The Protagonism of the Brazilian Health Regulatory System in the Evolution of Patient Safety in the Country: History, Dilemmas, and Current Challenges.

Objective: This article aims to identify and analyze the legal and regulatory frameworks with an interface with patient safety, considering the historical path of the patient safety policy in Brazil.

Methods: This is a historical review based on the relevant literature to the topic such as papers, legislation, and official documents with an interface with public health policies from 1988 to 2019. We also performed a documentary search to include data from the Brazilian Health Regulatory Agency (ANVISA) such as normative and nonnormative regulatory instruments. After organizing the data, the process of content analysis was performed.

Results: We debated initially the historical aspects of sanitary surveillance of health services in addition to main actions taken by the Brazilian Health Regulatory System, which includes sanitary regulation and patient safety challenges. We identified a diversity of regulations published by ANVISA in the past decade related to patient safety, in addiction to sanitary actions. These initiatives culminated in the establishment of the National Patient Safety Program in 2013, followed by other health improvements, such as surveillance, incidents monitoring, and safe practices self-assessment.

Conclusions: The regulation and sanitary actions directed to patient safety in Brazil have increased after the creation of ANVISA. In the face of this activities, the social role played by the Brazilian Health Regulatory System toward the advancement in the field of risk minimization in health services can be highlighted as a protagonist in the process of promoting patient safety.