title: A roundtable discussion: home healthcare-not a hospital in the home.
abstract: 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controlled clinical environment. 1 The FDA recently announced its Home Use Devices Initiative and issued the document, "Draft Guidance for Industry and FDA Staff-Design Considerations for Devices Intended for Home Use" on Dec. 12, 2012. 2 The Center for Devices and Radiological Health (CDRH)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.
authors.affiliation: AAMI, USA. mlogan@aami.org
authors.forename: Mary K
authors.initials: MK
authors.lastname: Logan
authors.forename: Chuck
authors.initials: C
authors.lastname: Parker
authors.forename: Daryle
authors.initials: D
authors.lastname: Gardner-Bonneau
authors.forename: Denny
authors.initials: D
authors.lastname: Treu
authors.forename: James
authors.initials: J
authors.lastname: Keller
authors.forename: Lisa
authors.initials: L
authors.lastname: Winstel
authors.forename: Mary
authors.initials: M
authors.lastname: Weick-Brady
authors.forename: Nancy
authors.initials: N
authors.lastname: Kramer
authors.forename: Reginald
authors.initials: R
authors.lastname: Cyrus
authors.forename: Scott
authors.initials: S
authors.lastname: Thiel
authors.forename: Vicki R
authors.initials: VR
authors.lastname: Lewis
authors.forename: Wendy
authors.initials: W
authors.lastname: Rogers
mesh_terms: D004869:Equipment Safety; D006699:Home Care Services; D006801:Humans; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing; D013673:Technology Assessment, Biomedical; D014481:United States; D014486:United States Food and Drug Administration