Patient decries response to fluid mix-up

It has all the trappings of a modern-day David and Goliath tale.

Carol Svec, a health writer from Raleigh, is almost single-handedly taking on Duke University Health System. Acting as an advocate for patients affected by the widely publicized hydraulic fluid mishap of November and December 2004, Svec is pushing for patients’ rights and calling for more transparency from DUHS administrators.

“We were put in this situation by no fault of our own. We were harmed while under Duke’s care,” Svec said, adding that she has spoken with more than three dozen affected patients the day before. “We would just like to be helped.”

In late 2004, employees at Duke Health Raleigh and Durham Regional Hospital—both DUHS facilities—used tainted surgical tools in more than 3,800 surgeries.

The instruments had been washed with elevator hydraulic fluid in one step of the standard cleaning process. An employee of a local elevator company had inadvertently drained the fluid into drums labeled as containing detergent.

Svec had rotator cuff surgery Nov. 15 at Duke Health Raleigh, and she has spent the last seven months drawing attention to the mix-up—supporting and comforting patients who previously felt they had few places to turn.

Patients have criticized Duke for not releasing information about the chemical composition of the liquid earlier; it took more than six months for Duke and Exxon Mobil Corporation—which produces the fluid—to make the data public.

In early July, Dr. Michael Cuffe, vice president for medical affairs at DUHS, said Duke should have responded more quickly and clearly when corresponding with patients about the specifics of the situation.

“Duke did the right thing immediately,” he said, citing Duke’s decision to correct the problem and analyze the data gathered to assess the impact of the mix-up. “But I think Duke could have done better in communicating with the patients.”

Cuffe also noted that Duke should have relayed the urgency of the situation to ExxonMobil when requesting information about the fluid.

Since the discovery of the mix-up, DUHS officials have stressed that the sterilization process of the surgical tools was not compromised and that patients were not put at higher risk of infection. DUHS has used data from three different studies to reach its conclusions.

The most recent study, conducted by independent firm RTI International, said any residual amount of fluid on the instruments after sterilization was, on average, only .08 milligrams.

“None of the chemicals were likely to be harmful in the extremely small amounts to which patients were exposed,” DUHS stated in letter sent June 27 to affected patients. It was the third letter delivered since the mix-up; the first two also emphasized that DUHS was confident patients’ health was not in jeopardy.

But as an author of health-related books who has studied the effects of foreign substances introduced into the body, Svec was not convinced by Duke’s explanations.

“If you hear the [patients’] stories, they are heartbreaking,” she said. “If you hear Duke talk, every time they say we aren’t sick it’s a slap in the face. It’s infuriating and frustrating.”

Several patients have said they suffered a variety of ailments after undergoing surgeries last fall after being operated on with tainted instruments.

Svec said she had minor side effects after her surgery, including lingering pain at the incision site and slow healing. She, like many patients, is unsure whether her afflictions were caused by the fluid mishap.

Svec’s fight against Duke began in January when she approached local media outlets to publicize Duke’s lack of transparency about the situation.

Though the story faded from the headlines after a few weeks, Svec continued pleading with local media outlets for six months to dig deeper into the story.

In what she considers a turning point in her efforts, Svec said DUHS felt increased pressure to release more information when the story resurfaced in the local media and hit national headlines in mid-June, six months after the initial discovery of the mix-up.

Around the same time, Svec sent an e-mail to Dr. Victor Dzau, president and CEO of DUHS and chancellor for health affairs at Duke, asking him to use her to help the confused patients.

“I was willing to lick envelopes at that time,” she said. “This was a coping mechanism for me. I needed to get out and do something.”

In several correspondences with Svec, Dzau expressed his deep regret and concern about the situation.

“Duke is as much a victim as the many concerned patients who underwent surgery during that period. After all we received the material from the supplier,” he wrote in an e-mail to Svec. “I can assure you that we care deeply about our patients.”

After Dzau appointed Svec to a patient advocacy group within the hospital, she called for DUMC to set up a system for long-term tracking of patients affected by the mix-up.

But she resigned from her position after a short time, saying she felt she was being used as a pawn. “I began to feel [I was] being invited to participate only to deflect media attention,” Svec said.

Instead, Svec created a support group online to give affected patients a place to talk about their experiences. She hopes to organize a convention later this year, inviting psychologists and lawyers to address patients’ concerns.

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