Studies in health technology and informatics
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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.
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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
Security aspects for medical device vigilance information exchange.
The implementation of appropriate security mechanisms for an effective and efficient medical device vigilance information exchange is very important, as the system handles sensitive information. These mechanisms have to be designed in such a way that they maintain confidentiality, integrity and availability of the data of medical devices. In this paper the security aspects of the information exchange on medical device vigilance is examined in detail.