The Medical Device Safety Act of 2009

Patient safety is a national concern. Major stakeholders throughout our health care system agree that every step must be taken to ensure that medical interventions, used with the intention of improving patients' health, are as safe as possible. But every medical intervention has benefits and risks. Patient safety can be ensured only when the makers of drugs and devices fully and openly disclose both the benefits and the potential adverse effects associated with an intervention. As the Institute of Medicine has made clear, medical devices and drugs need to be assessed for risks and benefits throughout their life cycles.1 Unfortunately, . . .