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Update on Hydraulic Fluid Issue - 6/15/05

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Duke Health News 919-660-1306

To: Duke University Health System physicians and hospital staff

From: Victor J. Dzau, M.D., President/CEO of Duke University Health
System, Chancellor for Health Affairs

Date: June 15, 2005

Re: Update on Hydraulic Fluid Issue

You have no doubt seen the recent news reports of patients who have
indicated post-operative problems they believe are related to exposure to
instruments accidentally cleaned with hydraulic fluid (mistakenly delivered
to the hospitals by our supplier, Cardinal Health) prior to sterilization at
Durham Regional Hospital and Duke Health Raleigh Hospital last November and
December. While we understand that some patients have experienced symptoms
following their surgeries, everything we know would suggest that no causal
connection has been established between any of these patients' outcomes and
instruments exposed to the fluid in the presterilization process.

I understand that you and your patients may be concerned about these
media reports, and especially the suggestion that Duke has been unresponsive
to patients. I feel badly that any patient suffers post-operative
complications, but I know that there is always some risk of a poor outcome
in any surgery, wherever a procedure is performed, even under the best of
circumstances. I want to assure you that the health and welfare of our
patients will always be our top priority, and we have given the patients who
have contacted us the best information we have had at the time. We expect to
have updated information from outside experts in the next few weeks, and
when we get it, we will immediately share it with our physicians and their
patients.

To understand our communications with patients thus far, it is important
to understand the nature of the sterilization process. The best way to
explain it, perhaps, is to imagine a powerful dishwasher in your home. You
likely rinse off the dishes before you put them in the dishwasher, but the
real cleaning takes place in the dishwasher itself. In this case, there is a
manual cleaning followed by the automated process by which the instruments
are initially rinsed with the fluid, a small amount of which is diluted into
several gallons of hot water, and washed before the sterilization process
occurs. The sterilization process itself involves very high temperature
rinsing and then the equivalent of pressure-cooking in a 270-degree
(Fahrenheit) oven, which is designed to destroy any possible organisms. As
part of that process, a lubricant is applied to the clean instruments to be
sure that they do not lock up during surgery and rust is avoided. It is not
uncommon that following the sterilization process, the instruments may feel
a bit oily. Thus, when they did in November and December, it took us a while
to figure out that this was beyond the normal level of oiliness. As soon as
we did, we notified our patients and urged them to contact their doctors if
they had any concerns. Each and every one of the more than 100 patient calls
made to our two hospitals was answered, and patients were provided with the
information we had at the time.

Although the Center for Medicare and Medicaid Services, which reviewed
the situation, required prompt corrective action by both hospitals, CMS
subsequently certified that both Durham Regional and Duke Health Raleigh
Hospitals are in full compliance with CMS standards.

Our infection control experts have been monitoring the infection rates at
the hospitals, before, during the period when the fluid was used, and since
then. They have found no notable evidence of increased infection rates or
that the sterilization was not fully effective. An outside expert has
corroborated that the sterilization process was not compromised. In
addition, Duke has obtained the expertise of outside scientists to conduct a
trace chemical analysis of the surgical instruments that had been processed
with the fluid, in order to thoroughly examine any potential exposures to
patients. Given the unusual nature of this situation, the scientists
literally had to create a methodology by which they could conduct such an
analysis, which has taken more time than we had hoped. Nonetheless, their
preliminary results, when combined with our monitoring of infection rates,
reassures us that our patients have not been put at risk. As soon as we have
their final report, which we expect in the next few weeks, we will share the
results with our patients and our physicians.

In the last 24 hours, I have met with physician leaders across the Duke
Health System. I was encouraged, but not surprised by the absolute
commitment to patient safety and their support for the excellent work of our
Chief Patient Safety Officer, Dr. Karen Frush. At each of these meetings, we
discussed this situation and the importance of providing transparent
information, both to members of our health system community and to our
patients. We are committed to do so. I hope you find this information to be
helpful.

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