In December of 2000, decades after ultrasound was approved by the FDA for use in obstetric that Agency acknowledges that no one knows the delayed, long term effects of diagnostic levels of ultrasound on human development.
Millions of women and their unborn children are being exposed to diagnostic ultrasound during pregnancy and childbirth without the women being advised prior to exposure that there has been no well-controlled scientific investigation carried out to study the delayed, long-term effects of ultrasound on human development. Ova, embryos and fetuses are often exposed to prolonged sonography because the physician or technician lacks sufficient expertise to evaluate what he or she is seeing.
The FDA has yielded to pressure from industry and organized medicine to relinquish control over the amount of sonic energy that can be emitted by the new ultrasound devices used in obstetrics. The new ultrasound machines will beep at certain levels of energy output but essentially there will be little or no limit on the energy the health care provider may choose to use.
Despite the fact that the FDA’s Center for Devices and Radiologic Health acknowledged the potential risks of ultrasound used in obstetrics in its 1982 publication “An Overview of Ultrasound”, edited by Stewart and Stratmeyer, there is no evidence that health care providers are obtaining women’s truly informed consent to the use of ultrasound in pregnancy.
There are no state or federal regulations which require periodic calibration of ultrasound devices used in obstetric care. Nor are there any regulations that require a record to be kept of basic information such as:
The indication for the procedure
The written consent of the patient
The name of the manufacturer and the model number of the ultrasound equipment used
The type of ultrasound employed
The proposed intensity, as well as the actual intensity of exposure
The proposed and actual length of exposure
Maternal height, weight, and temperature
Identification of the hospital or the office where the procedure is carried out
Identification and qualification of sonographer
Date of exposure
Numerous studies have been carried out to evaluate the effectiveness of routine diagnostic ultrasound. None has shown the routine use of diagnostic ultrasound to improve maternal and infant outcome over that achieved when diagnostic ultrasound was used only when medically indicated….
Luckily things have improved since this article was written in 2000. Not.