临床医学工程服务的伦理隐患分析与对策

Study on hidden ethical troubles and solutions in clinical engineering service

为揭示现阶段临床医学工程服务伦理隐患,构建临床医学工程服务伦理秩序。从医院内部和外部两个层面对临床医学工程服务存在的伦理隐患进行分析。现阶段临床医学工程服务伦理责任担当错位、医学工程技术人员的作用得不到重视、落实责任担当受制于现行卫生政策、制度,对医疗器械产品供应商缺乏伦理约束机制,医疗器械产品研制(设计)的安全性和可靠性方案缺少伦理学审查。建议制定临床医学工程保障伦理公约,构建医学工程技术人员道德标准,强化医疗器械产品供应商的伦理管理,建立医疗器械产品研制伦理审核机制,树立医学工程技术人员是健康服务队伍成员之一的意识。临床医学工程服务的伦理学要求是由于临床诊疗大量使用医疗器械产品而产生的,应建立医疗器械产品应用伦理管理规范。

To study hidden ethical troubles and establish ethical order in clinical engineering service. Analysis was carried out to find hidden ethical troubles in clinical engineering from both internal and external aspect of hospital. The analysis results showed that current ethical duties and responsibilities were misplaced and role of medical engineering service was ignored, the implementation of the responsibility is hindered by the current health policy and the system, and there is lack of ethical constraints mechanism for medical equipment suppliers, as well as ethical review on safety and reliability for medical equipment producer. Therefore, systematical ethical standards should be set up for clinical engineering service and clinical engineering personnel, ethical requirement be constructed for medical device suppliers, and the concept be established that medical engineering technical personnel are members of health service. The ethical requirements of clinical medical engineering services are proposed by the extensive use of medical devices, so ethics management standards should be established for medical device products.