Electronic Health Records on the Top of Medical Device Incident Reports



: Kumpuvaara Krista, Jormanainen Vesa, Vainiola Tarja, Ikonen Tuija S

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

: Medical Informatics Europe

: 2022

: Medical informatics Europe

: Challenges of Trustable AI and Added-Value on Health

: Studies in health technology and informatics

: Stud Health Technol Inform

: Studies in health technology and informatics

: 294

: 947

: 948

: 978-1-64368-284-6

: 978-1-64368-285-3

: 0926-9630

: 1879-8365

DOI: https://doi.org/10.3233/SHTI220634

: https://ebooks.iospress.nl/doi/10.3233/SHTI220634

: https://research.utu.fi/converis/portal/detail/Publication/178244732


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.


Last updated on 2024-26-11 at 18:29