Ramsey S D, Luce B R, Deyo R, Franklin G
Center for Cost and Outcomes Research, University of Washington, Seattle, WA 98103, USA.
Am J Manag Care. 1998 Sep 25;4 Spec No:SP188-99.
Medical devices are an integral part of clinical practice and account for a substantial proportion of the national health budget. Clinical testing and regulation of medical devices, however, is vastly different from and inferior to the testing and regulation of drugs. As managed care organizations begin to exert controls on device use, providers are being caught between the policies of their organizations and the demands of device manufacturers and patients, who want wider access to devices. We outline several reasons for the poor state of medical device evaluations and the dangers of using devices without adequate information, and include the recently developed device assessment and reporting guidelines created by the Task Force on Technology Assessment of Medical Devices.
医疗设备是临床实践不可或缺的一部分，在国家卫生预算中占相当大的比例。然而，医疗设备的临床试验和监管与药物的试验和监管有很大不同，且不如药物。随着管理式医疗组织开始对设备使用施加控制，医疗服务提供者夹在组织政策与设备制造商及患者需求之间，患者希望能更广泛地使用设备。我们概述了医疗设备评估状况不佳的几个原因以及在缺乏充分信息的情况下使用设备的风险，并纳入了医疗器械技术评估特别工作组最近制定的设备评估和报告指南。
