FDA warns against commercial prenatal ultrasound videos
http://www.100md.com
《英国医生杂志》
New York
Prenatal ultrasound videos called "keepsake videos" and taken by commercial studios may affect the fetus, warns the US Food and Drug Administration. The administration shut down such studios 10 years ago and is again considering regulatory action. Ultrasound is a form of energy and can't be considered harmless, even at low levels, it says.
The studios have been springing up in shopping centres in cities and towns across the United States. Typically they use the latest high powered ultrasound equipment, which can cost up to $100 000 (￡54 000; 81 000), to produce videos of the moving fetus.
The studios offer expectant parents one or more sessions at different stages of the pregnancy for $125 to $250. The videos show the fetus's fingers and toes, hair, muscles, facial features, and genitals and show it sucking a thumb or moving about. Some of the studios' websites post testimonials from parents who say that they bonded with their forthcoming baby and recognised features, such as the father's nose. The studios say they are an optional service and do not replace prenatal care. The cost of the service is not reimbursed by health insurance.
The American College of Obstetricians and Gynecologists' April newsletter to its members says that the studios typically offer "a 30- to 45-minute ultrasound session with as many as eight guests welcome; a video to take home, often set to music selected by the parents; a set of photos, both print and digital; gender determination if requested."
In contrast, doctors use two dimensional ultrasound at a low power level to check for size, location, number, and age of fetuses and to check for birth defects, breathing, and heartbeat. The result is a grainy black and white picture.
Images such as these produced by Fetal Fotos, Connecticut, require ultrasonography, which, the FDA says, cannot be considered harmless
Credit: FETAL FOTOS
An article in the January and February issue of FDA Consumer magazine points out that diagnostic prenatal ultrasound examinations are carried out by trained professionals, while commercial ultrasonography is done by untrained people and may involve long exposures, up to an hour (www.fda.gov/fdac/104_toc.html).
Although brief ultrasonography at low levels is considered safe, the FDA says that at higher levels it is used daily to speed the healing of fractures and, because of its heating effect, to treat sprains and pulled muscles. Even at low levels ultrasound can cause jarring vibrations and a rise in temperature. Modern equipment can produce intensities that are eight times higher than those produced by equipment used 10 years ago.
The American Institute of Ultrasound in Medicine "strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes." Dr John Seed, who heads the department of obstetrics and gynaecology at the Virginia Commonwealth University School of Medicine, said that although there is no proof that ultrasound is damaging, "we used to think that about x rays too."(Janice Hopkins Tanne)
Prenatal ultrasound videos called "keepsake videos" and taken by commercial studios may affect the fetus, warns the US Food and Drug Administration. The administration shut down such studios 10 years ago and is again considering regulatory action. Ultrasound is a form of energy and can't be considered harmless, even at low levels, it says.
The studios have been springing up in shopping centres in cities and towns across the United States. Typically they use the latest high powered ultrasound equipment, which can cost up to $100 000 (￡54 000; 81 000), to produce videos of the moving fetus.
The studios offer expectant parents one or more sessions at different stages of the pregnancy for $125 to $250. The videos show the fetus's fingers and toes, hair, muscles, facial features, and genitals and show it sucking a thumb or moving about. Some of the studios' websites post testimonials from parents who say that they bonded with their forthcoming baby and recognised features, such as the father's nose. The studios say they are an optional service and do not replace prenatal care. The cost of the service is not reimbursed by health insurance.
The American College of Obstetricians and Gynecologists' April newsletter to its members says that the studios typically offer "a 30- to 45-minute ultrasound session with as many as eight guests welcome; a video to take home, often set to music selected by the parents; a set of photos, both print and digital; gender determination if requested."
In contrast, doctors use two dimensional ultrasound at a low power level to check for size, location, number, and age of fetuses and to check for birth defects, breathing, and heartbeat. The result is a grainy black and white picture.
Images such as these produced by Fetal Fotos, Connecticut, require ultrasonography, which, the FDA says, cannot be considered harmless
Credit: FETAL FOTOS
An article in the January and February issue of FDA Consumer magazine points out that diagnostic prenatal ultrasound examinations are carried out by trained professionals, while commercial ultrasonography is done by untrained people and may involve long exposures, up to an hour (www.fda.gov/fdac/104_toc.html).
Although brief ultrasonography at low levels is considered safe, the FDA says that at higher levels it is used daily to speed the healing of fractures and, because of its heating effect, to treat sprains and pulled muscles. Even at low levels ultrasound can cause jarring vibrations and a rise in temperature. Modern equipment can produce intensities that are eight times higher than those produced by equipment used 10 years ago.
The American Institute of Ultrasound in Medicine "strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes." Dr John Seed, who heads the department of obstetrics and gynaecology at the Virginia Commonwealth University School of Medicine, said that although there is no proof that ultrasound is damaging, "we used to think that about x rays too."(Janice Hopkins Tanne)