Re: Non-Diagnostic Use of Ultrasound
From: art fougner, md (evsono@pipeline.com)
Wed Jul 31 09:32:37 2002
now that you have defined the "crime", where's the punishment? i've
noticed a few of these places involve members of SDMS and in one case,
an MFM.
art
At Tue, 30 Jul 2002, DuBose, Terry wrote:
>
>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
--
art fougner, md
ich bin ein New Yorker
|
|
