医疗设备在临床使用中的潜在风险及对临床治疗的不良影响探讨

Hidden risks of medical equipment during clinical operation and their effects on medical treatment

目的 :对临床使用中医疗设备的潜在风险及影响因素进行分析,总结可行性措施以减少潜在风险给临床正常诊疗带来的不良影响。方法:分析医疗设备在临床使用中机器自身因素、环境因素、人员因素等方面的潜在风险,建立和完善医疗设备使用中不良事件的监测机制以应对潜在风险。结果:临床需对医疗设备日常使用中的潜在风险主动施行有效的管理和监控。依据国际标准ISO 14971进行风险管理,院内医疗设备的临床操作医师、电子网络系统维护工程师及医疗设备厂商等各方面人员均承担起日常风险监管的责任,及时识别、发现并规避潜在风险的发生。结论:临床对医疗设备日常使用潜在风险的有效管理和监控,维护了其在临床应用的合理、合法、安全、有效。

Objective To analyze the potential risks and possible influencing factors of medical equipment during clinical operation, and to propose feasible measures to weaken the influences to medical treatment. Methods The hidden risks were analyzed from the aspects of equipment, environment, personnel and etc, and adverse events supervision mechanism was established to eliminate the risks. Results The hidden risks had to be supervised during daily clinical operation according to ISO 14971 standard, and the staffs such as clinical technician, electrical network system maintenance engineer and medical equipment supplier were suggested to be gifted with the responsibilities to recognize, find and treat hidden risks. Conclusion The supervision of hidden risks of medical equipment contributes to enhancing its safety and efficiency during clinical operation.