Sterility of Pediatric Lipid Emulsions Repackaged by an Automated Compounding Device

Abstract

Background: The daily requirement of intravenous (IV) lipid in pediatric patients is often less than the volumes and sizes available in prepackaged, commercially available preparations. In clinical practice, IV lipid emulsions (IVLEs) have been repackaged into syringes to prevent infusions from exceeding 12 hours, to reduce waste, and to improve patient safety. Recent data suggest an increasing risk of contamination when these preparations are repackaged manually. This study investigates the sterility of small volumes of IVLE that have been repackaged into empty IV bags by means of an automated compounding device (ACD). Methods: A total of 152 IVLE bags were repackaged with an ACD in an International Standards Organization class 5 environment. IVLE repackaging was conducted over a period of 3 weeks (week 1, n = 52; week 2, n = 52; week 3, n = 48). Forty commercially available bags of IVLE served as controls. At 0, 24, 48, and 120 hours after repackaging, IVLEs were filtered and placed onto blood agar medium. Results: Microbial growth occurred in 12 of the 152 repackaged preparations compared with 0 of the 40 controls (7.9% vs 0%, P = .07). Positive cultures consisted of gram-positive cocci (n = 5, 3.3%), gram-positive rods (n = 5, 3.3%), and yeast (n = 2, 1.3%). There was no difference in positive bacterial or yeast growth between weeks 1, 2, and 3, suggesting an absence of outside contamination during preparation. Conclusions: The positive microbial growth suggests a concerning incidence of contamination of IVLEs repackaged with an ACD. Additional research is needed to further identify and validate the clinical impact of these preparations.