Anne van Dalen

128 I Chapter 4 TABLE 3. Overview of relevant safety threat events based on the 35 MDR outcome reports. Category (Total number of threats n=400) Subcategories Number of observations Examples Person (N= 279) Unsafe act Suboptimal Clinician Condition Inadequate Experience / Knowledge Leadership Failures Team Effectiveness Issues Communication Failures 236 4 5 4 5 24 Active attention failure, Substandard skill/technique error, Protocol violation Lack of situation awareness, Suboptimal mental state Insufficient task or tool experience/knowledge Failure to explore concerns, Failure to guide/supervise Personnel late, Suboptimal team dynamics, Unnecessary conversation Unclear, absent or delay Tasks (N = 23) Suboptimal Task Demands / Workload Preventable Secondary Tasks Patient-Related Challenges Disruptions 4 8 6 5 Bad ergonomics, Time pressure Diversion; personnel or tool/technology or workspace issue Patient complexity, Challenging patient management, Challenging anatomy Unnecessary verbal interruption, Other case interruption Tools & Technology (N = 23) Lack of Familiarity Substandard Functionality / Utility Safety / Reliability Issues Usability Issues 1 14 8 0 Unfamiliar configuration/setup/tool Malfunction, Assembly failure Unintended effects, Inconsistent functionality, Tool/task mismatch Suboptimal ergonomics, Inefficient, Technology instructions unclear