Devices for kids never tested in kids

Most medical devices used in children have never been tested in children, says a new study.

Researchers from Harvard University looked at all high-risk medical devices-such as stents and artificial heart valves- approved by the US Food and Drug Administration (FDA) for use in children since Congress passed the Pediatric Medical Device Safety and Improvement Act of 2007, which was intended to spur pediatric device development. The Act was reauthorized in 2012 with support from the American Academy of Pediatrics.

The researchers found that the FDA approved 25 devices for use in patients aged younger than 21 years between 2008 and 2011, but approved only 3 of the 25 for children aged younger than 18 years. The FDA Center for Devices and Radiological Health considers patients aged 18 to 21 years as part of the pediatric population.

The investigators then looked at the clinical trials used to obtain FDA approval. They found that more than half (59%) of the devices received approval based on nonrandomized studies. More than two-thirds (68%) were approved based on open-label studies, and more than three-quarters (77%) received approval on the basis of studies that used surrogate effectiveness end points. All but 4 of the devices were untested on any patients aged younger than 18 years.

The FDA approved three-quarters (76%) or 19 of the devices with the stipulation that the manufacturers conduct postmarketing studies, but studies for only 3 of the devices included children.

The researchers recommend that parents ask their children’s physicians how much evidence exists supporting the safety and efficacy of any medical device being used in their children. They also recommend that parents consider allowing children to participate in clinical trials, because without participation, the situation will not improve. 

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