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Ultrasound and Legal Liabilities

April 2004
By: Thomas Glessner

Reprinted from "NIFLA Clinic Tips," Vol. 2 No. 1.

The powerful impact of an ultrasound examination upon a woman contemplating an abortion cannot be overstated. An article in the New England Journal of Medicine, February 17, 1983, related an anecdote that portrays the influence such an examination can have:

One of us pointed to the small, visibly moving fetal form on the screen and asked, "How do you feel about seeing what is inside you?"

She answered crisply, "It certainly makes you think twice about abortion!" When asked to say more, she told of the surprise she felt on viewing the fetal form, especially on seeing it move. "I feel that it is human. It belongs to me. I couldn't have an abortion now." The mother was asked about her experience with ultrasound. She said, "It really made a difference to see that it was alive." Asked about her position on the moral choice she had to make, she said, "I am going all the way with the baby. I believe it is human."

Because of the powerful impact an ultrasound examination can have upon a woman's choice, many pregnancy help centers are now seriously looking at using this tool in their counseling with abortion-minded clients. Yet, in contemplating this move, centers should take into consideration recent actions by the Federal Drug Administration (FDA).

In 1994 the FDA undertook efforts to halt an outcropping of businesses that were using ultrasound equipment to produce for the parents of unborn children prenatal videotapes for entertainment purposes. The FDA confiscated ultrasound equipment from several businesses that had been set up to perform ultrasound examinations without the guidance, supervision, and direction of a medical doctor. The FDA in a written report stated: "Persons who promote, sell, or lease ultrasound equipment for making 'keepsake' fetal videos should know that we view this as an unapproved use of a medical device, and that we are prepared to take regulatory action against those who engage in such misuse of medical equipment."

In support of the FDA's actions, the American Institute of Ultrasound in Medicine (AIUM) stated: "While ultrasonic fetal scanning is generally deemed to be safe, we feel strongly that its use is only indicated for a prescribed medical purpose. The use of ultrasound for producing videos for 'entertainment purposes' simply cannot be justified."

The FDA has indicated that ultrasound imaging should be used only under the supervision and direction of a licensed M.D. 

It should be noted that the FDA's actions were not against crisis pregnancy centers. However, the language used by the FDA in taking these steps strongly emphasizes that ultrasound should be used only under the supervision and direction of a licensed M.D. Because of this, it is NIFLA's strong recommendation that pregnancy help centers not attempt to use ultrasound unless they are licensed medical clinics.

When operating as a medical clinic, a pregnancy help center can use ultrasound under the supervision of the medical director for recognized medical purposes. Standards set forth by the American College of Obstetricians and Gynecologists (ACOG) provide for three levels of ultrasound examinations.

• The targeted examination. The targeted ultrasound is intended to specifically search for a fetal abnormality or handicap. This type of examination requires more precise scrutiny in order to determine whether the developing child has an abnormality.

• The basic examination. The basic ultrasound is a general examination performed on the patient not known to be at risk for any specific fetal problem. If this examination uncovers reason to suspect problems, then the client is referred for a second, targeted exam.

• The limited examination. The limited ultrasound is used under certain circumstances to get specific limited information or under urgent conditions.

In all three of these types of examinations, liability arises primarily from: (1) a failure to use the technique when indicated, (2) a failure to perform a standard service, and (3) a failure to properly interpret the information.

Pregnancy help medical clinics should be concerned only with the limited ultrasound examination. Under such an examination the limited information sought is only to diagnose the existence of a viable pregnancy and the existence of a fetal heartbeat. The limited ultrasound examination does not attempt to diagnose the health of the baby or the presence of fetal abnormalities. Because of its limited nature, this examination carries with it the least exposure for legal liability.

Giving the client clear and specific communication about the restricted scope of the limited examination and informing her that the examination is only to obtain specific limited information minimizes the risk of liability.

The client should sign an appropriate release form with very specific language indicating that she understands the limited nature of the ultrasound examination being given. The Pregnancy Help Medical Clinic Manual has a Medical Services Consent and Release Form that contains recommended language for the client to acknowledge the limited nature of this exam:

If an ultrasound is recommended, I understand that it is only for the purposes of confirming my pregnancy, detecting fetal heart tones, estimating a due date, and determining fetal age. I understand that it is not for the purposes of diagnosing or detecting any medical problem or condition for myself or my baby. I will not hold the pregnancy help medical clinic responsible for diagnosing or failing to diagnose any abnormalities or conditions relating to my pregnancy or my baby and hereby release the pregnancy help medical clinic from any and all liability in this regard.

Thomas A. Glessner, J.D., is president of National Institute of Family and Life Advocates (NIFLA) and can be contacted at NIFLA@aol.com.



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