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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Stud Health Technol Inform · Jan 1996
Medical device accident reporting: does it improve patient safety?
A significant number of patient injuries and deaths are associated with the use of medical devices. After several decades of experience in device evaluation and accident investigation, ECRI believes that many of these adverse effects could not be predicted in advance, even with the most sophisticated design validation techniques. Reporting networks with investigational capability that identify problem devices and provide feedback about adverse effects to manufacturers and medical device users are essential to meet the health communities obligation to provide safe and effective products and patient care.
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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.