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Movie Star Use of Medical Device Opposed by ACR

by Barbara Kram, Editor | December 05, 2005
RESTON, Va - Actors Tom Cruise and Katie Holmes may be placing their unborn child at risk if they are performing fetal ultrasound on Holmes with no medical supervision and, if so, should not, in any way, view their fetal keepsake ultrasound images as a substitute for appropriate medical attention. Use of such medical equipment by unlicensed individuals may also be a violation of federal law.

The ACR fully supports the views of the US Food and Drug Administration that fetal ultrasound be performed only for medical purposes, by certified technologists, with a prescription from an appropriately licensed provider.

"This is a patient safety issue. Untrained people, even if they have the financial means, should not buy, or be allowed to buy and operate, ultrasound machines which are, in fact, medical devices and should not be used without a medical indication," said Carol M. Rumack, MD, chair of the ACR Ultrasound Commission. "Images of the fetus are an opportunity to diagnose problems before birth that may require treatment. These images should be obtained by certified technologists under the supervision of physicians properly trained in ultrasound. The images should then be interpreted by properly trained physicians and discussed with the parents and treating physicians in order to plan for the best care of the baby and mother."
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Ultrasound imaging, also known as ultrasound scanning or sonography, is a method of obtaining images from inside the human body through the use of high frequency sound waves. The sound waves' echoes are recorded and displayed as a real-time, visual image.

Ultrasound is generally considered safe when used by properly trained providers for medical purposes. Physicians routinely use ultrasound imaging to check the size, location, number or age of fetuses in the womb; the presence of some types of birth defects; fetal movement; breathing; and heartbeat. However, ultrasound should not be considered completely innocuous. Laboratory studies have shown that diagnostic levels of ultrasound can produce physical effects in tissue, such as mechanical vibrations and rise in temperature, particularly when used for a prolonged period of time.

The FDA stated on August 30, 2005, that "public health experts, clinicians and industry agree that casual exposure to ultrasound, especially during pregnancy, should be avoided. Viewed in this light, exposing the fetus to ultrasound with no anticipation of medical benefit is not justified."