Regulatory assessment of technical complaints about strip-based glucose meters: performance and usability in glycemic monitoring among patients with diabetes
Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02482| Published on: 04/02/2026
DOI:
https://doi.org/10.22239/2317-269X.02482Keywords:
Diabetes Mellitus, Blood Glucose Self-Monitoring, Medical Device, Product Surveillance Postmarketing, Adverse EventsAbstract
Introduction: This study addresses the evaluation of blood glucose monitoring systems using strip-based glucometers by regulatory agencies, comparing Brazil with Canada, the United States of America (USA), Japan, Australia, and countries in the European continent. It was developed to provide technical support to the Brazilian Health Regulatory Agency (ANVISA). Objective: To identify evidence on complaints or adverse events related to the use of glucometers with strips by patients with type 1 or type 2 diabetes mellitus, with regard to the nature and form of monitoring these occurrences. Method: An integrative review was conducted to investigate how regulatory agencies evaluate technical complaints associated with blood glucose monitoring systems using glucometers and reagent strips. Searches were performed in MEDLINE (via PubMed), Embase, and SCOPUS databases, as well as in secondary sources, civil society documents, and through manual reference checks. Results: A total of 1,220 citations were retrieved. Eight studies were selected, with data on device accuracy, human factors involved in use, and user experiences. The findings indicate frequent failures in the use of devices, low reporting of adverse events by users and a lack of public information on regulatory flows, except in Australia, which adopts a structured risk-based model. The results point to the need for greater regulatory transparency and educational actions
for the safe use of these devices. Conclusions: Information from regulatory agencies focuses on standards, regulations and guidelines for medical devices, with emphasis on the Australian agency’s approach to managing adverse events. There are no details on how other agencies deal with user complaints about the routine use of these devices.
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Author Biographies
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Andrea Queiróz Ungari, Divisão de Assistência Farmacêutica, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brasil
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Maíra Catharina Ramos, Programa de Evidências para Políticas e Tecnologias em Saúde (PEPT), Fiocruz, Brasília, DF, Brasil
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Flávia Tavares Silva Elias, Programa de Evidências para Políticas e Tecnologias em Saúde (PEPT), Fiocruz, Brasília, DF, Brasil
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