Infection risk associated with a closed luer access device.

Area of Science:

• Microbiology
• Medical Devices
• Infection Control

Background:

• Needleless closed luer access devices (CLADs) are crucial for preventing bloodstream infections.
• Evaluating the microbial contamination risk of new CLADs is essential for patient safety.
• The Q-Syte CLAD is a recently developed device requiring rigorous safety assessment.

Purpose of the Study:

• To evaluate the in vitro potential for microbial contamination associated with the Q-Syte CLAD.
• To determine the maximum number of activations before a risk of contamination arises.
• To assess the protective capabilities of the Q-Syte CLAD against external microbial contamination.

Main Methods:

• Inoculation of Q-Syte CLAD compression seals with Staphylococcus epidermidis in human blood.
• Disinfection with isopropyl alcohol followed by sterile saline flushing.
• Challenging multiple-activated devices with S. epidermidis-contaminated syringe tips.
• Microbial analysis of saline flushes and device components.

Main Results:

• 96% of saline flushes remained sterile after up to 70 device activations.
• No microbial passage occurred through devices activated up to 70 times, despite external contamination.
• Micro-organisms were detected on syringe tips and seals before decontamination, but not in the fluid pathway post-activation.

Conclusions:

• The Q-Syte CLAD can be activated up to 70 times without increasing microbial contamination risk in the fluid pathway.
• The device demonstrates potential for protecting against microbial transfer from contaminated external surfaces.
• Findings support the Q-Syte CLAD's safety and efficacy in clinical settings.