Evaluation of Microbial Contamination Associated with Pharmacy Preparation of Intravenous Fat Emulsion

Purpose: Provision of intravenous fat emulsion (IVFE) is problematic in neonates and infants due to smaller volumes of IVFE utilized for daily doses, lack of commercially available IVFE units < 100 mL, potential for overdose with larger volumes, and controversy over recommended IVFE infusion times. While many institutions repackage IVFE to decrease cost and waste and allow for infusion via syringe pump, repackaging has been associated with microbial contamination. Our institution utilizes drawn down IVFE, whereby the original manufacturer’s containers are infused at bedside after excess volume has been removed. The objective of this study was to evaluate the potential for microbial contamination in different IVFE preparations over time.

Methods: Three different IVFE preparations were evaluated: manufacturer’s container spiked with IV tubing, drawn down unit spiked with IV tubing, and repackaged syringe. Samples were obtained for sterility testing from each unit at baseline, 18, and 30 hours. Since IVFE is prepared £ 6 hours prior to infusion, the 18 and 30 hour assessments simulate 12 and 24 hour infusion under actual use conditions. All IVFE preparation, tubing insertion, and sample collection occurred under USP 797 conditions by one of the investigators or an IV technician. Sterility testing by the hospital clinical microbiology laboratory consisted of incubation in blood culture bottles for 5 days. Samples with no growth were subcultured on blood agar plates with olive oil and incubated in a carbon dioxide incubator for an additional two days to assess for Malassezia furfur.

Results: Samples from 30 manufacturer’s containers, 88 drawn down units, and 89 repackaged syringes showed no bacterial or fungal growth.

Conclusions: In this study, contamination previously described with repackaged IVFE did not result from pharmacy preparation under USP 797 conditions. Drawn down IVFE is an alternative to repackaged IVFE that also avoids infusion-related errors in vulnerable patients.