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Non-Diagnostic Use of UltrasoundFrom: DuBose, Terry (DuboseTerryJ@uams.edu)Tue Jul 30 13:55:21 2002
This just in from the SDMS Sound News: 4. Non-Diagnostic Use of Ultrasound There has been a recent proliferation of businesses who are performing ultrasound imaging of fetuses to make "keepsake" pictures and videos. In some cases, the ultrasound equipment is reportedly used for as long as an hour to obtain a video of the fetus. The Federal Food and Drug Administration (FDA) position on this activity is quite clear: "Persons who promote, sell or lease ultrasound equipment for making "keepsake" fetal videos should know that FDA views this as an unapproved use of a medical device, and that we are prepared to take regulatory action against those who engage in such misuse of medical equipment." Businesses that use ultrasound equipment for non-medical purposes should be reported, IN WRITING, to the FDA : Diagnostic Devices Branch Office of Compliance Center for Devices and Radiological Health HFZ-322 2098 Gaither Rd Rockville MD 20850 Additional information is available at: SDMS Position Statement http://www.sdms.org/positions/videoob.asp AIUM Official Statement http://www.aium.org/consumer/statement_selected.asp?statement=2 FDA Statement on Use of Non-Diagnostic Ultrasound http://www.fda.gov/cdrh/consumer/fetalvideos.html Peace, Terry J. DuBose, M.S., RDMS Assistant Professor & Director, Diagnostic Medical Sonography Program University of Arkansas for Medical Sciences, CHRP 4301 West Markham St. Mail Slot #563 Little Rock, Arkansas, 72205 USA 501-686-6510 http://www.io.com/~dubose/ http://www.uams.edu/CHRP/dmshome.htm http://www.obgyn.net/us/panel/panel.htm
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