Kubey W, Straka P, Holmes C J
Scientific Affairs, Renal Division, Baxter Healthcare, McGaw Park, Ill., USA.
Blood Purif. 2001;19(1):62-7. doi: 10.1159/000014480.
The objective of this study was to compare, using in vitro quantitative microbiology, the ability of two commercially available peritoneal dialysis solution delivery systems to prevent and remove, via convective fluid flow, intralumenal fluid path bacterial contamination. The two systems (A and B) differed in both the configuration of their flow control, or Y-junction and the method of fluid flow control and also in the design of their Luer tubing connectors. System A had a tubing type Y-junction that requires clamps to control fluid flow and uses a connector with a male Luer that is deeply recessed within a shroud. System B has a dial-type rigid Y-junction with in-line flow control and a connector with a male Luer that is shrouded but not recessed. System A connectors allowed significantly (p<0.0001) fewer bacteria to be transferred into the fluid path than System B after simulated touch contamination. Also, when an equivalent number of bacteria were deliberately placed into the fluid paths of both systems, System A was more effective in removal of the bacterial contamination by convective fluid flow than System B (p<0.0001), resulting in fewer organisms infused into the simulated peritoneum. Specific design features of System A, such as a recessed male Luer, and a Y-junction fluid flow path with low turbulence were likely explanations for its superior results. This study emphasizes the importance of connector and fluid path flow design in the aseptic performance of peritoneal dialysis delivery systems.
本研究的目的是使用体外定量微生物学方法，比较两种市售腹膜透析溶液输送系统通过对流液流预防和清除管腔内液体路径细菌污染的能力。这两种系统（A和B）在其流量控制配置或Y型接头、流体流量控制方法以及鲁尔管接头的设计方面均有所不同。系统A具有一种管型Y型接头，需要用夹子来控制流体流动，并使用一个带有阳鲁尔接头的连接器，该接头深深地凹入一个护罩内。系统B具有一个带在线流量控制的刻度盘式刚性Y型接头和一个带有阳鲁尔接头的连接器，该接头有护罩但没有凹陷。在模拟接触污染后，系统A的连接器允许进入流体路径的细菌数量明显少于系统B（p<0.0001）。此外，当在两个系统的流体路径中故意放入等量细菌时，系统A通过对流液流清除细菌污染的效果比系统B更有效（p<0.0001），导致注入模拟腹膜的微生物数量更少。系统A的特定设计特点，如凹陷的阳鲁尔接头和低湍流的Y型接头流体流动路径，可能是其优异结果的原因。本研究强调了连接器和流体路径流动设计在腹膜透析输送系统无菌性能中的重要性。
