s not surprising to me that these errors continue to happen,” Dr. Smith-Bindman said.“The only way to fix the situation is to have hospitals be accountable by having to record the dose and reveal that to patients.”

David J. Brenner, who directs theCenter for Radiological ResearchatColumbia 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 medicalX-rayscans, and it seems high time that we consider national legislation.”

Ms. Riley said the industry had responded responsibly to the Food and Drug Administration’s recommendations on how to make medical radiation safer.“Individual companies that have been the subject of the F.D.A.’s investigation and other members of industry are now working on improvements to dose information in their labeling, as well as equipment safety features that will reduce the likelihood of additional exposures,” she said.

Source