Medical device adverse incident reporting in interventional radiology.

Area of Science:

• Medical Device Safety
• Interventional Radiology

Background:

• Adverse incidents with medical devices can impact patient care.
• Effective reporting mechanisms are crucial for device safety surveillance.

Purpose of the Study:

• To assess adverse incident reporting practices among British Society of Interventional Radiology (BSIR) members.
• To identify challenges and attitudes towards reporting device-related adverse incidents.

Main Methods:

• A survey was distributed to BSIR members between November 2012 and January 2013.
• The survey collected data on adverse incident reporting experiences and attitudes towards device "Instructions for Use".

Main Results:

• The majority of surveyed interventional radiologists reported experiencing adverse incidents with medical devices.
• While most incidents were reported locally, direct reporting to the MHRA was low (42%) due to time constraints and lack of awareness.
• Significant confusion exists regarding the appropriate channels and methods for direct MHRA reporting.

Conclusions:

• Interventional radiologists frequently encounter adverse incidents with medical devices.
• Current reporting systems face challenges including confusion, duplication of effort, and insufficient feedback.
• Enhancing education, simplifying reporting, and improving feedback are essential for improving the quality and quantity of adverse incident reports to ensure patient safety.