Healthcare Industry News: PSA
News Release - May 5, 2006
ACR: California Legislature Should Ban Sale of Ultrasound Equipment to Fetal Keepsake Studios as Part of 'Tom Cruise Ultrasound Bill'
Ultrasound Equipment a Medical Device to Be Used by Trained Medical PersonnelRESTON, Va., May 5 (HSMN NewsFeed) -- The American College of Radiology (ACR) applauds the California Assembly for passing AB2360, the "Tom Cruise law," which would prohibit the sale of diagnostic ultrasound equipment to anyone but appropriately licensed health care providers, but urges the California Senate to include the prohibition of sale to fetal keePSAke studios (facilities which provide sonogram videos to parents for entertainment only) in the legislation.
"This bill is an important first step in protecting parents, perhaps unaware of potentially harmful effects of misuse of ultrasound technology, from placing their unborn children at risk," said James P. Borgstede, MD, FACR, chair of the American College of Radiology Board of Chancellors. "However, the legislation should include a ban on the sale of ultrasound equipment to fetal keePSAke studios, as they most often lack onsite physician supervision, the tests are almost always not the result of a physician prescription, and may cause parents to mistakenly believe that they do not need appropriate medical attention."
The ACR fully supports the views of the US Food and Drug Administration (FDA) that fetal ultrasound be performed only for medical purposes, by certified technologists, with a prescription from an appropriately licensed provider.
"Ultrasound images can allow doctors to diagnose potential problems prior to birth. 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 Borgstede. This process reportedly was not followed during the pregnancy of Mr. Cruise's fiance, Katie Holmes, and most often is not observed in fetal keePSAke studios."
The FDA has previously 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."
Actor Tom Cruise commented publicly that he bought ultrasound equipment and performed exams on his fiance Katie Holmes, who recently gave birth to the couple's first child. AB2360 was introduced following these media reports and subsequent concerns raised by the ACR and overwhelmingly passed the California state assembly by a 55-7 vote Thursday. However, the bill, in its present form would reportedly not include a ban on the sale of ultrasound equipment to fetal keePSAke studios.
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."
Please visit http://www.fda.gov/cdrh/consumer/fetalvideos.html to read the FDA statement on fetal keePSAke ultrasound videos.
For more information on ultrasound (sonography), please visit http://www.acr.org or http://www.radiologyinfo.org
Source: American College of Radiology
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