How Providers First Did More Harm This Week

Cheryl Clark, November 11, 2010

Healthcare news this week was speckled with examples of how the healthcare system—no doubt with the best of intentions—sometimes ends up doing more harm than good.

To be sure, there are well-energized agencies, movements, systems and regulations, laws, and hundreds of thousands of well-meaning people trying to prevent unintended consequences.  But as the saying goes, "stuff happens."

First, the U.S. Food and Drug Administration released its long-awaited findings on the mishaps that caused 385 patients at five hospitals in California and one in Alabama to receive harmful overdoses of radiation during brain perfusion scans intended to rule out stroke.  Of the 385 patients, 260 patients received the scans during an 18-month period at Cedars Sinai Medical Center in Los Angeles.

"The FDA found that when properly used, the CT scanners (made by GE Healthcare and Toshiba America Medical Systems) did not malfunction. Instead it is likely that the improper use of the scanners resulted in these overdoses," the FDA said this week. The FDA was not forthcoming on what exactly those users did improperly to cause the overexposures; though that would be helpful to know.

Many of the overexposed patients suffered burns, rashes, and now run a higher risk of getting cataracts. Many of them worry they now have a higher risk of getting cancer, as well. But the FDA noted that it "found no evidence that the manufacturers were involved in modifying any of the hospitals' scanning protocols so as to cause overexposures."

The advisory makes clear that the FDA now says imaging professionals responsible for conducting CT procedures "must define the equipment parameters needed to provide an adequate image at the lowest dose."


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