Challenges to Reporting Medical Device-Associated Adverse Events: Perspectives of Various Stakeholders

Area of Science:

• Medical Device Surveillance
• Patient Safety
• Healthcare Quality Improvement

Background:

• Effective medical device surveillance relies on voluntary adverse event reporting by healthcare professionals.
• The current materiovigilance (MV) program in India faces challenges in gaining momentum despite awareness initiatives.
• Limited research exists on healthcare professionals' knowledge and reporting practices in India.

Purpose of the Study:

• To identify barriers faced by healthcare workers in reporting medical device-related adverse events.
• To assess the awareness level of healthcare professionals regarding the materiovigilance (MV) program.
• To explore potential solutions for improving medical device adverse event reporting.

Main Methods:

• A qualitative study employing purposive sampling for focus group discussions with clinicians, nurses, pharmacists, and administrators.
• Semi-structured interviews were conducted to explore awareness, reporting experiences, and barriers.
• Thematic analysis of transcribed discussions was performed using inductive qualitative coding.

Main Results:

• A significant disparity in knowledge regarding medical device adverse event reporting was identified.
• Psychological and logistical hurdles, including fear of professional blame and excessive documentation, impede reporting.
• Lack of institutional support, vendor issues, and device quality concerns were highlighted as critical patient safety risks.

Conclusions:

• Robust training and a feedback-driven culture are essential for effective materiovigilance (MV) and consistent reporting.
• Accessible reporting tools, such as digital forms, can streamline data collection and improve healthcare staff support.
• Establishing a no-blame environment is crucial for encouraging honest and comprehensive adverse event reporting.