The Dalkon Shield: Device RegulationThe deadly flaw that created modern device safety
From the show
Rules Written in BloodDiscover how a deadly design flaw revolutionized healthcare regulations. In the 1970s, the Dalkon Shield caused severe infections and deaths, exposing a legal void where medical devices faced less oversight than toys. This tragedy directly forced the FDA to establish the strict risk classification system used today, forever altering the balance between innovation and patient safety.
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