The U.S. Food and Drug Administration (FDA) has expressed concern over the use of over-the-counter use of Doppler ultrasound heartbeat monitors Doppler fetal ultrasound heartbeat monitors are hand-held ultrasound devices used to listen to the heartbeat of the fetus.
The over-the-counter sale and use of Doppler ultrasound heartbeat monitors is an object of concern for the FDA because little is known about the affect of frequent exposure to ultrasound may have on a fetus.
Product Only Intended For Use By Health Professionals
While the product is intended for use by only health care professionals, expectant mothers have also been found to use the product to hear their fetus’s heartbeat.
According to Shahram Vaezy, Ph.D., an FDA biomedical engineer:
- “When the product is purchased over the counter and used without consultation with a health care professional taking care of the pregnant woman, there is no oversight of how the device is used. Also, there is little or no medical benefit expected from the exposure.”
“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.”
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Concerns
“Although there is a lack of evidence of any harm due to heartbeat monitors, prudent use of these devices by trained health care providers is important,” Vaezy continues, “Ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles (cavitation) in some tissues.”
The long-term effects of tissue heating and cavitation are not known. Therefore, ultrasound scans should be done only when there is a medical need, based on a prescription, and performed by appropriately-trained operators.
See the FDA Consumer Update for more information.
