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 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.
Ramsey
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SD
Center for Cost and Outcomes Research, University of Washington, Seattle, WA 98103, USA. sramsey@u.washington.edu
Luce
B R
BR
Deyo
R
R
Franklin
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G
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000191:economics / Q000592:standards; D017408:Guidelines as Topic; D007255:Information Services; D019458:Insurance Coverage; D011640:Public Policy; D013673:Technology Assessment, Biomedical / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration