Tom Cruise Ultrasound Bill should ban keep-sake scans, says ACR
25 May 2006 Reston, Virginia, USA. The announcement last year by Tom
Cruise that he had bought an ultrasound scanner to observe his unborn child
is still making waves in the medical and legislative community. Tom Cruise
and fiancée Katie Holmes have been widely criticised for potentially putting
the foetus at risk. At the time
Carol M. Rumack, MD, FACR, Chair of the ACR Ultrasound Commission said, "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." With
the passing of new legislation in California, the American College of
Radiology (ACR) has announced that it 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. In addition, it urges the California Senate to include the
prohibition of sale to foetal 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. The FDA consumer advice on
keepsake ultrasound states: "...ultrasound energy delivered to the fetus
cannot be regarded as 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. Although there is no
evidence that these physical effects can harm the fetus, public health
experts, clinicians and industry agree that casual exposure to ultrasound,
especially during pregnancy, should be avoided. Viewed in this light,
exposing the foetus to ultrasound with no anticipation of medical benefit is
not justified." "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 foetal keepsake
studios." The FDA has previously stated, "Persons who promote, sell or
lease ultrasound equipment for making 'keepsake' foetal 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 fiancé 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 early in
May. However, the bill, in its present form would reportedly not include a
ban on the sale of ultrasound equipment to foetal 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 foetus to ultrasound with no anticipation
of medical benefit is not justified." Please visit
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
www.acr.org/ or
www.radiologyinfo.org/
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