Capitalizing on the infatuation many parents-to-be have with their babies-to-be, commercial enterprises are making and selling "keepsake " ultrasound images. In a related trend, some consumers are purchasing Doppler ultrasound heartbeat monitors over the counter and without the required prescription for their use.
Capitalizing on the infatuation many parents-to-be have with their babies-to-be, commercial enterprises are making and selling “keepsake “ fetal ultrasound images--a trend that alarms officials at the US Food and Drug Administration (FDA).
Turned into videos these commercial ultrasound images sell for hundreds of dollars and can even be purchased at shopping malls.
Once considered private medical records, the images have become ones many expectant parents are eager to share.
One online entrepreneur is even selling fetal ultrasound images made into
Meanwhile, in a related trend, the FDA said it is concerned that some consumers are purchasing Doppler ultrasound heartbeat monitors over the counter and using them to listen to the heartbeat of the fetus, again without medical supervision or the required prescription.
Repeating a warning it issued 10 years ago, the FDA on Dec. 16 released a
consumer update urging pregnant women not to subject their fetuses to these medically unnecessary scans or to heartbeat monitoring.
“Although there is a lack of evidence of any harm due to ultrasound imaging and heartbeat monitors, prudent use of these devices by trained health care providers is important," says Shahram Vaezy, Ph.D., an FDA biomedical engineer. "Ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles (cavitation) in some tissues."
Vaezy acknowledged that these prospective parents think they are doing something to “promote bonding between the parents and the unborn baby” but that in the hands of these commercial operators, safety may suffer.
In creating fetal keepsake videos, there is no control on how long a single imaging session will last, how many sessions will take place, or whether the ultrasound systems will be operated properly. For instance, the ultrasound operator not working in a medically supervised setting might take as long as an hour to get a video of the fetus.
"Furthermore, the number of sessions or the length of a session in scanning a fetus is uncontrolled, and that increases the potential for harm to the fetus and eventually the mother,"Vaezy said.
At the North Shore-LIJ Health System, in Manhasset, NY John Pellerito MD, said he shared those concerns. He is vice chairman of radiology for the system.
The scans should not be done "purely to bring home pretty pictures, he said.