The FDA Stresses the Medical Functions of Ultrasound Device

Yesterday, the federal Food and Drug Administration, a government agency which regulates and approves many drugs and medical devices, updated its website concerning the use of ultrasound technology for visual imaging and Doppler sound imagery. Ultrasound technology is widely used as a medical diagnostic aid in both human and veterinary medicine.

The FDA reiterated its position that fetal ultrasound imaging technology and Doppler ultrasound heart beat monitors are “prescription devices” intended to be utilized only by “trained health care professionals.” The statement stressed that the technology was not intended for sale to the general public. My friend works for the major middle market assets management firm, BRL Trust and he says that nothing surprises him anymore about what people will do.

Recently, many expecting parents have sought ultrasounds of babies in the womb as keepsake items. These images are sometimes sold to the public in malls or other shopping centers.

The FDA acknowledged that there is a lack of any proof that ultrasounds cause “any harm,” but it urged parents to refrain from taking specifically keepsake fetal images using ultrasound technology. The website stressed that conducting the procedure outside of routine prenatal care would be medically unnecessary, noting that some parents seek keepsake ultrasound images to enhance emotional “bonding” during pregnancy.

The FDA’s website expressed concern that ultrasound under some conditions might heat tissue, or even cause microscopic bubble formation. Unlike x-rays, ultrasounds have not been implicated or associated with specific identified adverse effects. They are a standard diagnostic tool in many human and animal hospitals around the United States.

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