美国FDA对医学超声波成像设备滥用的警告: (页面存档备份,存于互联网档案馆),
From a medical standpoint, ultrasonic fetal scanning is generally considered safe and is properly used when medical information on a pregnancy is needed. But ultrasound energy delivered to the fetus cannot be regarded as completely innocuous. Laboratory studies have shown that diagnostic levels of ultrasound can produce physical effects in tissue, such as mechanical vibrations and rise in temperature. Although there is no evidence that these physical effects can harm the fetus, public health experts, clinicians and industry agree that casual exposure to ultrasound, especially during pregnancy, should be avoided. Viewed in this light, exposing the fetus to ultrasound with no anticipation of medical benefit is not justified. For additional information about the "prudent use" of diagnostic ultrasound, see the statement from the American Institute of Ultrasound in Medicine (AIUM).
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.
FDA notified the medical community and the ultrasound industry in August 1994 regarding its concerns about the misuse of diagnostic ultrasound equipment for non-medical purposes, and asked them to discourage their patients from having sonograms for non-medical reasons.
美国FDA对医学超声波成像设备滥用的警告: (页面存档备份,存于互联网档案馆),
From a medical standpoint, ultrasonic fetal scanning is generally considered safe and is properly used when medical information on a pregnancy is needed. But ultrasound energy delivered to the fetus cannot be regarded as completely innocuous. Laboratory studies have shown that diagnostic levels of ultrasound can produce physical effects in tissue, such as mechanical vibrations and rise in temperature. Although there is no evidence that these physical effects can harm the fetus, public health experts, clinicians and industry agree that casual exposure to ultrasound, especially during pregnancy, should be avoided. Viewed in this light, exposing the fetus to ultrasound with no anticipation of medical benefit is not justified. For additional information about the "prudent use" of diagnostic ultrasound, see the statement from the American Institute of Ultrasound in Medicine (AIUM).
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.
FDA notified the medical community and the ultrasound industry in August 1994 regarding its concerns about the misuse of diagnostic ultrasound equipment for non-medical purposes, and asked them to discourage their patients from having sonograms for non-medical reasons.