FDA: Pregnant Women Should Avoid Fetal Keepsake Images, OTC Heartbeat Monitors

FDA: Pregnant Women Should Avoid Fetal Keepsake Images, OTC Heartbeat Monitors

December 17, 2014

The U.S. Food and Drug Administration (FDA) is warning pregnant women to avoid fetal keepsake images or purchasing over-the-counter heartbeat monitors because their long-term effects remain unknown.

While also proclaiming their safety for diagnostic procedures, the FDA continues to issue the warning as more women undergo ultrasounds to create images, videos and other recordings as a keepsake from their pregnancy. The agency has long-held the stance that performing ultrasounds that are medically unnecessary constitutes as an unauthorized use of a medical device.

"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," said FDA biomedical engineer Shahram Vaezy in a statement.

Ultrasounds create images by sending out, and then capturing, sound waves that bounce off body tissue. Unlike X-rays, ultrasounds don't expose a patient to radiation.

But, ultrasound can heat tissues slightly and can also produce very small bubbles called cavitation. Since the long-term effects of tissue heating and cavitation aren't known, medical professionals say that ultrasounds, including those using handheld heartbeat monitors, should only be done when there is a medical need, performed by a trained professional and with a prescription.

Doppler heartbeat monitors are legally marketed as prescription devices, despite being readily available online for sale or rent.

"When the product is purchased over the counter and used without consultation with a health care professional taking care of the pregnant woman, there is no oversight of how the device is used. Also, there is little or no medical benefit expected from the exposure," said Vaezy.

The industry continues to grow with businesses providing expectant parents images and videos of their growing baby. The FDA warns that in creating these images, there is no control over how long the imaging session will last, how many will take place and if the systems are operated properly.

While the FDA is responsible for regulating the medical device, it's up to the state or county to regulate the people operating them.

Hardly a new phenomenon, in 2004 the American College of Obstetricians and Gynecologists endorsed a statement by the American Institute of Ultrasound Medicine (AIUM). "The AIUM strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes."

In 2005, the American Medical Association announced that fetal keepsake videos were an unapproved use of a medical device and resolved to lobby the government to increase enforcement of FDA standards.

Pregnant women should seek medical advice from their doctor before undergoing an elective ultrasound. Many businesses that perform these keepsake services require customers to be under a doctor's care and may require paperwork from healthcare providers acknowledging that they are aware their patients will be undergoing the procedure.