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

Biomed Instrum Technol 2013 ;Suppl:10-5

AAMI, USA.

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clinical environment. 1 The FDA recently announced its Home Use Devices Initiative and issued the document, "Draft Guidance for Industry and FDA Staff-Design Considerations for Devices Intended for Home Use" on Dec. 12, 2012. 2 The Center for Devices and Radiological Health (CDRH)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

Download full-text PDF

Source
http://dx.doi.org/10.2345/0899-8205-47.s1.10DOI Listing
July 2013
27 Reads

Publication Analysis

Top Keywords

medical devices
8
devices
6
"draft guidance
4
guidance industry
4
document "draft
4
initiative issued
4
issued document
4
industry fda
4
intended use"
4
use" dec
4
devices intended
4
considerations devices
4
fda staff-design
4
staff-design considerations
4
devices initiative
4
fda announced
4
people will
4
will continuing
4
estimated people
4
2050 estimated
4

Similar Publications