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We describe a prospective analysis, in one hospital, of reported significant observations involving unsafe practices and working conditions during anaesthesia. Of the 549 significant observations reported voluntarily during a period of 18 months, 82% involved occurrences which were considered preventable and 27% could have been fatal if they had not been(More)
In virtually all safety-critical industries the operators of systems have to demonstrate a systematic and thorough consideration of safety. This is increasingly being done by demonstrating that certain goals have been achieved, rather than by simply following prescriptive standards. Such goal-based safety cases could be a valuable tool for reasoning about(More)
In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency(More)
Recent years have seen an increasing use of sophisticated interaction techniques in the field of command and control systems. The use of such techniques has been required in order to increase the bandwidth between the users and the systems and thus to help them deal efficiently to increasingly complex systems. These techniques come from research and(More)
For risk assessment and control of the failing Björk-Shiley convexo-concave heart valve, we present a life cycle-based complex system model and a risk intensity assessment model, allowing consistent analysis of this complex medical problem and identification of all pertinent aspects of product-related risks to patients.
In the Netherlands, the incidence of fractured Björk-Shiley convexo-concave heart valves led to investigations regarding the extent, impact, and management possibilities of this public health problem. Apart from an epidemiological study, we performed a safety management study. This study led us to conclude that: (1) the Björk-Shiley convexo-concave heart(More)