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Duke Health News

919-660-1306

June 27, 2005

Dear,

We are writing to share with you additional information we have just
received about the incident last winter, in which surgical instruments were
accidentally exposed to hydraulic fluid before being sterilized at Durham
Regional Hospital.

Last week we wrote to share with you the findings of an extensive,
five-month study by outside scientists that investigated whether hydraulic
fluid compromised the sterilization of the surgical instruments. This
independent study, conducted by Professor William A. Rutala, Ph.D., M.P.H.,
director of the Statewide Program in Infection Control and Epidemiology at
the UNC School of Medicine, confirmed our initial assessment that the
sterilization of the surgical instruments was fully effective. We hope this
independent, outside verification was reassuring to you.

Today we are writing to inform you of the findings of a second external
study done by scientists at RTI International in Research Triangle Park. In
January we asked RTI to conduct an analysis to determine how much hydraulic
fluid remained on surgical instruments after they had been rinsed in very
hot water and then sterilized, as was the case in the incident at Durham
Regional Hospital.

We received the final results of the RTI study on June 24. Their report
concluded that the residual amount of fluid on the instruments tested was
very small, approximately 0.08 milligrams per instrument, on average. This
is the equivalent of 0.002 of a drop.

To address the concern that heavy metals might have been introduced into
the used hydraulic fluid as it circulated in the elevator mechanisms, the
researchers also tested for the presence of contamination by 11 metals. With
the exception of zinc, which is in one of the additives in the original
fluid and present at the expected low level, the majority of the metals were
not detectable and a few were barely detectable using sophisticated testing
equipment.

The amount of zinc in one milligram of used hydraulic fluid was
approximately 0.0004 milligrams. This amount is extremely small. For the
sake of comparison, the amount of zinc in a Centrum adult multi-vitamin is
15 milligrams. This means someone would have to ingest 10 gallons of the
used hydraulic fluid to ingest the amount of zinc found in one Centrum adult
multi-vitamin.

Based on this new information, along with a full list of the chemical
ingredients in the fluid provided by the manufacturer, Exxon-Mobil, we can
now tell you with even greater certainty that this very low exposure, on the
broad surface of an instrument or device, was not harmful to patients.

Woodhall Stopford, M.D., a toxicologist in the Duke University School of
Medicine, reviewed RTI's analysis of the fluid, along with chemical safety
information provided by Exxon-Mobil. Based on this information, Dr. Stopford
performed an initial risk assessment and concluded that none of the
chemicals was likely to be harmful in the extremely small amounts to which
patients were exposed. Because these findings are so important, we wanted to
share Dr. Stopford's comments with you:

"The original hydraulic fluid is greater than 99% solvent-refined mineral
oil that has been extensively tested for acute and chronic toxicity. It has
been shown to be non-toxic in various animal species tested and does not
cause chronic health effects. The additives in the oil are present in
extremely small amounts. Based on our initial analysis, they would not be
expected to represent a risk to exposed patients."

The findings to date are very good news, yet we realize that many
patients have been frustrated because this information has been slow in
coming. There have been two main reasons for this. First, the independent
studies we commissioned were very extensive. It took the researchers months
to design and conduct them, and additional time to verify the accuracy of
their findings. In the case of the RTI study, the detailed questions we
asked required the researchers to adapt complex methods of testing for this
specific analysis. We could have done less sophisticated studies – and
produced results faster – but that information would not have been as
reliable.

We were also hampered by delays in obtaining information about the
hydraulic fluid from the manufacturer, Exxon-Mobil. In February we requested
from Exxon-Mobil a detailed list of the chemical ingredients present in the
fluid at the time it was manufactured. This information was not provided to
Duke until June 7, because the company considers it proprietary – in
layman's terms, a trade secret. Exxon-Mobil provided the information under
the condition that it would be made available only to the scientists
conducting the analyses. Once the chemical formula was received, the
scientists were able to complete their work.

We recognize that despite these authoritative findings by two outside
groups of scientific experts, you may continue to be concerned that this
incident may have affected your health. If you have such concerns, we
recommend that you contact one of the physicians that Duke has made
available. Dennis Darcey, M.D. and Carol Epling, M.D., who are experts in
environmental medicine, are available at no cost to you to consult with you
and your physician on this matter. To make an appointment with either Dr.
Darcey or Dr. Epling or to learn more about this service, please call
919-286-3232, ext. 223. Ms. Ellen O'Briant at the Duke Occupational Health
Research Triangle Clinic will assist you. The clinic is located in Research
Triangle Park at 1005 Slater Road, Suite 101, Durham NC 27705. So far, 17
patients have called to discuss consultations with these physicians.

This phone number for the clinic also serves as an information hotline
where you can call with any questions about the incident. We welcome your
call and look forward to assisting you. Next week we will announce the
appointment of a patient liaison who will be available to assist patients
with questions or concerns related to this incident.

The trust that you have placed in Durham Regional Hospital is one that we
do not take for granted. The entire staff at Durham Regional sincerely
regrets any concerns you may have experienced following your care with
us.

In addition to the above, we are now considering a method to provide
long-term follow-up for these patients.

We will continue to communicate with you as new information becomes
available. In the meantime, if you have any questions or concerns, please
call our information hotline at 919-286-3232, ext. 223.

Sincerely,

Victor J. Dzau, M.D.
President and CEO
Duke University Health System

David P. McQuaid
CEO
Durham Regional Hospital

June 27, 2005

Dear,

We are writing to share with you additional information we have just
received about the incident last winter, in which surgical instruments were
accidentally exposed to hydraulic fluid before being sterilized at Duke
Health Raleigh Hospital.

Last week we wrote to share with you the findings of an extensive,
five-month study by outside scientists that investigated whether hydraulic
fluid compromised the sterilization of the surgical instruments. This
independent study, conducted by Professor William A. Rutala, Ph.D., M.P.H.,
director of the Statewide Program in Infection Control and Epidemiology at
the UNC School of Medicine, confirmed our initial assessment that the
sterilization of the surgical instruments was fully effective. We hope this
independent, outside verification was reassuring to you.

Today we are writing to inform you of the findings of a second external
study done by scientists at RTI International in Research Triangle Park. In
January we asked RTI to conduct an analysis to determine how much hydraulic
fluid remained on surgical instruments after they had been rinsed in very
hot water and then sterilized, as was the case in the incident at Duke
Health Raleigh Hospital.

We received the final results of the RTI study on June 24. Their report
concluded that the residual amount of fluid on the instruments tested was
very small, approximately 0.08 milligrams per instrument, on average. This
is the equivalent of 0.002 of a drop.

To address the concern that heavy metals might have been introduced into
the used hydraulic fluid as it circulated in the elevator mechanisms, the
researchers also tested for the presence of contamination by 11 metals. With
the exception of zinc, which is in one of the additives in the original
fluid and present at the expected low level, the majority of the metals were
not detectable and a few were barely detectable using sophisticated testing
equipment.

The amount of zinc in one milligram of used hydraulic fluid was
approximately 0.0004 milligrams. This amount is extremely small. For the
sake of comparison, the amount of zinc in a Centrum adult multi-vitamin is
15 milligrams. This means someone would have to ingest 10 gallons of the
used hydraulic fluid to ingest the amount of zinc found in one Centrum adult
multi-vitamin.

Based on this new information, along with a full list of the chemical
ingredients in the fluid provided by the manufacturer, Exxon-Mobil, we can
now tell you with even greater certainty that this very low exposure, on the
broad surface of an instrument or device, was not harmful to patients.

Woodhall Stopford, M.D., a toxicologist in the Duke University School of
Medicine, reviewed RTI's analysis of the fluid, along with chemical safety
information provided by Exxon-Mobil. Based on this information, Dr. Stopford
performed an initial risk assessment and concluded that none of the
chemicals was likely to be harmful in the extremely small amounts to which
patients were exposed. Because these findings are so important, we wanted to
share Dr. Stopford's comments with you:

"The original hydraulic fluid is greater than 99% solvent-refined mineral
oil that has been extensively tested for acute and chronic toxicity. It has
been shown to be non-toxic in various animal species tested and does not
cause chronic health effects. The additives in the oil are present in
extremely small amounts. Based on our initial analysis, they would not be
expected to represent a risk to exposed patients."

The findings to date are very good news, yet we realize that many
patients have been frustrated because this information has been slow in
coming. There have been two main reasons for this. First, the independent
studies we commissioned were very extensive. It took the researchers months
to design and conduct them, and additional time to verify the accuracy of
their findings. In the case of the RTI study, the detailed questions we
asked required the researchers to adapt complex methods of testing for this
specific analysis. We could have done less sophisticated studies – and
produced results faster – but that information would not have been as
reliable.

We were also hampered by delays in obtaining information about the
hydraulic fluid from the manufacturer, Exxon-Mobil. In February we requested
from Exxon-Mobil a detailed list of the chemical ingredients present in the
fluid at the time it was manufactured. This information was not provided to
Duke until June 7, because the company considers it proprietary – in
layman's terms, a trade secret. Exxon-Mobil provided the information under
the condition that it would be made available only to the scientists
conducting the analyses. Once the chemical formula was received, the
scientists were able to complete their work.

We recognize that despite these authoritative findings by two outside
groups of scientific experts, you may continue to be concerned that this
incident may have affected your health. If you have such concerns, we
recommend that you contact one of the physicians that Duke has made
available. Dennis Darcey, M.D. and Carol Epling, M.D., who are experts in
environmental medicine, are available at no cost to you to consult with you
and your physician on this matter. To make an appointment with either Dr.
Darcey or Dr. Epling or to learn more about this service, please call
919-286-3232, ext. 223. Ms. Ellen O'Briant at the Duke Occupational Health
Research Triangle Clinic will assist you. The clinic is located in Research
Triangle Park at 1005 Slater Road, Suite 101, Durham NC 27705. So far, 17
patients have called to discuss consultations with these physicians.

This phone number for the clinic also serves as an information hotline
where you can call with any questions about the incident. We welcome your
call and look forward to assisting you. Next week we will announce the
appointment of a patient liaison who will be available to assist patients
with questions or concerns related to this incident.

The trust that you have placed in Duke Health Raleigh Hospital is one
that we do not take for granted. The entire staff at Duke Health Raleigh
Hospital sincerely regrets any concerns you may have experienced following
your care with us.

In addition to the above, we are now considering a method to provide
long-term follow-up for these patients.

We will continue to communicate with you as new information becomes
available. In the meantime, if you have any questions or concerns, please
call our information hotline at 919-286-3232, ext. 223.

Sincerely,

Victor J. Dzau
President, CEO
Duke University Health System

James P. Knight
Chief Executive Officer
Duke Health Raleigh Hospital