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

29 Nov, 2005, 00:00 ET from American College of Radiology

    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.
 
 

SOURCE American College of Radiology
    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.
 
 SOURCE  American College of Radiology