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

Abstract

Adverse event reporting for medical devices is essential for post-market surveillance and public health, preventing harm like patient injury, misdiagnosis, or death and is shaped by regulation that defines policies, enforcement, and responsibilities. Various factors-poor maintenance, manufacturing defects, user error, or clinical issues-can cause adverse events, complicating root cause identification, sometimes leading to ambiguous accountability and hindering prevention. To examine perceptions,