Analysis of Adverse Events in Medical Devices for Diabetes

Area of Science:

• Medical Device Technology
• Patient Safety
• Diabetes Management

Background:

• Home-use medical devices are crucial for diabetes management.
• Identifying adverse events and their causes is essential for patient safety.
• Focus on devices for blood glucose monitoring and insulin delivery.

Purpose of the Study:

• To identify adverse events associated with home-use medical devices for diabetes patients.
• To categorize the probable causes of these adverse events.
• To propose strategies for mitigating identified risks.

Main Methods:

• Utilized technovigilance alert databases from Brazil (ANVISA) and the USA (MAUDE-FDA).
• Analyzed data from January 2019 to December 2024.
• Included blood glucose monitors (BGM), continuous glucose monitoring systems (CGM), and insulin pumps.

Main Results:

• Significant notification volumes for BGM (52,601), CGM (1,624,664), and insulin pumps (1,339,652) were recorded.
• Adverse event mitigation strategies addressed human, technological, and environmental factors.
• Hypoglycemia and hyperglycemia were the primary patient-reported issues.

Conclusions:

• Encouraging adverse event reporting is vital for evidence generation.
• Strategies include developing user-centered, accessible, and reliable technologies within an interdisciplinary framework.
• Interconnectivity and lifecycle management are key for ubiquitous technological process management.