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The story details how medical device companies have benefited, and many consumers have been injured, because of a 25-year-old loophole, repeatedly expanded by Congress despite sharp criticism from health safety advocates, that allowed medical devices never tested on humans to be put directly into use. The reporters show that dozens of different devices approved through this loophole have malfunctioned over the years, injuring tens of thousands of patients. Doctors, health advocates and the General Accounting Office have called for changes to the law. But, in part because of heavy donations to members of a key House committee, the loophole remains - and some members of Congress are trying to expand it.