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ACR: Tom Cruise's Reported Unsupervised Use of Fetal Keepsake Ultrasound Raises Risk for Baby and Is Potentially Illegal

Posted on: Tuesday, 29 November 2005, 18:00 CST

RESTON, Va., Nov. 29 /PRNewswire/ -- Actors Tom Cruise and Katie Holmes may be placing their unborn child at risk if they are performing fetal ultrasound on Ms. 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 American College of Radiology (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, FACR, 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," said Dr. Rumack.

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."

"The ACR is concerned that Tom Cruise has been badly advised regarding the use and potential abuse of ultrasound. There are many abnormalities that may be missed by the untrained eye. Also, if it is not medically necessary, the use of ultrasound raises unnecessary physical risk to the fetus," said Dr. Rumack.

The FDA has also stated, "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."

"It is disconcerting that a company would sell a medical device to a person not qualified in any way to perform or interpret ultrasound. In medicine, our basic rule has been 'first, do no harm.' No medical procedure is performed or drug given without weighing the risk and the benefit to the patient. If there is no medical supervision for this process, I see no benefit to the patient, which in this case, is Mr. Cruise's unborn child," said Dr. Rumack.

Please visit http://www.acr.org/dyna/?doc=media/index.html to read the ACR position statement on Fetal Keepsake Ultrasound Videos.

Please visit http://www.fda.gov/cdrh/consumer/fetalvideos.html to read the FDA statement on fetal keepsake ultrasound videos.

American College of Radiology

CONTACT: Shawn Farley, Public Relations Manager of American College ofRadiology, +1-703-648-8936, shawnf@acr.org

Web site: http://www.acr.org/http://www.fda.gov/cdrh/consumer/fetalvideos.html

Source: PRNewswire

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