Tuesday, February 15, 2011

Most recalled medical devices received speedy FDA review

The L.A. Times reports:
A disproportionate number of medical devices recalled because of possible links to serious health problems or deaths — including external defibrillators and insulin infusion pumps — were approved under an abbreviated process that did not require advance testing on patients, according to a five-year study of such recalls.

More than 70% of the 113 recalled devices were cleared for market under a shorter Food and Drug Administration review because they were deemed similar to products already on the market, the study found.
Gee, the government imprimatur doesn't provide safety from risk. It's time to separate medicine from state.