Medical Device Incident Reports by Professional Users in Finland 2014-2021
: Kumpuvaara Krista, Jormanainen Vesa, Vainiola Tarja, Ikonen Tuija S
: Mantas John, Gallos Parisis, Zoulias Emmanouil, Hasman Arie, Househ Mowafa S., Diomidous Marianna, Liaskos Joseph, Charalampidou Martha
: International Conference on Informatics, Management, and Technology in Healthcare
: 2022
: Studies in Health Technology and Informatics
: Advances in Informatics, Management and Technology in Healthcare
: Studies in health technology and informatics
: Stud Health Technol Inform
: Studies in Health Technology and Informatics
: 295
: 414
: 417
: 978-1-64368-290-7
: 978-1-64368-291-4
: 0926-9630
: 1879-8365
DOI: https://doi.org/10.3233/SHTI220753
: https://ebooks.iospress.nl/doi/10.3233/SHTI220753
: https://research.utu.fi/converis/portal/detail/Publication/176158169
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. Among the total 5,897 records, annual numbers of incident reports varied between 463 and 1,190. Approximately 80% of the medical device incident reports were near misses, 18.7% were person injuries and 1.3% deaths. The number of annual medical device incident reports between hospital districts varied more than expected when related to the population of catchment area. There was a tendency towards lesser reports per population from smaller hospital districts. In conclusion, medical device incident reporting activity of the professional user varied both annually and geographically. A high number of incidents caused person injuries or even death, which arouses safety concerns. A further analysis is required to explore the causes behind our findings.
