The US Food and Drug Administration (FDA), in response to an increasing incidence of non-medical commercial use of ultrasonic imaging in the USA during pregnancy, has expressed concerns about this use of the technology and have issued the following warning: “Ultrasound imaging is the most widely used medical imaging method during pregnancy providing real-time images of the fetus. Doppler fetal ultrasound heartbeat monitors are hand-held ultrasound devices that let you listen to the heartbeat of the fetus. Both are prescription devices designed to be used by trained health care professionals. They are not intended for over-the-counter (OTC) sale or use, and the FDA strongly discourages their use for creating fetal keepsake images and videos.”

An article in the January 3, 2015 issue of the Lancet provides the following summary of concerns expressed in the FDA warning against the use of ultrasound scans outside health settings  While ultrasound imaging in pregnancy, which uses high-frequency sound waves to view the fetus, has been used in health-care settings in the USA and other countries for decades with an excellent safety record, the advisory notes that: “Several US companies now offer fetal keepsake images and videos using ultrasound. In some cases, the ultrasound machine might be used for as long as an hour to video the fetus. Several sessions might also take place, amplifying the number of scans a woman normally has during a healthy pregnancy. As well as ultrasound scans, the FDA also warns against use of over-the-counter Doppler ultrasound heartbeat monitors, noting that although there is a lack of evidence of any harm, “prudent use of these devices by trained health care providers is important.

Ultrasound imaging introduces energy into the body. Laboratory studies have shown that diagnostic levels of ultrasound can produce physical effects in tissue, such as pressure oscillations and rises in temperature. In some cases, it can create small pockets of gas in bodily fluids or tissues. The long-term consequence of these effects are unknown, but on the basis of what is known, the FDA have recommended that health-care providers minimize exposure to ultrasound while maintaining diagnostic quality. The warning about commercial use of ultrasound is therefore understandable and welcome.”

The article notes that, “in addition to potential biological effects, commercial ultrasound might cause unnecessary anxiety for the consumer if images, videos, or monitor readings are misinterpreted by them or an untrained provider. Similar concerns exist about other medical services that are being used outside clinical settings, such as memento MRI scans and personal whole genome sequencing” and offers the opinion that “the increasing commercialisation of health technologies is a trend all medical regulatory agencies need to be vigilant about.”