The FDA is aware of several enterprises in the U.S. that are commercializing ultrasonic imaging of fetuses by making “keepsake” videos. In some cases, the ultrasound machine may be used for as long as an hour to get a video of the fetus. We are concerned about this misuse of diagnostic ultrasound equipment.
Ultrasound is a form of energy used for many purposes in industry and medicine. Obstetricians routinely use ultrasound imaging to check the size, location, number or age of fetuses in the womb, the presence of some types of birth defects, and fetal movement, breathing and heartbeat. At somewhat higher exposure levels, given daily for weeks at a time, ultrasound is used to speed the healing of bone fractures. At much higher exposure levels, ultrasound produces a heating effect in tissue which is useful in treating sprains and pulled muscles.
From a medical standpoint, ultrasonic fetal scanning is generally considered safe and is properly used when medical information on a pregnancy is needed. But ultrasound energy delivered to the fetus cannot be regarded as completely innocuous. Laboratory studies have shown that diagnostic levels of ultrasound can produce physical effects in tissue, such as mechanical vibrations and rise in temperature. Although there is no evidence that these physical effects can harm the fetus, public health experts, clinicians and industry agree that casual exposure to ultrasound, especially during pregnancy, should be avoided. Viewed in this light, exposing the fetus to ultrasound with no anticipation of medical benefit is not justified. For additional information about the “prudent use” of diagnostic ultrasound, see the statement from the American Institute of Ultrasound in Medicine (AIUM).
Persons who promote, sell or lease ultrasound equipment for making “keepsake” fetal videos should know that FDA views this as an unapproved use of a medical device. In addition, those who subject individuals to ultrasound exposure using a diagnostic ultrasound device (a prescription device) without a physician’s order may be in violation of State or local laws or regulations regarding use of a prescription medical device.
FDA notified the medical community and the ultrasound industry in August 1994 regarding its concerns about the misuse of diagnostic ultrasound equipment for non-medical purposes, and asked them to discourage their patients from having sonograms for non-medical reasons.
Key point: FDA alert about non-medical ultrasound videos cites possible physical effects.
FDA Medical Devices Safety Alert, updated May 2011
Fetal Keepsake Videos
(http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm064756.htm)
The FDA is aware of several enterprises in the U.S. that are commercializing ultrasonic imaging of fetuses by making “keepsake” videos. In some cases, the ultrasound machine may be used for as long as an hour to get a video of the fetus. We are concerned about this misuse of diagnostic ultrasound equipment.
Ultrasound is a form of energy used for many purposes in industry and medicine. Obstetricians routinely use ultrasound imaging to check the size, location, number or age of fetuses in the womb, the presence of some types of birth defects, and fetal movement, breathing and heartbeat. At somewhat higher exposure levels, given daily for weeks at a time, ultrasound is used to speed the healing of bone fractures. At much higher exposure levels, ultrasound produces a heating effect in tissue which is useful in treating sprains and pulled muscles.
From a medical standpoint, ultrasonic fetal scanning is generally considered safe and is properly used when medical information on a pregnancy is needed. But ultrasound energy delivered to the fetus cannot be regarded as completely innocuous. Laboratory studies have shown that diagnostic levels of ultrasound can produce physical effects in tissue, such as mechanical vibrations and rise in temperature. Although there is no evidence that these physical effects can harm the fetus, public health experts, clinicians and industry agree that casual exposure to ultrasound, especially during pregnancy, should be avoided. Viewed in this light, exposing the fetus to ultrasound with no anticipation of medical benefit is not justified. For additional information about the “prudent use” of diagnostic ultrasound, see the statement from the American Institute of Ultrasound in Medicine (AIUM).
Persons who promote, sell or lease ultrasound equipment for making “keepsake” fetal videos should know that FDA views this as an unapproved use of a medical device. In addition, those who subject individuals to ultrasound exposure using a diagnostic ultrasound device (a prescription device) without a physician’s order may be in violation of State or local laws or regulations regarding use of a prescription medical device.
FDA notified the medical community and the ultrasound industry in August 1994 regarding its concerns about the misuse of diagnostic ultrasound equipment for non-medical purposes, and asked them to discourage their patients from having sonograms for non-medical reasons.