Warning Issued Against Unsupervised Use of Handheld Fetal Ultrasound Devices

The US Food and Drug Administration have issued a public safety notice about unsupervised use of handheld fetal ultrasound imaging devices and Doppler fetal ultrasound heartbeat monitors.

The FDA (Silver Spring, MD USA) recommends that ultrasound scans be performed by prescription only and carried out only by appropriately trained operators.

Hand-held fetal ultrasound imaging devices create real-time images of the fetus, while Doppler fetal ultrasound heartbeat monitors let parents listen to the heartbeat of their fetus. The FDA discourages parents form using these devices for creating home videos and keepsake images.

Both are prescription devices in the United States and not intended for over-the-counter (OTC) sale, however some manufacturers are beginning to commercialize the devices and their use without professional supervision could lead to overuse and excessively long imaging sessions of up to one hour for one fetal video. The long-term effects of tissue heating and cavitation from long-term exposure to ultrasound imaging are not known.

The FDA recommends that the devices be operated only with professional supervision to ensure the health of pregnant mothers and their babies. FDA biomedical engineer Shahram Vaezy, PhD, said, "Although there is a lack of evidence of any harm due to ultrasound imaging and heartbeat monitors, prudent use of these devices by trained healthcare providers is important. Ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles (cavitation) in some tissues."

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US Food and Drug Administration