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This lecture deals with the impact of regulation on medical device technology, especially in the U.S. Prof. Lysaght will describe the genesis of U.S. device regulation and the array of regulatory pathways formed to govern the development, manufacture, and marketing of products in high-tech medicine. He will note that medical devices are not demonstrably safer in the U.S. than in countries with more permissive legal environments or than they were prior to the initiation of device regulation in 1976. Recent unfortunate experiences with artificial hips, hemodialyzers, and stents highlight the discrepancy between the objectives of the current system and the level of safety that it actually provides. The implicit premise of device regulators, 'more regulation results in less risk' needs to be challenged, as does the corollary that high-tech medical implants can be rendered '100 percent safe'. Dr. Lysaght will conclude by asking if a 'soft touch' approach to medical device regulation would better serve the U.S. healthcare system.