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  • Title: User reporting of medical device related incidents.
    Author: Sievänen H.
    Journal: Med Device Technol; 2003 May; 14(4):26-9. PubMed ID: 12774575.
    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.
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