Profile of Notifications of Technical Complaints of Blood Bags Marketed in Brazil After Publication of the New Technical Regulation

Abstract

Blood bags are risk III-high complexity products designed to collect, store and transfer blood efficiently and safely. The national reference for the analysis of this product is the National Institute of Quality Control in Health (INCQS) -Oswaldo Cruz Foundation, responsible for the preliminary analysis to the registry and control of these products. RDC publication No. 35/2014 replaced Ordinance No. 950/1998, which optimized and validated the methodologies. This study aims at evaluating the profile of