June 27, 2005
Duke Pledges to Hand Over Fluid Sample
By MARGARET LILLARD
ASSOCIATED PRESS
RALEIGH, N.C. (AP) - Duke University Health System officials pledged Monday to hand over a sample of the hydraulic fluid in which surgical instruments were mistakenly washed at two of its hospitals last year.
The hospital system and lawyers for a group of patients appeared before a Durham County Superior Court judge to formalize an agreement that also called for the health care provider to release an analysis of the fluid's contents, patients' lawyer David Stradley said.
The data was to be turned over Monday afternoon, while a testing firm hired by the patients would arrange to collect fluid samples later in the week, he said. It was unclear when that firm would produce its own analysis, he said.
"Since we've had no access to the fluid or the information prior to today, our experts haven't even been able to formulate an estimate," he said.
Stradley declined to name the lab that would perform the tests.
Stradley represents seven patients among more than 3,800 who had surgery at Duke Health Raleigh Hospital and Durham Regional Hospital with tools that were accidentally washed in hydraulic fluid instead of soap. The errors occurred over two months at the end of 2004.
Duke has maintained that the hydraulic fluid did not alter the effectiveness of the sterilization process, and that there was no risk of injury to patients who were affected. But patients have complained of aching joints, infections and other problems they believe were caused by the tainted instruments.
The mistake was made after elevator workers drained the hydraulic fluid into empty soap containers and capped them without changing the labels. At one point, the containers were returned to the soap supplier, which redelivered them to the hospitals.
The lawsuit names the elevator company and the detergent supplier; Duke is not being sued.
Stradley said he first asked Duke for the data and a fluid sample in February, then subpoenaed the material this month. The hospital system agreed Friday to provide them.
Duke spokesman Jeff Molter said Monday that the hospital was in the process of mailing a letter to the affected patients, describing the results of the tests it commissioned on the fluid "and their significance to all the patients."
Also Monday, a committee created to improve patient relations at Duke hospitals held its first meeting. Carol Svec, who had surgery with tainted instruments, said she, three Duke officials and two patient advocates attended.
Svec, of Raleigh, said the meeting was mainly organizational, defining the panel's mission as improving relations with all patients, not just those affected by the current controversy.
She also said members addressed some immediate goals, including ways to track patients who had surgery with tainted instruments so that the longterm impact of the exposure can be measured.
"This is something that has never happened before in the history of medical literature," Svec said. Tracking "is not going to happen tomorrow, but it sure looks like it's going to happen."
Also at the meeting were Dr. Victor Dzau, chief executive officer of Duke University Health System; Dr. Karen Frush, the system's chief of patient safety; Dr. William J. Fulkerson, the chief executive officer of Duke University Hospital; and two patient advocates Svec declined to identify. Other patient representatives will be added later, she said.
Duke Pledges to Hand Over Fluid Sample
By MARGARET LILLARD
ASSOCIATED PRESS
RALEIGH, N.C. (AP) - Duke University Health System officials pledged Monday to hand over a sample of the hydraulic fluid in which surgical instruments were mistakenly washed at two of its hospitals last year.
The hospital system and lawyers for a group of patients appeared before a Durham County Superior Court judge to formalize an agreement that also called for the health care provider to release an analysis of the fluid's contents, patients' lawyer David Stradley said.
The data was to be turned over Monday afternoon, while a testing firm hired by the patients would arrange to collect fluid samples later in the week, he said. It was unclear when that firm would produce its own analysis, he said.
"Since we've had no access to the fluid or the information prior to today, our experts haven't even been able to formulate an estimate," he said.
Stradley declined to name the lab that would perform the tests.
Stradley represents seven patients among more than 3,800 who had surgery at Duke Health Raleigh Hospital and Durham Regional Hospital with tools that were accidentally washed in hydraulic fluid instead of soap. The errors occurred over two months at the end of 2004.
Duke has maintained that the hydraulic fluid did not alter the effectiveness of the sterilization process, and that there was no risk of injury to patients who were affected. But patients have complained of aching joints, infections and other problems they believe were caused by the tainted instruments.
The mistake was made after elevator workers drained the hydraulic fluid into empty soap containers and capped them without changing the labels. At one point, the containers were returned to the soap supplier, which redelivered them to the hospitals.
The lawsuit names the elevator company and the detergent supplier; Duke is not being sued.
Stradley said he first asked Duke for the data and a fluid sample in February, then subpoenaed the material this month. The hospital system agreed Friday to provide them.
Duke spokesman Jeff Molter said Monday that the hospital was in the process of mailing a letter to the affected patients, describing the results of the tests it commissioned on the fluid "and their significance to all the patients."
Also Monday, a committee created to improve patient relations at Duke hospitals held its first meeting. Carol Svec, who had surgery with tainted instruments, said she, three Duke officials and two patient advocates attended.
Svec, of Raleigh, said the meeting was mainly organizational, defining the panel's mission as improving relations with all patients, not just those affected by the current controversy.
She also said members addressed some immediate goals, including ways to track patients who had surgery with tainted instruments so that the longterm impact of the exposure can be measured.
"This is something that has never happened before in the history of medical literature," Svec said. Tracking "is not going to happen tomorrow, but it sure looks like it's going to happen."
Also at the meeting were Dr. Victor Dzau, chief executive officer of Duke University Health System; Dr. Karen Frush, the system's chief of patient safety; Dr. William J. Fulkerson, the chief executive officer of Duke University Hospital; and two patient advocates Svec declined to identify. Other patient representatives will be added later, she said.
