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Medical Q&A: “Can we just do ultrasounds without becoming a medical clinic?”

Posted by Sandy Christiansen, MD, FACOG on Apr 10, 2018 7:00:00 AM

Short answer: Absolutely not. The use of ultrasound energy in any form is considered the practice of medicine.

Explanation:

This is a question that comes up for centers who are just embarking on the idea of providing ultrasound services for their clients. Perhaps, the board does not have anyone on it with a medical background and they have heard about people who offer keepsake ultrasounds to pregnant women for a fee. Expectant parents may purchase a variety of equipment that allows them to see and/or hear their baby's heartbeat. Some even buy ultrasound machines!

So, is it appropriate for a pregnancy center to offer this kind of service?

The Food and Drug Administration (FDA) terms this sort of ultrasound “recreational,” since it is not being performed at the request of a physician, or prenatal care provider. The FDA is responsible for approving all prescription drugs and medical devices for human use. They explicitly prohibit the use of ultrasound energy for "recreational, non-medical" purposes. The reason is because the use of ultrasound energy is considered the practice of medicine and must be done for clear medical indications and be performed by trained and licensed medical providers.

From the FDA website:1

Fetal ultrasound imaging provides real-time images of the fetus. Doppler fetal ultrasound heartbeat monitors are hand-held ultrasound devices that let you listen to the heartbeat of the fetus. Both are prescription devices designed to be used by trained healthcare professionals. They are not intended for over-the-counter (OTC) sale or use, and the FDA strongly discourages their use for creating fetal keepsake images and videos.

"Although there is a lack of evidence of any harm due to ultrasound imaging and heartbeat monitors, prudent use of these devices by trained health care providers is important," says Shahram Vaezy, Ph.D., an FDA biomedical engineer. "Ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles (cavitation) in some tissues." The long-term effects of tissue heating and cavitation are not known. Therefore, ultrasound scans should be done only when there is a medical need, based on a prescription, and performed by appropriately-trained operators.

The FDA doesn’t have an enforcement arm, so these folks who offer keepsake scans are not going to be fined or arrested, but they are in direct opposition to the federal government’s regulations.

Bottom line:

Medical pregnancy centers must function in accordance with all the laws and guidelines that regular physician's offices follow. The performance of ultrasound in any form (limited exam to confirm the presence of a living pregnancy in the uterus, heartbeat monitor, handheld Doppler) is a medical procedure that constitutes the practice of medicine and must be performed by an appropriately trained and licensed medical professional, under the authority of a licensed physician.

Care Net requires that affiliates follow the FDA’s stipulations that ultrasound exams be performed by trained healthcare professionals, under the order of a licensed physician.

In addition, pregnancy centers are frequently the target of attacks and accusations of being “fake clinics,” thus the goal is to be above reproach, and, in some cases, function at a higher level than even some doctor's offices.

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Sandy Christiansen, MD, FACOG, is Care Net's National Medical Consultant and the Medical Director of Care Net of Frederick (MD).

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