The end of the beginning: complexity and craftsmanship and the era of sustained work on patient safety.
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Biomedical subjects
Publications and source records attributed to R I Cook.
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BACKGROUND: Unexpected awareness is a rare but well-described complication of general anesthesia that has received increased scientific and media attention in the past few years. Transformed electroencephalogram monitors, such as the Bispectral Index monitor, have been advocated as tools to prevent unexpected recall. METHODS: The authors conducted a power analysis to estimate how many patients would be needed in an appropriately powered study to demonstrate the Bispectral Index monitor reduces awareness, as well as a cost analysis to assess the cost of using the monitor for this purpose alone. RESULTS: If unexpected recall is rare (1 in 20,000), it will require a large study to demonstrate that the monitor reduces awareness (200,000-800,000 patients), and the cost of using it for this purpose alone would be high ($400,000 per case prevented). If awareness is common (1 in 100), then the number of patients needed in a study to demonstrate that the monitor works becomes tractable (1,000-4,000 patients), and the cost of using the monitor for this purpose alone becomes lower ($2,000 per case prevented). Because there are reported cases of awareness despite Bispectral Index monitoring, the authors are certain that the effectiveness of the monitor is less than 100%. As the performance of the monitor decreases from 100%, the size of the study needed to demonstrate that it works increases, as does the cost of using it to prevent awareness. CONCLUSION: The contention that Bispectral Index monitoring reduces the risk of awareness is unproven, and the cost of using it for this indication is currently unknown.
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The effects of new technology on human performance in domains such as anesthesiology, commercial aviation, and nuclear power operations remain controversial. To study the impact of new technology on skilled practitioner performance, we observed the introduction of a new, highly integrated, microprocessor-based physiological monitoring system for use in cardiac anesthesia. The new computer system differed from its predecessors in method of display, human interface, level of integration, and automation of functions. A process-tracing technique was used to examine physician-computer interaction in the context of 22 anesthesia procedures for cardiothoracic surgery, most of which involved cardiopulmonary bypass. Practitioners experienced a series of problems with the new computer system. Computer system characteristics relative to the specific context of cardiac surgery created new cognitive and physical burdens that tended to congregate at times of high demand, the characteristic feature of clumsy automation. Practitioners as individuals and as a group tried to overcome these problems by adapting the computer system (system tailoring) and their behavior (task tailoring) as they learned about the interaction between characteristics of the new system and characteristics of their field of practice.
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Although human engineering features are widely appreciated as a potential cause of operating room incidents, evaluating the human engineering features of devices is not widely understood. Standards, guidelines, laboratory and field testing, and engineering discipline are all proposed methods for improving the human engineering of devices. New microprocessor technology offers designers great flexibility in the design of devices, but this flexibility is often coupled with complexity and more elaborate user interaction. Guidelines and standards usually do not capture these features of new equipment, in part because technology improvements occur faster than meaningful guidelines can be developed. Professional human engineering of new devices relies on a broad, user-centered approach to design and evaluation. Used in the framework of current knowledge about human operator performance, these techniques offer guidance to new equipment designers and to purchasers and users of these devices.
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Comparison of 46 handwritten and electromechanically generated blood pressure records revealed substantial differences between the recordings. The highest automated record pressures exceeded the highest pressures found in corresponding handwritten records. Similarly, the lowest pressures from automated records were lower than those from handwritten records. Seventeen records (37%) had at least three automatic blood pressure determinations with values substantially in excess of the most extreme values recorded by hand. No handwritten record contained a diastolic pressure above 110 mmHg. Discrepancies between handwritten and automatic records may arise from one or more causes. Among these are readings captured automatically but not observed by the anesthesiologist, faulty reconstruction of handwritten records from memory, and bias in favor of less controversial values.
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