DURHAM, N.C. — A woman who teaches surgical tool cleaning processes said she felt she had to come forth with her doubts about a health care giant's claims concerning a medical mix-up in which used hydraulic fluid was mistakenly used in the cleaning process of surgical instruments.
Tammy Holden, the director of Durham Technical Community College's Surgical Technology Program, told WRAL that she questioned Duke University Health System's claims that the tools, which were used on approximately 3,800 patients, were still sterile and would not increase the risk of infection in patients.
"I just have doubts," Holden said. "I know the process. I know that oil and water don't mix."
Duke Health officials said the tools affected in the mix-up involving two hospitals last year underwent an eight-stage cleaning process that included steam sterilization, but Holden said steam sterilization is not a reliable way to clean tools that use petroleum-based products, such as hydraulic fluid. She said that tools that use lubrication on hinges go through a dry-heat sterilization process instead.
"I just question when you throw a little oil into the mix, are those steamed instruments sterile?" Holden asked.
Since the mistake was discovered, Duke Health has maintained that the risk of infection for any of the affected surgeries is not expected to be higher as a result of the mistake. Duke Health stands by its statement based on a study by UNC Hospitals Director of Epidemiology William Rutala.
The study re-created the mix-up to test the effectiveness of the sterilization process. While Rutala said Holden is correct about the way the cleaning process is supposed to be practiced, he said the steam sterilization still worked, despite the presence of hydraulic fluid.
Rutala told WRAL that bacteria and spores were placed on tools along with an exaggerated amount of the used hydraulic fluid. In 20 tests, sterilization still worked 20 times, he said.
Still, Holden said she was concerned about the patients' possible exposure to tainted surgical instruments.
"I felt morally and ethically that I had to speak up," she said. "There's [nearly] 4,000 patients; they need to know this."
In January, Duke Health sent letters to thousands of patients who had surgeries over a two-month period at Raleigh Duke Health and Durham Regional Hospital about the medical mix-up. Since then, the health care system has started tracking patients' health concerns, set up an information line and developed a Web site to provide information on the case.
While no lawsuits have been filed against Duke Health, there are two pending against the detergent supplier, Cardinal Health, and the elevator repair company, Automatic Elevator Co., blamed in the mix-up.
A report by the N.C. Department of Health and Human Services' Division of Facility Services revealed that the error happened after elevator workers at Duke Health Regional Hospital drained hydraulic fluid into empty detergent containers without changing the labels.
According to the report, Cardinal Health later picked up the containers and somehow redistributed them to the Duke Health-affiliated hospitals, as well as a Winston-Salem hospital.
Lawyers for patients involved have also claimed that patients exposed to the surgical instruments are at a higher risk than Duke Health experts want to admit. In their own independent analyses, researchers said they found more metals in the fluid than what Duke reported.
The difference in analysis, according to experts WRAL interviewed, comes down to how the two studies were conducted. The Duke Health study looked at the risk from the amount left on surgical tools, whereas the lawyers' study looked at the entire contents of a larger sample.