The implementation of an integrated vigilance system is a comprehensive process that involves constant communication for exchange of information on adverse events reported worldwide in order to prevent their reoccurrence at another place and time. This communication should be characterized by the confidential nature of the data and be supported by experts who will investigate incidents and suggest possible solutions. It should be noted that such a system is required by the European Medical Devices Directives and by the National legislations.
A prerequisite for the implementation of a Vigilance system is the existence of an updated inventory of medical equipment, available in electronic form. All incidents resulting in patient or staff injuries, associated with the use of medical equipment, should be notified immediately to the Competent Authorities.
A part of the services provided by INBIT is the identification of medical devices that are installed in a hospital and which have previously been reported in adverse incidents. In such cases, a report on the necessary actions to be taken is elaborated and submitted to the hospital.
INBIT is a unique agency, which for more than two decades has addressed this issue and has been actively involved in European actions to tackle the problem. Also, through international collaborations, INBIT has access to primary sources of information and has created a constantly updated database of adverse incidents that have been reported worldwide.
As the main contractor of the EUROMEDIES project, funded by the EU under the Health Care Telematics program, INBIT developed for the first time means to electronically exchange information on alerts concerning medical equipment.
MEDURIS is a software application for exchange of information concerning vigilance related issues. The design and development is customized to satisfy the specific requirements within the healthcare sector in Greece. It supports user reporting for alerts and incidents caused by medical devices at a regional or national level. MEDURIS is web-based application and service that features electronic creation, management and communication of incident reports.
Odos Stadiou, Platani, 265 00 Rio, Patras, Greece
Tel. +30 2610 911590 911591, Fax. +30 2610 911592