FDA Says Fetal Ultrasound “Keepsake” Images, Heartbeat Monitors Could Harm Baby

Health officials are alerting parents of potential risks associated with medically unnecessary use of fetal ultrasound imaging and heartbeat monitors.

In a consumer update earlier this month, the U.S. Food and Drug Administration (FDA) advised parents to avoid unnecessary fetal ultrasound “keepsake” images, videos and heartbeat monitors during pregnancy because the long-term effects to the fetus are unknown.

Ultrasound is a valuable tool for monitoring fetal development during pregnancy. Fetal ultrasound imaging uses high-frequency sound waves to produce a real-time image of the fetus. The ultrasound operator will often capture keepsake images of the fetus for the parents and family during routine prenatal examination. Doppler fetal ultrasound heartbeat monitors are devices for listening to the fetal heartbeat. These are both prescription ultrasound devices and when used by trained health care providers in a clinical setting, carry little risk to the fetus and mother. However, those risks increase with unnecessary or prolonged exposure to ultrasound energy or by improper use of the devices by untrained users.

“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.”

The FDA recommends use of these devices only by trained health care professionals when there is a medical need for the procedure because the long-term effects of the tissue heating and cavitation are unknown. There are businesses in the United States promoting use of fetal ultrasound solely for creating keepsake videos and the agency warns that the fetus and mother could suffer uncontrolled or prolonged exposure to ultrasound energy during the making of such videos.

There are also concerns about exposure from medically unnecessary use of ultrasound heartbeat monitors (also called doptones).

“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,” Vaezy says. “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.”

Photo Credit: CDC/ Jim Gathany