Analysis of Adverse Events in Medical Devices Used in Homecare
Main Article Content
Keywords
Adverse events, Medical devices, Techno-surveillance, Homecare, Health technology management
Abstract
This article aims to analyze adverse events and their probable causes associated with medical devices used in homecare to identify and categorize main problems. The work aims to establish strategies in health technology management in techno-surveillance processes to mitigate risks. A quantitative study of adverse events reported in Brazilian and North American databases between 2019 and 2024 was conducted. Reports regarding glucose monitors and continuous positive airway pressure were analyzed and the Ishikawa diagram quality tool was applied to categorize the causes of adverse events. The number of techno-surveillance notifications for medical devices reported by Brazilian National Health Surveillance Agency between 2019 and 2024 was 106,900, while on the Manufacturer and User Facility Device Experience/Food and Drug Administration (MAUDE/FDA) platform, there were 12,457,700 notifications for the same period. Medical devices used in homecare are among the technologies with the highest number of notifications. The probable causes of the failures were categorized into six factors: human, technological, environmental, interconnectivity and data security, metrological, and protocol. Technological development inserted in a Living Lab ecosystem and implementing accessible guidance resources are some strategies presented to mitigate the occurrence of adverse events. The occurrence of adverse events in medical devices in homecare has a direct impact on the quality of care. These technologies are operated by the users themselves to support decision-making. Therefore, strategies to mitigate the occurrence of adverse events in medical devices in homecare should be applied in the pre- and post-marketing stages.
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