FDA cracks down on use of ultrasound for `keepsake' videos

Prenatal videos are available at shopping malls

The Food and Drug Administration has launched an investigationof small entrepreneurs operating businesses that produce ultrasound"keepsake" videos of fetuses. While the videos may bea cherished memento for expecting families, the FDA maintainsthat the videos have no medical purpose and are a misuse of diagnosticultrasound equipment.

The keepsake ultrasound market is minuscule when compared tothe diagnostic ultrasound business, but it is a growing cottageindustry. Small local newspapers and magazines frequently carryads promoting keepsake ultrasound directly to consumers, manyof whom are not aware that the ultrasound energy delivered tofetuses is not considered totally harmless by the FDA.

According to Byron Tart of the FDA's Office of Compliance,many keepsake ultrasound businesses are run by radiologists ortechnologists, but some are located in such clinically dubioussites as shopping malls. Other operations boast of "on-sitevisits" in which the ultrasound equipment is transportedvia mobile van to the expecting mother's home, where the examis conducted in private.

According to Tart, the videos range in duration from 30 minutesto an hour, and are provided to expecting families at a cost ofabout $100. Parents are primarily interested in the shape andsize of the fetus, as well as its movement in the womb.

Ultrasound has an exemplary safety record and is generallyconsidered one of the least invasive medical imaging modalities,with no known side-effects. To the FDA, however, any use of medicalimaging when not clinically indicated represents an unnecessaryrisk to patients.

FDA offices around the country have received numerous complaintsfrom physicians and other health-care practitioners regardingkeepsake ultrasound videos, according to Tart. The FDA regardsthe practice as an off-label use of the modality and is readyto take aggressive action to nip the problem in the bud, he said.

In a letter from the FDA to associations such as the AmericanAcademy of Family Physicians and the Academy of Pediatrics, theagency has asked for assistance in reporting keepsake ultrasoundbusinesses to the Office of Compliance.

In a sign of its resolve, the FDA embargoed equipment at twoTexas operations, Peek-a-Boo Inc. and Baby Images, according tothe American Institute of Ultrasound in Medicine. The agency maybegin seizing scanners in other states as well. State health officialsin Texas, California, New York and Kentucky are also conductinginvestigations, the AIUM reported.

The use of routine ultrasound when not clinically indicatedwas criticized last year by the Routine Antenatal Diagnostic Imagingwith Ultrasound (RADIUS) study in the Sept. 16, 1993, editionof the New England Journal of Medicine (SCAN 9/16/93). The studyimplied that excessive routine screening of pregnant women byphysicians for ob/gyn purposes could cost the U.S. more than $1billion a year. Clinicians and ultrasound vendors pointed outat the time that routine scanning when not clinically indicatedhas never been accepted by the medical community.

The FDA emphasized that its crackdown on keepsake ultrasoundbusinesses is a completely separate issue from the kind of physician-prescribedultrasound described in the RADIUS study. As such, the agency'sscrutiny will probably have a minimal impact on ultrasound salesand overall procedure volume.