Simulated evaluation of a non-Luer safety connector system for use in neuraxial procedures

Abstract

Spinal syringes, needles, and other devices with connectors that will not also connect with Luer devices could substantially reduce wrong-route drug administration errors. This study aimed to evaluate a newly designed non-Luer safety connector system for neuraxial procedures in terms of clinical acceptability and cross-connectivity with conventional Luer devices. A non-Luer safety connector system (BD UniVia-6 Safety Connector system), which included non-Luer spinal needles, syringes, and blunt fill filter needles, was evaluated in a prospective, simulated use, randomized study. Clinicians evaluated the acceptability and performance characteristics using a normal saline injectate on an artificial back model. Forty-nine clinicians participated in the study. For 93 of 98 spinal injection procedures, clinicians agreed that overall, the safety system was clinically acceptable (94.9%; 95% lower bound 89.6%). Forty-eight clinicians (98%; 95% lower bound: 90.7%) agreed that the safety system prevented or reduced the risk of misconnection between a conventional syringe and a safety spinal needle. A lower proportion (63.3%; 95% lower bound: 50.5%) agreed that the safety system would prevent or reduce the risk of misconnections between a safety syringe filled with medication intended for spinal injection and an i.v. Luer device. Our study demonstrated that study clinicians found the safety system to be acceptable with minimal impact on technique in a simulated-use setting. The non-Luer system also appeared to decrease the risk of administration of i.v. medications into the intrathecal space. Further modifications will be required to completely eliminate the risk of administering intrathecal medication i.v. and evaluation in a clinical setting will help determine the true impact of this non-Luer system on patient safety.