Wednesday, August 31, 2005

Parents flock to fetal heart monitors

Some experts express concern that devices may overexpose fetus to an excess of ultrasound.

By Ron Lieber / Wall Street Journal

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It's a thrilling moment for expectant parents when they get to hear the heartbeat of their unborn child at a prenatal checkup -- so thrilling that some parents can't stand the weeks of wait between appointments.

Now, a new industry has popped up to satisfy their craving for an audible reminder: fetal heart monitors for use at home.

Hand-held devices that are similar to the ones in doctors' offices, which use Doppler ultrasound to amplify the heartbeat, are widely available on the Web at sites like babybeat.com and heartones.com. They can be rented for about $20 to $50 a month, or purchased outright for between $150 and $600.

Several thousand monitors are rented or sold each year to families, according to varying estimates.

It's all part of a move to cater to expectant parents who want to exert the same control over childbirth that they do over their careers and lifestyles.

The problem with the heart monitors is that many Web sites are skirting the law by renting and selling them. Fetal heart monitors are in a class of medical devices regulated by the Food and Drug Administration that patients must have a prescription to purchase.

The concern is that people using the devices without any supervision might overuse them and harm their unborn children by exposing fetuses to more ultrasound than is necessary.

In recent months, two sites, heartbeatsathome.com and fetalsure.com, changed their policies and began requiring prescriptions following a call from a reporter asking how they handle the FDA requirements.

Other sites, however, merely post a note suggesting that users discuss the matter with their doctors. Some, like storkradio.com, ask buyers to pledge that they have consulted a licensed medical professional about the use of the device.

Julie Zawisza, an FDA spokeswoman, says that a pledge doesn't satisfy the prescription requirement. Stork Radio declined to comment on how it currently handles the prescription requirement.

The easy availability of the Doppler monitors has gotten the attention of regulators.

The FDA plans a public meeting later this year to address the question of whether the monitors should be available without a prescription.

Ultrasound technology has been used in obstetrics for nearly 50 years, and dozens of studies have turned up no ill effects on the fetus during normal usage.

The devices that are being used at home typically involve a small wand that is held over the belly and is attached to a base unit with speakers that emit the signature, rhythmic sound of a fetal heartbeat. But none of the studies have involved extended, unsupervised home use by expectant parents.

"Simply because no adverse effects have been revealed, it is not acceptable to conclude that no adverse effects exist," wrote Linda S. Kahan, an FDA deputy director, in response to one physician's petition to allow over-the-counter sales of the monitors.

Continuous Doppler ultrasound, which is what most of the hand-held fetal monitors use to let people listen to the fetus's heartbeat, deploys acoustical energy that is lower in intensity than standard ultrasound. But the energy needs to be emitted more continuously for the machines to do their work.

The risk here is that heat generated could damage developing fetal tissue if used for long periods of time. Most experts agree that the risk, if there is any, is highest during the first trimester.

Despite this theoretical risk, most doctors use these machines themselves. That's because the risk of not using the machines -- and missing an emerging developmental problem -- is much greater than the chances of causing harm.

Many parents buy the hand-held devices for entertainment value, but some doctors say they could be life-saving. Other doctors say it's highly unlikely that a layperson could detect a problem. Many doctors have a more practical objection: They're worried people won't use the machines correctly and will panic when they can't find the heartbeat.