AIUM Discourages the Sale and Use of Ultrasound Equipment for Personal Use in the Home
LAUREL, MD - In response to recent news of a celebrity purchasing an ultrasound machine for home use, the American Institute of Ultrasound in Medicine (AIUM) reaffirms its statement on the prudent use of ultrasound. “Tom Cruise’s recent purchase of an ultrasound machine for personal use at home is both inappropriate and in violation of FDA rules addressing the sale of medical equipment,” asserts AIUM President Lennard Greenbaum, MD, of The Hughes Center for Fetal Diagnostics at the Arnold Palmer Hospital, Orlando, Florida.
Joshua Copel, MD, of Yale University School of Medicine, New Haven, Connecticut, and AIUM president-elect, adds, “While diagnostic ultrasound has never been shown to have any adverse fetal effects, the use of ultrasound at home by untrained individuals and for nonmedical purposes exposes Mr Cruise’s and Ms Holmes’ baby to unnecessary ultrasound energy.”
Since 1994, the US Food and Drug Administration (FDA) has been notifying the ultrasound community and manufacturers that the use of diagnostic ultrasound for entertainment purposes constitutes an unapproved use of a medical (prescription) device.
The AIUM statement on the prudent use of ultrasound during pregnancy states,
The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the nonmedical use of ultrasound for psychosocial or entertainment purposes. The use of either two-dimensional (2D) or three-dimensional (3D) ultrasound to only view the fetus, obtain a picture of the fetus, or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice. Although there are no confirmed biological effects on patients caused by exposures from present diagnostic ultrasound instruments, the possibility exists that such biological effects may be identified in the future. Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient.
This statement has been also 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.
The American Institute of Ultrasound in Medicine is a multidisciplinary association dedicated to advancing the safe and effective use of ultrasound in medicine through professional and public education, research, development of guidelines, and accreditation.
For more information about the use of ultrasound for entertainment purposes, visit the AIUM website at www.aium.org, and click on “Entertainment Ultrasound” under “Patient Info.”
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