SDMS Position: Non-Diagnostic Use of Ultrasound

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FDA Letter

Ultrasound Equipment Used in Making Prenatal Videos for Entertainment

Department of Public Health & Human Services
Food and Drug Administration
1390 Piccard Drive
Rockville, MD 20850

August 1, 1994

Ms. Laura Logan
Society of Diagnostic Medical Sonography
2745 Dallas Pkwy Ste 350
Plano, TX 75093-8730

Dear Ms. Logan:
The Food and Drug Administration (FDA) has become aware of several enterprises in the U.S. that are commercializing ultrasonic imaging of fetuses by making "keepsake" videos. We are concerned about this misuse of diagnostic ultrasound equipment

From a medical standpoint, ultrasonic fetal scanning is generally considered safe, and should be used without hesitation when clinical benefit is expected. But ultrasound energy delivered to the fetus cannot be regarded as innocuous. Viewed in this light, exposing the fetus to ultrasound with no anticipation of medical benefit is not justified. Thus, we believe that these prenatal entertainment videos should not be performed.

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 against those who engage in such misuse of medical equipment.

FDA is asking for your help in the following ways:

If you have not already done so, please advice your members of the concern about the misuse of diagnostic ultrasound equipment for non-medical purposes, and ask that they discourage their patients from having sonograms for non-medical reasons. Feel free to copy this letter to convey our message to your membership.

Please ask your members (and their patients) to notify FDA if they become aware of an operation of this type in their communities, so that we can take action. This information may be provided in writing to the following:

  Promotion and Advertising Policy Staff
  Office of Compliance
  Center for Devices and Radiological Health, FDA
  2098 Gaither Road
  Rockville, Maryland 20850

Information may also be provided by phoning 301-594-4639, or FAXing 301-594-4609.

Thank you for your assistance in getting this important public health message to maternity patients across the country.

Sincerely yours,

D. Bruce Burlington, M.D.
Director
Center for Devices and
Radiological Health