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Response to FDA Safety Statement

Jeanette Burlbaw - Wednesday, December 31, 2014

The FDA has issued a safety warning since 2000 when the first franchise of 3D imaging opened.  The medical community was concerned about the mom & pop businesses that were given 2 weeks training by the franchise. The initial action was taken by  GE who will not sell equipment to any office that doesn't offer traditional diagnostic studies also.  If you look at the statement you will see how they want to reassure but alert you to the need to make sure it is in the hands of a credentialed sonographer.

"Ultrasound imaging has been used for over 30 years and has an excellent safety record. It is based on non-ionizing radiation, so it does not have the same risks as X-rays or other types of imaging systems that use ionizing radiation."

"Although ultrasound imaging is generally considered safe when used prudently by appropriately trained health care providers, ultrasound energy has the potential to produce biological effects on the body. Ultrasound waves can heat the tissues slightly. In some cases, it can also produce small pockets of gas in body fluids or tissues (cavitation). The long-term consequences of these effects are still unknown. Because of the particular concern for effects on the fetus, organizations such as the American Institute of Ultrasound in Medicine [disclaimer icon] have advocated prudent use of ultrasound imaging in pregnancy. Furthermore, the use of ultrasound solely for non-medical purposes such as obtaining fetal ‘keepsake’ videos has been discouraged. Keepsake images or videos are reasonable if they are produced during a medically-indicated exam, and if no additional exposure is required."

The FDA goes on to state: "In fetal ultrasound, three-dimensional (3D) ultrasound allows the visualization of some facial features and possibly other parts such as fingers and toes of the fetus. Four-dimensional (4D) ultrasound is 3D ultrasound in motion. While ultrasound is generally considered to be safe with very low risks, the risks may increase with unnecessary prolonged exposure to ultrasound energy, or when untrained users operate the device.

" Having served on  the AIUM bio effects committee I know the true concern is to the nonmedical person opening up an office offering the opportunity to "see" their baby.  These people are using old equipment and have no idea how to create an image ensuring they use As Low As Reasonably Achievable (ALARA).  If a malformation is present they would not be aware.  If a sonographer holds the transducer they will always evaluate the anatomy simply while showing you your baby, it's second nature.

The AIUM (American Institute of Ultrasound in Medicine) advocates prudent use, but they allow pregnant women to be used for models in their Continuing Medical Education meetings.  They don't feel there will be any biological effects. The published guidelines are:

 Guidelines for Hands-on Scanning in Pregnant Subjects During AIUM-Sponsored Educational Activities Approved 3/27/2010.

 5. Exposure time, ie duration of "hands-on" teaching session, should not exceed 1 hour per subject.

6. Exposure to pulsed Doppler should be restricted to instructor scanning for short durations only.

7. Examinations should be performed in a manner consistent with the As Low As Reasonably Achievable (ALARA) principle, including limiting the TI (≤1.0) and MI (<1.9) as necessary for educational purposes.

8. Only courses approved for Continuing Medical Education (CME) credit are acceptable.

ACOG has  issued statements on standard of care.  They explain: Why may special tests be needed during pregnancy? Special testing during pregnancy most often is done when the fetus is at increased risk of problems that could result in pregnancy complications or lead to stillbirth. This can occur in the following situations:

  • High-risk pregnancy (a woman has had complications in a previous pregnancy or has a preexisting health condition such as diabetes or heart disease)
  • Problems during pregnancy, such as fetal growth problems, Rh sensitization, or high blood pressure
  • Decreased movement of the fetus
  • Pregnancy that goes past 42 weeks (postterm pregnancy)
  • Multiple pregnancy with certain complications

What are the types of special tests? The tests used to monitor fetal health include fetal movement counts, the nonstress test, biophysical profile, modified biophysical profile, contraction stress test, and Doppler ultrasound of the umbilical artery.

The biophysical exam is performed each week from about 30 weeks till delivery.  It's a 30 minute exam.  This is considered safe because it is performed by a sonographer.

I understand the FDA and AIUM's concern.  To ensure your safety when having any sonography ask the person performing the exam if they have the credential, ARDMS.  You will be surprised how many physicians hold this credential also.

Wishing you happy healthy babies.

Jeanette Burlbaw BS RDMS FSDMS FAIUM