Brandão Mariana Ribeiro, Marques Jefferson Luiz Brum, Ojeda Renato Garcia
Institute of Biomedical Engineering (IEB-UFSC), Federal University of Santa Catarina, Florianópolis, Brazil.
J Diabetes Sci Technol. 2025 Sep 15:19322968251368860. doi: 10.1177/19322968251368860.
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.
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.
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.
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.
本研究的目的是识别家庭环境中使用的医疗设备所涉及的不良事件，重点关注糖尿病患者，并对可能的原因进行分类。
选择对血糖监测至关重要且用于用户决策的技术有：血糖仪（BGM）、连续血糖监测系统（CGM）和胰岛素泵。在寻找证据时，使用了2019年1月至2024年12月技术警戒警报收集的两个数据库：巴西国家卫生监督局（ANVISA）的技术警戒分析平台和美国食品药品监督管理局（FDA）的制造商与用户设备使用经验数据库（MAUDE）。
在MAUDE-FDA平台上，通知的总数分别为：血糖仪52,601条、连续血糖监测系统1,624,664条、胰岛素泵1,339,652条。提出了减轻不良事件发生的策略，涉及人为、技术和环境因素。关于报告的患者主要问题，是低血糖和高血糖。
本文强调需要鼓励报告行为以生成证据，并提出减轻不良事件的策略，例如开发以生活实验室形式融入跨学科生态系统的以用户为中心的技术；在开发和整合过程中考虑可及性方面；为用户开发指导资源；考虑计量方面以确保技术可靠性；以及纳入可持续性、安全性和数据隐私行动。互联互通为技术过程在整个生命周期的普遍管理创造了机会。
