麻醉导管断裂监管对策的思考

Consideration of the Evaluation of Catheter Rupture and Supervision

随着我国医疗器械制造业的蓬勃发展,麻醉穿刺包已达到完全国产化。硬膜外麻醉技术的广泛应用和随之而来的麻醉导管断裂的不良事件屡见报道,该文试图从医疗器械监管角度对麻醉导管断裂带来的危害和对策进行探索和思考。

With the vigorous development of medical device manufacturing industry in China,anesthetic puncture bag has been completely localization.The extensive application of anesthesia technology and the subsequent adverse events of anesthesia catheter rupture have been reported frequently.This paper attempts to explore and think about the harm and countermeasures of epidural anesthesia catheter fracture from the point of view of medical device supervision.