SMTL undertook a multicentre simulation of the (at the time) proposed ISO 80369-6 connector for the neuraxial route in 2014 (the standard was published in 2016, and the connectors are now known as NRFit connectors).
The standard was produced to help mitigate the risk of wrong route injections, such as the case of Wayne Jowett in 2001 where intravenous chemotherapy was accidentally injected spinally, resulting in Wayne Jowett's death.
Thirty-eight doctors and 17 nurses performed simulated clinical procedures on manikins, using devices fitted with either Luer connectors or draft ISO 80369-6 ‘non-Luer’ connectors. The procedures included spinal anaesthesia; intrathecal chemotherapy; lumbar puncture, cerebrospinal fluid collection and pressure measurement; epidural catheter placement with bolus injection and critical care use. Participants attempted cross connection between neuraxial connectors and a range of other medical device connectors to check that the design achieved the deiredlevel of non-connactability.
The results of the usability testing have been published in Anaesthesia:
Cook TM, Wilkes A, Bickford Smith P, Dorn L, Stacey M, Kinsella SM, Sharpe P, Phillips P. Multicentre clinical simulation evaluation of the ISO 80369-6 neuraxial non-Luer connector. Anaesthesia. 2019 May;74(5):619-629.
Most cross-connection attempts failed, even using above clinical forces and, when successful, were judged of low clinical risk potential; the exception was a malaligned connection between the non-Luer slip and female Luer connectors. This led to revision of the dimensional tolerances of the non-Luer connector to reduce this risk, before publication of the final specification in 2016.
The authors concluded that the ISO 80369-6 neuraxial non-Luer connector was suitable for clinical use.