Nonmedical Fetal Ultrasound—
Why All the Noise?

The nonmedical use of ultrasound in pregnancy is best defined as employing ultrasound to view the fetus, take its picture, or determine its sex without a medical indication (1). Synonyms for nonmedical fetal ultrasound include “keepsake,”“entertainment,” and “boutique” imaging. These services have been available for well over a decade, and rapidly raised concerns in the medical community (2). In response, the U.S. Food and Drug Administration (FDA) issued a 1994 warning that 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 (3). The warning was reiterated in 2002 and 2004 in response to continued proliferation of entertainment ultrasound (4,5). The FDA statement noted that 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 (4). Professional organizations in the United States taking official positions on entertainment ultrasound universally oppose using the technology outside a diagnostic medical procedure. The American Institute of Ultrasound in Medicine published the first such statement in 1999 (6), updating it in 2005 (7). The American College of Obstetricians and Gynecologists (ACOG), American College of Radiology, and Society of Diagnostic Medical Sonographers all released similar statements in 2004 (8–10). Despite these declarations, the nonmedical use of fetal ultrasound persists in the United States. The Canadian federal health agency, Health Canada, also denounced entertainment ultrasound (11), and the British Medical Ultrasound Society noted that ultrasound should only be used for medical diagnosis if endorsed by a medical practitioner. However, although disapproving first trimester keepsake ultrasound, safety guidelines are provided for nondiagnostic use, such as souvenir imaging at later gestational ages (12). Not surprisingly, in the United States keepsake ultrasound providers now find their services becoming the target of state legislative activity. As of 2004, California … requires that a person or facility that offers fetal ultrasound, or a similar procedure for keepsake or entertainment purposes, to make a written disclosure to a client prior to performing the procedure, that the federal Food and Drug Administration does not approve of the use of ultrasound equipment for these purposes (13). Although admirably intended, we believe that this legislation conflicts with the FDA determination that entertainment ultrasound is not an approved use of a medical device. Moreover, this statute contributes to the legitimization of keepsake fetal imaging. During 2004, bill S.6776-A introduced to the New York State Senate sought to restrict the use of fetal ultrasound to an order or referral by a physician, nurse practitioner, or licensed midwife. The bill would also prohibit ultrasound for entertainment purposes, with violations classified as a Class A misdemeanor, punishable by up to 1 year in prison (14). Finally, the 2005 ACOG legislative program sought to “prohibit the nonmedical use of ultrasound in pregnant women for entertainment purpose”(15). Why is there so much noise about nonmedical fetal ultrasound? Although authorities recognize that “there are no confirmed biological effects on patients caused by exposures from present diagnostic ultrasound instruments, the possibility exists that such biological effects may be identified in the future”(6). Moreover, the current generation of machines with 3D and 4D capability, the technologies most widely advertised to consumers, are capable of higher energy outputs than previous generation equipment. Thus, concerns arise for potentially longer periods of fetal ultrasound exposure at greater output settings than normally experienced during diagnostic medical imaging. Entertainment ultrasounds may not be conducted with the principle of ALARA (as low as reasonably achievable) in mind, or with regard to acceptable thermal and mechanical indices (16–18). Nonmedical fetal ultrasound also incurs possible maternal risks. Unnecessary anxiety may be provoked if poor quality images of a normal fetus lead the woman to believe that an undiagnosed anomaly is present. Undue anxiety is even more likely to result from recognition of an anomaly or soft marker without physician availability to diagnose and counsel the woman properly. When boutique imaging is performed within the clinical setting, anxiety may be elicited in others. Specifically, women carrying fetuses with known or suspected anomalies awaiting a diagnostic medical ultrasound may be subjected to the keepsake customer unknowingly or insensitively sharing her “baby pictures” in the waiting room (19). Alternatively, entertainment ultrasound may provide women with false reassurance of fetal health when abnormalities are missed or disregarded during nonmedical imaging. Such an occurrence would be more likely if a woman foregoes a medical examination following a boutique scan, regardless of sales disclaimers distinguishing between the two imaging types and customers’ understanding of those disclaimers. Should a subsequent diagnostic medical ultrasound reveal fetal anomalies unrecognized or undisclosed during a keepsake imaging session, the woman could conceivably have a harder time processing and accepting news of the fetal condition (20). Entertainment ultrasound is commonly advertised as a means of determining fetal gender, and thereby purports to make a diagnosis despite disclaimers to the contrary. The accuracy of fetal gender determination in the boutique setting is unknown. In this regard, nonmedical ultrasound could be construed as practicing medicine without a license. Importantly, fetal sexing by second trimester diagnostic medical studies is imperfect. Genitalia may not be adequately visualized in 6.7 to 10.6 percent of fetuses, and errors in sonographic gender determination occur in 0.7 to 3.3 percent of cases (21, 22). Significant concerns exist about keepsake ultrasound centers’ direct advertising to consumers. Common statements that imaging is performed with the same high-quality equipment used in physicians’ offices by experienced or certified sonographers are misleading. Despite disclaimers to the contrary, one cannot help but infer that entertainment imaging is safe for the fetus, will be performed with the same care, to the same standards, and by the same qualified personnel as in a diagnostic medical examination. This notion is simply not true, based on keepsake imagers’ own disclaimers. Of more concern are “conditional” boutique imaging services, that is, imaging sessions that occur only after customers present documentation of a prior medical obstetrical ultrasound, enrolment in prenatal care, and physician awareness of, or consent for, nonmedical fetal imaging. This approach enlists physicians to directly or indirectly legitimize the entertainment ultrasound—involvement that should be strongly opposed. Furthermore, these prerequisites should not absolve the keepsake imager from taking responsibility for what is visualized during the ultrasound session. Perhaps of even greater concern is keepsake imaging performed as a “revenue enhancer” within the clinical setting. In this instance, physician economic self-interest can potentially undermine the physician-patient relationship (19). Not surprisingly, the American Medical Association opposes profit making from nonhealth-related goods in physicians’ offices (23). By their own admissions and disclaimers, entertainment ultrasound providers have so categorized their product. Alternatively, if keepsake fetal images are provided gratis or at cost, and without extending imaging time beyond that required to complete the medical examination, no such concerns are warranted (19). Medical and ethical considerations suggest that nonmedical ultrasound to view the fetus is unacceptable. We subscribe to this position, as do the regulatory and professional organizations encompassing ultrasound practitioners. Currently several pathways are available to curb entertainment ultrasound. Physicians can refrain from providing consent or prescriptions when required by imaging center. The FDA and similar regulatory agencies in other countries can use their enforcement capacity to prevent the sale and use of ultrasound machines to and by inappropriate individuals. State licensing boards may prevent individuals from using medical equipment for nonmedical purposes and without physician supervision. Professional organizations could strengthen their current positions by further educating their respective membership about the inappropriateness of keepsake imaging. Failing this approach, available sanctions, following due process, could include formal warnings to offending members, loss of membership, and notification of the appropriate licensing body and the country's government regulatory agency. Advocates of fetal ultrasound for entertainment purposes bear the responsibility of presenting evidence of acceptable maternal and fetal risk/benefit ratios, an ethical justification, and methodological framework to ensure fulfillment of the former prerequisites. If these criteria are met, the FDA, other similar governmental regulatory agencies, and respective professional organizations should be willing to rejoin the debate about nonmedical fetal ultrasound.

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