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From an understanding of human psychology and the reliability of high-technology systems, this review considers critical threats to the safety of patients undergoing sedation outside of the operating room, and will stratify these threats along what we define as the ‘Patient Risk Continuum’. We then consider interventions suitable for addressing identified risks.The technology, organization and delivery of healthcare continue to become more complex, highlighting the importance of maintaining the safety of patients. Sedation outside of the operating room is known to be associated with higher rates of adverse events. However, a number of recent safety initiatives have shown benefit in improving patient safety.The following threats to patients undergoing sedation, in increasing order of risk, are discussed: equipment and environmental factors, known patient risks, poor team performance, combinatorial problems and egregious violations. To address these threats, we discuss a number of approaches consistent with the systems approach to safety, namely: encouraging functions, forcing functions, cognitive safety nets, information sharing, recovery strategies and regulatory change. Demonstrating improvement with any safety initiative relies critically on quality data collected on the problem area in question.