Expectant parents can now record their baby’s heartbeat anywhere, anytime, using smartphone-based fetal heart rate monitoring systems. But are they safe?
Aside from finding out you’re pregnant, hearing your baby’s heartbeat for the very first time is one of the most moving and memorable moments of your entire pregnancy. Aside from the obvious relief you feel at hearing an actual heartbeat coming from the little peanut growing inside you, it’s also a moment of intense bonding.
Current heart beat monitoring systems
Back in the day, and even now for most of us, fetal heart rate monitoring is usually done around the 12-week mark during a routine visit with your doctor, midwife or doula. The safe and painless procedure to capture the heart rate is usually done via an ultrasound, stethoscope or hand-held Doppler system, all of which are held against your belly. The tests are done to monitor fetal growth and development.
Medicine first, entertainment second
While the internal and external clinical and office-based tools used to measure fetal heart rates have been used for generations—and are obviously considered the most trustworthy medical devices—several entrepreneurs in the United States, Canada and Britain are leveraging the digital health revolution to create home-based, smartphone, entertainment-type fetal heartrate systems.
The systems being sold vary from non-digital hand-held doppler devices moms-to-be simply hold up against their bellies, to apps that use smartphones as well as dopplers to jointly capture and record the heartbeat for e-mailing or posting. Add an ultrasound photo of your little bundle-in-training and you have some irresistible keepsakes.
Several fetal heartrate systems available
Some of these fetal heartrate systems include Baby Beat, Summer Infant Heart-Heart Digital Pre-Natal Listening System, BellaBeat, UnbornHeart and FetalBeats. Only one of the products, Fetal Beats (a smart phone app and doppler system), claims to be the first FDA-approved device.
“We are having so much fun it’s amazing!” said Cheryl Hickey, host of Canada’s Entertainment Tonight of FetalBeats. “Sent two clips to grandparents and can’t wait for my son to hear tomorrow!"
FDA warning about “keepsake” ultrasound and fetal heartrate monitors’ safety
In a recent warning to expectant parents, the FDA issued a statement last December urging parents to “Avoid Fetal 'Keepsake' Images and Heartbeat Monitors.”
With regard to ultrasound imaging, the FDA said,
“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 health care professionals. They are not intended for over-the-counter sale or use, and the FDA strongly discourages their use for creating fetal keepsake images and videos.”
The warning went on to say that while the long-term effects of heating and “cavitation” are not known, ultrasound scans in particular should be done only when medically necessary, by prescription and by appropriately-trained operators.
"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 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."
With respect to heartrate monitors, the FDA had similar concerns surrounding the over-the-counter sale and use of doppler ultrasound heartbeat monitors.
“These devices, which are used for listening to the heartbeat of a fetus, are legally marketed as ‘prescription devices,’ and should only be used by, or under the supervision of, a health care professional."
"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," Vaezy said. "Furthermore, the number of sessions or the length of a session in scanning a fetus is uncontrolled, and that increases the potential for harm to the fetus and eventually the mother."
Like anything over the counter, whether it’s a digital health smartphone app or a hand-held medical device, it’s best to consult your physician before you use anything that may negatively impact your health or that of your unborn child.
Digital health devices are undoubtedly transforming the way we care for patients and ourselves, but perhaps the words “smart” and “health” should be top of mind versus “fun” and “entertaining.”
About the author: Holly Bridges, APR, is an award-winning copywriter from Ottawa, Canada. She is a former CBC Radio and TV journalist, author of “The UnHysterectomy. Solving Your Painful, Heavy Bleeding Without Major Surgery” and has a particular interest in digital health and wellness. You can follow her on Twitter: @hollybridges5
The innovatemedtec blog is intended to contribute to discussion and stimulate debate on important issues in global digital health. The views are solely those of the author. These are some related articles:
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