47例臭氧治疗仪不良事件分析

      Analysis of 47 Cases of Adverse Events of Ozonic Therapeutic Instrument

      • 摘要: 采用回顾性研究法,对47份臭氧治疗仪不良事件报告进行分类、汇总与评价。结果表明25例不良事件明确与臭氧治疗仪的使用有关;上报单位以使用单位为主体,因器械故障延误治疗是最常见的不良事件表现;不良事件的发生与产品质量、患者体质、技术人员操作、器械消毒等风险因素有关。应加强臭氧治疗仪不良事件监测和风险控制,降低其不良事件发生率,维护患者用械安全。

         

        Abstract: With retrospective case study, this paper classified, summerized and evaluated 47 reports induced by ozonic therapeutic instrument. The results showed:25 cases of adverse events were clearly related to the use of instruments; the cases mainly reported by equipment use enterprises; the delay treatment by instrument failure was the most common adverse event performances; adverse events might be relevant to the risk factors of product quality, technical operation, patient specificity and instrument disinfection. Monitoring should be strengthened in order to reduce the ozonic therapeutic instrument adverse events and maintenance of public safety.

         

      /

      返回文章
      返回