Approximately three years ago, 3,648 patients of Duke University hospitals were exposed to hydraulic fluid mistakenly used to clean surgical instruments. Today, some of these patients report health problems, debilitating infections, rapid weight loss and skin rashes.
A new Duke-funded study suggests, however, that patients exposed to the tainted surgical instruments did not suffer adverse health problems as a result of the mix-up.
The study concluded that 10.5 percent of the patients involved reported new infections or hospitalizations. In addition, the 67 reported deaths among exposed patients is within the typical range expected given the age and previous health status of the affected patients, the study reported.
Since news of the contamination of the instruments broke in 2005, Duke has continued to highlight the fact that the instruments washed with hydraulic fluid were later sterilized as part of the standard cleaning process.
The incident occurred after an employee of a contractor drained hydraulic fluid into drums labeled as detergent in September 2005.
Some scientists, however, including Steve Marshall, an epidemiologist at the University of North Carolina at Chapel Hill, would have liked to see more research put into the study.
"As a scientist, in order to make a conclusion that there is no effect on a patient, we would like to see a comparison group of patients who were not exposed," Marshall said. "This study does not do that."
Further problems with the study could also bias the conclusions made by the University, he added.
"First, since the study was funded by Duke, some people feel reticent to return to the place they believe made them ill," Marshall said. "You might even argue that these people who are hesitant to return are those who were most severely affected by the hydraulic fluid."
Another potential problem with the inquiry was the target group examined by PharmaLink, the independent group conducting the study, Marshall said. PharmaLink looked at patients with high and low exposure, whereas a more effective study might have focused solely on those most exposed to the fluid, he said.
The report was released just months before the statute of limitations for filing lawsuits against the Duke University Health System expires. Thus far, only one patient has filed a lawsuit against Duke, but he later dropped it. Several other patients have sued the elevator company and medical supply company that may have been responsible for filling detergent containers with hydraulic fluid.
However, many patients may be hesitant to file lawsuits because it is difficult to prove a correlation between exposure to hydraulic fluid and serious illnesses, Marshall said.
"You could make some guesses that potentially instruments didn't get cleaned and potentially reinfection would be an issue," he said. "But as for whether toxins from the fluid are causing problems, it would be much harder to speculate. This is not something that has been well-studied by scientists."
Although Marshall said he would like to see more investigation into the effects of the hydraulic fluid mix up on patients, he said that Duke has made a strong effort to research and fix the problem that it created.
"Duke is trying to be a good citizen," he said. "Many other hospitals would not have had the money or put forth the effort to even do what Duke has done."
DUHS officials were not available for comment.
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