Objectives: Patient morbidity and mortality associated with contaminated and improperly prepared sterile products has captured national attention. In response, both the United States Pharmacopeia (USP) and Centers for Disease Control (CDC) have published recommendations in an effort to minimize the risk of infection. While the CDC recommends that administration sets are not changed more frequently than every 72 hours, the USP recommends a maximum beyond use date of 48 hours. Neither organization provides specific guidance on expiration dating once the intravenous drug is dispensed. Likewise, neither addresses the length of time that a bag containing medication for continuous infusion may hang once administration to the patient has begun. We evaluated the sterility of medications that are commonly administered by continuous infusion to pediatric patients. Because frequent manipulation of infusion and administration sets may predispose the patient to adverse events, we evaluated sterility for extended beyond use dating up to 72 hours.
Methods: Thirty-five common intravenous (IV) continuous infusions using 94 standard concentrations and diluents were identified. IV solutions were mixed using sterile technique in the laminar flow hood in accordance with USP guidelines. Medications were excluded for short stability, short durations of use or high cost. A sample from each solution was tested for contamination or bacterial growth at 72 hours. Any visible discoloration suggesting physical instability was also evaluated.
Results: None of the syringes or chambers resulted in contamination, bacterial growth or discoloration after 72 hours.
Conclusions: This study provides sufficient data that these compounded sterile products may be stored using a beyond use date up to 72 hours for a number of commonly used continuous IV infusions in pediatric patients. In our institution, this allows for a more convenient and consistent change of both administration sets and continuous infusions at 72 hours to potentially minimize adverse events, workload and cost.
Keywords: continuous infusions; expiration; pediatric; sterility.