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FW: "keepsake" fetal sonogramsFrom: DuBose, Terry (DuboseTerryJ@uams.edu)Fri Jun 7 10:09:03 2002
-----Original Message----- From: Daniel A Merton Sent: Friday, June 07, 2002 9:39 AM Subject: "keepsake" fetal sonograms This topic has come up again with everyone seeming to wonder...WHATS WITH THE FDA? Here is a quote (the concept of which most are familiar) from the FDA document found here: http://www.fda.gov/cdrh/consumer/fetalvideos.html "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" Shouldn't US taxpayers be able to hold the FDA accountable for enforcing their own regulations? Maybe its time for a mass letter-writing campaign from the memberships (AIUM, SDMS, etc etc). A scenario: Everyone that knows of such practices writes to the Office of Compliance (address below) to express their concern ("as an US professional") over the public's naivete and overall health and welfare of the unborn fetus and includes SPECIFIC INFORMATION regarding the name and address of the entrepreneur. Maybe the Feds will recognize the prevalence of these centers and finally do more than make idle threats. Diagnostic Devices Branch Office of Compliance Center for Devices and Radiological Health HFZ-322 2098 Gaither Road Rockville, Maryland 20850 or notify FDA by phoning 301-594-4591 or FAXing 301-594-4636 just one sonographer's thoughts..... TGIF! "In the 1940s and 1950s, medicine was too much an art and not enough of a science. Now we have more science than we know what to do with." Louis J. Kettel (Assoc. of American Medical Colleges, in US News and World Report, April, 1991)
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