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

TL;DR

This study explores why healthcare professionals in India are hesitant to report medical device-related adverse events, identifying knowledge gaps, fear of blame, and logistical challenges as key barriers.

Contribution

The study provides new insights into the challenges of medical device adverse event reporting in India through stakeholder perspectives.

Findings

Healthcare professionals face psychological and logistical barriers to reporting adverse events, such as fear of blame and burdensome documentation.

A lack of institutional support and vendor accountability directly impacts patient safety and device quality.

Participants suggested digital tools and a no-blame environment to improve reporting and encourage transparency.

Abstract

Background

The effective operation of a medical device surveillance system relies heavily on healthcare professionals and other stakeholders voluntarily reporting adverse events related to medical devices. Despite measures to increase awareness among stakeholders and ensure user-friendly reporting procedures, the materiovigilance (MV) program is yet to pick up pace. Studies on knowledge and reporting of medical device-associated adverse events have been carried out in other countries, while in India, there has been limited investigation into this. This study aimed to understand the readiness of healthcare professionals in reporting adverse events related to medical devices.

Objectives

The objectives of this study were to identify hurdles to reporting medical device-related adverse events among healthcare workers, determine the awareness of MV among healthcare professionals, and resolve the challenges faced.

Methodology

This qualitative study used purposive sampling to conduct focus group discussions with selected healthcare workforce, including clinicians, nursing staff, pharmacists, and administrators from a tertiary care teaching hospital. Following Institutional Ethics Committee or IEC approval, we obtained informed consent from all participants before commencing the study. Each group consisted of six to eight participants to ensure diverse input across different levels of seniority and policy-making. A semi-structured framework was used to evaluate awareness, reporting experiences, and strategies to overcome barriers in MV. The discussions were recorded and transcribed. The transcribed data were thematically analyzed using inductive qualitative coding to develop subthemes and themes.

Results

The four themes elicited from the codes and subthemes were knowledge and awareness, hurdles in reporting, socioeconomic and logistical factors, importance of reporting, and resolutions in MV. The study identified a significant disparity in knowledge. Participation was further restrained by psychological and logistical hurdles, including a fear of professional blame and the burden of documentation. The important phrases that came to the fore, quoted verbatim, were as follows: (1) “if we report, they might get into trouble” and (2) “is there a Google form; the writing process is too much.” Challenges such as a lack of institutional support, vendor-related problems, and device quality issues were found to directly impact patient safety. To mitigate these risks, participants emphasized the need for structured resolutions, including feedback and appreciation, inter-departmental collaboration, and enhanced vendor accountability.

Conclusion

Effective MV is crucial for patient safety and device quality, yet it requires robust training and a culture of feedback to encourage consistent reporting. Implementing accessible reporting tools such as digital forms or dedicated registers allows monitoring centers to streamline data collection and receive better support from healthcare staff. A no-blame environment is essential to encourage honest reporting.

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