FDA Cracks Down on Ultrasound-Video Sales

WASHINGTON —  It was probably inevitable, what with the explosive growth of the video industry: the birth of the “keepsake” ultrasound video. That is, “entertainment” videos of Junior in the womb, carefully edited with music, fancy graphics and even subtitles for showing-and-telling by expectant parents.

But this is one newfangled idea government officials hope to kill. The Food and Drug Administration has reacted to non-medical video companies opening at malls or in private homes with a swift uh-uh. The FDA has sent warning letters to several companies, threatening to seize ultrasound equipment if the practice doesn’t cease. The equipment is used to produce a picture of the fetus, then the images are transferred to a videotape.

Doctors generally use ultrasound to check the size, location, number or age of fetuses in the womb, and to look for some types of birth defects and fetal movement, breathing and heartbeat.

But physicians usually provide less-sophisticated snapshots of the fetus; the commercial companies add music and graphics to the sometimes not-so-zippy shots of the fetus swimming in utero. And while ultrasound exams in doctors’ offices usually take a very short time, the FDA says “entertainment video” companies might take as long as an hour.

“Persons who promote, sell or lease ultrasound equipment for making ‘keepsake’ fetal videos should know that we view this as an unapproved use of a medical device, and that we are prepared to take regulatory action,” the FDA wrote.

Laboratory studies have shown that ultrasound can produce physical effects in tissue such as a rise in temperature and jarring vibrations, says FDA spokeswoman Sharon Snider. “Although there’s no evidence that this can harm the fetus, public health experts agree that casual exposure to ultrasound, especially during pregnancy, should be avoided. Viewed in this light, exposing the fetus to ultrasound when no medical benefit is expected cannot be justified.”

The videos raising concern should not be confused with routine sonograms ordered by a physician, FDA officials stress. Often parents are given a keepsake still photo from these tests.