Background: The tested device is a new connecting tool for infusion systems that has been designed to replace conventional single-use stopcocks. Because outbreaks of bloodstream infections have been observed during the use of similar connectors in the United States, we examined the microbiological safety of the connecting device after artificial contamination in the laboratory setting and during routine clinical use.
Methods: In the first part of the study, the new device was tested in 3 types of in vitro experiments. In the second part of the study, surgical intensive care patients had their entry ports capped with novel devices (n=27) or with conventional stopcocks (n=32), and samples of infusion fluids and swabs from entry ports were taken after completion of infusion periods.
Results: The new device did not perpetuate bacterial contaminations in spite of high artificial inocula in the in vitro experiments. Microbial contamination rates after 96 hours of infusion therapy for the novel connecting tool versus conventional stopcock groups were as follows: swabs from 3-way ports, 6/129 versus 1/111; rest fluid from infusion lines, 0/20 versus 1/22; rest fluid from infusion bottles, 2/196 versus 2/208; rest fluid from perfusor syringes, 7/180 versus 6/142 (all differences not significant).
Conclusion: The novel connecting device was microbiologically safe and did not increase microbial contamination rates of intravenous infusion systems.
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