Bacterial safety of a closed-administration system for enteral nutrition solutions

The purpose of this study was to investigate the bacterial integrity of a newly designed closed-administration system for enteral formula delivery. Three clinical simulations, designated Phases I, II, and III, were tested: dispersal of (I) 3 L formula over a 24-hour period, (II) 2 L formula over a 24-hour period, and (III) 2 L formula over a 48-hour period. Within each 24- or 48-hour simulation phase, a single administration set was used. Samples were withdrawn for bacterial analysis at 4- or 8-hour intervals. Simulations and samplings were completed under controlled, but not aseptic, conditions. Results indicated that bacterial growth was insignificant across all three simulation phases. Re-utilization of the administration set did not introduce bacterial contamination into subsequent liters of formula. Alcohol cleansing of the administration set was not found to be necessary for maintenance of bacterial closed integrity. Even when administered over a 24- or 48-hour period, the formula dispersed through this closed system did not develop any significant degree of bacterial growth. Results of this study suggest that this newly designed system for the administration of enteral formula significantly minimizes the risk of bacterial contamination.