Medical Device Incident Reports by Professional Users in Finland 2014-2021.

Area of Science:

• Healthcare safety
• Medical device regulation
• Public health surveillance

Background:

• Medical device incident reporting is a legal requirement for healthcare professionals in Finland.
• Analyzing national incident repository data provides insights into device safety and user practices.

Purpose of the Study:

• To analyze trends and geographical variations in medical device incident reports in Finland.
• To identify the types of incidents and their severity (near misses, injuries, deaths).

Main Methods:

• Retrospective analysis of 5,897 medical device incident reports from January 2014 to August 2021.
• Data categorized by annual frequency, geographical distribution (hospital districts), and incident type.

Main Results:

• Annual reports ranged from 463 to 1,190, with significant variation between hospital districts relative to population size.
• Near misses constituted approximately 80% of reports, while 18.7% involved person injuries and 1.3% resulted in deaths.
• Smaller hospital districts tended to have fewer reports per capita.

Conclusions:

• Medical device incident reporting by professionals in Finland is inconsistent annually and geographically.
• The occurrence of injuries and deaths from medical device incidents highlights significant patient safety risks.
• Further research is needed to understand the underlying reasons for these reporting variations and safety concerns.