Banta H D, Thacker S B
Am J Public Health. 1979 Sep;69(9):931-5. doi: 10.2105/ajph.69.9.931.
Electronic fetal monitoring (EFM) is an example of a medical technology that has been widely accepted since its introduction in the mid-1960s. However, review of the literature does not provide convincing evidence of EFM efficacy, and four recent, controlled, clinical trails show little if any benefit in terms of preventing death or long-term disability of the baby. Public and private policies have largely acted to encourage use of EFM, and none have acted to slow or prevent its spread. This need for mechanisms to assure the timely evaluation of new medical technologies before they are accepted as a medical practice has led to a new medical devices program in the Food and Drug Administration, consensus development groups at the National Institutes of Health, and congressional legislation to establish a new National Center for Health Care Technology.
电子胎儿监护(EFM)是自20世纪60年代中期引入以来已被广泛接受的一种医疗技术。然而,文献回顾并未提供令人信服的EFM有效性证据,并且最近的四项对照临床试验表明,在预防婴儿死亡或长期残疾方面几乎没有益处。公共政策和私人政策在很大程度上都起到了鼓励使用EFM的作用,而没有一项政策起到减缓或阻止其传播的作用。这种在新医疗技术被接受为医疗实践之前确保及时评估的机制需求,促使美国食品药品监督管理局制定了一项新的医疗设备计划,美国国立卫生研究院成立了共识发展小组,以及国会立法设立了一个新的国家医疗保健技术中心。