Technical complaints submitted to the Regulatory Health Notification and Investigation System

Abstract

This study aimed to evaluate technical complaints submitted to the Regulatory Health Notification and Investigation System between 2006 and 2014 through cross-sectional, quantitative, documental research of a secondary public database. It was identified that, of the 245,940 notifications put forward, 109,311 referred to technical complaints. The Southeast region presented the highest information submission (53.5%) and the North presented the greatest difference in quantity of notifications between states (coefficient of variation = 159.2), followed by the Northeast (coefficient of variation = 124.8). Most of the cases of notifications were on medical articles (53.09%) with equipment being the most notified product (19%). Risk to patient health was identified in 56,777 cases, with the highest frequency being in regard to materials of low or medium risk. SentinelaNetwork hospitals were the principal sources of notifications. In the analyzed period there was a gradual annual increase in the number of technical complaint notifications, especially regarding medical articles used in invasive procedures.