Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual...

Area of Science:

• Medical device safety
• Regulatory science
• Human factors engineering

Background:

• Medical device adverse event reporting is vital for risk mitigation.
• Accurate reporting relies on individuals recognizing events as adverse.
• Individual perception differences can influence medical device adverse event judgment and reporting.

Purpose of the Study:

• To investigate individual differences in the perception of medical device adverse events.
• To explore variations in understanding the start of 'patient use' for medical devices.
• To assess consensus in applying international medical device vigilance guidelines.

Main Methods:

• Trained 23 participants from 12 Asia-Pacific Economic Cooperation (APEC) economies on international medical device vigilance guidelines.
• Utilized six virtual cases and six questions to compare participant opinions across six groups.
• Surveyed national opinions on the definition of 'patient use' phases: inspecting, preparing, and applying.

Main Results:

• Participant responses on the 'patient use' start point were divided: 28.6% (phase 1), 35.7% (phase 2), and 35.7% (phase 3).
• Consensus on applying international guidelines to virtual cases was achieved on only one of six questions across all groups.
• Significant disagreements in judgment were observed for the remaining five questions in at least two groups.

Conclusions:

• No consensus exists regarding the 'patient use' point for medical devices.
• Substantial differences in interpreting adverse event definitions were found, affecting medical device incident reporting.
• International harmonization efforts are necessary to align regulations and address diverse user perspectives in medical device use.