'Keepsake' ultrasound raises medical hackles

A growing number of private enterprises are using ultrasound to provide nonmedical fetal "keepsake" videos and/or prenatal portraits to pregnant women and their families. Eye-catching names such as 3DBabyVu, Fetal Fotos, Peek-A-Boo Baby, and Womb With a View are popping up in shopping centers across the country.

The elaborate Web sites of these enterprises feature inviting fetal images and imaginative captions such as "Mommy tummy tours, we believe in love at first sight" or "Fruit of the womb." Depending on the business location, the costs of these services range from $75 for a "best gender guess" to more than $300 for a "complete package," which may include still 2D or 3D photos and real-time 3D (4D) images on videotape or DVD. Although insurance companies usually reimburse the cost of ultrasound examinations during a pregnancy, studies for nonmedical reasons are not reimbursed.

Keepsake operations use the same ultrasound scanners that are used for diagnostic imaging in hospitals and clinics (Figure 1). The goal of a keepsake operation, however, is to produce pleasing pictures rather than diagnostic information. The most experienced sonographer will routinely encounter difficulty obtaining favorable pictures in a timely manner for diagnostic purposes, and not all keepsake facilities employ sonographers with the training and experience required to produce acceptable images. In the hands of an inexperienced operator, a scanner could expose a fetus for protracted periods and at higher ultrasound intensities than are usual in a medical environment (Figure 2).

OPPOSITION GELS

Many members of the medical community have expressed concerns about the use of ultrasound merely to provide an appealing photograph or determine the sex of a fetus. Although no biological effects on patients have been confirmed at the present time, the possibility exists that such effects may be identified in the future. Another concern is that an ultrasound examination performed solely for entertainment or emotional reasons may be misinterpreted by expectant parents as a medical examination. It may induce a false sense of security about the health of the fetus and provide misleading information.

Several professional associations have issued policies or statements expressing these concerns and offering guidelines for ultrasound use:

- Society of Diagnostic Medical Sonography. Members of the SDMS include sonographers, educators, students, clinical managers, and others whose goal is to promote, advance, and educate its members and the medical community in the science of diagnostic medical sonography. The SDMS has recently revised its policy statement, Nondiagnostic use of ultrasound. The group expresses opposition to the practices of keepsake businesses.

SDMS policy states that "Diagnostic medical sonography is a medical procedure that is requested by a physician (or their designated healthcare provider), performed by a sonographer, and interpreted by a physician (Figure 3)."

Because keepsake imaging is provided for "entertainment" purposes only, the SDMS considers it nondiagnostic and opposes its use solely for this purpose. The position of SDMS has also been endorsed by many other professional organizations.

- American Institute of Ultrasound in Medicine. The AIUM considers the use of ultrasound without a medical indication inappropriate and contradictory to the responsible practice of medicine. The AIUM recently reaffirmed its May 1999 official statement, Prudent use of diagnostic ultrasound:

"The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the nonmedical use of ultrasound for psychosocial or entertainment purposes. The use of either two-dimensional (2D) or three-dimensional (3D) ultrasound to only view the fetus or determine fetal gender without a medical indication is inappropriate and contrary to responsible medical practice."

The AIUM has also issued an official statement, Interpretation of ultrasound examinations:

"Ultrasound studies shall be supervised and interpreted by a physician with training and experience in the specific area of ultrasonography. Findings must be recorded and results communicated in a timely fashion to the physician responsible for care. Although a sonographer may play a critical role in extracting the information essential to deriving a diagnosis, the rendering of a final diagnosis of ultrasound studies represents the practice of medicine, and therefore, is the responsibility of the supervising physician."

- Food and Drug Administration. The FDA supports the AIUM's official statements and its opposition to the use of entertainment ultrasound and cautions against the use of ultrasound equipment in making prenatal videos or keepsake images. According to the FDA:

"Persons who promote, sell, or lease ultrasound equipment for making 'keepsake' fetal videos should know that FDA views 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."

The FDA also warns that there is no justification in exposing a fetus to ultrasound without anticipating a medical benefit. The FDA considers a diagnostic ultrasound scanner as a prescription device, and many keepsake operations do not require physicians' prescriptions from their customers. In some cases, there is no physician oversight. In others, there may be a physician-owner relationship but not a physician-patient relationship.

While the FDA regulates medical devices, it does not regulate the credentialing and conduct of sonographers and physicians. The use of diagnostic ultrasound equipment without a physician's order may, however, be in violation of state or local laws or regulations. Although it is unclear how the FDA will discourage the nonmedical uses of diagnostic ultrasound equipment, other than by notifying the public, it has asked members of the medical community to notify the agency if they become aware of a keepsake operation.

- American College of Radiology. This organization supports the FDA's position. It holds that fetal ultrasound should be performed only for medical purposes with a prescription from an appropriately licensed provider. During its recent annual meeting, the ACR approved a resolution opposing the use of fetal ultrasound solely for entertainment videos or keepsake images. The college also renewed its support for the AIUM's Prudent use of ultrasound statement.

- American Registry of Diagnostic Medical Sonography. Although the experience level among ultrasound technicians employed by keepsake facilities varies, some facilities claim that their technicians are board-certified by the ARDMS. This is an independent nonprofit organization that administers examinations and awards credentials in various diagnostic ultrasound specialties-obstetrics and gynecology included. The ARDMS does not condone the use of diagnostic ultrasound for entertainment purposes. Like many other professional organizations, it endorses the AIUM's Prudent use statement.

The ARDMS is unable to prohibit improper use of diagnostic ultrasound equipment by sonographers, but it applies sanctions and publicizes a listing of persons who violate the organization's disciplinary rules.

- ECRI. Formerly the Emergency Care Research Institute, this independent nonprofit health services research agency promotes safety, quality, and cost-effectiveness in healthcare to benefit patient care through research, publishing, education, and consultation. ECRI does not support the use of fetal ultrasound solely for nonmedical applications and agrees with the positions of the SDMS, AIUM, FDA, ACR, and ARDMS. According to ECRI:

"Fetal ultrasound for nonmedical, entertainment purposes is being inappropriately performed and marketed to pregnant women and their families. Although no adverse effects have been associated with routine ultrasound examinations, the biological effects of casual, longer exposure to ultrasound are unknown. Fetal ultrasound examinations for keepsake or entertainment purposes can result in unnecessary follow-up tests and added cost of care."

REGULATION NECESSARY

Although opposition to nonmedical sonography from members of the medical community is abundant, it is highly unlikely that keepsake ultrasound enterprises will cease to function. They will continue to diffuse rapidly, due to heavy marketing and consumer demand, as long as no regulations rule against the practice. Strongly worded policy statements from professional organizations and implied pressure from the FDA have not discouraged these businesses-even slightly.

One ultrasound scanner manufacturer, SonoSite, openly supports the positions of the ACR, AIUM, and SDMS, but many others continue to supply ultrasound scanners for keepsake or entertainment purposes. A solution will be realized only with robust implementation and enforcement of federal, state, and local regulations.

Mr. Pinkney is a senior project engineer with ECRI's Health Devices Group, a registered diagnostic medical sonographer, member of the Society of Diagnostic Medical Sonography, and senior member of the American Institute of Ultrasound in Medicine. He can be reached at 610/825-6000 or npinkney@ecri.org.