药物熏蒸设备在临床使用中的故障风险分析

Failure Risk Analysis of Medical Fumigation Equipment in Clinical Use

药物熏蒸设备作为常见的一类中医治未病理疗设备,同时作为我国纳入到第二类有源医疗器械管理产品,其临床使用的安全性和有效性至关重要。通过本院近五年药物熏蒸设备在临床使用过程中发生的故障类不良事件的汇总分析以及对该产品文献资料的检索,将该产品临床使用中的故障类风险点进行归纳分析,以期为医疗机构对该设备的维保提供支持。

As a common kind of physical therapy equipment for disease prevention in traditional Chinese medicine,the medical fumigation equipment is also included in the second kind of active medical device management products in China,so the safety and effectiveness of its clinical use is very important.Through the summary and analysis of the failure adverse events in the clinical use of intelligent fumigation equipment in our hospital in the past five years,as well as the retrieval of the product literature,the failure risk points in the clinical use of the product are analyzed in order to provide evidence-based support for the maintenance of the equipment by medical institutions.