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More Oversight Urged for Child Devices

Jul 18, 2005 | AP

Monitoring of medical devices sold for children must be improved, a major new report concludes, citing missed opportunities to uncover side effects and make crucial treatments safer for the tiniest patients.

Improved tracking of device safety and other steps will also benefit adult recipients of medical devices, notes Monday's report from the Institute of Medicine.

But "special focus needs to be on children," said Dr. George Lister, a pediatrician at the University of Texas Southwestern Medical School who co-authored the report.

That's because very often, doctors must jury-rig adult medical devices to fit children's small bodies and special needs. Far fewer medical devices are manufactured especially for children than for adults because the pediatric market is much smaller.

Regardless of pre-sale testing, unanticipated side effects or device flaws can arise once they're used more widely in either adults or children. So manufacturers are required to tell FDA of any reported side effects, and the government sometimes requires makers to study long-term risk even as their products are sold.

Congress asked the Institute of Medicine  an independent group that advises the government on health matters to study postmarket safety monitoring of children's medical devices.

The report concluded that one big problem is a lack of data on how devices affect children's growth and development.

In addition, a youngster's rough-and-tumble lifestyle or the hormonal changes of puberty can affect a device's functioning, noted IOM panelist Mark Bruley, a biomedical engineer at the nonprofit health research agency ECRI.

The panel cited a preschooler who needed an implantable defibrillator to treat a rare irregular heartbeat. While it saved the girl by shocking her heart back into rhythm several times, one day she suddenly collapsed with chest pain. Cardiologists discovered her rapid growth had broken one of the device's parts, causing it to misfire.

Implanted defibrillators are used mostly in adults and haven't been adequately studied in young children, the report said.

Problems can occur even with the simplest devices, like a medication syringe for babies that caused some near-chokings when parents didn't know to remove a hard-to-see clear-plastic cap.

Only if parents or health workers report such problems can safety warnings be issued or devices be built better, the report noted. For example, complaints from a surgeon who suspected static electricity from playground equipment was zapping his patients' cochlear implants led the maker to revamp the hearing devices.

But too often parents and even health workers assume that devices wear out or break, or they don't know to whom they should direct complaints, Lister said.

Among the panel's recommendations:

Congress should give FDA the authority to require postmarket studies of any device; today, it can force them to perform such studies only for certain products.

Congress should require FDA to establish a public database showing those studies' status and findings.

Congress should fund improved postmarket surveillance for device-related problems in both adults and children. Lawmakers authorized an extra $6 million this year for FDA to do that but ultimately never provided the money, the report said.

FDA should collaborate with the National Institutes of Health to prioritize research on devices used on children despite a lack of manufacturers' studies.

FDA should work with parents, patient advocates, health organizations and the industry to increase reporting of side effects or potential device flaws.

The IOM panel "made some important recommendations," said Susan Gardner, who oversees FDA's device tracking and is assessing the report. It already is moving toward enacting one recommendation — creating a public database of certain postmarketing studies.

"Children are always last in line when it comes to safety of drugs and devices," said Mark Isaac of the Elizabeth Glaser Pediatric AIDS Foundation, which is pushing Congress for improvements. "We must raise the level of vigilance for devices used in children or we risk causing serious problems for the young patients we are trying to help."

The device industry's trade group, AdvaMed, declined immediate comment but had told the IOM panel that FDA has adequate authority to ensure device safety.

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