Refereed article in conference proceedings (A4)

Electronic Health Records on the Top of Medical Device Incident Reports

List of AuthorsKumpuvaara Krista, Jormanainen Vesa, Vainiola Tarja, Ikonen Tuija S

EditorsBrigitte Séroussi, Patrick Weber, Ferdinand Dhombres, Cyril Grouin, Jan-David Liebe, Sylvia Pelayo, Andrea Pinna, Bastien Rance, Lucia Sacchi, Adrien Ugon, Arriel Benis, Parisis Gallos

Conference nameMedical Informatics Europe

Publication year2022

JournalMedical informatics Europe

Book title *Challenges of Trustable AI and Added-Value on Health

Journal name in sourceStudies in health technology and informatics

Journal acronymStud Health Technol Inform

Title of seriesStudies in health technology and informatics

Volume number294

Start page947

End page948







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Medical Device incident reporting is a legal obligation for professional users in Finland. We analyzed all medical device incident reports recorded into the national incident repository from January 2014 to August 2021. Almost 30% of the total of 5,897 recorded incidents were caused by top ten devices, of which electronic health records were the most common (332 incidents). High number of incidents caused by electronic health records arouses safety concerns. A further analysis is required to explore the causes of findings.

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Last updated on 2023-03-03 at 09:29