International overview of single‑use medical devices reprocessing Panorama internacional do reprocesamiento de productos médicos de uso único
DOI:
https://doi.org/10.5327/Z1414-4425201600040005Keywords:
Regulação. Reutilização de equipamento. Política de saúde.Abstract
Introduction: The reuse of single-use products occurs worldwide and it leads to major issues. Objective: To analyze the international regulatory
framework for the reprocessing of single-use medical products, including the Brazilian regulations. Methods: This is a narrative review of the literature,
using databases with specific descriptors. Results: Internationally, there are a variety of regulations on the reuse of single-use medical products that
aim at preventing damage. The regulatory environment comprises well-structured protocols, such as the American, Australian, and German protocols,
to lack of regulations at a national level, as identified in developed countries such as Canada, Japan, and some European countries. Conclusion: Current
regulatory controls have considerable gaps that hinder their implementation by the health services and manufacturers. An alternative approach may be
the formulation of a regulatory framework of single-use products focused on the control of the processes instead of the current control of products.
Keywords: Patient safety. Equipment reuse. Health policy.
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