Dr. Ilias Iakovidis, EU/Greece
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 | Prof. Nicolas Pallikarakis, Greece
Professor of Medical Physics |
| Short CV |
Studied Physics, Instrumentation, Biophysics and Medical Physics in Greece,
United Kingdom and Belgium. He is currently Professor of Medical Physics,
University of Patras, Chairman of the Board of the Institute of Biomedical
Technology (INBIT) and Director of the European postgraduate course on
Biomedical Engineering. He is the author of more than 70 scientific papers, 3
books and 3 educational CD ROMs.
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| Title: | Patient Safety and Medical devices Vigilance |
| Abstract | Hospitals provide today the setting for the treatment of otherwise fatal conditions using advance diagnostic and therapeutic services and sophisticated medical technology. But access to these services comes with certain costs and a lot of concerns have been raised about the quality and safety of health care delivery today. Patient safety depends on a large number of factors, involving medical procedures, staff experience, knowledge and skills, malpractice, failure or lack of appropriate infrastructure, misuse of medical devices etc. The human factor is the most serious one as far as adverse incidents in a hospital are concerned. A number of reports addressing this problem have shown that medical accidents affect more than 10 % of patients. They also contribute significantly to patient morbidity and mortality. Medical devices are in some cases the cause of these accidents and their prevention when possible, has been a major issue over the last 15 year. Various Medical Devices User Reporting and Vigilance Systems have been developed in different countries in order to address the problem and collect information concerning adverse incidents, in order to avoid reoccurrence. The implementation of these systems permitted to undertake recall actions, following registered adverse incidents and at the same time is contributing to improve medical device performance and safety. The data available by FDA in US and the recently established EUDAMED in the EU, reveal interesting information. It is worth to notice that, according to an analysis of reports of Medical Device failures over the past several years, a significant number of failures are associated with software. Although there is certainly a problem of under-reporting of software failures in medical devices, it has been shown that about 1/3 of recalls of medical equipment incorporating software, are due to the software itself. There are also indications of an increasing trend for this fraction, reflecting the growing importance of complex software in Medical Devices. Patient Safety is a major issue. Every effort should be made to improve it and the Medical Technology sector is very sensitive to this goal. |
