A roundtable discussion: home healthcare-not a hospital in the home.

Home healthcare is vital for a large percentage of the population. According to data from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), 7 million people in the United States receive home healthcare annually. The use of medical devices in the home and other nonclinical environments is increasing dramatically. By the year 2050, an estimated 27 million people will need continuing care in the home or in the community and not in a controlled clinical environment. 1 The FDA recently announced its Home Use Devices Initiative and issued the document, "Draft Guidance for Industry and FDA Staff-Design Considerations for Devices Intended for Home Use" on Dec. 12, 2012. 2 The Center for Devices and Radiological Health (CDRH) regulates medical devices, but that regulatory authority alone is not enough to ensure safe and effective use of devices in the home. To address these and other issues, AAMI and FDA will co-host a summit on healthcare technology in nonclinical settings Oct. 9-10, 2013.

Risk-based decision making to manage contaminated sediments.

This paper summarizes discussion among the 7 authors who served on an expert panel at the Third Battelle International Conference on Remediation of Contaminated Sediments held in New Orleans, Louisiana, USA, in January 2005. In this article, the authors review how sediment management decisions are currently made and address the question of how management decisions should be made in the future. It is arguably the case that sediment remediation presents greater challenges and more complexity than traditional land-based clean-ups. Although understanding of these challenges and complexities has grown over the last 25 y, there has been, until recently, relatively little innovation in the approaches used to manage the environmental risks posed by contaminated sediments. New methods that facilitate a more rigorous analysis of the multiple criteria considered in decision making have been developed. These methods, collectively known as multicriteria decision analysis (MCDA), coupled with the use of comparative-risk assessment and cost/benefit analysis, are proposed as an effective, efficient, and credible foundation for evaluating remedy alternatives at contaminated sediment sites.