Multicentre clinical simulation evaluation of the ISO 80369-6 neuraxial non-Luer connector

T. M. Cook*, A. Wilkes, P. Bickford Smith, L. Dorn, M. Stacey, S. M. Kinsella, P. Sharpe, P. Phillips

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)

Abstract

To 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.

Original languageEnglish
Pages (from-to)619-629
Number of pages11
JournalAnaesthesia
Volume74
Issue number5
Early online date8 Apr 2019
DOIs
Publication statusPublished - 1 May 2019

Bibliographical note

© 2019 Association of Anaesthetists.

Keywords

  • Anesthesia, Spinal/instrumentation
  • Antineoplastic Agents/administration & dosage
  • Clinical Competence
  • Equipment Design
  • Equipment Safety
  • Humans
  • Injections, Epidural/instrumentation
  • Injections, Spinal/instrumentation
  • Manikins
  • Medication Errors/prevention & control
  • Patient Safety
  • Spinal Puncture/instrumentation

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  • Cite this

    Cook, T. M., Wilkes, A., Bickford Smith, P., Dorn, L., Stacey, M., Kinsella, S. M., Sharpe, P., & Phillips, P. (2019). Multicentre clinical simulation evaluation of the ISO 80369-6 neuraxial non-Luer connector. Anaesthesia, 74(5), 619-629. https://doi.org/10.1111/anae.14585