Desafíos y dinámicas en la notificación de incidentes de dispositivos médicos: un estudio cualitativo

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, behaviors, and challenges in incident reporting among key stakeholders in the public and private sector in Israel, as a case study for a country where a Medical Devices Law is not yet effective.

A qualitative thematic analysis was conducted based on 31 in-depth interviews with stakeholders from the Ministry of Health, healthcare institutions (e.g., physicians, nurses, management), and medical device companies (e.g., CEOs, regulatory affairs managers). Interviews were transcribed and coded using inductive thematic analysis.

Four key themes emerged. First, the complexity of causality in device-related events often shifted responsibility between device manufacturer and user, complicating root cause identification and accountability. Second, communication among stakeholders was often described as complex and unclear, sometimes influenced by conflicting interests. Third, reporting behavior was shaped by organizational culture, particularly management's attitude, which could foster or suppress engagement. Nurses were generally more active reporters than physicians. Fourth, a lack of feedback was a recurring concern, reducing motivation to report.

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.