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No-go decision: A newly identified adverse event in orthopaedic surgery - causes and medico-legal implications
H Coudane1, E Benfrech2, C Lecoq3
1Service COTA, Chru Nancy, 24, avenue du Maréchal-de-Tassigny, 54035 Nancy, France; Équipe universitaire de recherche, (EA 7299) pratiques professionnelles : aspects méthodologiques,éthiques et juridiques, université de Lorraine, faculté de médecine, 9, avenue de la-forêt-de-Haye, 54500 Vandoeuvre-lès-Nancy, France; Organisme d'accréditation (OA) des chirurgiens orthopédistes, 56, rue Boissonnade, 75014 Paris, France.
Background:
No-go designates a decision not to perform surgery when it becomes apparent that safety and/or feasibility requirements are not met. No-go decisions can occur at any time between patient admission to a hospital department and immediately before the first incision. The primary objective of this study was to assess the causes of no-go decisions reported as healthcare-associated adverse events (HAAEs).
Hypothesis:
Most no-go decisions in orthopaedic surgery are related to problems with medical devices.
Material And Methods:
A preliminary retrospective study assessed HAAEs reported over the 1-year period from 1st October 2014 to 30th September 2015, using the risk-management tool ALARM. A prospective survey was then performed by emailing a 15-item questionnaire to the 1828 members of Orthorisq (the French orthopaedic surgeon accreditation agency). Responses were either yes/no or open. Statistical comparisons were performed, using the paired Wilcoxon signed-rank test to estimate p values.
Results:
Among reported HAAEs, 5.6% were no-go decisions. Of the 101 reported no-go decisions, 43.5% and 45.2% were due to problems with managing implantable medical devices in the retrospective and prospective assessments, respectively. In over 85% of cases, surgery was cancelled or postponed. Over half the no-go decisions were associated with unnecessary anaesthesia. Checklist completion was performed in only half the cases and was not associated with no-go decisions (p>0.8).
Discussion:
This study provides descriptive data on no-go decisions in orthopaedic surgery. Healthcare professionals use many methods to enhance patient safety by preventing adverse events or diminishing their impact. Errors in managing implantable medical devices are the leading cause of no-go decisions. The current checklist is not appropriate for managing implantable medical devices in orthopaedic surgery, in part because it does not include checking devices upon receipt. Before surgery, patients should be informed of the risk of a no-go decision, since unnecessary anaesthesia occurs in over half the cases.
Level Of Evidence:
IV, prospective study.
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