Learning from the hydraulic fluid incident On Dec. 29, 2004, my mobile phone buzzed. It was the chief operating officer of the Duke University Health System calling with bad news.
Six months earlier, I had accepted the honor to lead this complex organization employing more than 18,000 dedicated physicians and employees. Patients come from across the globe to seek care at Duke, reflecting our ranking as one of the nation's top hospital systems.
Every time a patient improves under our care, we quietly celebrate. We focus relentlessly on compassionate care of the highest quality. That's why we're here. And yet, as in any large organization, challenging issues can and do arise, try as you might to prepare for all contingencies.
My heart sank that December day as I heard the news: Our staff had discovered that some surgical instruments had been inadvertently washed in hydraulic fluid instead of detergent at our two community hospitals, Duke Health Raleigh and Durham Regional.
The fluid was accidentally substituted for detergent in the multistage, high-heat cleaning process. The instruments were rinsed of the fluid in a washing machine and later sterilized with steam and dry heat.
Within a few hours, we had gathered a crisis team to assess the situation. The atmosphere was somber. We asked for facts. Were patients harmed? How could this have happened? Have we fixed the problem? Is this a systemic problem? Are any other hospitals affected?
At that point, we did not know the circuitous chain of events that led to a mix-up that victimized both our health system and our patients (as we later learned, elevator company workers had drained used hydraulic fluid into empty detergent containers, which were then returned to the detergent company and subsequently redistributed to several hospitals as detergent).
But soon I realized that everyone in the room felt the same way that I did. Our first concern was for our patients. This was not the time to cast blame, but to jump into action.
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We unanimously agreed that we must immediately inform the 3,800 affected patients and their physicians, and release new information as we learned more. Our discussion centered on how to deliver an accurate message while avoiding unnecessary anxiety or confusion. Our first letters went out on Jan. 6.
We designated the chief medical officer of each hospital as the primary patient contact, asking them to respond to patients and work with their physicians to provide appropriate care. Since the exposure to the instruments occurred over a defined period, the months of November and December, we were able to immediately examine the post-operative infection rate compared to normal rates. Our Infection Control physicians put into place a vigilant surveillance program. There proved to be no out-of-the-ordinary spike in infections.
To assure that the sterilization procedure had not been compromised, we quickly sought an outside expert, Dr. William Rutala, a UNC professor and director of the Statewide Program in Infection Control and Epidemiology at the UNC School of Medicine. We received his final report and conclusions June 15.
Using the actual used hydraulic fluid, Dr. Rutala found that replacing cleaning detergent with the fluid did not alter the effectiveness of the high-heat sterilization process.
We also recognized at the outset that we should address any potential exposure to chemicals in hydraulic fluid (although we felt confident that any exposure would be slight, since the instruments were rinsed and sterilized before use). In January we retained world-renowned RTI International in Research Triangle Park to conduct a chemical analysis of the used hydraulic fluid, to determine what quantities of the fluid were left on the instruments and to help us understand any risk to patients. The results showed that a miniscule amount of fluid was detected on the instruments that was determined not to be harmful to patients.
While we continue to monitor the situation and carefully assess the facts, we currently know of no link between any illness and the pre-sterilization incident.
We shared the results of these studies with our patients as quickly as possible. We also wanted them to know we were ready to address any complaint or concern. We established a hotline to answer their questions and also offered patients the opportunity to be evaluated at an independent Duke clinic specializing in environmental medicine. My goal was to allay our patients' fears and directly answer their questions.
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From Day 1 of this situation, my goal has been to maintain close contact with our patients, keep them updated with accurate information and address their concerns. At the same time, I wanted to balance urgency -- the need to get information out quickly -- with an exacting need for accuracy.
Looking ahead, I am committed to taking whatever steps are necessary, even painful steps, to ensure that no similar errors occur in the future. We must uphold the trust of the more than 300,000 patients a year who seek care within our system.
Our newly appointed physician leader of Medical Affairs has made patient advocacy his top priority, moving quickly to form a committee of patients and citizens who share our commitment. They will serve as patient advocates, providing important input related to patient communication issues and concerns.
This has been a trying time for our health system, especially for our doctors and nurses who care so deeply about our patients. Many challenging questions, criticisms and issues have been raised. It is our job to listen and respond appropriately. Our response has not been flawless, but we have learned much. In hindsight, we should have been more responsive to our patients' concerns. We have been reminded that sharing scientific results is not enough; we must sympathize with our patients, considering not only their diseases but their concerns and anxieties. This is our Hippocratic Oath.
But know this: We are determined that our health system will emerge from this incident as a stronger, safer and more caring institution. On that, you have my word.