endorsed by the American College of Obstetricians and Gynecologists (ACOG), American College of Radiology (ACR), Society for Maternal-Fetal Medicine (SMFM), Society of Radiologists in Ultrasound (SRU), and American Registry for Diagnostic Medical Sonography (ARDMS). The Society of Diagnostic Medical Sonography (SDMS) has developed a similar statement.

The AIUM further recommends that licensed medical professionals (either physicians, certified/registered sonographers, or sonography registry candidates) with specialized training in fetal imaging perform all obstetric ultrasound scans. These individuals have been trained to recognize medically important conditions, recognize artifacts that can mimic or obscure pathology, and use techniques to minimize ultrasound exposure to the fetus.

A statement updated in August 2005 from the FDA reads "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. In addition, those who subject individuals to ultrasound exposure using a diagnostic ultrasound device (a prescription device) without a physician's order may be in violation of State or local laws or regulations regarding use of a prescription medical device" (available at: http://www.fda.gov/cdrh/consumer/fetalvideos.html). The AIUM calls on the FDA to investigate the purchase of this machine to determine whether it was directly from a manufacturer of ultrasound equipment or through some other source. Because the sale of regulated medical equipment to consumers violates FDA regulations, the AIUM also urges the FDA to take appropriate action against the source of this ultrasound machine.

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Contact: Carmine Valente
cvalente@aium.org
3014984100
American Institute of Ultrasound in Medicine
28-Nov-2005

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