MEDICAL DEVICES VIGILANCE AND PATIENT SAFETY

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 proposal, 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.

The work will be organized in five work packages (WP):

  1. Analysis, Design and Methodology;
  2. Information Collection and Data Mining;
  3. Research and Development of a prototype e-MD Vigilance System;
  4. Evaluation and Analysis of the Results;
  5. Project Management.

It is expected that the proposed project through the design, development and implementation of modern ICT tools for MDs vigilance, will create a prototype system, which will provide critical, on time and customised information to health care institutions, in addition to the existing traditional Systems and consequently will considerably improve patient safety.

Project info

Acronym:
MEDEVIPAS
Coordinating Institution:
University of Patras
Scientific Coordinator:
Pallikarakis Nicolas
Research Team 2 Leader:
Koutsouris Dimitrios
Research Team 3 Leader:
Petrakis Euripides

Stats

I.D.:
43
Mis:
377003
Duration (months):
45
Diavgeia:
ΑΔΑ: Β4ΛΡ9-1Κ5

Document Library

News