Devices made for adults are often adapted for children. All too often in medicine, 'children are merely treated like miniature adults.'

The report by the National Academy of Sciences' Institute of Medicine found that the FDA lacks effective procedures for monitoring safety studies that the agency sometimes demands of manufacturers when approving devices. It calls on Congress to make sure the FDA establishes procedures and makes information from studies available to the public.

The academy is chartered by Congress to advise the government on science policy and regulatory questions.

"It's all about protecting the health of children," says Hugh Tilson, chairman of the institute committee that wrote the report and professor of epidemiology at the University of North Carolina-Chapel Hill.

'Treated Like Miniature Adults'

FDA officials say the report offers an important blueprint for reform. "In some areas we've made significant strides; in other areas we still have a job to do," says Susan Gardner of the FDA's Center for Devices. "The report will be very helpful to us. It targets areas where we need to improve."

The analysis was prompted by a provision in an FDA reform bill in 2002 by Rep. Diana DeGette, D-Colo. DeGette, who has long focused on children's health, says that all too often in medicine, "children are merely treated like miniature adults."

Medical manufacturers make thousands of devices that are used for children, as diverse as lice combs and limb prostheses. Some devices are designed solely for use in medical settings; others are meant for use at home. More than half of all devices are considered "high risk" and require FDA approval.

Many, such as mechanical ventilators, do double duty "as the care of children shifts from the hospital to home," says report co-author George Lister of the University of Texas Southwestern Medical School in Dallas.

"There's not much data to tell us how these devices function in the real world."

Meeting Children's Special Needs

The report focuses only on devices that have been approved. It doesn't address drug firms' reluctance to study experimental devices in children before the devices reach the market or to manufacture devices that meet children's special needs.

Devices made for adults are often adapted for children. "It's called jury-rigging. It's what we do around here frequently," says Kathy Jenkins of Harvard's Children's Hospital.

"Innovative physicians can become very good at it, but it isn't always the safest or best way to proceed."