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Endotracheal Tube, Cuffed



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NMU-P019 T- valve
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NMU-P015 Single reversal valve

Single reversal valve

Single reversal valve used in “day use” devices (used on multiple patients through a day without reprocessing between patients) are intended to reduce the potential for cross-contamination between patients resulting from the backflow of patient fluids. Single reversal valve are typically designed to withstand high levels of backpressure 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 one-way valves were placed in low pressure configurations. Following flushing in the intended direction of flow, bacteriophage, bacteria, or dye was placed “patient” side for 24 hours. The upstream “device” side of the valves was then evaluated for microbial growth or presence of visible dye. Results: Leakage (i.e., backflow) of the microorganisms occurred with a variety of one-way valve designs across a range of fluid properties tested. Conclusion: This study describes testing of the one-way valves (component-level testing) for the potential of cross-contamination. Although “day use” medical device systems may employ numerous other factors to prevent patient cross-contamination, this work demonstrates that one-way valves themselves may not prevent leakage of contaminated fluid if the fluid is able to reach the upstream side of the one-way valve. Page 2 of 10 Introduction There are a wide variety of reusable medical devices that are used on more than one patient, e.g., surgical instruments, endoscopes, etc. To prevent cross-contamination of microorganisms between patients, reusable medical devices are reprocessed between uses, which may involve cleaning, disinfection, and/or sterilization, in order to render the device fit for a subsequent reuse1 . There is a subset of medical devices in which a component or components not in direct contact with a patient would be reused on multiple patients throughout an entire day (e.g., 24 hours) without reprocessing between patient uses. These “day use” 2-4 devices (also referred to as “24-hour use” devices) are typically discarded after the end of the day. Since day use devices have a component that only make indirect patient contact (e.g., tubing sets used with various types of irrigation/fluid systems), they are typically connected to a devices that makes direct patient contact, and are typically either 1) used on a single patient and then discarded (single patient use) or 2) appropriately reprocessed between patient uses. Some measures are necessary to prevent cross-contamination between patients in these types of day use devices. One design measure often incorporated into day use devices in a one way valve which combat the risk of backflow of potentially contaminated patient fluids. The use of ‘day use’ devices to cut healthcare costs, and is particularly attractive when infusing expensive drugs or when healthcare workers must limit their exposure to certain solutions (e.g., radioisotopes). However, there have been reports of infection outbreaks in dialysis patients where oneway valves were implicated 5-9, demonstrating that one-way valves may not prevent cross-contamination between patients.

Currently, there are no established methods to evaluate the performance of one-way valves in terms of infection control. The test parameters that could impact the one-way valve performance include pressure magnitude and fluctuation, duration of use, flow rates, and fluid properties. Differing performance of one-way valves reported in the literature is likely due to the different experimental conditions. Previous work by Ellger and colleagues2 simulated the clinically relevant pressure and flow parameters of an infusion system. Those authors observed a failure to prevent contamination in a test system that monitored increasing backpressure. Notable in the results was that there was a difference depending on the fluid used. Propofol was more likely to fail than 0.9% NaCl. Radke and colleagues3 conducted studies to show using two check valves in the system can prevent contamination in a day-use system specific to a piggy-back IV setup. The recognition that test parameters are device system dependent led us to develop a simplified evaluation test method which focuses on the functionality of the one-way valve as component of a system to prevent backflow of fluids “contaminated” with simulated pathogens (e.g., dyes, bacteria and viruses).

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