对一次性使用输注器具的安全性评价

Safety Evaluation of Infusion Sets for Single Use

本文从技术评价角度,结合一次性使用输注器具产品特点及以往注册评价中存在的共性问题,论述了我国一次性使用输注器具的现状、安全性评价的基本要求,产品管理常见问题与处理其在医疗器械管理与技术评价中如何通过安全性评价等问题。本文提出:1.一次性使用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。2.一次性使用输注器具的安全性依赖于新技术、新材料、新工艺,要加强上述研究并制定和修订原材料标准。3.加强生产工艺过程控制和深入研究推进一次性使用输注器具研发与评价发展。

This article discusses the present situation, the basic requirements of safety evaluation, the common problems of product management and how to pass the safety evaluation in the medical device management and technical evaluation based on technical evaluation, and linked with the features of infusion sets for single use and the common problems in the previous registered evaluation. And the article also puts forward to the points in the following： 1. 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. 2. 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. 3. To strengthen the control of product procedure and further study the research and development of infusion sets for single use.