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Thursday, December 01, 2005

Society of Diagnostic Medical Sonography Concerned About Tom Cruise's Use of 'Sonogram Machine'

Society of Diagnostic Medical Sonography Concerned About Tom Cruise's Use of 'Sonogram Machine'

PLANO, Texas, Dec. 1 /PRNewswire/ -- The Society of Diagnostic Medical Sonography (SDMS) has raised concerns about press reports that actors Tom Cruise and Katie Holmes have purchased an ultrasound machine and will do their own sonograms. While Cruise's offer to donate the machine to a hospital after the baby is born is laudable, the Society is concerned about the safety of Cruise's decision to purchase a medical device and perform a medical diagnostic procedure without appropriate training.

Diagnostic medical sonographers complete educational programs and take national certification examinations to ensure they can perform sonograms safely and in a manner that obtains accurate results. "Sonography is a difficult skill requiring knowledge, hand/eye coordination, and pattern recognition. Reading the manufacturer's manual or having a one hour orientation is not sufficient," said the SDMS' Executive Director, Donald F. Haydon, CAE.

According to a letter issued by the Food and Drug Administration to the SDMS in 1994, "From a medical standpoint, ultrasonic fetal scanning is generally considered safe, and should be used without hesitation when clinical benefit is expected. But ultrasound energy delivered to the fetus cannot be regarded as innocuous. Viewed in this light, exposing the fetus to ultrasound with no anticipation of medical benefit is not justified. Thus, we believe that these prenatal entertainment videos should not be performed. Persons who promote, sell or lease ultrasound equipment for making "keepsake" fetal videos should know that we view this as an unapproved use of a medical device, and that we are prepared to take regulatory action against those who engage in such misuse of medical equipment."

Jean Spitz, MPH, RDMS, President of the SDMS and a professor at the University of Oklahoma's Health Sciences Center stated, "We have been working to convince the Food and Drug Administration to stop the proliferation of 'entertainment' use of ultrasound. Unfortunately, the FDA has failed to take action despite many concerns directed to the agency."

Spitz added, "The problem is compounded by the lack of any national requirement for the person holding the transducer during a sonogram to be certified or registered." While more than 45,000 sonographers have been registered through the American Registry of Diagnostic Medical Sonography, there is no guarantee that the person performing the sonogram has been registered and is knowledgeable or skilled in the diagnostic procedures being performed. Spitz recommends patients ask their sonographer if they are registered prior to the start of the sonogram.

Last year in California, State Assemblyman Leland Yee of San Francisco led a successful effort to require sonographers to be nationally registered if performing fetal sonograms. The bill was passed but only applied to Medicaid patients receiving a sonogram in California. A similar effort is currently underway in Massachusetts that would require nationally registered sonographers for all Medicaid patients receiving a sonogram in Massachusetts.

Registered sonographers practice procedures that use "as little as reasonably achievable" energy (also known as ALARA standards) to ensure the fetus is not exposed to high levels of ultrasound energy for significant periods of time during normal sonograms. "In the hands of a registered sonographer, a sonogram is safe. In the hands of an actor pretending to be a sonographer, there could be risk to the fetus," said Ms. Spitz. "Hopefully Mr. Cruise will recognize that his performing the sonograms is not in the best interest of his unborn child and will let a registered sonographer conduct all future sonograms under the supervision of a physician in a qualified medical setting," added Ms. Spitz.

The complete SDMS policy on non-diagnostic use of ultrasound and links to additional Food and Drug Administration information may be found at: http://www.sdms.org/positions/nondiagnostic.asp

The Society of Diagnostic Medical Sonography is a professional membership organization founded in 1970 to promote, advance, and educate its members and the medical community in the science of diagnostic medical sonography. The SDMS, with over 17,500 members, is the largest association of sonographers and sonography students in the world.

Source: The Society of Diagnostic Medical Sonography

CONTACT: Jean Lea Spitz MPH, RDMS, FSDMS, Professor, College of Allied
Health, University of Oklahoma Health Sciences Center, +1-405-271-6477 ext.
41161, cell: +1-405-590-4681, jspitz@sdms.org, for SDMS

Web site: http://www.sdms.org/positions/nondiagnostic.asp

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