Physical characterization of Peripherally-Inserted Central Catheters (PICC)

ABSTRACT Peripherally-inserted central catheters (PICC) are widely used in neonates hospitalized in Neonatal Intensive Care Units (NICU). The aim of the study entertained herein was to evaluate the physical characteristics of PICC, through application of the standards ABNT NBR ISO 10555-1:2003 and ABNT NBR ISO 10555-3:2003, and compare the results produced in the analysis of PICC at the beginning of their production process (extruded catheters only) with those obtained in the analysis of the finished product. Experimental tests were performed in PICC manufactured by a domestic manufacturer between the years 2011 and 2012. The data was gathered from tests performed on both catheters that were just extruded, i.e. without painting the demarcations, cutting and other processes related with quality assurance, and on catheters after completion of the overall manufacturing process. In the present study, one included all stages of the catheter production process that can generate some type of modification in the product that could impart risks to the patients needing to use them. The catheters were analyzed for strength to rupture, radiopacity, flow characteristics, leakage of fluid under pressure, and occurrence of air leak in the suction tube assembly, as advocated by the NBR ISO 10555-1:2003 and NBR ISO 10555-3:2003 standards. The results obtained were satisfactory in all analysesperformed, except for the resistance to rupture, which did not meet the specifications advocated by the standards for catheters made of silicone. One has also examined catheters made of polyurethane, which in turn did meet the standards with regard to resistance to rupture. As standards do not specify important points to be taken into account for conducting tests unequivocally, suggestions were made for revision of those standards.