'Keepsake' ultrasounds raise concerns
OPPORTUNITIES ARE INCREASING FOR TAKING PRE-BIRTH PICTURESJul 2, 2006 | www.kentucky.com 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.
Simmering controversy over safety and ethics exploded last year when a famous celebrity 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 who can afford it can buy an ultrasound machine.
In the right hands, ultrasound technology is perfectly safe, many medical experts think. 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."
Typically, doctors do "diagnostic" ultrasound exams at about 20 weeks to check for growth, general anatomy, placental location and for some birth defects. Many will give patients a keepsake snapshot from a diagnostic exam.
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 has harmed a fetus when used properly.
The Food and Drug Administration 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 most states do not license sonographers or regulate keepsake use of the machines.
Dr. Joshua Copel, of Yale University School of Medicine, who headed a task force on "keepsake" ultrasounds last year, says "I wanted to find a way to make it ethical." But medical professional groups had problems with charging patients for non-medical services, and others raised concerns about false alarms or problems being missed by untrained operators.