Challenges and dynamics in reporting medical device incidents: a qualitative study

Barriers to reporting include regulatory gaps, unclear procedures, communication challenges, and legal concerns. Still, many participants described positive inter-organizational collaboration. Stronger regulation and feedback mechanisms, clearer role definitions, particularly between physicians and nursing staff, and supportive managerial attitudes may foster a more responsive reporting culture. By incorporating diverse stakeholder perspectives, this study highlights lessons of broader relevance for improving medical device vigilance and patient safety worldwide.