Purpose and study design

 

The purpose of this study(1) was to evaluate the microbial barrier performance of the K-Zero needlefree connector.

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The study was carried out by an independent laboratory (Nelson Laboratories, 6280 South Redwood Road, Salt Lake City, UT 84123, U.S.A).

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The test conditions simulate extreme use conditions over the anticipated time the devices will be used clinically.

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Fluids from the simulated administrations were captured, filtered and incubated to detect the presence of microorganisms that could be introduced into the fluid pathway.

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The test procedure addressed a clinical simulation in which the K-Zero test samples were exposed to extreme use conditions through repeated connections to the K-Zero needlefree connector over time.

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To simulate anticipated extreme clinical conditions, the septum of the K-Zero was inoculated with a minimum concentration of 1,000 colony forming units (CFU) of the challenge organism prior to disinfection.  Following disinfection, the K-Zero devices were activated and flushed with saline.

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The saline was collected, filtered and scored for growth of the challenge organism.

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The K-Zero devices were activated a minimum of 50 times per day.  This was repeated for seven days for a total of at least 350 activations per K-Zero device.

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The K-Zero devices were inoculated, activated and flushed one more time on the 8th day.

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Testing consisted of six test samples, two positive controls for each organism and two negative controls.

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Two Gram positive bacterial organisms, Staphylococcus aureus American Type Culture Collection (ATCC) #6538 and Staphylococcus epidermidis ATCC #12228, were used during the study.

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All test method acceptance criteria were met.