FDA warns against inappropriate use of fetal ultrasound imaging and heartbeat monitoring

Courtesy of Wolfgang Moroder

The FDA issued a warning against unnecessary and excessive fetal ultrasound imaging and heartbeat monitoring using Doppler heartbeat monitors, advising women not to receive or perform the procedures at home or for nonmedical reasons.

"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," said FDA biomedical engineer Shahram Vaezy in the warning to consumers. "Ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles (cavitation) in some tissues."

An example of misuse of ultrasound imaging is fetal keepsake videos, especially those in which the ultrasound is machine used for as long as one hour, the agency said.

"Proper use of ultrasound equipment pursuant to a prescription ensures that pregnant women will receive professional care that contributes to their health and to the health of their babies," Veazy said.

The advent of cheap and portable ultrasound systems can save lives, especially in poor countries, but also raises the probability of inappropriate use at home by the untrained.

Similarly, the FDA warned against over-the-counter use of Doppler ultrasound heartbeat monitors to listen to unborn babies' heartbeat, pointing out that legally they are supposed to be marketed as "prescription devices."

Is a crackdown on websites like Heartbeats At Home and bellybeats.com, which "makes it possible for you to hear the fetal heart beat anytime you want to" by offering the device on rental, in the cards? Meanwhile, BellaBeat, which makes "nature-inspired pregnancy tracking devices to help moms-to-be to connect with their babies," sells a heartbeat monitor for moms-to-be but says it is safe because it does not use ultrasound waves. On its website, the heavily VC-backed company claims the monitor does not require FDA approval.

The risk posed by inappropriate use of both devices has been known for some time. In 2009, The New York Times ran a blog about a pregnant woman who did not go to the hospital when she suspected something was wrong with her unborn child because she heard its heartbeat using a fetal heart monitor. A couple of days later the ultrasound scan determined that the fetus was dead.

- read the warning from FDA
- here's The New York Times blog

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