Guest Editorial: Entertainment ultrasound: Risky Business or Mission Impossible?
Dr. Raskin is a neuroradiologist at University Medical Center, Tamarac, FL. He is also legal counsel to the Florida Radiological Society and a member of the editorial board of this journal.
Some medical eyebrows were raised when actor Tom Cruise, star of the movie, Risky Business , disclosed to Barbara Walters in 2005 that he and his fiance, Katie Holmes, had purchased their very own ultrasound machine solely for the purpose of determining the sex of their unborn child. The medical community was concerned about the nonmedical use of ultrasound devices and that nonmedical people could purchase them. This prompted immediate statements from the American Medical Association (AMA), the American College of Radiology (ACR), the American Institute of Ultrasound in Medicine (AIUM), and the American College of Obstetricians and Gynecologists (ACOG) that strongly opposed the nonmedical use of ultrasound for “entertainment” purposes, suggesting their belief that this amounted to Risky Business, even for a Top Gun like Tom Cruise.
But this is nothing new. The Federal Drug Administration (FDA) notified the medical community and the ultrasound industry in August 1994 regarding its concerns about the misuse of diagnostic ultrasound equipment for nonmedical purposes and asked them to discourage their patients from having sonograms for nonmedical reasons. They have stated that fetal ultrasound should be performed only for medical purposes with a prescription from an appropriately licensed provider. The FDA considers a diagnostic ultrasound device to be a prescription device. Any person who promotes, sells, or leases ultrasound equipment for making “keepsake” fetal videos should be aware that the FDA considers this an unapproved use of a medical device. However, the FDA is a regulatory agency and can take actions against individuals only in the form of a warning letter or a possible seizure of a medical device.
The real “fuss” has been caused by the unfettered and exponential growth of facilities that perform “keepsake,” “entertainment,” or “boutique” ultrasound studies without any diagnostic purpose. There are hundreds of such facilities throughout the United States, and most advertise that they have the latest 3D/4D ultrasound equipment, and some even tout wide-screen movie theaters that seat up to 15 friends and family and serve popcorn and soda. It’s better than going to the movies!
Although the general use of ultrasound for medical diagnosis is considered safe, ultrasound energy has the potential to produce biological effects. Nevertheless, both the AIUM and ACR promote diagnostic ultrasound as a safe procedure and acknowledge that there is no convincing evidence of actual harm to a fetus. Those who support the so-called “keepsake” photographs or video clips have maintained that it promotes “bonding” for the parents with their unborn baby. However, for years, these so-called “keepsake” photographs or video clips have been provided to our patients during the course of a medically indicated ultrasound examination. In fact, in 1998, the AIUM released an official statement that images of a portion of the ultrasound examination may be given to the mother, if requested.
The ACR fully supports the opinion of the FDA that fetal ultrasound should be performed only for medical purposes with a prescription from an appropriately licensed provider. They oppose the use of fetal ultrasound solely for entertainment videos or keepsake images. The ACR strongly considers this a patient safety issue, as ultrasound should not be used without a medical indication. Images of the fetus provide an opportunity to diagnose many problems before birth that may require treatment. This opportunity may be lost if the ultrasoundimages are not interpreted by qualified physicians.
In 2006, California passed a bill called the “Tom Cruise Bill,” which prevented selling, leasing, or distribution of an ultrasound device to any individual for private ownership. The bill was “terminated” by Governor Schwarzenegger on September 30, 2006. Three other states— New York, Illinois, and New Jersey attempted to pass similar bills. The New Jersey bill mirrored the California bill but also incorporated FDA language. Nevertheless, none of these bills survived committee review and none has become state law. Why? Because the bills are all fiawed as written, since none of them rely on factual findings of harm to the fetus. Instead, they rely on statements from agencies and organizations that discourage entertainment ultrasound because of the potential to cause harm. It is unlikely that legislators, who would probably like to see in utero movies of their new child or grandchild, are going to aggressively move to stop the practice.
In 2007, the Iowa Board of Medical Examiners reminded physicians that the FDA has not approved fetal ultrasound for keepsake purposes. They also recognized the AIUM position that the use of ultrasound for nondiagnostic fetal imaging is inappropriate and contrary to responsible medical practice. Further, they concluded that the use of fetal ultrasound should not be used for nonmedical purposes,including ultrasound for keepsake photos and videos.
The reality is that no state really wants to stop this practice since most people want it. Several medical organizations, such as the ACR, AIUM, and AMA, initially took a strong stand against nonmedical ultrasound but now remain relatively silent. Most legislators won't touch it and see it as patient-driven. It seems that in Hollywood anything is acceptable and nothing is Mission: Impossible . So where does that leave us? Unfortunately, we’re waiting in the wings until the next actor wants to buy an ultrasound machine.