The U.S. Food and Drug Administration has issued a revised consumer update that "strongly discourages" the use of fetal ultrasound imaging and Doppler fetal ultrasound heartbeat monitors for non-medical reasons, such as "keepsake" videos.
"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," Shahram Vaezy, an FDA biomedical engineer, said in the update. "Ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles [cavitation] in some tissues."
The problem is that the long-term effects of tissue heating and cavitation are unknown; therefore, FDA believes ultrasound scans should only be conducted when there is a medical need, and it's based on a prescription and performed by trained personnel.
Fetal keepsake videos have no medical benefit that is gained by exposing the fetus to ultrasound. Furthermore, according to the update, the FDA is aware of keepsake sessions run by commercial operations that end up exposing the fetus to ultrasound for as long as an hour in order to get a video.
There is no way of controlling how often these keepsake sessions will last, how many will be performed on a single fetus and whether or not the ultrasound systems are being operated properly, the update states. Therefore, according to Veazy, "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."
The issue of "keepsake" ultrasound imaging has become more controversial as more and more nonmedical ultrasound centers pop. Earlier this year, two Canadian medical associations--the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the Canadian Association of Radiologists (CAR)--issued a joint policy statement in the Journal of Obstetrics and Gynaecology Canada opposing the nonmedical use of fetal ultrasound.
To learn more:
- see the consumer update from FDA
- see the policy statement from the two Canadian associations