Shaffer M J, Gordon M R
Med Instrum. 1979 Jul-Aug;13(4):209-15.
The growing volume and complexity of biomedical equipment in hospitals are creating legal implications for the clinical engineer. Statutory regulations, court decisions on product liability, and the patient's right to privacy and confidentially affect daily operations. The doctrines of agency, negligence, strict liability, and breach of contract, plus the medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act, and the Joint Commission on Accreditation of Hospitals' 1976 standards, complicate the conventional clinical engineering functions. The need for the clinical engineer to be alert to his legal obligation is assessed.
医院生物医学设备数量的不断增加及其复杂性的日益提高，给临床工程师带来了法律问题。法律法规、关于产品责任的法院判决以及患者的隐私和保密权都影响着日常运营。代理、过失、严格责任和违约等原则，再加上1976年对《联邦食品、药品和化妆品法案》的《医疗器械修正案》以及1976年医院评审联合委员会的标准，使传统的临床工程职能变得复杂。文中评估了临床工程师了解自身法律义务的必要性。
