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Session: Medical devices & safety
Session starts: Thursday 24 January, 10:30
Presentation starts: 11:45
Room: Lecture room 535

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Linda Wauben (Delft University of Technology)
Connie Dekker-van Doorn (Rotterdam University of Applied Sciences)
Johan Lange (Erasmus MC)
Jan Klein (Delft University of Technology)

Abstract:
Introduction: Despite decreasing rates of healthcare-related avoidable harm, unintended events still occur, especially in the complex-dynamic environment of the operating room (OR). To prevent unintended events from occurring, a Time Out Procedure plus debriefing (TOPplus) was designed and implemented. The goal of this study was to establish risk-factors for avoidable harm and adapt TOPplus accordingly to prevent future unintended events. Methods: OR team members were asked to self-report ‘details’ (remarks and unintended events) about the surgical procedure before introduction of TOPplus (T0 baseline measurement) and six months after introduction (T1). Hospitals joined the TOPplus study voluntarily over time (not pre-selected). Details were registered via paper registration forms and were digitalised and categorized into remarks and incidents (unintended events). Both remarks and incidents where subdivided in subcategories relating to: anaesthesia, surgery, communication, instruments and equipment, leadership, situation awareness, teamwork, perfusion, and TOPplus. Results: In total 8 out of 15 participating hospitals in the TOPplus project completed T0 and T1: 3 academic, 2 teaching and 3 general hospitals. Figures 1 and 2 show the results. Figure 1: Number of self-reported remarks and incidents (unintended events). Figure 2: Situation awareness and instruments; main self-reported incidents (unintended events). Discussion & Conclusion: Defect and incomplete instruments and equipment and suboptimal situation awareness were the main causes of unintended events in the OR and therefore the main risk-factors for patient harm. The number of incidents most probably was higher due to underreporting. Although unintended events relating to a lack of situation awareness can be addressed and prevented by TOPplus, the ‘defect’ instrument and equipment need redesign to further improve patient safety.