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"Keepsake" ultrasounds: Should a medical device be used for fun?
Seattle Times staff reporter
In the world of health care, it's often hard to find the truth amid conflicts over science, turf and money.
Throw in motherhood, babies, bonding — plus a high-profile movie star — and sorting it all out gets even weirder.
"Keepsake" ultrasounds — those adorable fuzzy pre-baby pictures — have pitted eager consumers against industry guidelines and federal finger-wagging over the "off-label" use of a medical device for "entertainment" purposes.
A simmering controversy over safety and ethics exploded last year when Tom Cruise bought an ultrasound machine to peek at his unborn child.
Critics immediately panned Cruise for exposing the baby to "unnecessary risk." Worse, he let the world in on a dirty little secret: Anyone — at least anyone plunking down some serious money — can buy an ultrasound machine.
Incensed California legislators took action. A bill restricting sale of the machines to licensed medical professionals overwhelmingly passed the Assembly there last month and is now in the Senate.
If you've decided to get a "keepsake" ultrasound:
Don't have an ultrasound for more than half an hour. While the risk is likely small, experts warn against lengthy exposures unless there's a medical necessity. Most places that do "keepsake" ultrasound scans will let a woman have a rain check if they can't get a good picture in 10 or 15 minutes because of fetal position.
Know the difference between a "diagnostic" and a "keepsake" ultrasound. Does your doctor approve of a "keepsake" exam? Critics say some women may be confused, mistakenly thinking that the "keepsake" ultrasound scan will be used to look for and diagnose possible problems. Some sonographers at retail studios say they will alert doctors if the scan reveals possible problems, but customers should not assume they will.
Carol Ostrom, Seattle Times staff reporter
In the right hands — likely not Tom Cruise's — ultrasound technology is perfectly safe, many medical experts believe. But when it comes to keepsake ultrasounds, in most states there's a gaping hole between local and federal oversight that some worry could leave consumers at risk.
"It's an unregulated industry that's using medical diagnostic equipment without supervision," says Dr. Larry Shields, an obstetrician-gynecologist at the University of Washington Medical Center. "At the same time, if the equipment is used properly, you cannot say that that extra scan, done purely for entertainment, is harmful."
Consumer enthusiasm for the pictures has created a cottage industry of entrepreneurs, including two in the local area, offering ultrasound pictures and videos.
Both local studios — Baby Pictures Ultrasound in Bellevue and Innervision Ultrasound in Seattle's Greenwood area — are owned and operated by trained medical sonographers with considerable experience. In addition, some medical clinics will do keepsake scans.
The newer 3-D technology, which gives the appearance of depth, and 4-D, which adds the time dimension to create a video or DVD, can create startlingly clear pictures after about 30 weeks of gestation. Cost is typically about $200.
Shelley Whitney, a 28-year-old Green Lake-area mother-to-be, said she and her husband broke into tears recently at Innervision as they watched their unborn daughter suck her thumb, yawn and stretch.
For her husband, that made her pregnancy "real," she said.
"As soon as we got home, he was like, 'Let's watch the DVD!' "
Deirdre and John Hayes, of Kenmore, saw Shane in the womb in February at Innervision. He was flipping them the bird, a gesture he's continued since birth May 2, John said. "We know they didn't switch babies in the hospital!"
On a more serious note, the DVD allowed Deirdre's father, on his deathbed in Ireland, to see images of his grandson before he died, John said.
"Keepsake" fetal ultrasounds
Here's the word from the FDA and a professional group:
The American Institute of Ultrasound in Medicine (AIUM): Advocates "responsible use" of diagnostic ultrasound, despite "growing pressures from patients" for keepsake images for "bonding and reassurance purposes."
Bottom line: Images or videos done for medically indicated reasons can be given to parents at cost. Imaging must be done by "appropriately trained and credentialed medical professionals" — licensed physicians, registered sonographers or candidates for registration — who have received specialized training in fetal imaging to recognize abnormalities and "artifacts" that could be mistaken for abnormalities, and who use techniques to avoid unsafe exposures. All imaging must be documented, signed by a physician, and added to the patient medical record.
On the Web: www.aium.org/publications/
Food and Drug Administration (FDA): Persons who promote, sell or lease ultrasound equipment for making "keepsake" fetal videos are engaged in the unapproved use of a medical device. 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.
On the Web: www.fda.gov/cdrh/consumer/
So what's the problem? Happy consumers pay a little cash, get pictures, go away reassured and more bonded to the little cupcake in the oven.
At the heart of the dispute is the use of a "medical device" for "entertainment."
Typically, doctors do "diagnostic" ultrasound exams at about 20 weeks to check for growth, general anatomy, placental location and for some birth defects.
Since the late 1990s, when cheap, fast computer power helped put 3-D and 4-D technology and its awesome images into many clinics, parents have begged for more pictures.
Ultrasound, which uses sound waves instead of radiation, has to be one of the safest scanning technologies around. Used for more than 30 years, there's no evidence it's ever harmed a fetus when used properly.
Still, most doctors have been reluctant to schedule non-medical ultrasound sessions, although many will give patients a keepsake snapshot from a diagnostic exam.
The clearest keepsake pictures, though, are taken later in pregnancy, prompting patients to search for places that will do sonograms strictly for fun.
Some clinics, such as The Everett Clinic, have responded to consumer demand by offering separate keepsake sessions.
Dr. Erica Peavy, associate medical director, says the technology is safe and has been widely used in clinics for years.
Catherine Russell, clinic spokeswoman, said non-medical ultrasounds, like cosmetic surgery or Botox injections, are not "medically indicated," but something patients want.
At $175 for images and a video, "it's not a moneymaker," she says.
"We offered it because patients were asking for it, and we wanted to make sure it was offered in a comprehensive medical setting under physician direction. We didn't want them going off to the mall."
Going to "the mall"
Around the country, though, "the mall" is where most prospective parents have been getting their videos and pictures.
But who is operating that machine?
Both Melissa Dachs at Baby Pictures and Innervision's Heidi Toy are trained sonographers registered with the American Registry of Diagnostic Medical Sonographers.
Dachs, a former X-ray technician who has 16 years' medical ultrasound experience, says Baby Pictures, which opened in 1994, was the first keepsake studio in the nation.
Innervision Ultrasound, one of United Imaging Partners' network of 90 studios around the country, is owned and operated by Toy, a registered sonographer since 1992 and former product manager for a local ultrasound company.
Dachs requires women to be under prenatal care, and Toy requires verification of a previous diagnostic ultrasound. Both require permission from a woman's doctor, and, while they emphasize the difference between a diagnostic exam and a keepsake scan, both say they will call the doctor if the scan reveals a possible problem.
Mostly, though, they just have fun with their clients.
"There's a lot to be gained from bonding, from reassuring people," Dachs says.
But, she cautions, clients should always ask about the training of the ultrasound operator. In one retail establishment she checked, the operator was a receptionist and the "physician adviser" was a podiatrist.
Her training in medical sonography was as rigorous as nursing school, Dachs says. And while ultrasound is very safe, an untrained person could turn the wrong dial, possibly doing harm. "It's a lot more involved than just pushing on a button," Dachs says.
The Food and Drug Administration (FDA) considers keepsake fetal videos an "unapproved use of a medical device," and says using one without a physician's order may violate state or local laws.
But this state, like most, does not license sonographers or regulate keepsake use of the machines. "Anyone could do the ultrasound," says Deanna Whitman, a spokeswoman for the state Department of Health. "There's no oversight by the state."
Safety is key
Dr. Joshua Copel, of Yale University School of Medicine, who headed a task force on keepsake ultrasounds for the American Institute of Ultrasound in Medicine last year, says "I wanted to find a way to make it ethical."
But medical professional groups had problems with charging patients for nonmedical services, and others raised concerns about false alarms or problems being missed by untrained operators, he says.
He notes that the FDA says while ultrasound fetal scanning is "generally considered safe," it "cannot be regarded as completely innocuous" because it can produce vibrations and rise in temperature of tissues. While there is no evidence these physical effects harm a fetus, the FDA says, "casual exposure" ought to be avoided.
Shields, at the UW, says the machine wasn't designed to make "pretty baby pictures." High settings can cause "thermal heating of tissue," he says. "If it's high enough, you literally fry the tissue." So it's "incredibly important" that the operator understand the underlying physics, he says.
Copel says there's little risk to a fetus if the ultrasound is done by a trained sonographer. Even so, he adds, "If there is any risk — and I believe it's small — I want to have some medical benefit."
Carol M. Ostrom: 206-464-2249 or email@example.com
Copyright © 2006 The Seattle Times Company