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

Abstract

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 and Spinalok 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.