ACR: Tom Cruise's Unsupervised Use of Fetal Keepsake Ultrasound Ill Advised, Irresponsible, and Potentially Dangerous18 April 2006
Actor Tom Cruise's claim to be qualified to perform unsupervised ultrasound exams on his fiance, Katie Holmes, because he "read the manual" that came with the machine is irresponsible, potentially dangerous, and due to his celebrity status, may incorrectly influence others to place their unborn children at risk by performing such exams with no medical supervision.
"Radiologist physicians, certain other doctors, and ultrasound technologists receive years of specialized education and training in order to safely and effectively perform these exams. Others should not think that unsupervised use of medical equipment is completely safe and should, under no circumstances, view fetal keepsake videos as a substitute for appropriate medical attention or emulate Mr. Cruise's reported unsupervised use of ultrasound equipment," said James P. Borgstede, MD, FACR, chair of the American College of Radiology Board of Chancellors.
Untrained individuals, 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 that are not to be used without a medical indication.
Accordingly, the ACR and the California Radiological Society support efforts such as (CA) Assembly Bill 2360 (AB 2360), in its current form, recently introduced into the California legislature, which would ban companies from providing ultrasound equipment to unlicensed, untrained individuals.
The US Food and Drug Administration (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."
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," said ACR Chair Borgstede.
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 American College of Radiology fully supports the FDA views that fetal ultrasound be performed only for medical purposes, by certified technologists, with a prescription from an appropriately licensed provider.
"Fetal images are an opportunity to diagnose problems prior to 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 be interpreted by properly trained physicians and the results discussed with the parents and treating physicians in order to plan for the best care of the baby and mother," said ACR Chair Borgstede. "Mr. Cruise has not indicated that his ultrasound equipment has been used in this manner."
Please visit http://www.leginfo.ca.gov/pub/bill/asm/ab_2351- 2400/ab_2360_bill_20060327_amended_asm.html to read California Assembly bill, AB 2360.
Please visit http://www.acr.org/s_acr/doc.asp?CID=2192&DID=16912 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: prnewswire
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