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To the chagrin of some in sonography, that fickle entity known as consumer demand is also luring sonography into a new realm: fetal entertainment ultrasound scanning.

Also known as "keepsake" ultrasound scans, these typically consist of high-resolution 3D and 4D images of the developing fetus. As profit-making facilities pop up in strip malls across the country to provide these scans, mothers-to-be are jumping at the chance to see their unborn babies before delivery date.

Many sonographers and the FDA, however, aren't as keen on the idea-or the impact it might have on the modality. Some fear the trend's potentially adverse impact on the modality's reputation, not to mention the potential hazards that might accompany the performance of a sonogram by an inexperienced and/or uncertified operator. Since entertainment ultrasound scans aren't intended to be diagnostic, the persons performing them often aren't qualified to recognize or inform parents-to-be of any problems with the fetus, according to the FDA's own webpage on keepsake ultrasound scans. (For more information, visit www.fda.gov.

"It's giving sonography a bad name," Terry DuBose, MS, RDMS, FSDMS, FAIUM, said bluntly. DuBose is director of the diagnostic medical sonography program at the University of Arkansas for Medical Sciences, Little Rock, Ark. "One place in North Carolina offers "intensive" two-week training programs, which means they don't have a clue what they're doing. We need people who actually know what they're doing so when there is an anomaly they know what they're doing."

Martha Morgan, president of Little Sprout Imaging, a non-medical fetal imaging center in Towson, Md., argues that many facilities like hers are committed to addressing the concerns of the FDA and the AIUM.

"We only employ RDMS (OB) sonographers, and they are familiar with the general fetal anatomy in a 2D setting," Morgan explained. "If they do not have prior 3D/4D experience, they work with a staff sonographer to learn the new technology."

Morgan said she implemented an "Image is Everything" educational campaign " . in an effort to inform those seeking 3D sonograms that all 3D centers are not created equal." She said her employees follow a strict set of procedures when performing sonograms to ensure the safety of the mother and her unborn baby.

Brian S. Garra, MD, meanwhile, suggested that obstetricians and sonographers consider finding creative ways to compete with the companies that provide keepsake ultrasound scans. Currently most obstetricians don't offer them because insurance companies won't cover the extra images or the extra exam time.

"I expect that this will continue to increase, and you don't want to give them (keepsake ultrasound companies) a competitive advantage," said Dr. Garra, a radiology professor at the University of Vermont/Fletcher Allen Health Care in Burlington, Vt. "If a major medical center offers the same service, then people would probably rather go somewhere that assures quality. That hasn't happened yet, but I can see it happening with the proliferation of small ultrasound machines."

Stacy Stanislaw is the editorial assistant at ADVANCE. She can be reached at sstanislaw@merion.com.


 

I am proud to add this article as a comment to this discussion. This was featured in the last SDMS newsletter. We believe it is possible to have the best of both worlds, the popular 3D opportunity for parents but in a medically safe and supervised setting.

Prenatal ‘Memory’ Ultrasounds are Trendy Yet Risky in Wrong Hands; Darlene Ginnett, RDMS, Pacific Coast Ultrasound, Urges Expectant Parents to Scrutinize Credentials

--90 percent of expectant parents surveyed had little or incorrect knowledge about the short- and long-term risks of undergoing a 3D/4D ultrasound--

Los Alamitos, CA, March 30, 2007 ----Congratulations. You are having a baby! Now you can sit back and enjoy your nine months of pregnancy worry free. Right? “Wrong,” says Darlene Ginnett, RDMS, CEO of Pacific Coast Ultrasound, a Los-Alamitos, CA-based certified independent diagnostic facility that specializes in prenatal ultrasound offering full diagnostics as well as 3D/4D limited diagnostic/elective ultrasounds.
Ginnett’s important message is this: Now is the time to arm yourself with all sorts of vital healthcare information to ensure that you and your baby enjoy nine healthful months, starting with understanding the risks and benefits of choosing to have a trendy 3D/4D elective memory or “keepsake” ultrasound. Expectant parents should know that they have the choice of both worlds: a wonderful emotional look at their infant before birth and the assurance of medical safety by choosing carefully the facility for their memories ultrasound.
In a recent survey conducted by Los Alamitos-based Pacific Coast Ultrasound, it was alarming to discover that 90 percent of expectant parents surveyed had little or incorrect knowledge about the short- and long-term risks of undergoing a 3D/4D ultrasound. One of the most startling revelations was that expectant parents believed that all memories or “keepsake ultrasound facilities” are equal. They are not.
According to Ginnett, it is vitally important for the public to be aware of the difference between keepsake boutique and a full-service, regulatory compliant facility that provides full medical and physician oversight like Pacific Coast Ultrasound. She explains, “Patients have the right to ask about the credentials and supervision of the providing facility, which should employ only registered ARDMS technologists but also include a California board-certified radiologist and medical director. They have the right to ask if they can perform diagnostic examinations and bill healthcare insurance, in addition to providing elective prenatal sessions.”
The memories ultrasound uses 3D and 4D technology to provide for an exciting preview of their baby with detailed graphic image quality and motion. Says Ginnett, “This can be a great way for you and your family to bond with your unborn baby, but it can also pose risks to you and your baby -- a fact very few 3D/4D facilities make public.”

Why is this risky? Ginnett explains that these 3D/4D facilities are increasingly operated by non-medical professionals that provide these tests in unlicensed, and non-regulatory compliant facilities, often by poorly trained or untrained-technicians who are not given a health provider’s approval and without physician oversight. In fact, the FDA and American Institute of Ultrasound in Medicine (AIUM) warn parents-to-be that these non-medical, non-supervised ultrasounds are unapproved and inappropriate.

Ginnett urges expectant parents to scrutinize the medical credentials of the ultrasonographer conducting your 3D/4D scan. Says Ginnett, “Is the technician an unskilled ‘photographer,’ or a certified ultrasonographer – it makes a huge difference.” Pacific Coast Ultrasound is overseen by a board certified medical director and supervising radiologists. Ms. Ginnett holds a Diagnostic Medical Sonography certification and is accredited by the American Registry of Diagnostic Medical Sonographers (RDMS), in the subspecialties of obstetrics/gynecology, and abdomen and small parts.

Should expectant parents be concerned? According to Ginnett, they should absolutely be concerned! Besides concern that unskilled technicians could be performing and interpreting such ultrasounds and that the procedure is not always done under the supervision of a qualified physician, some facilities may be using equipment that is not in good working order.
Roya Rahkshani, MD, a respected obstetrician/gynecologist in Fountain Valley, CA, says that she is concerned if an untrained technician provides the 3D/4D test, a medical condition (mother or baby) or birth defect may go undetected leaving the mother with a false sense of security that her pregnancy is normal and well imaged at these sites.
Moreover, "Not all ultrasounds are created equal," says Nancy Hueppchen, MD, a maternal fetal medicine specialist at Johns Hopkins Hospital in Baltimore. "Patients don't know the level of expertise of the person performing the procedure." Hueppchen says there is also the worry about ultrasounds not being conducted in medical settings. "These portrait facilities are not equipped to provide counseling should something go wrong, or proper guidance if a gross abnormality is suspected," she says.
The FDA also notes that some video companies have been known to use the ultrasound machine on higher energy exposures for as long as an hour to get the pictures. The procedure should always be done at the lowest possible energy output and for the least amount of time. Exposure to ultrasound for longer than the time specified by the FDA for fetal monitoring could pose a potential risk to the health of the mother and her developing fetus. Only a true medically compliant practice has the requirements of following these safe guidelines. For Medicare credentialing these practices must have state board certified reading radiologists and a medical director. The medical director is standard to assure the equipment is safe, calibrated for diagnostic accuracy and to require all medical licenses and CEU’s are up to date on all the ARDMS, (American Registry Diagnostic Sonographer), technologists staffed to perform the studies.


Darlene Ginnett,  CEO,  Pacific Coast UltrasoundApril 30, 2007
Los Alamitos, CA



Christina,it's a lost cause. The ordering physician will never pick up the ball and explain the reason for the obstetrical sonogram. The average patient has no clue of what the sonogram's purpose is. All she cares about is seeing the baby, and her family seeing it as well. The same can be said however, for sonography in general. The public is not aware of the many examinations we perform. As a member of the S.D.M.S., the many comments in the discussion areas will attest to this.

Alex Fernandez, RDMS,  Medical SonographerApril 30, 2007
Bellflower, CA



Entertainment ultrasonography is not an isolated problem from the enterpreneurs setting up 3d/4d entertainment ultrasonography. This all started when a obstetricians started ordering obstetric ultrasound with false reasons because they wanted to satisfy their patient's curiosity of the fetus gender. Majority of obstetricians buy their own ultrasound machines and perform their own ultrasound examinations. The problem is that although their MD, they have not gone through proper training in ultrasonography. I have met an obstetrician that diagnosed twin seeing the head and abd of the same fetus. "Oops, sorry. It's a harmless exam anyway so I'll just tell her the machine was blurry."
But bill the insurance anyways.
That's why the problem really lies in regulating not just sonographers but also the physician operators. After all, they order the exams and some even scan and bill in their own practice.

Nowell April 28, 2007



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