The Food and Drug Administration (FDA) is warning consumers that fetal ultrasound imaging and Doppler fetal ultrasound heartbeat monitors are prescription devices designed to be used by trained healthcare professionals and are not intended for over-the-counter (OTC) sale or use for creating fetal keepsake images and videos.
Because the long-term effects of heating and cavitation in tissues due to ultrasound are unknown, ultrasound scans should only be performed by appropriately-trained operators when there is a medical need based on a prescription. Similarly, Doppler ultrasound heartbeat monitors are legally marketed as prescription devices and should only be used by, or under the supervision of, a healthcare professional.
This warning is due to the increasing popularity of fetal keepsake videos produced by several enterprises in the U.S. that are commercializing ultrasonic imaging; in some instances, the ultrasound machine may be used for as long as an hour to capture video of the fetus. In these sessions, 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. This can increase the potential for harm to the fetus and eventually the mother. Proper use of ultrasound equipment by healthcare professionals is pursuant to a prescription.
Although the FDA does acknowledge that fetal imaging can promote bonding between the parents and the fetus, these opportunities are routinely provided during medically-supervised prenatal care.
For more information visit FDA.gov.