The American Institute of Ultrasound in Medicine has updated its policy on fetal ultrasound studies performed without medical indications. Though the revised statement still targets keepsake imaging entrepreneurs, the new language looks at potential ethical violations by accredited ultrasound practitioners as well.
The AIUM distinguishes three different categories of fetal keepsake imaging. In the first, parents receive images or video clips during the course of a medically indicated obstetric ultrasound exam. The second includes nonclinical imaging sites that offer these images for entertainment purposes. The third accounts for clinics or hospitals that provide keepsake imaging services as added costs beyond patients' insurance.
"The first scenario is the only one consistent with the ethical principles of AIUM membership," said public relations coordinator Adam Freestone.
For some time, the AIUM has been documenting patients' increasing demand for ultrasound exams that provide reassurance and bonding with their unborn babies. The scant literature points at 3D sonography's role in feeding the trend.
The clinical and legal implications of sharing diagnostic ultrasound images with patients have not been established, but the AIUM encourages the practice when a clinically indicated obstetric evaluation grants the opportunity. Charging extra fees to patients for these images or copies of their medical records, however, may violate the principles of medical ethics of the American Medical Association and the American College of Obstetricians and Gynecologists. The new policy states that no extra markup should be added for these services when they are part of an ultrasound examination, Freestone said.
Only properly accredited sonologists and sonographers with specialized training in fetal imaging should perform ultrasound scanning of pregnant women. Imaging studies should be properly documented, signed by a physician, and include copies of the final report for the patient. Any other use of ultrasound may constitute practice of medicine without a license, AIUM officials said.
"We support this kind of practice," said Robert Britain, vice president of medical products for the National Electrical Manufacturers Association. "We would only support diagnostic ultrasound procedures when they are necessary and medically indicated. If the exam is not necessary for medical purposes, it shouldn't be done, plain and simple."
Ultrasound manufacturer SonoSite worked closely with the AIUM to develop its own corporate guidelines in 2004. The company's sales representatives are instructed specifically not to cater to the keepsake imaging market. Unlike some competitors, the firm's Web site does not promote keepsake ultrasound business, said Pat Martin, director of medical society relations for SonoSite.
"We would not sell any products to unauthorized practitioners. We want to make sure the profession is protected, that our customers comply with societal guidelines, and that we market our products appropriately," Martin said.
At least two states have started a crackdown on keepsake imaging entrepreneurs. Several Texas ultrasound businesses agreed not to advertise their services as entertainment after Austin-based Clearview Ultrasound was fined $2000 and ordered to pay attorney fees by the state's attorney general. New York as well introduced legislation in 2004 to prohibit nonmedical ultrasound use.
