FDA Issues Warning on Commercialized Ultrasonic Fetal ImagingJanuary 27, 2015
The U.S. Food and Drug Administration has issued a warning on non-medical fetal ultrasounds and heartbeat monitors that have been used by consumers for personal reasons including the creation of keepsake images and videos.
Keepsake fetal imaging comes in the form of images and videos taken during the course of diagnostic ultrasound examination. Although these services allow parental-fetal bonding, the FDA discourages this process due to potential fetal health risks.
“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,” explained Shahram Vaezy, Ph.D., an FDA biomedical engineer. “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 exposures, she also added.
Furthermore, several medical groups have also posed concerns against this 3D and 4D imagery of fetuses. Among these groups are the American Medical Association, American College of Obstetricians and Gynecologists, American College of Radiology, American Institute of Ultrasound in Medicine, and American Pregnancy Association.
The safe use of diagnostic fetal ultrasound devices is one of the major requirements in diverse maternal healthcare facilities. AIV is dedicated to providing leading-edge fetal monitoring solutions for optimal neonatal and maternal care.
Learn more about AIV’s line of fetal monitoring equipment accessories, replacement parts, and repair services at www.aiv-inc.com/www.aiv-inc.com/fetal-monitor-transducers.html.
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