Deutsch E, Fischer G
Med Prog Technol. 1982;9(2-3):177-80.
The article deals with the protection the law provides against risks emanating from the use of biomedical equipment. After a brief discussion of public safety regulations, it turns to civil liability for damages involving patients or other persons. Doctors and hospitals using or failing to use biomedical equipment can be held liable for negligent conduct only. The standards of care to be observed in biomedical engineering are thus explained, as is the correct use of the equipment, the safety precautions to be taken, and the expertise of the operator. Another very important subject of the article is the liability of the manufacturers of biomedical equipment. Finally, the extremely difficult question is discussed as to what extent doctors and hospitals are obliged to acquire new but very expensive equipment, and what are the economic limits of this obligation.
本文论述了法律针对使用生物医学设备所产生风险提供的保护。在简要讨论公共安全法规之后,文章转向涉及患者或其他人员损害的民事责任。使用或未使用生物医学设备的医生和医院仅可能因过失行为而承担责任。因此,文中解释了生物医学工程中应遵循的护理标准、设备的正确使用方法、需采取的安全预防措施以及操作人员的专业知识。本文另一个非常重要的主题是生物医学设备制造商的责任。最后,文章讨论了一个极其棘手的问题,即医生和医院在何种程度上有义务购置新的但非常昂贵的设备,以及这一义务的经济限度是什么。