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Fetal Ultrasound Guidelines - "Evidence that there may be a biological effect on the fetus."

(Copy-Paste from Health Canada website)

Health Canada is recommending parents not expose their unborn babies to fetal ultrasound for the purpose of making “keepsake” videos.

Background
Fetal ultrasound creates images of the unborn baby in the womb. The procedure uses very short bursts of sound vibrations that travel as waves through the body in a series of focused beams. Echoes from the beams are converted into real-time images that show the movement, surface features, internal organs and, with special techniques, even the blood flow of the fetus. The images are viewed on a monitor and can be stored on CDs. When the procedure is used to obtain images for medical purposes, it is called diagnostic fetal ultrasound.

Diagnostic fetal ultrasound is done only on referral from a licenced health care provider. It is performed in a clinical setting by highly qualified professionals. Health Canada recommends that diagnostic fetal ultrasound should be done only when the expected medical benefits outweigh any foreseeable risk.

Recently, some businesses have started promoting the use of fetal ultrasound machines for the sole purpose of making videos of babies in the womb as a keepsake for parents. In this setting, the ultrasound provides no information about the baby’s health.

The Benefits and Safety Record of Diagnostic Fetal Ultrasound
Diagnostic fetal ultrasound provides important medical information, such as the size, age and state of health of the baby in the womb. It can also detect twins and can diagnose certain birth defects. The clinical use of fetal ultrasound has grown rapidly and it has an excellent safety record. There have been millions of these examinations over the past few decades with no confirmed health risks for the baby or the mother. This finding is consistent with the majority of scientific studies on the effects of ultrasound.

Although this is very reassuring, there is also suggestive evidence that there may be a biological effect on the fetus even during diagnostic use. Research is ongoing to ensure the continued safety of diagnostic fetal ultrasound.

Concern about Fetal Ultrasound for Keepsake Videos
In all instances, the risks of fetal ultrasound will depend on the ultrasound levels and duration of exposure. The ultrasound level is now displayed on the monitor, and this lets qualified operators assess the potential for damaging the fetus. Risks can be minimized by keeping the ultrasound level and exposure time as low as possible without losing the information needed for diagnosis.

When fetal ultrasound is done for a keepsake video, no medical information is provided to justify exposing the baby to ultrasound.

Minimizing Your Risk
Do everything you can to give your baby a healthy start in life. If you are pregnant, seek appropriate prenatal care. Diagnostic fetal ultrasound provides medical information that will help your health care professional care for you and your baby. Discuss any concerns you have with your health care provider so that you can make an informed decision about the use of fetal ultrasound during your pregnancy.

Health Canada recommends that you have fetal ultrasound only on referral from a licenced health care provider.

Health Canada’s Role
Health Canada regulates diagnostic ultrasound devices under the Food and Drugs Act, the Radiation Emitting Devices Act, and the Medical Devices Regulations. This ensures the safety and effectiveness of the devices when they are used for their licenced diagnostic purposes and according to guidelines for safe use.

Health Canada has established Guidelines for the Safe Use of Diagnostic Ultrasound. The Guidelines state that ultrasound should not be used for any of the following activities:

to have a picture of the fetus, solely for non-medical reasons
to learn the sex of the fetus, solely for non-medical reasons
for commercial purposes, such as trade shows or producing pictures or videos of the fetus
Health Canada is also working with the Society of Obstetricians and Gynecologists of Canada (SOGC) to develop a user-friendly clinical practice guideline on the safety of obstetric ultrasound.

Need More Info?
For more information, contact:

Medical Devices Bureau, Health Canada
Room 1605, Statistics Canada Main Building
Tunney’s Pasture
Ottawa, ON K1A 0L2
Telephone: (613) 957-4786

and/or

Consumer and Clinical Radiation Protection Bureau, Health Canada
775 Brookfield Road
Ottawa, ON K1A 1C1
Telephone: (613) 954-6699

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