Abstract

ABSTRACT Introduction Health organizations are faced with daily challenges, requiring them to provide a quality service, ensuring effectiveness and efficiency. Risk management is one of the conditioning factors to achieve this purpose, ensuring preventive actions for all processes, promoting the identification of risk to the mitigation of its consequences for the patient, professionals, or organization. Patient safety is a priority and healthcare organizations should be concerned with the implementation of methodologies and tools to promote risk management, such as Healthcare Failure Mode and Effects Analysis (HFMEA). HFMEA has a high potential for risk management in healthcare organizations, with a proactive, prospective, and continuous approach to improvement. Objective Translation and adaptation of the HFMEA instrument into European Portuguese. Materials and methods A methodological study was carried out based on the proposal presented by Beaton and followed the recommendations of the International Test Commission and World Health Organization. Results The HFMEA 2021 was linguistically translated and culturally adapted to the new context ensuring reliability, content validity was assured by a group of experts, which ensured semantic, idiomatic, experimental, and conceptual equivalence between the original instrument and the translation. Conclusions HFMEA 2021 was successfully translated and adapted to European Portuguese, allowing its application.

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