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AIUM supports FDA decision to deny over-the-counter use of handheld doppler fetoscopes

The American Institute of Ultrasound in Medicine (AIUM) supports the decision of the US Food and Drug Administration (FDA) to deny a request that would permit over-the-counter (OTC) sales of certain handheld Doppler ultrasound fetal listening devices, also referred to as Doppler "fetoscopes."

The FDA conducted a public meeting on March 29, 2006, to discuss the issue in response to a petition for OTC use filed in June 2004. Representatives from the AIUM attended the session and provided both their input and opposition to the petition. AIUM President Lennard Greenbaum, MD, stated that 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." AIUM Bioeffects Committee Chair Jacques Abramowicz, MD, and AIUM President-Elect Joshua Copel, MD, presented the AIUM's scientific findings, concluding that caution should be exercised in using these devices, emphasizing adherence to the ALARA or "as low as reasonably achievable" principle. In addition, they thought there was no clear benefit to the consumer from OTC availability of handheld fetal Doppler devices.

Doppler fetoscopes are currently available by prescription for home use, usually in cases involving high-risk pregnancies. 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."


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Contact: Jennifer Hilderbrand
jhilderbrand@aium.org
301-498-4100
American Institute of Ultrasound in Medicine
20-Oct-2006


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