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controlled clinical environment. 1 The FDA recently announced its Home Use Devices Initiative and issued the document, "Draft Guidance for Industry and FDA Staff-Design Considerations for Devices Intended for Home Use" on Dec. 12, 2012. 2 The Center for Devices and Radiological Health (CDRH)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.

An Innovative Approach to Minimizing Downtime in Continuous Kidney Replacement Therapy.

Continuous kidney replacement therapy (CKRT) is often utilized to stabilize patients with severe acute kidney injury associated with significant electrolyte abnormalities and/or oliguria and concomitant fluid accumulation. Circuit downtime may reduce daily treatment time and affect delivered doses of CKRT. Studies have found clotting to be the leading cause of downtime and underdosing, which are associated with negative treatment outcomes. The NxStage Cartridge Express with Speedswap (NxStage Medical, Inc.) was designed to minimize downtime by allowing filter priming to occur in parallel with ongoing CKRT and by permitting filter exchanges without the need to replace the entire cartridge. Data from pilot studies suggest that filter exchanges using this system interrupt treatment by an average of 4 minutes per exchange-a considerable reduction from traditional systems that require treatment to be discontinued while the filter is primed, which can take 30 minutes or more. In addition to increasing patient time on therapy, this system has the potential to reduce costs for patients who require a high number of filter changes, and reduce nursing labor and environmental impact (reduced plastic waste). Future studies should confirm whether patients at higher risk of clotted/clogged filters benefit from CKRT with a system designed for rapid filter changes.

Reengineering hemodialysis for the home environment.

Denny Treu of NxStage Medical, Inc., who has led the development of six dialysis systems with various companies, reports here on a home hemodialysis system that his company successfully designed specifically for home use.