Concerns About 3D Ultrasound Safety for Baby
With the increasing use of 3D ultrasound for nonmedical purposes, medical entities have weighed in on the safety of these devices outside of a medical setting, whether in the hands of a layperson technician or a trained sonographer employed by a freestanding fetal imaging center.
Companies that offer 3D and 4D ultrasounds for reassurance and keepsake purposes point to statements by the American Institute of Ultrasound in Medicine and the U.S. Food and Drug Administration that ultrasound is generally considered not to be harmful. But several medical organizations, as well as the FDA, have spoken against the use of fetal ultrasound for nonmedical purposes.
The FDA states: “Persons who promote, sell or lease ultrasound equipment for making ‘keepsake’ fetal videos should know that FDA views this as an unapproved use of a medical device. In addition, those who subject individuals to ultrasound exposure using a diagnostic ultrasound device (a prescription device) without a physician’s order may be in violation of State or local laws or regulations regarding use of a prescription medical device.” The FDA has seemingly backed off on warning some such companies that their use of certain ultrasound systems for keepsake videography “is in violation of the law,” as it did several years ago.
Some states have passed laws such as California’s AB 2049, requiring providers of keepsake ultrasounds to disclose: “The federal Food and Drug Administration has determined that the use of medical ultrasound equipment for other than medical purposes, or without a physician’s prescription, is an unapproved use.”
General Electric, which manufactures 3D ultrasound machines as well as the only 4D unit on the market, official states, “GE supports the AIUM guidelines for nonmedical use of ultrasound.” (The AIUM opposes ultrasound use for nonmedical purposes.) However, some companies that provide nonmedical ultrasounds point out that the AIUM has a financial interest in keeping ultrasounds in the domain of the medical profession. Additionally, it is unclear why GE makes its machines available for purchase in non-medical settings.
At any rate, medical experts generally agree that, if used for the same time period at the recommended intensity, 3D ultrasound uses the same degree of sound waves and exposes the baby to everything a traditional, 2D, black-and-white ultrasound does.