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Ultrasound - memory photos? FDA warns

Comments of important international institutions

Attention! The legal situation regarding the use of ultrasound during pregnancy has changed. Doctors and all other persons are forbidden to use ultrasound on unborn children if there is no medical necessity. This makes baby television - as a private, self-paid service - a misdemeanour, as do CTG measurements and fetal monitors applications. The Federal Ministry for the Environment, Nature Conservation and Nuclear Safety follows the recommendation of the Radiation Protection Commission (SSK) and places consumer protection above the economic interests of ultrasound users.
The three so-called "basic ultrasound examinations" continue to be offered as part of medical pregnancy monitoring. The parents decide whether they want to have their child examined with ultrasound or not.
You can find out more in this press release.

Original text FDA statement:

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.
Original text American Institute of Ultrasound in Medicine (AIUM):
The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes. The use of either two-dimensional (2D) or three-dimensional (3D) ultrasound to only view the fetus, obtain a picture of the fetus or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice.
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.
American Institute of Ultrasound in Medicine
Original text European Committee for Medical Ultrasound:
The embryonic period is known to be particularly sensitive to any external influences. Until further scientific information is available, investigations should be carried out with careful control of output levels and exposure times. With increasing mineralization of the fetal bone as the fetus develops, the possibility of heating fetal bone increases. The user should prudently limit exposure of critical structures such as the fetal skull or spine during Doppler studies.
FDA Consumer Magazine, Jan-Feb 2004
FDA cautions against ultrasound "keepsake" images.

 

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