Patient safety is a national concern. Major stakeholders throughoutour health care system agree that every step must be taken toensure that medical interventions, used with the intention ofimproving patients' health, are as safe as possible. But everymedical intervention has benefits and risks. Patient safetycan be ensured only when the makers of drugs and devices fullyand openly disclose both the benefits and the potential adverseeffects associated with an intervention. As the Institute ofMedicine has made clear, medical devices and drugs need to beassessed for risks and benefits throughout their life cycles.1
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