• T M Cook, A Wilkes, P Bickford Smith, L Dorn, M Stacey, S M Kinsella, P Sharpe, and P Phillips.
• Department of Anaesthesia and Intensive Care Medicine, Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.
• Anaesthesia. 2019 May 1; 74 (5): 619-629.

AbstractTo avoid potentially fatal wrong-route neuraxial drug errors, international standard ISO 80369-6 specifying a non-Luer neuraxial connector design was published in 2016. We describe usability studies used in development of the design. Thirty-eight doctors and 17 nurses performed simulated procedures on manikins, using devices fitted with 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, including those from the ISO 80369 small-bore connector series. Video recording analysis was used for all assessments. Participants subjectively assessed performance of the draft non-Luer connector, including suitability for routine clinical use. Participants performed 198 procedures. The connector achieved easy, leak-free connections. The willingness of participants to use the non-Luer connectors were: spinal anaesthesia 100%; intrathecal chemotherapy 88%; lumbar puncture, cerebrospinal fluid collection and pressure measurement 93%; epidural catheter placement with bolus injection 78%; critical care use 100%. Concerns raised were generally device related, rather than connector related. 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. We conclude that the ISO 80369-6 neuraxial non-Luer connector is suitable for clinical use.© 2019 Association of Anaesthetists.

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