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INTRODUCTION AND BACKGROUND
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Most consider the modern era of patient safety to have been catalyzed by the Institute of Medicine’s publication of To Err Is Human in 1999. This famously estimated that 44,000-98,000 deaths occur each year due to preventable medical harm in America. Death is an extreme example of what is known in medicine as an adverse event, which represents harm to a patient resulting from medical care as opposed to underlying disease. In 2019, the World Health Organization (WHO) estimated that adverse events due to unsafe medical care are one of the 10 leading causes of death and disability in the world.
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Avoidable surgical complications account for a large proportion of morbidity and mortality globally. According to the WHO Guidelines for Safe Surgery 2009, the annual volume of major surgery was estimated at 234 million operations worldwide, which is roughly one operation annually for every 25 people alive. It is reasonable to assume a 3% perioperative adverse event rate and a 0.5% mortality rate globally, meaning that nearly seven million surgical patients suffer complications each year, and one million die during or immediately after surgery. Data suggest that at least half of these events are preventable.
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Fortunately, some progress has been made over the past few decades. According to data from the Agency for Healthcare Research and Quality National Scorecard in 2016, it is estimated that 3.1 million fewer incidents of harm occurred annually from 2011 through 2015 as compared with 2010. About 42% of this reduction is from a decrease in adverse drug events, about 23% from a decrease in pressure ulcers, and about 15% from a decrease in catheter-associated urinary tract infections. In the operating room (OR), some of the most significant recent improvements in safety have resulted from improvements in the delivery of anesthesia. In a 10-year period, the overall death rate for a healthy patient undergoing general anesthesia dropped by more than 95%, now estimated at one in 200,000 general anesthetics.
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These improvements and others are the result of a systematic approach to evaluating safety and the widespread acceptance of the fact that human error is persistent and can never be fully eliminated. Furthermore, it was learned that catastrophic safety failures are rarely due to the isolated error of an individual, but rather are the result of multiple errors occurring in an environment with serious underlying flaws. Thus, meaningful improvements in patient safety require an understanding of human errors and the application of systems-based thinking.
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Beyond causing harm to patients, the OR environment contains unique hazards for those who work there. The prevention of occupational harms, both immediate and latent, requires constant vigilance and active management.
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Understanding Human Error
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In 1990, British psychologist James Reason famously published “Human Error: Models and Management,” a classic paper that remains highly relevant to patient safety. Reason suggested there are ...