The answer is a definitive yes. Every day pediatric surgeons across the country improvise using marketed adult devices off-label to treat and save the lives of pediatric patients. Pediatric cardiologists, for example, treating infants with a heart condition that requires a pacemaker, must use an adult-size pacemaker in their patients. Because of the size of the device, the pacemaker must be placed in or near the infant’s abdomen. Dr. Charles Berul, a cardiac electrophysiologist at Children’s National Health System, speaks about a patient, Alice, who received her first pacemaker at three days old. Because she was quite small for her age and the device was large, she was not able to sit upright until she was 13 months old until her body grew sufficiently to accommodate the pacemaker.
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