This is What the FDA Says About Ultrasounds

The Food and Drug Administration (FDA) helps to govern and promote public health through a variety of regulations and controls, and ultrasound scans fall directly under their purview. It’s no surprise that the FDA has quite a lot to say on the subject.

Below, we present the FDA information most important to patients planning an ultrasound scan. This will give you a better idea of just how important a role the government plays in the safety of these devices, and by extension, the safety of each and every patient who undergoes diagnostic imaging.

The FDA’s Technical Description of an Ultrasound

Ultrasound scans use high-frequency sound waves create an image of the inside of the human body in real time. Compare this to other imaging procedures, such as an MRI, which creates images to be viewed later. Unlike an X-ray, the ultrasound does not expose patients to any ionizing radiation. Instead, it uses reflections of sound waves off of body structures to provide an image. Technicians accomplish this task with a non-invasive probe and a small coating of gel on the skin.

Benefits of Ultrasounds, According to the FDA

The FDA points to lots of uses and benefits associated with ultrasounds. These include doppler fetal heart rate monitors and fetal ultrasounds. Both procedures give expectant mothers a first glimpse of their baby. Doctors have used ultrasounds for more than 20 years. Over this time, they’ve established an extraordinary safety record. Not only do ultrasounds provide instant imaging capabilities, they are also generally painless and easy to perform on the patient.

FDA Warnings About the Risks of Ultrasounds

Although the risks of an ultrasound are minimal, some do exist, according to the FDA. Among those potential side effects are the slight and localized heating of tissue and the creation of small pockets of gas in bodily fluid or tissue. The long-term effects of these concerns remain unclear. Due to a particular worry about expectant mothers, the FDA recommends caution when ordering ultrasounds for pregnant women. This brings us to our next point…

The FDA’s Guidance on Ultrasounds for Expectant Mothers Might Be a Surprise

As with any medical procedure, no matter how small, the FDA recommends that patients consult with a medical professional. This holds especially true with expecting mothers. While examinations that include ultrasounds are often a routine occurrence during pregnancy, the FDA strongly discourages the use of unnecessary ultrasounds. This includes the use of over-the-counter fetal heartbeat monitoring systems, which are also labeled as doptones, as well as ultrasounds for non-medical purposes such as keepsake images or videos. This is not to say that a mother should never obtain a keepsake video or image, but that these mementos should emerge only as part of a routine and necessary medical appointment.

Further FDA Information on Ultrasounds

As with any medical device concern, any patient who suspects a problem with an ultrasound procedure or device should promptly report to the FDA MedWatch, the agency’s adverse event reporting platform. For further information, including how to find the most affordable ultrasound option near you, visit or call us at 888-322-7755.