Tom Cruise
Ultrasound Bill should ban keepsake
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."
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"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.
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For more
information on ultrasound (sonography), please visit
www.acr.org/
or
www.radiologyinfo.org/
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