More Medical Devices Needed for Babies

From: Atlanta Journal Constitution, GA - Sep 21, 2004

By LAURAN NEERGAARD
AP Medical Writer

WASHINGTON (AP)--Frustrated doctors say they too often find themselves jury-rigging adult medical devices to fit children's tiny bodies and special needs. Now pediatric experts have begun a major push to fill the gap.

''There's an ethical responsibility to assure that we have safe and effective devices for use in children,'' says Dr. Jon Abramson, pediatric chairman at Wake Forest University.

But he and others told a recent meeting organized by the American Academy of Pediatrics of being forced to treat their smallest patients with devices intended for adults, or create makeshift equipment to get the job done.

''It's an incredible burden'' to create innovative pediatric devices, says Dr. Robert Campbell, a University of Texas Health Science Center orthopedic surgeon who spent 15 years struggling to get his expandable artificial rib to market. The Food and Drug Administration approved its sale last week.

''A surgeon from the 1930s would have no difficulty recognizing most of the devices I use to fix deformity or stabilize trauma,'' he added with a sigh.

Pediatricians have long complained that the majority of drugs they prescribe for children are adult medications never properly tested in youngsters. Now medical devices are raising similar concern.

There's no count of how often children receive adult or makeshift devices for lack of a better alternative.

But by month's end, the FDA is to report to Congress the major barriers to developing child devices. The pediatrics academy is hosting a series of meetings this fall to determine doctors' most urgent device needs.

And the prestigious Institute of Medicine is studying how to improve tracking of devices used in children to uncover side effects--like the almost accidental 2002 discovery that children getting cochlear implants to restore hearing are at risk of meningitis and thus should be vaccinated before surgery.

Among specialists' complaints:

• Dialysis equipment often is too big or powerful for very young children.

• Non-invasive ventilators lack masks that fit babies, leading to either inadequate respiratory treatment or invasive treatment, with tubes placed into their throats.

• For the heart, balloons and other equipment used to fix birth defects often don't come in small-enough sizes. Heart pumps that keep patients alive while awaiting a transplant aren't available for tots younger than 5. There's no artificial heart valve that expands as the child grows, requiring repeat surgeries.

• Shunts that alleviate fluid buildup and implanted catheters for intravenous treatments become infected far more often in children than adults, yet there are few efforts aimed at creating germ-resistant pediatric versions.

• Artificial joints and other bone implants don't accommodate children's growth, which can make implants shift to other parts of the body.

Simply making adult devices smaller isn't always enough. They often require engineering changes to account for such differences as young children's naturally faster heartbeat and respiratory rate.

Cost is a major barrier. Manufacturers sell far fewer child devices than adult ones, yet both require extensive and expensive testing for FDA approval. Companies are more likely to take on the challenge if doctors tell them what pediatric devices they need most, says the industry group AdvaMed.

Even then, it's a hard sell, says Texas' Campbell, who recalls ''knocking on a hundred doors'' to find a manufacturer for his artificial rib.

Since Campbell's first implant in 1989, about 300 children have received the rib, experimentally, for a variety of lung-squeezing chest conditions. Made of lightweight titanium, the rib expands somewhat like a drapery rod as the child grows--Campbell simply adjusts the length through a tiny, outpatient incision.

Although it's a small market, the rib can be lifesaving. Consider Andrew Katka of San Antonio, sent home to suffocate at age 6 as muscular dystrophy-induced scoliosis bent his back parallel to the floor.

''This was our last option,'' said his mother, Kim Katka--and it worked. Now 11, Andrew sits almost straight, the implanted rib forcing him upright so his lungs fully fill. Last spring, his twin Jordan received the rib implant, too.

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EDITOR'S NOTE--Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

Copyright 2004, The Associated Press.