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User reporting of medical device related incidents
1Medical Devices Department, National Agency for Medicines, Helsinki, Finland. harri.sievanen@nam.fi
Medical Device Technology
|May 31, 2003
Abstract:
In many countries, health-care professionals are required to notify relevant authorities about certain incidents that can be linked to properties, performance and usability issues of medical devices. This study examines whether the user-reporting scheme could add to the information that is already available from manufacturer incident reports.