2024. Human Factor Considerations in Support of a Flexible IV Connector Safeguard to Prevent Central Line Associated Blood Stream Infections (CLABSI)

Abstract

Abstract Background One of the sources of central line infections is contaminated and poorly disinfected IV connectors(CON). A recent study found 23% of IV-line CONs were contaminated with bacteria, despite strict infection control guidelines that include the use of alcohol-lined caps (ALC). Contamination (CONT) occurs after protective ALC has been removed in preparation for an infusion, and nurses perform their multiple tasks. These include purging air bubbles from the IV line, setting pumps, verifying medications, and keeping an eye on the patient. It is not surprising that nurses admitted that sterilization of IV CONs was not prior to 3% - 4% of infusions. Schielded IV connector Methods A flexible rounded shield extending above a standard needleless CON to protect it from CONT was designed and tested (Pat pend). A total of 4, 2 ICU Medical Inc. needleless CONs, one shielded and one unshielded, and two Komashine Inc. CONs, also one shielded and one unshielded were disinfected with 70% alcohol and their lines taped to the abdomen of 2 volunteers wearing loose shirts over the connectors. The CONs remained on the volunteers for 3 hours, in 2 sessions. All 16 CON ends were cultured on Columbia blood agar, and plates held 48 h. Readings were evaluated by statistical analysis of 16 predictions (coinflips). Results It was confirmed that the tested shielded CONs were easy to sterilize, connect to infusion lines and that there was ample space left to screw on and off alcohol caps. Colonies were absent from the protected connector ends, whereas all the unshielded ends grew several colonies. The probability of observing the projected efficacy results, 8 unshielded with subsequent bacterial growth, and eight shielded, remaining sterile, i.e. not growing bacteria is < 0.00002. The lack of contamination on the shielded ends proved that the air currents generated by the movements of the volunteers, between their skin and their skirts did not transport bacteria to the shielded connector ends. Conclusion A properly designed flexible contamination shield will prevent the proportion of line infections that are caused by human factors. Pls, submit severe adverse event reports (prolongation of hospitalization or death) caused by contemporary "defective" IV connectors to the FDA to change their faulty design. Disclosures All Authors: No reported disclosures.