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FDA Warning on Over-the-Counter Ultrasound

Bonnie Harp2 years ago

According to MassDevice, the U.S. Food and Drug Administration (FDA) is warning consumers to be cautious of over-the-counter (OTC) fetal ultrasound imaging and fetal heartbeat monitors due to health risks posed by these devices.

About the OTC Heartbeat Monitor/Ultrasound Imaging Warning

The FDA has issued a warning against over-the-counter fetal heartbeat monitors and ultrasound imaging in order to discourage expecting parents from using the unregulated devices.

The Food and Drug Administration is concerned for the health of the fetus and expecting mothers when said devices are operated by anyone other than untrained medical professionals. The fetal ultrasound imaging is heat activated, posing a health risk of cavitation of tissues.

Furthermore, The FDA suggests that expecting mothers only receive ultrasounds as prescribed. These should be conducted by a trained medical professional. It is imperative that when conducting said medical equipment that both session-length and amount of sessions is controlled. Unregulated over-the-counter fetal ultrasound imaging and heartbeat monitoring are not monitored or controlled.

There is no evidence that over-the-counter fetal ultrasounds and heartbeat monitors have caused harm to consumers. However, there are no proven medical benefits either, leading the FDA’s suggestion that expecting mothers only receive these services by clinically trained healthcare professionals. 


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