{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T18:07:18Z","timestamp":1789927638143,"version":"4.0.1"},"reference-count":29,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2019,2,21]],"date-time":"2019-02-21T00:00:00Z","timestamp":1550707200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["associationofanaesthetists-publications.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Anaesthesia"],"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:p>\n                    To avoid potentially fatal wrong\u2010route neuraxial drug errors, international standard\n                    <jats:styled-content style=\"fixed-case\">ISO<\/jats:styled-content>\n                    80369\u20106 specifying a non\u2010Luer neuraxial connector design was published in 2016. We describe usability studies used in development of the design. Thirty\u2010eight doctors and 17 nurses performed simulated procedures on manikins, using devices fitted with Luer connectors or draft\n                    <jats:styled-content style=\"fixed-case\">ISO<\/jats:styled-content>\n                    80369\u20106 \u2018non\u2010Luer\u2019 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\n                    <jats:styled-content style=\"fixed-case\">ISO<\/jats:styled-content>\n                    80369 small\u2010bore connector series. Video recording analysis was used for all assessments. Participants subjectively assessed performance of the draft non\u2010Luer connector, including suitability for routine clinical use. Participants performed 198 procedures. The connector achieved easy, leak\u2010free connections. The willingness of participants to use the non\u2010Luer 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\u2010connection 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\u2010Luer slip and female Luer connectors. This led to revision of the dimensional tolerances of the non\u2010Luer connector to reduce this risk, before publication of the final specification in 2016. We conclude that the\n                    <jats:styled-content style=\"fixed-case\">ISO<\/jats:styled-content>\n                    80369\u20106 neuraxial non\u2010Luer connector is suitable for clinical use.\n                  <\/jats:p>","DOI":"10.1111\/anae.14585","type":"journal-article","created":{"date-parts":[[2019,2,22]],"date-time":"2019-02-22T01:17:35Z","timestamp":1550798255000},"page":"619-629","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Multicentre clinical simulation evaluation of the\n                    <scp>ISO<\/scp>\n                    80369\u20106 neuraxial non\u2010Luer connector"],"prefix":"10.1111","volume":"74","author":[{"given":"T. M.","family":"Cook","sequence":"first","affiliation":[{"name":"Department of Anaesthesia and Intensive Care Medicine Royal United Hospitals Bath NHS Foundation Trust Bath UK"},{"name":"School of Medicine University of Bristol Bristol UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Wilkes","sequence":"additional","affiliation":[{"name":"Independent Medical Device Consultant Edinburgh UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Bickford Smith","sequence":"additional","affiliation":[{"name":"Retired Consultant Anaesthetist Bradford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Dorn","sequence":"additional","affiliation":[{"name":"Associate Director Clinical Development Baxter Healthcare Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Stacey","sequence":"additional","affiliation":[{"name":"Cardiff &amp; Vale University Hospitals Board Cardiff UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S. M.","family":"Kinsella","sequence":"additional","affiliation":[{"name":"University Hospitals Bristol NHS Foundation Trust Bristol UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Sharpe","sequence":"additional","affiliation":[{"name":"University Hospitals of Leicester NHS Trust Leicester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Phillips","sequence":"additional","affiliation":[{"name":"Surgical Materials Testing Laboratory Princess of Wales Hospital Bridgend UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,2,21]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"ToftB.External inquiry into the adverse incident that occurred at Queen's Medical Centre Nottingham 4th January 2001. 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NHS England.2015 Crown copyright.https:\/\/www.england.nhs.uk\/wp-content\/uploads\/2015\/03\/never-evnts-list-15-16.pdf(accessed 05\/01\/2018)."},{"key":"e_1_2_7_10_1","unstructured":"Patient Safety Alerts NPSA\/2009\/PSA004A.Safer spinal epidural and regional anaesthesia devices \u2013 Part A.2009.http:\/\/www.apagbi.org.uk\/sites\/default\/files\/images\/NRLS-0972B-Safer-spinal-d~part-B-2009.11.24-v1.pdf(accessed 05\/01\/2018)."},{"key":"e_1_2_7_11_1","unstructured":"National Patient Safety Agency Patient Safety Alert.NPSA\/2011\/PSA001 Safer spinal epidural and regional anaesthesia devices \u2013 Part A.2011.http:\/\/www.nrls.npsa.nhs.uk\/resources\/patient-safety-topics\/medical-device-equipment\/?entryid45=94529(accessed 05\/01\/2018)."},{"key":"e_1_2_7_12_1","unstructured":"NHS Improvement.Rapid Response Report NPSA\/2011\/RRR003 Minimising Risks of Mismatching Spinal Epidural and Regional Devices with Incompatible Connectors.2011.http:\/\/www.nrls.npsa.nhs.uk\/resources\/patient-safety-topics\/medical-device-equipment\/?entryid45=132897(Accessed 05\/01\/2017) (Accessed 05\/01\/2018)."},{"key":"e_1_2_7_13_1","unstructured":"The introduction of new neuraxial connectors into the NHS. A Position Statement from: The Association of Anaesthetists of Great Britain and Ireland The Royal College of Anaesthetists The Obstetric Anaesthetists\u2019 Association Regional Anaesthesia UK The Association of Paediatric Anaesthetists of Great Britain and Ireland Royal College of Anaesthetists Patient Liaison Group. Updated2011.http:\/\/www.aagbi.org\/sites\/default\/files\/Neuraxial%20position%20statement.pdf(accessed 18\/01\/2018)."},{"key":"e_1_2_7_14_1","unstructured":"Patient Safety alert.Stage Three: Directive Alert reference number: NHS\/PSA\/D\/2014\/002.Non\u2010Luer spinal (intrathecal) devices for chemotherapy. NHS England2014.https:\/\/www.england.nhs.uk\/wp-content\/uploads\/2014\/02\/non-Luer-spinal-alert.pdf(accessed 5\/01\/2018)."},{"key":"e_1_2_7_15_1","unstructured":"Patient safety alert.NHS\/PSA\/RE\/2017\/004. Resources to support safe transition from the Luer connector to NRFit\u2122 for intrathecal and epidural procedures and delivery of regional blocks. 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