What Pediatric Robotic Surgery Since 2000 Suggests About Ethics, Limits, and Innovation

Abstract

Since the US Food and Drug Administration first approved robotic surgery for clinical use in 2000, it has gained widespread adoption across multiple surgical domains.While pediatric surgery has had a relatively slower adoption rate, robotic surgery has nonetheless grown in this context.This work traces the historical and regulatory aspects of pediatric robotic surgery, showing how it incorporated an existing robotic surgical system developed for adults; situates the technology within ethical frameworks for analyzing surgical innovation; and advocates for combined surgeon self-regulation and institutional oversight.Finally, the argument is made that there are key unmet technological needs pertaining to instrument size and adaptability secondary to pediatric robotic surgery's smaller market share and that clinicians and producers of robotic surgical systems should work to address these needs.Pediatric Robotic Surgery Robotic surgery facilitates improved visualization, increased degrees of freedom, and enhanced ergonomics. 1 Since its approval in the United States for clinical use in 2000, robotic surgery has grown rapidly in multiple specialties. 2,3Compared to adult robotic surgery, pediatric surgery-defined as surgery in patients from birth to 17 years-was slower to adopt the technology, but it has nonetheless expanded substantially in the last decade. 4,5,6,7In this work, we trace the historical and regulatory beginnings of pediatric robotic surgery and situate it within ethical frameworks for surgical innovation.We argue that there are key unmet needs pertaining to instrument specificity secondary to pediatric robotic surgery's smaller market share and that stakeholders should work to address these needs. State of the FieldThe US Food and Drug Administration (FDA) approved Intuitive Surgical's da Vinci as the first robotic surgical system for adult laparoscopic surgery in 2000. 8After clearance for use in prostatectomy in 2001, da Vinci gained rapid adoption among urologists and became the dominant surgical system. 2,3,9Soon, new surgical specialties began to incorporate da Vinci without explicit FDA approval for novel use.For example, pediatric robotic pyeloplasty was first reported in 2002. 6Although other robotic surgical devices