FDA tightens grip on handheld ultrasound

The FDA has denied a request for over-the-counter sales of handheld Doppler fetoscopes. The American College of Radiology and the American Institute of Ultrasound in Medicine, which have aggressively lobbied to stop unwarranted use of ultrasound technology by nonmedical personnel, hailed the decision.

"This is great news," said Dr. Carol Rumack, head of the ACR's ultrasound commission. "The concern we had is that patients should understand that ultrasound is very useful, but it needs to be done only when medically necessary. People have to avoid its use for entertainment purposes."

The FDA's move comes on the heels of a study published by Yale University researchers that found that exposing pregnant mice to high-frequency ultrasound for 30 minutes or more could result in brain damage to their fetuses, Rumack said.

"We need to restrict ultrasound like any other medical test to avoid putting people at risk," she said.

The FDA held a public meeting in March to discuss whether low-output ultrasound-based listening devices fit a request to make them available for over-the-counter sales. Dr. Russel J. Thomsen, an ob/gyn physician from Silverdale, WA, filed the citizen petition in July 2002. Thomsen cited technical, clinical, and constitutional grounds to put in the hands of every woman a device that "might save the life of their unborn babies."

ACR and AIUM representatives testified at this hearing against the petition.

"The AIUM strongly discourages the nonmedical use of ultrasound, and although there are no confirmed biological effects on patients caused by exposure from present diagnostic ultrasound incidents, the possibility exists that such biological effects may be identified in the future," said AIUM president Dr. Lennard Greenbaum.

Dr. Jacques Abramowicz and Dr. Joshua Copel, AIUM's bioeffects committee chair and president-elect, respectively, presented at the hearing scientific data suggesting that caution should be exercised in using these devices. They also testified that putting these devices for sale over the counter had no clear benefit to consumers.

Doppler fetoscopes, intended to detect and monitor fetal heart rates, are currently available to pregnant women by prescription only for home use, usually in cases involving high-risk pregnancies. Brand names include products such as Baby Beat, BabyCom, and Hi Bebe BT200.

In its letter declining the petition, the FDA stated its belief that "the available scientific literature and the consensus of the scientific community substantiate the current regulatory status of these devices, which provides access for home use when the mother and her physician decide such monitoring is indicated."

For more information from the Diagnostic Imaging archives:

Study rings alarm bell on ultrasound exposure risks

California ultrasound legislation implements Cruise control

AIUM toughens policy on keepsake ultrasound

Keepsake ultrasound entrepreneurs target parents in Europe