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Patient safety movement calls for reexamination of multidose vial use



From the June 14, 2000 issue

PROBLEM: The Centers for Disease Control (CDC) recently reported that a contaminated multidose vial (MDV) of saline was the likely source of transmitting hepatitis C virus (HCV) to at least three patients1. Although the vial was not available for testing, the CDC concluded that saline flushes from a 20 mL MDV were the only exposure associated with the infection. Investigators suspect that the MDV was contaminated either from reuse of a needle or syringe or improper decontamination of the rubber membrane. There were 41 patients admitted to the hospital unit during the suspected outbreak, but only one had a documented history of HCV. While 15 patients died before the investigation, death certificates did not mention HCV as an underlying cause. Five of the remaining patients tested positive for HCV and the genotype was the same. CDC identified the source patient and three confirmed cases (and one unconfirmed case) of transmission to patients with no known HCV risk factors.

In 1990, Plott et al. demonstrated that 25% of practitioners misused MDVs by reentering the vial with a needle that had already been injected into a patient2. However, actual vial contamination rates vary in the literature, from no detectable contamination identified by Christensen et al., to a 23% contamination rate noted by Bothe3-4. Yet, ongoing reports of infections transmitted through contaminated MDVs clearly suggest that their use poses a tangible risk. While common preservatives used in MDVs may be highly effective for most bacteria, they are not antiviral agents. Also, there is a vulnerable window of time (about two hours) during which contaminating organisms may remain viable in MDVs before the preservative fully exerts its effect5. Even after the preservative inactivates the organism, endotoxins may be present and cause pyretic or febrile reactions. While faulty aseptic technique is often the primary cause of vial contamination, other influential factors include the design of the vial, storage conditions, the frequency of entering the vial, the environmental air injected into the vial, and its use for patients with highly contagious diseases. The patient's underlying health also influences the risk of transmitting the infection. Further, there is little guidance regarding an appropriate expiration date after initial entry of the MDV. Practices are variable, from discarding the vial within 24 hours, to reliance on the manufacturer's expiration date and visual inspection.

SAFE PRACTICE RECOMMENDATION: The reuse of MDVs is a balancing act between cost containment and patient safety. Certainly, there are a few settings in which the cost benefit outweighs the risk because potential contamination is significantly reduced. For example, the reuse of a MDV for a single patient, such as insulin for a diabetic patient, carries little risk of patient cross contamination. In the pharmacy, the risk of contamination is minimal when MDVs are used for compounding in an aseptic environment, using proper technique, with no potential for patient-to-patient contamination. MDVs of expensive drugs also may be safely stored in the pharmacy and dispensed to units in ready-to-administer syringes. Yet on patient care units, multiple staff members use the relatively inexpensive drugs and solutions commonly found in MDVs for many different patients. In fact, many (e.g., saline and lidocaine) require multiple entries into the vial for a single patient encounter. Further, many MDVs look alike and have been confused with other drugs packaged similarly. With such ripe opportunity for contamination, single unit packages in ready to use form are preferred. At a recent CDC conference, attendees were strongly encouraged to use prefilled syringes or single dose vials for inexpensive but widely used substances (e.g., saline, bacteriostatic water, heparin, lidocaine) to reduce the risk of contamination. Don't wait until you have a nosocomial outbreak to heed this advice.

References: 1). Multidose vial linked to nosocomial HCV outbreak. Hosp Infect Control, May 2000; 68-69. 2). Plott et al. Iatrogenic contamination of multiple-dose vials in simulated use. Arch Dermatol 1990; 126:1441-4. 3). Christensen EA, et al. Assessment of risk of microbial contamination by use of multidose containers of injectable products. J Hosp Infect. 1992; 20:301-4. 4). Bothe J. Study shows contamination in multiple-dose vials. AORN J. 1973;17:111-14. 5). Wilson, JP et al. Updating your multiple-dose vial policy: The background. Hosp Pharm. 1998;33: 427-32.

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