One area of ultrasound practice that concerns organizations that accredit ultrasound medicine is the spread of so-called “fetal keepsake video” installations that make ultrasound videotapes of babies still in the womb for parents to cherish as a bit of family history.
While these operations might seemand in fact may be most oftenharmless, nobody knows for sure the effect of prolonged exposure to ultrasonic waves on the fetus or, for that matter, on the mother.
“This is a big issue for us. We take this seriously,” says the AIUM’s director of accreditation, Paula Woletz. “There are a number of franchises where it is unclear if a physician is even involved. We see direct marketing to patients in the same way pharmaceuticals have been direct marketed. People can go to their local mall and get a sonogram without any indication for need, and without any medical benefits from having it.”
Woletz says the videos are marketed as “entertainment.” But will it be entertainment if the ultrasound does turn out to have an effect on the fetus? “Most likely, there is not an exposure danger, but there’s no way we can give you a definite no,'” Woletz says. “The FDA has lifted limits on the exposure given a patient.”
And the FDA itself cautions against unnecessary exposure to fetuses. In a September 2002 bulletin issued by the FDA’s Center for Devices and Radiological Health, there was the suggestion that some fetal keepsake videos might require as much as 1 hour of ultrasonic exposure. Then there was this comment: “Exposing the fetus to ultrasound with no anticipation of medical benefit is not justified. 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.”
The problem may not end with exposure either. Carol Rumack, MD, at the University of Colorado Health Sciences Center is chair of the ACR ultrasound commission. She worries that fetal keepsake videos may lull parents into thinking that a doctor has reviewed the pregnancy during the creation of the video, which may not be the case. “The parents think if a picture has been taken, everything must be OK,” Rumack says. She says the keepsake providers do not issue a medical report, so if there is a problem with the baby that goes undiagnosed, they cannot be sued. “The odds are the fetus will be OK,” Rumack says, “but we like to follow the ALARA principleAs Low as Reasonably Acceptable. Do the absolute minimum.”
George Wiley is a contributing writer for Decisions in Axis Imaging News.
