Analysis of Adverse Events in Medical Devices for Diabetes.

Abstract

Introduction: The objective of this study is to identify adverse events involving medical devices used in home environments with a focus on patients with diabetes and to categorize the probable causes.

Methods: The chosen technologies that are fundamental for monitoring blood glucose and used in users' decision-making were: blood glucose monitor (BGM), continuous glucose monitoring system (CGM) and Insulin Pump. In the search for evidence, two databases from the collection of technovigilance alerts between January 2019 and December 2024 were used: the Technovigilance Analytical Portal of the National Health Surveillance Agency (ANVISA) of Brazil and MAUDE-FDA-USA.

Results: On the MAUDE-FDA platform, the total number of notifications were: 52,601 BGM, 1,624,664 of CGM, and 1,339,652 Insulin Pump. Strategies to mitigate the occurrence of adverse events were presented, related to human, technological, and environmental factors. Regarding the main problems reported with the patient, they were hypoglycemia and hyperglycemia.

Conclusion: This paper highlights the need to encourage the practice of reporting to generate evidence and to present strategies to mitigate adverse events, such as developing user-centered technologies inserted in an interdisciplinary ecosystem in the form of a living laboratory; considering accessibility aspects in development and incorporation; developing guidance resources for users; considering metrological aspects to ensure technological reliability; and including sustainability, security, and data privacy actions. Interconnectivity opens up opportunities for the ubiquitous management of technological processes throughout the life cycle.