一次性使用高压造影注射器复用的思考

Consideration of Application Supervision of Reuse of Disposable High-pressure Contrast Injector

随着我国血管造影检查和增强扫描诊断技术的发展,高压造影注射器广泛应用于CT、MRI、DSA等检查中,笔者试图从医疗器械监管角度对一次性使用高压造影注射器复用带来的危害和对策进行探索和思考,以期有助于该产品的注册和技术审评。

With the popularization of angiography and enhanced scanning in China,high pressure contrast injector is widely used in CT,MRI,DSI and so on,the authors team try to explore and consider the harmfulness and countermeasures of the reuse of the disposable high-pressure contrast injector from the perspective of medical device supervision.Hope that it’s helpful to this registration and technical evaluation.