Wednesday, April 17, 2013

Spectrum of Medical Device Use with Children


The use of medical devices with children spans a wide spectrum, includingdevices that are used uniquely with children, devices that are reduced insize or otherwise modified for use with children, and devices that do notdiffer for adult and pediatric use. Use with children is explicitly precluded for some devices.Box 2.2 and the following discussion illustrate the spectrum of pediatricdevice use. The use of particular devices as examples does not necessarilyimply a committee judgment that the devices have been adequatelystudied for short- or long-term safety or effectiveness in use with children.Sometimes children, especially infants, have unique needs or conditionsfor which specialized devices are developed. The infant incubator is anobvious example.

In addition, children may so dominate the target population in need ofa device that the consideration of adult users is secondary rather thanprimary. One example of a device initially developed for children is theatrial septaloccluder. It was originally intended to treat children who havea hole in the wall separating the inflow chambers of the left and right sidesof the heart, but it has also been used to treat adults with that condition. To cite another example,FDA recently granted limited approval for a pulmonary valved conduit (akind of heart valve) that is, again, primarily intended to correct congenitalheart defects in children but can be used with adults. Although congenital heart disease is sometimes regarded as acondition of children, estimates suggest that there are at least as manyadults living with congenital heart disease as there are children.

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