Should surgical facilities wait 48 hours after sterilization before putting surgical instruments back into service so that biological indicators can be evaluated? That's the question before a Tennessee trial court, after a ruling last month in the Court of Appeals of Tennessee.
In 2002, Vanderbilt Hospital used reprocessor Steriltek, now a subsidiary of Steris, to decontaminate and sterilize orthopedic instruments at an offsite facility. A contract called for Steriltek to return the instruments to the facility within 8 hours of picking them up.
Steriltek used the Sterrad process to sterilize instruments and used chemical and biological monitors to evaluate efficacy. Two days after processing a load, Steriltek employee Kevin Allen, RN, learned that the biologic indicator on some of the instruments in the load tested positive. When he notified the hospital, some of the instruments were already in use in an osteotomy case that included a planned arthroplasty. The surgeon immediately aborted the case, deciding to wait to implant the prosthetic femur and knee. He used a cement spacer until he could complete the operation 2 months later.
Following the second operation, the patient, Jessica Jovan Turner, died and her mother, Sandra Yevette Turner, sued, charging that Steriltek failed "to warn, prior to the surgical procedure, that the equipment and/or instrumentation was contaminated, unsterile and unsafe to use," and that the hospital "negligently failed to have in place a system of proper surgical protocols, procedures and measures to assure that surgical instrumentation was clean, sterile and in a safe condition suitable prior to its actual use during the course of surgery."
Trial judges in Tennessee Circuit Court for Davidson County dismissed Steriltek from the case because Mr. Allen testified that the indicator test was a false positive — the instruments were in fact sterile — and because the court decided that Steriltek was not responsible for warning the hospital that biologic tests take 48 hours. The hospital knew that already, said the trial court. The Tennessee appeals court upheld that part of the decision. But in a second appeal, the court overturned the trial court's decision to dismiss the hospital from the case.
Vanderbilt's assistant administrative director of surgical support services Michael J. Hughes RN, BSN, MA, CNOR, testified that hospital policy gave employees the green light to use Sterrad-sterilized instruments immediately after completion of the sterilization process. Appellate court justices wrote that the plaintiff's claim that "the hospital should have implemented a policy or procedure to quarantine equipment and instruments for 48 hours after sterilization" was not obviously wrong and deserved consideration by a jury.
An attorney for Vanderbilt said that she was not able to comment on the case, because the litigation is ongoing.
Outpatient Surgery Magazine Staff
