Estudo das notificações de queixas técnicas de artigos médico-hospitalares no Brasil (2006–2024)

Introduction: Technical complaint reporting is aligned with international guidelines on patient safety. Technovigilance is responsible for monitoring these notifications, ensuring that problems are identified and addressed quickly. Objective: To discuss technical complaint notifications related to medical devices and select the five most reported medical devices in Brazil and their implications for patient safety. Method: This descriptive cross-sectional study discussed notifications related to hospital medical devices, using data from Anvisa’s Notivisa system to select the five most frequently reported devices. Results: 241,594 notifications were analyzed, of which 214,681 were related to medical and hospital supplies in Brazil between 2006 and 2024. Of this total, 202,168 are technical complaints. Conclusions: There are challenges such as underreporting, delays in analysis, and lack of detailed filters. The study highlights the importance of continuous training, transparency, and collaboration between the holders, professionals, and regulators to improve technovigilance in Brazil.

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Publication Details

Journal
Vigilância Sanitária em Debate
Published
2026-11-04
DOI
https://doi.org/10.22239/2317-269x.02545
Primary Topic
Healthcare Regulation
Type
article
Field-Weighted Citation Impact
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article

Estudo das notificações de queixas técnicas de artigos médico-hospitalares no Brasil (2006–2024)

Joyce Soares e Silva, Michele Feitoza-Silva
Vigilância Sanitária em Debate
Healthcare Regulation
article

Estudo das notificações de queixas técnicas de artigos médico-hospitalares no Brasil (2006–2024)

Joyce Soares e Silva, Michele Feitoza-Silva
article en

Abstract

Introduction: Technical complaint reporting is aligned with international guidelines on patient safety. Technovigilance is responsible for monitoring these notifications, ensuring that problems are identified and addressed quickly. Objective: To discuss technical complaint notifications related to medical devices and select the five most reported medical devices in Brazil and their implications for patient safety. Method: This descriptive cross-sectional study discussed notifications related to hospital medical devices, using data from Anvisa’s Notivisa system to select the five most frequently reported devices. Results: 241,594 notifications were analyzed, of which 214,681 were related to medical and hospital supplies in Brazil between 2006 and 2024. Of this total, 202,168 are technical complaints. Conclusions: There are challenges such as underreporting, delays in analysis, and lack of detailed filters. The study highlights the importance of continuous training, transparency, and collaboration between the holders, professionals, and regulators to improve technovigilance in Brazil.

Vigilância Sanitária em Debate
Openalex Percentile: Top 10%
Healthcare Regulation
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