Clinical engineering standards, obligations, and accountability.

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.