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zoom RSS 過剰な放射線量でCTスキャン/米国医療事情

<<   作成日時 : 2011/03/14 23:52   >>

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 ウェストバージニアの巨大病院は、連邦当局がこうしたタイプのスキャンを使用するときには特に慎重を期すように全国に警報を出してから1年以上も脳卒中疑いの患者へ過剰な放射線量でCTスキャンを使い続けていた。
 数百例の過量放射線問題についてFDAが最終報告を公表し、議会や州当局、専門家らが議論を積み重ねていた後、ウェストバージニアのキャベルハンティントン病院では、昨年11月末まで過量放射線を使用していた。
 36歳のMarcie Iseliは、2008-2009年にロサンゼルスのCedars-Sinai Medical Center やアラバマのハンツビル病院で起きたのと同様に、横縞に脱毛症が生じ、吐き気もあった。記録によれば少なくとも10倍の放射線量を受けて、「頭が燃えて、顔が熱かった」という。
 CT脳血流スキャニングと呼ばれる検査で問題が生じ、2010年11月9日出されたFDAの最終報告は、過量のほとんどが使用者の間違いの結果であるという。
 しかし、メーカーは使用者への訓練と教育をきちんとすべきで、放射線レベルが高いときは警告するような効果的な方法をとるべきだ。
 広く問題が知れ渡っていたはずなのに、キャベルハンティントン病院がこうした間違いを続けていたことは信じがたい。
 状況を改善する唯一の方法は、放射線用量を記録し、患者にそれを明らかにして病院に責任があることを規定することにある、とSmith-Bindman博士は言う。
 医療用X線スキャンからの放射線被曝について連邦規定がほとんどなく、立法にはちょうど良い機会である。

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West Virginia Hospital Overradiated Brain Scan Patients, Records Show
By WALT BOGDANICH
Published: March 5, 2011
http://www.nytimes.com/2011/03/06/health/06radiation.html

画像A large West Virginia hospital seriously overradiated patients suspected of having strokes with CT scans for more than a year after similar episodes prompted federal officials to alert hospitals nationwide to be especially careful when using those types of scans, interviews and documents show.

The patients, at Cabell Huntington Hospital in Huntington, W.Va., were overdosed with radiation until late November, records show, even after the Food and Drug Administration had 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 of hair loss that matches dozens of other patients who were overradiated in 2008 and 2009 at Cedars-Sinai Medical Center in Los Angeles and at Huntsville Hospital in 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 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.”

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.


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