Ultrasound Keepsake Images : Not a Wise Choice, Part 2

by Food and Drug Administration (FDA)

(Page 3 of 3)

Understanding the Laws

Ultrasound is conducted with a prescription medical device that is regulated by the FDA. The agency sets the standard for the level of energy to be used for various treatments or diagnoses, including fetal ultrasounds. This standard restricts ultrasound exposure to levels that produce few, if any, effects on the fetus, based on epidemiological evidence.

The FDA can take action against the keepsake industry in two ways: for promoting a device for other than its approved use, and for using a prescription device without a prescription from a medical professional. By promoting and advertising keepsake videos, the advertiser is creating a new intended use for the device, and this requires premarket review by the FDA. And many keepsake facilities do not appear to be requiring doctors' prescriptions from their customers.

Kimber C. Richter, M.D., a deputy director in the FDA's Office of Compliance, says that regulation of the commercial ultrasonic imaging of fetuses is complicated because each video company scenario is different.

"In some cases, there may be no prescription and no physician oversight," she says. "In others, there may be a physician involved but no clear doctor-patient relationship." And in still others, "the video might be made through an extra visit to the physician that the patient normally sees." Richter says the regulatory approach in all these cases varies. "FDA regulates devices, but the qualifications and behavior of technicians and physicians would be regulated by the states," Richter says.

The FDA announced in 2002 that anyone administering ultrasound to consumers without a medical prescription is breaking the law. "In the past," says Richter, "the FDA has taken regulatory action, such as a warning letter or even seizure, when these devices were used for entertainment purposes without a prescription."

Margaret T. Tolbert, deputy director of the FDA's Division of Device User Programs and Systems Analysis, says the agency is updating its current Web statement warning consumers about the unknowns of using ultrasound equipment for entertainment purposes and is developing a set of questions and answers to educate those considering keepsake videos as a business opportunity.

Since a number of advertising examples recently have come to the FDA's attention — suggesting an increase in entertainment ultrasounds — the FDA is currently taking a closer look at these businesses. "We are reviewing these cases and will consider regulatory action as appropriate," says Richter.

The Bottom Line

The prescription status of ultrasound equipment ensures that pregnant women will receive professional care that contributes to their health and to the health of their babies. Performing prenatal ultrasounds without following state and federal guidelines puts a mother and her unborn baby at risk. Therefore, the procedure should only be used to provide medical benefit. Besides being inappropriate and contrary to responsible medical practice, the bottom line is: Why take a chance with your baby's health for the sake of a video?

Legitimate Uses for Ultrasound Imaging

• Diagnosing pregnancy
• Determining fetal age
• Diagnosing congenital abnormalities
• Evaluating position of placenta
• Determining multiple pregnancies

Official Statements on Ultrasonic Fetal Imaging

Food and Drug Administration

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.

American Institute of Ultrasound in Medicine (AIUM)

The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes. The use of either two-dimensional (2D) or three-dimensional (3D) ultrasound to only view the fetus, obtain a picture of the fetus or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice. Although there are no confirmed biological effects on patients caused by exposures from present diagnostic ultrasound instruments, the possibility exists that such biological effects may be identified in the future. Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient.

European Committee for Medical Ultrasound

The embryonic period is known to be particularly sensitive to any external influences. Until further scientific information is available, investigations should be carried out with careful control of output levels and exposure times. With increasing mineralization of the fetal bone as the fetus develops, the possibility of heating fetal bone increases. The user should prudently limit exposure of critical structures such as the fetal skull or spine during Doppler studies (a type of ultrasound that detects movement, direction and speed, such as fetal heartbeat).

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.