"Prospective parents may consider fetal ultrasound portraits cute, but
the American Institute of Ultrasound in Medicine sees potential
dangers in the increasingly popular use of the modality.
In a Nov. 5 statement, the AIUM warned physicians and would-be imaging
entrepreneurs that 2D and 3D obstetrical ultrasound should not be used
to view, obtain pictures, or determine gender of a fetus without a
medical prescription. The policy was announced in response to the
proliferation of shopping mall 3D ultrasound services that specialize
in fetal imaging. The announcement reiterated the position the AIUM
first took in 1999.
The institute's main concern is that using ultrasound for
entertainment purposes may have harmful biological repercussions, said
Dr. Alfred B. Kurtz, AIUM president.
The FDA announced this year that anyone administering ultrasound to
healthcare consumers without a medical prescription may be breaking
state or local law regarding the use of a prescription medical device.
Officials of the agency urged physicians, sonographers, and healthcare
consumers to notify the FDA of suspicious operations."
AIUM bars fetal ultrasound for entertainment purposes
http://www.diagnosticimaging.com/magazines/di/newsclips.shtml#A
"The FDA also warns, exposing the fetus to ultrasound with no
anticipation of medical benefit is not justified. It has cautioned
that persons who promote, sell or lease ultrasound equipment for
making keepsake fetal videos should know that the FDA views this as an
unapproved use of a medical device.
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."
Why Sonograms Should Be Performed Only When Medically Indicated
http://www.aium.org/consumer/entertainment/handout.pdf
"Ultrasound images--sonograms--are legitimately used in diagnostic
examinations of internal organs and unborn infants in the womb without
surgery. However, similar to restrictions placed on use of X-ray
machines, the federally approved uses for sonogram equipment are
limited, and do not include nonmedical or recreational applications."
Health Commissioner Warns of Unapproved Uses of Sonogram Devices
http://www.tdh.state.tx.us/news/b_news38.htm
"In 1976, the Medical Device Amendments to the Food, Drug and Cosmetic
Act were added requiring the FDA to regulate all medical devices,
which included diagnostic ultrasound equipment."
[...]
"An ultrasonographer is expected to follow the general principles set
forth by the FDA to reduce the potential for adverse bioeffects. One
must learn to balance the risks and benefits of ultrasound use.
Currently, many manufactured ultrasound devices exceed the allowable
acoustic output for fetal exposure by almost eight-fold when compared
with the FDA standards and therefore the safety responsibility falls
on the individual user.
Ultrasonography is an integral diagnostic device in the field of
obstetrics and gynecology among other specialties of medicine.
Epidemiologically, its safety record has been unblemished, but
historically, the regulation of acoustic output levels has been based
upon the FDA’s 510-k Guide published in 1985. Today, new ultrasound
technology and its applications may not only increase the benefits of
ultrasound but also the potential risks. Therefore, educating the
individual ultrasound users about safety will decrease the potential
for adverse bioeffects."
FDA Recommendations for the Safe Use of Ultrasonography in Obstetrics
http://www.sonocredits.com/article.asp?TestID=2
The relevant regulations are here:
FEDERAL FOOD, DRUG, AND COSMETIC ACT
http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
Also, the FirstLook Fetal Monitor is, according to an OB/GYN
department representative at St. Vincent Mercy Medical Center in
Toledo (OH), not yet in production. She cautioned that the unit would
require testing and approval by the FDA before it could be marketed
and sold. Battelle products won an IDEA award in 2002 for its design,
but it does not appear to be available at this time. I've written to
Battelle for confirmation and information.
--Missy |
