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Report says FDA has failed to monitor child medical devices

Ambulatory Safety Monitor, July 21, 2005

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A new report shows that the Food and Drug Administration (FDA) has failed to adequately monitor the safety of children's medical devices, according to The Boston Globe.

The report by a committee convened by the Institute of Medicine, the federal governments adviser on public health, says that the FDA has rarely told information it has learned about device safety to the public.

The report also says that the FDA did not know whether dozens of companies it had asked to monitor the safety of devices used by children had actually done so.

Devices used for children include implants to improve hearing, artificial joints, and plastic tubing to permit chemotherapy, according to The Boston Globe.

There were 151,900 side effects associated with devices in 2004, with only 2,684 involving patients younger than 21. The figure reflecting children's side effects number is thought to be low due to under-reporting.

The committee has called on the FDA to create a system to track the studies conducted by the companies once the FDA contacts them.

It also hopes to involve parents in reporting problems with devices, possibly through the establishment of a database that captures reports submitted by parents. Doctors and consumer advocates are pushing for such a database, according to The Boston Globe.

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