Unclean instruments may have been used in NC
Unclean instruments may have been used in NC
Two hospitals run by Duke University Health System in North Carolina were cited in a Centers for Medicare & Medicaid (CMS) report for mistakenly washing surgical instruments in used hydraulic fluid instead of detergent and failed to notice the mix-up for weeks.
Approximately 3,800 patients were exposed to the contaminated instruments during surgery.
The incident occurred in 2004 but recently came to light when a report from CMS described the error and concluded that it put patients in "immediate jeopardy" and issued its most serious level of citation.
Staff complaints went unheeded
According to the CMS report, operating room doctors and nurses complained often about surgical tools feeling slick, and sterilization technicians reported having to run extra wash cycles, but hospital administrators still did not fix the problem for weeks.
The CMS report explained how in November and December 2004, 3,800 patients at Duke Health Raleigh (formerly Raleigh Community) and Durham Regional hospitals underwent surgery with instruments that not only were not properly cleaned, but were repeatedly drenched in used hydraulic fluid left over from an elevator repair.
"Administrative staff failed to heed the multiple complaints of staff sterilizing and using the instruments, thus delaying the discovery of the error and needlessly exposing patients to these instruments over a longer time period," according to the CMS investigation.
A spokesman for Duke University Health System did not return calls from Healthcare Risk Management seeking comment, but the system has confirmed publicly that the mistake occurred.
Symptoms reported months later
Months after their surgeries, patients are starting to report unusual infections and other unexpected complications of surgery, according to Thomas Henson Sr., JD, a lawyer representing 30 patients in a potential lawsuit against Duke.
"That’s the number for today," he says. "But call me tomorrow, and it’ll be higher. The phone is ringing off the hook."
Henson says his clients are very worried about the possible effects from the internal exposure to the hydraulic fluid. Symptoms so far include joint swelling and pain, tenderness, malaise, and other problems at the surgery site.
The first goal for Henson and his clients is to find out exactly what was in the hydraulic fluid so that they can determine what the possible effects might be, but he says Duke administrators are stonewalling on even that basic information.
"They won’t tell us specifically what the chemical compound is or what lab testing might been done on the material. They have not yet provided a fluid sample so the patients can test it themselves and find out from their own doctors what harm it might cause," he adds.
Henson says he is considering filing a legal petition demanding that Duke reveal the contents of the hydraulic fluid.
The patients know that the hydraulic fluid is a petroleum product called 32 AW manufactured by Exxon, but Henson says they need to know more specifically where and how the fluid was used so that they can determine what additional chemicals or particles may have been in the used fluid and how the use may have altered the fluid’s original chemical structure.
Calling lawyers to get answers
Duke’s alleged reluctance to work cooperatively with the patients prompted many to contact a lawyer, he explains. If the hospital had been more forthcoming and helpful, Henson says, he might not have so many clients.
"Clients are calling me not because they want to sue Duke but because they can’t get answers," he adds. "Right now, they feel like they’re being stonewalled, and they’re losing sleep over this. They’re worried."
Henson points out that in addition to the concerns about harmful effects from the hydraulic fluid, he and his clients are concerned about what biological material was not removed from the instruments because they were not properly washed.
Even if hydraulic fluid was not involved and some other inert liquid was used, such as plain water, the patients still would have reasons to be concerned that the instruments were not properly cleaned between procedures, he points out.
Even though his clients are interested primarily in seeking information at this point, Henson says the potential is great for legal action against Duke in the future.
Two patients already have filed lawsuits against an elevator repair company and a hospital supplier whose mistakes, together, apparently created the mix-up in the two hospitals.
According to the CMS report, the problem began in September 2004 when an elevator at Duke Health Raleigh was repaired.
Workers drained hydraulic fluid from the elevator into about a dozen empty 15-gallon detergent drums that they got earlier at Duke University Hospital when they fixed an elevator there. Most of the containers were labeled "Mon-Klenz," the brand name of the detergent used to wash surgical tools, and one was labeled "Hinge Free," a lubricant used for some instruments.
The used hydraulic fluid had a light-brown color that was similar to that of the detergent.
After filling them with the used hydraulic fluid, the drums were left in a corner of a parking lot until a hospital administrator ordered them moved.
The complaints continued
Hospital staff thought the containers held the detergent as labeled, so they called a supplier used by the hospital and had them picked up.
According to CMS, the supplier also assumed that the drums were labeled properly and took them to its warehouse.
When the hospitals ordered detergent in November and December, the company shipped the drums of hydraulic fluid. One barrel went to Duke, three to Duke Health Raleigh, five
to Durham Regional, and two to Wake Forest University Baptist Medical Center in Winston-Salem. The barrels sent to Duke and Wake Forest were not used.
The CMS report noted the hospitals accepted the barrels even though they were not sealed properly.
Within days of hooking them up to the sterilization equipment, staff at both hospitals began complaining about greasy instruments that often left an oily yellow stain on the tray liners.
The complaints continued through November and into December, and hospital staff repeatedly tried to fix the washing equipment.
No one checked the detergent barrels until December, even though a troubleshooting guide for the washing machines recommended checking the detergent if tools come out unclean.
CMS reported the operating room teams sometimes wiped down the tools with sponges because they were so slick.
At Duke Health Raleigh, cleaning technicians told investigators they were "frustrated and ticked off" because no one would listen to their complaints about being unable to clean the instruments of the greasy substance despite repeated runs through the machine.
No surgery was ever canceled due to the ongoing problem with the instruments, the report added.
Two hospitals run by Duke University Health System in North Carolina were cited in a Centers for Medicare & Medicaid (CMS) report for mistakenly washing surgical instruments in used hydraulic fluid instead of detergent and failed to notice the mix-up for weeks.Subscribe Now for Access
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