Instruments cleaned with elevator hydraulic fluid
Instruments cleaned with elevator hydraulic fluid
4,000 patients had procedures with instruments
At least 4,000 patients at two North Carolina hospitals underwent surgical procedures that used hydraulic fluid in the sterilization process. The hospitals, part of the Duke University Health System, determined that workers for an elevator company emptied the fluid into several empty detergent drums while performing maintenance in mid-September 2004. The workers capped the soap containers without changing the labels.
For almost two months, the hospitals cleaned instruments with a solution of hot water and hydraulic fluid and then sterilized the instruments, according to published reports and a Raleigh, NC-based law firm that is searching for patients who had surgery during that time.1,2 About 200 former patients have contacted the law firm, according to Thomas W. Henson Jr. of HensonFuerst.2
The hospitals’ errors were classified by the Centers for Medicare & Medicaid Services (CMS) as ones that put patients in "immediate jeopardy," according to a CMS spokesperson in the Atlanta office, who isn’t named according to department policy. That classification puts the hospitals on track to correct their performance, and there will be follow-up visits made to ensure the situation of immediate jeopardy has been corrected, the spokesperson says.
After a compliant was filed against Duke Health Raleigh, the North Carolina Department of Labor cited the hospital and Automatic Elevator Co. of Raleigh for "nonserious" violations because employees were not exposed to serious hazards, says spokeswoman Heather Crews.
The problem was identified after hospital staff and surgeons noticed the surgical instruments were slick and oily, according to HensonFuerst. Duke Health Raleigh Hospital and Durham Regional Hospital have notified those patients.
Here is a brief overview of Duke Health Raleigh’s communication from its CEO to patients, based on letters posted on the HensonFuerst web site at www.lawmed.com/duke-hydraulic-fluid-sample.php:
• Jan. 4, 2005: A letter informs patients of "a possible problem in the cleaning process of surgical instruments." The letter emphasizes that sterilization was not affected, but asks patients to report any signs of infections to their surgeon, physician, or Duke Health Raleigh’s chief medical officer. The letter says no increase in infection rates was noted during the period in question.
• June 20, 2005: A letter following media reports about the hydraulic fluid says a final report from the director of the Statewide Program in Infection Control and Epidemiology at the University of North Carolina School of Medicine says the hydraulic fluid "did not alter the effectiveness of the sterilization process. . . ." Patients are told they have access to two physician experts in occupational and environmental medicine.
• June 27, 2005: The letter reports about a second external study that showed the amount of hydraulic fluid on the instruments was approximately 0.08 mg per instrument, on average, which is described as the equivalent of "0.002 of a drop." The researchers also found zinc in the amount of 0.0004 mg per 1 mg hydraulic fluid, which the letter says compares to 15 mg zinc in one adult Centrum multivitamin. In addition, the letter says the results were reviewed by a toxicologist at Duke University School of Medicine, who concluded no chemicals were likely to be harmful in the small amounts to which patients were exposed.
At least one patient has filed suit against the elevator company complaining of severe infection, temporary loss of kidney functions, and other ailments, according to a published report.2 Some people are complaining of lingering pain and infection at the site of incision, which could be a result of the use of hydraulic fluid to sterilize the tools instead of detergent, according to HensonFuerst.1
The spokesperson at Durham Regional says both hospitals have created plans to prevent such problems in the future, which include:
- Employees are to report occurrences/events by one of four means: a web-based voluntary reporting system, a phone call to risk management, a visit to risk management, or correspondence.
- Educate 100% of decontamination and sterile process staff on the occurrence reporting policy.
- Create a policy/procedure and tracking form for labeling and receipt of products more than 5 gallons and require tamper-proof intact seals on products from vendors and throughout the distribution process until product is placed into use.
- Educate all receiving and decontamination staff on the policy/procedure.
- Educate OR staff on the occurrence policy, particularly the use of the voluntary reporting system, for reporting any unexpected event.
- Educate engineering leadership and staff to review manufacturer’s guidelines when troubleshooting equipment/processes and need to request vendor service representatives to come on site immediately for issues/concerns that internal staff are unable to address/diagnose.
- Educate sterile processing and OR leadership on performance improvement (PI) process, with special attention to initiation of PI/quality assurance/quality control when significant issues/concerns have been identified.
- Re-educate decontamination, sterile processing, and OR leadership and staff on the process for timely escalation of issues/concerns to supervisor and/or senior level leadership.
The potential problems for hospitals and surgery centers extend beyond decontamination, explains Mark Mayo, executive director of the Illinois Free-standing Surgery Center Association in St. Charles. "Same-day surgery programs should have policies in every area of the facility on how to properly receive, store, and return bulk storage items anywhere," he adds. "They should know when something has been opened and when something is slated for return."
References
- HensonFuerst, PA, Injury Lawyers. Duke Medical System Hydraulic Fluid. Raleigh, NC. Web: www.lawmed.com/duke-hydraulic-fluid.php.
- Thompson E. N.C. Surgeons unwittingly used dirty tools. Associated Press; June 13, 2005. Web: www.dslreports.com/shownews/64535.
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