The dilemma of reusing single use medical devices: historical and current aspects

• Autor(a) principal: Auxiliadora Magalhães Costa, Eliana
• Data de Publicação: 2021
• Outros Autores: Alves Costa, Ediná
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1411
• topic: Reutilização de Equipamentos; Reciclagem; Regulação; Risco; Saúde Coletiva; Equipment Reuse; Recycling; Regulation; Risk; Public Health

Introduction: The reuse of single-use devices is emblematic and involves technical, regulatory, economic, and environmental issues, as well as issues related to patient safety. Objective: To describe historical and current aspects of the reuse of single-use medical devices, in order to support an analysis of the dilemmas that involve this practice. Method: Academic essay, using narrative review data of the literature and expertise of the authors. Results: The reuse of these devices is controversial, although disseminated worldwide. Although there is a theoretical risk involved in the reuse of  these products, published data do not identify a causal relationship between adverse event and reuse of these devices. There are favorable and contrary arguments to this practice, in addition to different issues involved, such as patient consent, technical responsibility, distributive and social justice with dissemination of risk and benefit to patients, and can be analyzed in the light of utilitarianism, contractualism and ethics of land. The declaration that the product is single-use or multipurpose is the responsibility of the manufacturer and regulatory bodies do not request evidence attesting that the single-use product cannot be reused, pointing out inconsistencies in the definition of the single-use label. Conclusions: It is necessary to review the classification of products at the time of registration with regulatory agencies, in order to clarify the label of these products, whether multipurpose or single-use, the key point of the dilemma of the reuse of medical products. In addition, the State must be equipped not only with the ability to regulate health processes and services, but also to perform the sanitary control of these activities, in order to minimize risks to public health.