Eventos adversos e incidentes sem dano em recém-nascidos notificados no Brasil, nos anos 2007 a 2013

Abstract

This study aimed to analyze adverse events and near misses in newborns up to 28 days of life, reported to the Brazilian National Notification System for Sanitary Surveillance (NOTIVISA) system from 2007 to 2013. This was a quantitative, descriptive, retrospective study with analysis of secondary data. A total of 355 incidents were reported: 118 (33.3%) related to medical devices, 4 (1.1%) medical equipment, and 233 (65.6%) medicines. Silver nitrate and antibiotics were the most frequently reported medicines, and among medical devices and equipment, phlebitis associated with IV lines was the most frequently reported adverse event. The study unveils the reporting of adverse events and near misses, fostering discussion on what actually constitutes harm according to the person that reports the event. The challenge for NOTIVISA is to improve the system, and as with other information systems, this results from its use, critical analysis, and interaction with users – incident reporters and interested parties like teaching and research institutions.