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Child Device Oversight Urged

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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.