THE LIMITED STATE OF TECHNOLOGY-ASSESSMENT FOR MEDICAL DEVICES - FACING THE ISSUES

Medical devices are an integral part of clinical practice and account for a substantial proportion of the national health budget. Clinical t esting 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 ar e being caught between the policies of their organizations and the dem ands of device manufacturers and patients, who want wider access to de vices. We outline several reasons for the poor state of medical device evaluations and the dangers of using devices without adequate informa tion, and include the recently developed device assessment and reporti ng guidelines created by the Task Force on Technology Assessment of Me dical Devices.