A simulation-based evaluation of two proposed alternatives to Luer devices for use in neuraxial anaesthesia

P>The National Patient Safety Agency has issued a Patient Safety Alert with the aim of eliminating Luer connectors from equipment for lumbar puncture and subarachnoid injections by 1 April 2011, and from all neuraxial and regional anaesthesia equipment in 2013. B-link (UK) Ltd and InterVene Ltd have produced non-Luer connectors for neuraxial devices: the Neurax (R) and Spinalok (R) respectively. Using an adult spinal simulator, 59 experienced clinicians performed neuraxial procedures using these devices and reported on specific performance characteristics and overall usability. Cross-connectivity between non-Luer and Luer connectors was also examined. The median (IQR [range]) overall assessment scores (0-10 scale) of usability for the standard, Neurax and Spinalok systems were 8 (8-9 [7-10]), 6 (5-7 [0-8]) and 7 (6-8 [1-9]) for spinal procedures and 8 (8-9 [6-10]), 7 (5-8 [1-9]) and 4 (3-6 [0-9]) for epidural procedures, respectively. Both study systems scored significantly lower than standard equipment for overall performance of spinal and epidural procedures, although the performance of non-Luer devices was mostly rated 'adequate' or better. Both non-Luer connectors could cross-connect with one or more Luer connectors. Following feedback to the manufacturers, both systems have been modified and cross-connectivity apparently has been eliminated. Our results indicate that clinicians may not find non-Luer devices immediately 'user-friendly'. More importantly, some cross-connectivity with Luer devices was possible. Our findings illustrate that introducing equipment that is fully compliant with the National Patient Safety Agency alert poses a significant challenge to manufacturers and clinicians. We conclude that before introducing any non-Luer device into widespread use, independent, formal evaluation should be carried out.