Studies in health technology and informatics
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This overview of medical device vigilance at the U. S. ⋯ How FDA examines the data patterns in overall reporting, to identify signals in the database, and the potential actions FDA takes to respond to these problems are also presented. New initiatives include, for example, new methods to triage reports and the move developing an internationally harmonised nomenclature.
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The Institute for Defense Analyses (IDA) was contracted to perform a military standard task analysis of laparoscopic cholecystectomy, and to study the effectiveness of a virtual reality surgical skills simulator as a tool for surgical training and as a method for recording psychomotor behavior. This report describes the purpose of the study, its design, initial results, and implications for the field of medical education.
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Stud Health Technol Inform · Jan 1996
Robotic arm enhancement to accommodate improved efficiency and decreased resource utilization in complex minimally invasive surgical procedures.
Resource allocation, including manpower and other expenses, have limited the evolution of minimally invasive surgical procedures to provide humanism and to improve surgical care for patients. Robotic enhancement has been proposed as a mechanism to improve the cost-benefit relationship for patients. To this end, we have used the robotic arm enhancement to minimize resource and personnel utilization during minimally invasive procedures. ⋯ Further, this process improves versatility for the surgeon, increases concentration, reduces fatigue and does not interfere with the position of the surgeon. Areas for improvement which have been observed utilizing these techniques are (1) the use of appropriate and consistent voice activation terminology, (2) the proper positioning of the instrument tracking unit in the most appropriate locations on the video screen and on the instrument within the visual field, and (3) the appropriate use of head-directed control of the robotic arm. We have concluded from these experiences that the robotic technology will continue to reduce costs and minimize risk for patients undergoing minimally invasive surgical procedures; moreover, safety, versatility, and diminished use of resources will accrue utilizing the additive benefit of sequential sophisticated technologies requiring a simultaneous educational
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Post market procedures have been foreseen within the medical device directives. This in turn, led to the preparation of the guidelines on a medical device vigilance system, which is actually the establishment of a recommended procedure to deal with reported adverse incidents. ⋯ However, a number of potential problems can arise during its implementation. Proper use of the vigilance system improves the protection of health, by reducing the likelihood of repeating the same type of incident.