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Safe Medical Devices for Children
have failed to reduce rates of obstruction. This failure has heightened collective awareness concerning our incomplete understanding of CSF physiology and the pathophysiology of hydrocephalus. The question of whether or not a higher level of FDA regulation and more intense focus on the CSF shunt would have resulted in a shunt with lower risk of infection and malfunction cannot be answered from this retrospective look at the problem. It is, however, an important question worthy of further exploration.
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