Postsurgical Infections Associated with an Extrinsically Contaminated Intravenous Anesthetic Agent -- California, Illinois, Maine, and Michigan, 1990

In May and June 1990, the Hospital Infections Program in CDC's Center for Infectious Diseases received reports of four clusters of postsurgical infections and/or hyperthermic reactions occurring in patients after a variety of clean or clean-contaminated surgical procedures. These infections/reactions have been reported from four states and have been associated with three different pathogens. This report summarizes the preliminary results of investigations conducted at four hospitals.

California. During an 8-day period, five patients at one hospital developed Staphylococcus aureus surgical wound infections (SWI) following clean surgical procedures. All patients developed fever and surgical wound infection within 12-72 hours of surgery. All S. aureus isolates had the same phage type. An epidemiologic investigation identified use of an intravenous anesthetic, propofol (DiprivanPr*), delivered by an infusion pump and attendance by one anesthesiologist as risk factors. A throat culture of the implicated anesthesiologist grew S. aureus; the isolate had the same phage type as that recovered from the patients' wounds.

Illinois. During a 5-day period, four patients who underwent different surgical procedures at one hospital developed Candida albicans bloodstream infections and/or endophthalmitis. An epidemiologic investigation identified receipt of propofol by infusion pump and preparation of the infusion by one anesthesiologist as risk factors for infection. A review of anesthesia practices revealed numerous breaks in aseptic technique during preparation of the anesthetic. Cultures of unopened ampules of propofol from the same lots being used at the hospital were negative. Further studies to identify the source of C. albicans are ongoing.

Maine. During a 2-day period, two patients who each underwent different surgical procedures at one hospital developed fever (temperature greater than or equal to 40.4 C (greater than or equal to 104.8 F)) and hypertension (systolic blood pressure (BP) greater than or equal to 226 mm Hg, diastolic BP greater than or equal to 108 mm Hg) within 2 hours following surgery. Both patients recovered after aggressive supportive therapy. An epidemiologic investigation identified receipt of propofol by infusion pump and preparation of the infusion pump by one nurse anesthetist as risk factors for the reactions. The same infusion pump, syringe, and propofol preparation were used in the two patients; cultures of the propofol solution infusing at the time of the second patient's reactions grew Moraxella osloensis, and endotoxin assays using the Limulus amebocyte lysate assay method detected 3900-5000 ng/mL of endotoxin. Cultures and endotoxin assays of unopened ampules of propofol from the same lot being used at the hospital were negative.

Michigan. During a 2-week period, 13 (23%) of 56 patients at one hospital in which clean or clean-contaminated procedures were performed developed postoperative S. aureus bacteremia and/or SWI; all patient isolates had the same phage type. Epidemiologic studies identified receipt of propofol by infusion pump and preparation of the infusion pump by one nurse anesthetist as risk factors for infection. The risk of infection was not increased when propofol was given as a single bolus injection without the infusion pump. Cultures of unopened ampules of propofol from the same lot being used at the hospital were negative. Cultures of the hands of the implicated nurse anesthetist grew S. aureus; phage typing is pending. A review of anesthesia procedures revealed that when propofol remained in the infusion pump at the completion of one surgery it was used during the next surgical procedure. Reported by: S Carr, S Waterman, MD, Los Angeles County Dept of Health Svcs; G Rutherford, MD, California Dept of Health Svcs. R Martin, DVM, B Francis, MD, State Epidemiologist, Illinois Dept of Public Health. K Gensheimer, MD, State Epidemiologist, Maine Dept of Human Svcs. J Altamirano, MD, W Hall, MD, B Robinson, PhD, S Shah, MS, R Wilcox, MD, State Epidemiologist, Michigan Dept of Public Health. Center for Drug Evaluation and Research, Food and Drug Administration. Div of Field Svcs, Epidemiology Program Office; Hospital Infections Program and Div of Mycotic Diseases, Center for Infectious Diseases, CDC.

Editorial Note

Editorial Note: The simultaneous and sudden onset of clusters of postoperative infections following clean or clean-contaminated surgical procedures in multiple states is unusual. All cases at all four hospitals were associated with the use of propofol, a newly introduced intravenous hypnotic anesthetic agent that received Food and Drug Administration (FDA) approval in October 1989. Propofol is a sterile, nonpyrogenic, white, soybean oil-in-water emulsion to be used by intravenous delivery for induction (by bolus administration) and/or maintenance (by drip infusion) anesthesia. The product has no preservative and refrigeration is not recommended by the manufacturer.

For at least four reasons, the preliminary results of these investigations suggest that contamination of propofol was extrinsic (i.e., contaminated during manipulation after receipt from the manufacturer) and not intrinsic (i.e., contaminated at the time of manufacture). First, at each of the hospitals investigated, different lots of propofol were used, and cultures of previously unopened ampules from each hospital were sterile. Second, at each hospital, cases were associated only with propofol that was administered by infusion, using a 60 cc syringe in a pump, and prepared by a specific anesthetist/anesthesiologist. Third, aseptic technique was not observed during preparation of the propofol for use during infusion; syringes used for bolus administration of propofol were used only on single patients, whereas those used in the infusion pump were usually used on multiple patients. Fourth, since infusions are delivered over a longer period of time, extrinsically contaminating microorganisms could proliferate during the infusion interval and between use in different patients. Growth studies performed at CDC show that when propofol is inoculated with low numbers (101-102 cfu/mL) of S. aureus, the organisms rapidly proliferate to high numbers (105-106 cfu/mL) within 24 hours at 33 C (91.4 F).

Two recent surveys of anesthesia personnel show that aseptic technique and infection control practices are frequently not implemented during administration of anesthesia (1,2). In these surveys, from 48% to 90% of respondents reused syringes to administer drugs to multiple patients. The investigation of the current clusters suggests that severe, life-threatening complications may occur in patients as a consequence of breaks in health-care workers' aseptic technique in combination with the use of a drug that is capable of supporting the rapid growth of microorganisms. These outbreaks underscore the importance of aseptic technique and infection control in anesthesia practice. The manufacturer of propofol, in conjunction with the FDA, is revising the label and package inserts and notifying all anesthesiologists and nurse anesthetists in the United States to emphasize the importance of using aseptic technique in the preparation and administration of propofol.

Physicians are requested to report clusters of infections in postoperative patients suspected to be associated with the use of propofol through state health departments to the Epidemiology Branch, Hospital Infections Program, Center for Infectious Diseases, CDC; telephone (404) 639-3406.

References

1. Kemper PM, Learned DW. Anesthesia practice: a vector of infection? (Abstract). Anesthesiology 1989;71:A948.

2. Rosenberg AD, Bernstein RL, Ramanathan S, Albert DB, Marshall MH. Do anesthesiologists practice proper infection control precautions? (Abstract). Anesthesiology 1989;71:A949. *Use of trade names is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services.

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