A Surgeon's Perspective of Medical Device Regulation John W. Brantigan, M.D. Journal of Spine Disorders, Vol. 8, No. 5, 1995 A Surgeon's Perspective of Medical Device Regulation The Medical Device Amendments of 1976 and 1992 had the legitimate purpose of protecting the public from unsafe or ineffective devices promoted by companies motivated by greed or incompetence. Enforcement of these acts by the FDA, however, has had the unintended effect of blocking medical device research, restricting the legitimate treatment choices of doctors and patients, unnecessarily raising the cost of medical care, and perpetuating the use of devices and treatments known to be deficient. The generic scientific elitism of the FDA ignores the productive history of device development, excludes physician innovators from the research and review process, trivializes the complex research process that includes far more than the device, ignores ethical obligations to study subjects, and ignores the real-world uncertainties and healthy controversies of medicine. The FDA wields its authority in an arrogant, vindictive manner, accountable to no one. The FDA can never answer questions once and for all because of changing circumstances and uncontrollable clinical variables. Pluralistic opinion and controversy are healthy and constructive. Patients and physicians are not as confused by the uncertainties of medical practice as FDA engineers. A patient who trusts a surgeon to operate also trusts that surgeon to answer medical controversies on his or her behalf, believing that the answers will more likely be correct than if the controversies are answered by a distant government regulator. There is an urgent public need to reevaluate our methods of device regulation and to institute responsible, accountable policy. The federal government must stop the FDA from criminalizing productive people and stop the FDA's vindictiveness and financial destruction of those that dare to criticize them. Outside the federal government, the scientific mechanism is already in place in the universities and professional societies to conduct capable device development, to evaluate the results, and to debate the controversies. Researchers who are doing productive work should be allowed to continue their research without interference from others who are untrained in the field. In evaluating new devices and treatments, the highest practical level of science should be followed in study design with randomized controlled protocols whenever possible. However, simple questions should be answered simply. For example, changes in device configuration to improve anatomic fit should be made more easily. Devices that enable satisfactory early treatment results should be available more quickly when prior treatment methods have produced poor results. Animal and mechanical testing should be relied upon to answer as many question as possible. Devices with demonstrated superiority over devices in current use should be immediately available, with concurrent studies continuing to provide long-term success and complication rates. There is a crisis in the regulation of medical devices in the United States. The crisis is political and not scientific. Back to Papers and Presentations |
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