输注器具对临床用药安全性影响及控制研究

Safety Evaluation of Infusion Sets for Clinical Medication

本文论述了影响临床输液安全有效性的因素,包括输注器具对药物的吸附作用,材料残留物与溶出物引发的问题,微粒污染与空气中微生物污染,输注器具避光效果与光敏感药物等等。同时对DEHP增塑的PVC输注器具进行了讨论。保障输注器具产品安全性的重要因素需要从原材料控制、物理机械性能指标、生产条件及灭菌控制等方面综合考虑降低风险的有效途径。提出输注器具生产过程复杂,影响安全性的因素多,需从各环节严格控制以确保临床使用安全有效。其安全性依赖于新技术、新材料、新工艺。

This article discusses the basic requirements of safety evaluation on infusion sets for single use.And the article also puts forward to the points in the following： Infusion sets for single use with complicated producing process have many factors on influencing safety and need to be controlled strictly in all links to ensure the safety in clinical application.The safety of infusion sets for single use depends on new technology,new materials and new procedure,so we need strengthen the study above and establish and revise the raw material standards.To strengthen the control of product procedure and further study the research and development of infusion sets for single use.