Evaluation of 1-way valves used in medical devices for prevention of cross-contamination

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Although day use medical device systems may use numerous other factors to prevent patient cross-contamination, this work demonstrates that 1-way valves themselves may not prevent leakage of contaminated fluid if the fluid is able to reach the upstream side of the 1-way valve” Nandy et al (2017).

Abstract:

Background: One-way valves used in day use devices (used on multiple patients throughout a day without reprocessing between patients) are intended to reduce the potential for cross-contamination between patients resulting from the backflow of patient fluids. One-way valves are typically designed to withstand high levels of back pressure before failure; however, they may not be explicitly designed as a means of infection control as used in medical device applications.

Methods: Five different medical grade 1-way valves were placed in low pressure configurations. After flushing in the intended direction of flow, bacteriophage, bacteria, or dye was placed patient side for 24 hours. The upstream device side of the valve was then evaluated for microbial growth or presence of visible dye.

Results: Leakage (ie, backflow) of the microorganisms occurred with a variety of 1-way valve designs across a range of fluid properties tested.

Conclusions: This study describes testing of the 1-way valves (component-level testing) for the potential of cross-contamination. Although day use medical device systems may use numerous other factors to prevent patient cross-contamination, this work demonstrates that 1-way valves themselves may not prevent leakage of contaminated fluid if the fluid is able to reach the upstream side of the 1-way valve.

Reference:

Nandy, P., Young, M., Haugen, S.P., Katzenmeyer-Pleuss, K., Gordon, E.A., Retta, S.M., Wood, S.C. and Lucas, A.D. (2017) Evaluation of 1-way valves used in medical devices for prevention of cross-contamination. American Journal of Infection Control. March 27th. [epub ahead of print].

DOI: http://dx.doi.org/10.1016/j.ajic.2017.02.015

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