Medical Devices Vigilance and Patient Safety The MEDEVIPAS project

Abstract

Biomedical Technology has contributed decisively to the impressive progress of modern healthcare over the past fifty years. Although recent technological advancements have led to much more reliable and safer Medical Devices (MDs), potential risks of failure and the associated adverse incidents cannot be neglected. In fact adverse incidents, due to MDs, have recently increased in absolute terms, because of the exponential increase in the number of devices used today. Patient safety is a fundamental cornerstone of care and a critical component of all healthcare systems. To create a safer environment in terms of technology, it is necessary to provide rapid and accurate information for adverse events, in order to avoid their repetition at another time, in another place. The traditional approach of MD Vigilance based only on official user reports of adverse incidents has been proven inadequate today. A modern approach to the problem, subject of this work, is based on the introduction of additional means, such as data mining, extraction, standardization and codification of the information, from different direct and indirect sources worldwide, and its systematic classification and archiving in dedicated databases. The aim is to timely extract the information on potentially hazardous MDs and make it available where appropriate. It is expected that this work through the design, development and implementation of modern ICT tools for MDs vigilance, creates a prototype system, which provides critical, on time and customised information to health care institutions, in addition to the existing traditional systems and consequently considerably improves patient safety.