Tightening Rules for Medical Equipment Approval

A 49-year-old businessman and father died during a routine heart procedure. A defective medical device went out of control and slashed his heart tissue. We discovered that, if a 25¢ brake was added during manufacturing, the problem would have been prevented. Loose rules allowed Boston Scientific to avoid FDA review of the equipment. Along with doctors, Garcia & Karam petitioned the U.S. Food and Drug Administration (FDA) to tighten rules on how they approve medical equipment.