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.摘要 外周置入中心静脉导管（Peripherally-inserted central catheters, PICC）被广泛应用于新生儿重症监护病房（Neonatal Intensive Care Units, NICU）住院的新生儿群体中。本研究旨在依据ABNT NBR ISO 10555-1:2003与ABNT NBR ISO 10555-3:2003标准，评估PICC的物理性能，并对比分析其生产初期（仅挤出成型导管）与成品阶段的检测结果。本研究的实验对象为2011至2012年间某国内厂商生产的PICC，数据采集自两类导管：一类为刚完成挤出成型、未进行标记喷涂、裁切及其他质量保障相关工序的导管，另一类为完成全部生产流程后的成品导管。本研究涵盖了所有可能对导管产品造成改性、进而给使用导管的患者带来健康风险的生产环节。依据NBR ISO 10555-1:2003与NBR ISO 10555-3:2003标准的要求，对导管开展了破裂强度、射线不透性、流量特性、加压渗漏以及负压管路组件漏气情况的检测。所有检测项目的结果均符合要求，唯有硅酮材质导管的破裂强度未达到标准规定的技术指标；而聚氨酯材质导管的破裂强度则符合标准要求。鉴于现有标准未明确规定部分关键检测要点，本研究提出了相关修订建议。