See frequently asked questions about:

• Patient Risk
• Duke's Response
• Medical Consultations

For an overview of the incident and Duke’s response to date, please click here: Overview of Events

Patient Risk

Q.
Do we know exactly what health risks patients face from the exposure to instruments washed in hydraulic fluid?

Dr. Cuffe: “Well, we had two concerns after this incident. First, were the instruments sterile—because if they weren’t, that would increase the risk of infection. Second, what was the exact nature of the patients’ exposure to residuals from the hydraulic fluid. We took immediate steps to answer these questions.

“For the sterilization question, our director of infection control and his team examined the infection rates for those patients, and they saw no notable increase in infections. The infection rates were still well below the state average for the operations during that period of time. We also engaged an external expert, Dr. Rutala, and his conclusion was that the sterilization process worked and the instruments were in fact sterile. So, that addressed one concern, sterilization and infection risk.

“To help us determine the potential exposure of patients to hydraulic fluid and the chemicals contained within the fluid, we engaged RTI International to conduct a chemical analysis of exposed instruments. RTI is one of the best organizations in the country for this kind of analysis. They adapted an existing methodology to conduct the analysis; it was a very aggressive methodology that even pulled some of the metal out of the instruments. Even with this aggressive process, what they found was very tiny amounts of residual.

“Our internal toxicology group examined the RTI report and concluded that there was no identified health risk for patients. In other words, the risk is very, very small--not quantifiable.”

Q.
What types of surgical instruments were exposed to hydraulic fluid?

Dr. Cuffe: “There are many types of instruments and supplies used in surgery. Most of these supplies are thrown away after a single use. These disposable items include gloves, gowns, drapes, plastic tubing, breathing tubes, needles, scalpel blades, and other tools; these are shipped to us sterile and therefore were not exposed to the fluid.

“Certain metal instruments, such as clamps, needle holders, and scalpel handles, are reused after cleaning and sterilization. It was this type that was exposed during the washing process. Other, more fragile surgical tools, such as endoscopes (used for endoscopic procedures), go through a hand sterilization process and therefore did not come into contact with the hydraulic fluid.

“Duke has contacted patients who had any type of surgical procedure during the time in question, regardless of which type of instrument or supplies were used.”

Duke’s Response

Q.
Why did it take weeks for the hospitals to discover that the instruments were being washed in hydraulic fluid, especially when several physicians and staff reportedly complained that the instruments felt greasy?

Dr. Frush: “I think the perception is that Duke completely ignored what everyone was saying, but that’s not the case. Our managers did hear from several staff members who were concerned that the instruments felt oilier than usual, and they took steps to find out what was wrong. We performed numerous checks of the equipment, looking at the volume of fluids released into the wash cycle and similar things, and those inspections did not reveal any problems with the equipment. Unfortunately, it took a while to realize that the detergent itself might be the problem. But as we engaged additional individuals to evaluate the concerns, we discovered that the problem was occurring at both Durham Regional Hospital and Duke Health Raleigh Hospital. This helped us identify the detergent rather than the equipment as the common factor.

“We do want to make sure that any issues staff raise concerning patient safety are addressed immediately. We’ve worked to formalize that process by developing a new policy called ‘STOP FOR SAFETY.’ It explicitly states that any staff member who believes something is wrong can and should raise that concern at any point and the whole team must stop, evaluate the situation, and as a group make a decision as to what to do. At a health system level, we’ve also worked to make sure that problems at any one of our facilities will not go unnoticed at others—as in this case, when we had two hospitals that were experiencing similar problems but were unaware of each other’s situations for weeks. In response, we’ve put a new communication algorithm into place to improve the transfer of information across the health system.”

Q.
According to the RTI chemical analysis report there was very little hydraulic fluid residual left on the instruments after the cleaning process (approximately 0.08 milligrams per instrument, on average). If this is so, why were the instruments noticeably oilier to staff?

Dr. Cuffe: “Actually, many staff didn’t notice any difference. Some commented that they thought instruments were oilier. There is a lubricant that is routinely applied to instruments before sterilization that makes them slick, so additional lubricant, even if it is a tiny amount, on the surface of a stainless steel instrument that is already lubricated can perhaps make it feel that much slicker.”

Q.
Is it true, as insinuated in some media reports, that the instruments analyzed were not representative of the instruments actually used in patients?

Dr. Cuffe: “No. When they realized what was happening, the staff did two things that were very smart. First, they immediately set to work to reprocess and re-clean the instruments so that they could continue with their surgical work. Hospitals like Duke Health Raleigh and Durham Regional only have enough instruments for one to two days of surgery, that’s all. Sometimes instruments might even be needed more than once in a day.

“At the same time, staff at Duke Health Raleigh realized that testing might be needed, so they pulled several sets of instruments aside. Those instruments were sequestered and there was a good chain of custody from their time at Duke Health Raleigh to when they were taken to RTI for testing. All such remaining instruments are in RTI’s possession. There is no reason to believe the instruments tested are either more or less representative than any of the affected instruments. In essence they are a random selection of instruments that were processed with the hydraulic fluid in the system.”

Q.
Why did it take so long to get results back from both the sterilization study and the chemical analysis?

Dr. Cuffe: “The studies we commissioned were both complicated and unusual, and it took months to design and conduct them. The researchers had to adapt existing methods of analysis to test the residual fluid left on the instruments after the washing and sterilization process, because this is what patients were exposed to. They could not have gotten accurate results through simply testing the used hydraulic fluid itself." [Note: This used fluid is what was tested by plaintiffs’ attorneys. See a related Duke statement issued Sept. 21, 2005.]

Q.
Some patients feel frustrated that information about the health risks associated with this incident was so slow in coming out. How do you respond to this?

Dr. Frush: “We have heard from a number of patients who were frustrated with a lack of communication on our end, and we understand their feelings. From our perspective, we were working hard internally to determine exactly what this exposure meant, to approach it from the perspective of hard science. We needed to understand how this exposure would affect patients and then come to them with complete and accurate facts, instead of alarming them unnecessarily. However, this resulted in a communication delay that in retrospect was entirely too long. As a result, we are working with patient advocates to develop new communication processes designed to allow much faster communication with our patients. [Note: To learn about some of the efforts to date, please see our letter to patients from August 3, 2005.]

“What we did well was to let patients know there was a problem immediately, and to quickly move forward to address the concerns of exposure and infection. We did not do a good job of giving patients avenues to continue to express concern, to have reassurance and consultation and updates on our progress. The second letter, although it came with new test results, came out five months later, and in the interim we did not have sufficient methods of communication in place. We have learned from this mistake, and we are working to strengthen our focus on quality and safety with more attention than ever before to good communication with our patients.”

Q.
I am a Duke Health System employee. How should I respond to patients’ questions about this incident?

Dr. Cuffe: “No doubt, many employees have been asked questions about these events by friends and family. We greatly appreciate our employees' service as ambassadors of the Health System and their efforts to provide accurate and helpful answers to such questions. To assist in these efforts, we make additional information resources available for employees to use in responding to such inquiries. DUHS created this Web site as a resource for patients, employees and the media; it is intended to answer questions and promote a clearer understanding of the incident and its resolution.

“We also periodically update our employees with information to help them respond to questions, whether the questions are about the care provided to noted patients (for example, the Benton sisters from the London bombing in July 2005), the hydraulic fluid incident, or other news stories.

“These resources help employees to field the basic questions they may receive. If employees receive inquiries from the news media on any subject, they are to be referred to Chris DiFrancesco at the Duke University Health System News Office, 919-684-4148.”

Q.
What has been done to make sure this type of accident doesn’t happen again?

Dr. Frush: “We put a number of safeguards into place right away, including a risk assessment for all containers that have potential for patient contact, and a new container management policy under which we will not accept or use containers without the appropriate seals and labels in place. We also instituted online safety training in container management, which health system employees have now completed. We’re also continuing our constant efforts to create a broad culture of safety through initiatives like STOP FOR SAFETY (see above), safety walkrounds, and the implementation of safety teams."

Medical Consultations

Q.
Duke has offered affected patients the opportunity to receive a medical consultation at no cost from Duke environmental medicine specialists. Are these consultations confidential?

Dr. Cuffe: “Yes, even more so than our usual high level of confidentiality. All medical records are subject to HIPAA privacy requirements, but they can typically be viewed within the Duke health system for purposes of quality assurance. In this case we have not allowed even that level of access to the records. There are only three ways the records can become available to others in the Duke health system outside of the environmental medicine clinic: The patient must agree to disclose the records, state or federal law can compel the records, or our specialists, Dr. Darcey and Dr. Epling, can provide pertinent data for patient care reasons. We will study this data in aggregate to determine whether there are any unusual health patterns in affected patients as a group.”

Q.
A number of patients have said they no longer trust Duke after this incident and would not return here for the free medical consultations or other care. How would you respond to that?

Dr. Frush: “It saddens me to think that people wouldn’t want to come back to Duke for their care. As I’ve said multiple times, we remain committed to providing the best possible care for our patients. I understand that people are upset due to the delay in setting up the clinic, but that doesn’t change the quality of care provided there. The physicians and staff who work at our Occupational and Environmental Medicine Clinic are nationally, even internationally recognized experts on how these kinds of exposures affect patients. These are people of great integrity, who have devoted their entire lives to helping people in similar situations, and at their request we have taken extra steps to ensure that their patients’ medical information will be held in the strictest confidence. I don’t think any patient who visits them would question the quality of care and caring that they provide.”

What Happens Next

Q.
Did Duke track the long-term health of patients exposed to these instruments?

Dr. Cuffe: “As part of our commitment to the continued well-being of our patients, we established a program to monitor the health of patients involved in the hydraulic fluid incident. Many patients expressed their interest in such a program, yet many others asked that we do not contact them further. The follow-up was designed to respect patients’ wishes and privacy, and also to address patient concerns.

“We tracked long-term health through calls we received from patients and their physicians and through health data obtained through medical care at Duke. The program, which was conducted by an independent company, PharmaLinkFHI, did not identify health event rates that were increased above those expected of a general or similar patient population.”

Q.
Are any further studies or tests planned?

Dr. Cuffe: “With the conclusion of the PharmaLinkFHI follow-up registry, no further studies are planned.

“We did provide samples of the used hydraulic fluid to law firms who had it tested independently. The important point we hope people will remember, though, is that our patients were not exposed to hydraulic fluid—they were exposed to the residual left on the instruments after a 16-minute wash and rinse cycle and after a 50-minute sterilization process. That residual, the substance patients were actually exposed to, is what the RTI report quantified.”

Q.
Do patients have a voice in the Duke University Health System on this and other issues?

Dr. Cuffe: “Each of the hospitals in Duke’s Health System receives advice from the community through Patient-Visitor Relations, customer surveys, complaints, and community membership on our governance boards. We are also grateful for the host of community volunteers throughout our hospitals and clinics. This incident, however, has highlighted the need for more focused advocacy within Duke’s senior leadership, and so we have created a new patient advocacy board. This board will complement our existing lines of advice and will meet regularly to help Duke’s leadership focus on patients’ needs across all areas. Patient members of the board represent different groups, hospitals, and counties, and include a representative involved in the hydraulic fluid incident.”

Q.
Is Duke planning future contact with these patients?

Dr. Cuffe: “We will let patients know whenever we have new information that may be of interest to them. We have heard from several patients who felt we were giving them too much information—they only wanted to know if we had discovered a problem. If patients want to be removed from the mailing list for updates, they can contact our hotline at 919-286-3232, extension 223.”