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

Area of Science:

• Medical device safety
• Public health surveillance
• Regulatory science

Background:

• Adverse event reporting for medical devices is vital for post-market surveillance and preventing patient harm.
• Factors like maintenance, manufacturing, user error, and clinical issues complicate root cause analysis and accountability.
• Existing regulations shape policies, enforcement, and responsibilities in adverse event reporting.

Purpose of the Study:

• To examine perceptions, behaviors, and challenges in medical device incident reporting.
• Focus on key stakeholders in public and private sectors in Israel.
• Case study for a country awaiting an effective Medical Devices Law.

Main Methods:

• Qualitative thematic analysis of 31 in-depth interviews.
• Stakeholders included Ministry of Health, healthcare institutions (physicians, nurses, management), and medical device companies (CEOs, regulatory affairs managers).
• Interviews were transcribed and coded using inductive thematic analysis.

Main Results:

• Causality complexity shifted responsibility, hindering root cause identification and accountability.
• Communication among stakeholders was complex, unclear, and sometimes affected by conflicting interests.
• Reporting behavior was influenced by organizational culture; nurses reported more than physicians; lack of feedback reduced motivation.

Conclusions:

• Barriers include regulatory gaps, unclear procedures, communication issues, and legal concerns.
• Positive inter-organizational collaboration was noted.
• Stronger regulation, feedback, clearer roles, and supportive management can foster a responsive reporting culture for improved medical device vigilance and patient safety worldwide.