Medical Device Incident Reports by Professional Users in Finland 2014 2021

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.Peer reviewe