Ultrasound Keepsake Images : Not a Wise Choice

by Food and Drug Administration (FDA)

(Page 2 of 3)

The History of Fetal Photos

The FDA first learned about keepsake video productions from consumers in Texas in 1994. The Texas Department of Health and the FDA's Dallas district office jointly inspected three firms. The FDA then initiated investigations of similar firms in other parts of the country. Investigators uncovered numerous companies offering a wide variety of ultrasound packages. Among the agency's findings were that ultrasound was being performed by untrained, unlicensed technicians and often without a doctor's supervision.

The FDA wrote about its concerns to 10 health professional organizations and the National Electrical Manufacturers Association, stating that anyone promoting, selling or leasing ultrasound equipment for making keepsake fetal videos could be breaking the law. The agency asked the organizations to have their members discourage patients from having ultrasound procedures for non-medical reasons and to notify the FDA of any keepsake video operations in their communities.

Not a Wise Choice

For every reason a mother-to-be wants a keepsake video, there are good reasons she shouldn't have one. Women cite early bonding with their babies, determining the baby's sex, and a desire to share their prenatal experiences with friends and families as major reasons in favor of the videos. And the quality of images in commercial videos makes them especially tempting. Because many obstetricians still use two-dimensional imaging, which is considered standard in prenatal care, women may seek the more advanced three- and four-dimensional images used by some keepsake businesses, in which the features of an unborn infant are more easily recognizable to the non-professional.

But health experts say these are not medical reasons for having an ultrasound. Lawrence D. Platt, M.D., president-elect of the International Society of Ultrasound in Obstetrics and Gynecology and a practicing obstetrician-gynecologist in Los Angeles, adds that while physicians need to be sensitive to expectant mothers' feelings, "We have to go beyond emotions in this case. We have to do the right thing," he says. "Ultrasound is a form of energy and it must be respected."

Besides concern that unskilled technicians could be performing and interpreting such ultrasounds and that the procedure is not always done under the supervision of a qualified physician, some facilities may be using equipment that's not in good working order.

"Not all ultrasounds are created equal," says Nancy Hueppchen, M.D., a maternal fetal medicine specialist at Johns Hopkins Hospital in Baltimore. "Patients don't know the level of expertise of the person performing the procedure." Hueppchen says there's also the worry about ultrasounds not being conducted in medical settings. "These portrait facilities are not equipped to provide counseling should something go wrong, or proper guidance if a gross abnormality is suspected," she says.

The FDA also notes that some video companies have been known to use the ultrasound machine on higher energy exposures for as long as an hour to get the pictures. The procedure should always be done at the lowest possible energy output and for the least amount of time. Exposure to ultrasound for longer than the time specified by the FDA for fetal monitoring could pose a potential risk to the health of the mother and her developing fetus.

Some companies make it clear that they are not providing diagnostic ultrasounds, but those that don't may wrongly give women the impression that their ultrasound examination will identify problems.

The FDA and the American Institute of Ultrasound in Medicine (AIUM), which also strongly discourages the non-medical use of ultrasound, have concerns that women are being wrongly reassured by commercial sonograms. Women may misinterpret the studio ultrasound as a medical examination, thus giving them a false sense of security. And inaccurate findings may cause them to undergo unnecessary follow-up tests.

"Even in the best of hands," says Hueppchen, "fetal structural problems can be missed due to technical and gestational age limitations, thus falsely reassuring the patient."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.