A bill introduced in the California state legislature would prohibit a manufacturer or other person in the state from selling ultrasound equipment to anyone other than a licensed physician or medical facility. A violation of this provision would be a misdemeanor.

The measure (Assembly Bill No. 2360) may be debated in committee as early as March 26. Specifically, the bill "would prohibit a manufacturer or other person in California from selling, leasing, or otherwise distributing in this state an ultrasound diagnostic imaging machine to any person other than a licensed physician or surgeon, or a licensed medical facility..."

It stems from a high profile case in which actors Tom Cruise and Katie Holmes made public that they had bought an ultra sound machine to view their unborn child.

"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, chair of the ACR Ultrasound Commission.

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 Rumack.

At the same time, the FDA is holding a public workshop to discuss whether hand-held Doppler ultrasound prenatal listening devices should be made available for use over-the-counter. The public workshop will be held on Wednesday, March 29, 2006. The deadline for registration is Friday, March 10, 2006. Requests to make presentations at the public workshop and written or electronic comments will be accepted until Friday, March 10, 2006.