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FDA Warns Against 'Keepsake' Ultrasounds by Non-Medical Providers

FDA Warns Against 'Keepsake' Ultrasounds by Non-Medical Providers

December 18, 2014 — FDA is advising pregnant women to avoid undergoing medically unnecessary "keepsake" ultrasounds and Doppler heartbeat scans by commercial providers because they could pose potential risks if improperly administered, according to HealthDay/U.S. News & World Report (Preidt, HealthDay/U.S. News & World Report, 12/16).

Background

Unlike health care providers, commercial sonographers offer non-medically necessary ultrasound videos and images to women for profit, often promoting the idea that the image will aid bonding. Commercial sonographers typically operate in shopping malls and charge women several hundred dollars for the service, according to The Hill (Viebeck, The Hill, 12/16).

FDA first discouraged non-medical ultrasounds in 1994, according to The Atlantic. Thereafter, the agency has continued to advise against the practice, issuing a warning in 2002 that it is illegal to administer an ultrasound to a person without a prescription.

FDA has also noted that women could use images from medical professionals, rather than commercial providers, for bonding purposes, if they were so inclined.

Several major medical organizations oppose commercial ultrasounds as well, including the American College of Obstetricians and Gynecologists, the American College of Radiology, the American Institute of Ultrasound in Medicine, the American Medical Association and the American Pregnancy Association (Romm, The Atlantic, 12/16).

Latest Warning

In an FDA statement, Shahram Vaezy, a biomedical engineer at the agency, said that while there is no evidence that women or their fetuses have been harmed by the commercial scans, "prudent use of these devices by trained health care providers is important."

Vaezy explained, "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 cavitation and tissue heating are unknown, and, as a result, ultrasounds should be conducted only by trained medical professionals and when medically necessary, Vaezy added (HealthDay/U.S. News & World Report, 12/16). For example, commercial operators can take up to an hour to capture video of the fetus and could be inattentive to power and heat settings (The Hill, 12/16).