Burke Eoghan, Devine Michael, Harkins Patricia, Fenn Sarah, Khan Mohammad Faraz, McGuire Barry B
Royal College of Surgeons in Ireland, Dublin, Ireland.
Royal College of Physicians in Ireland, Dublin, Ireland.
J Robot Surg. 2025 May 15;19(1):218. doi: 10.1007/s11701-025-02356-8.
Since the Food and Drug Administration in the United States approved the first robotic platform for use in humans in 2000, there has been a steady increase in the popularity of robotic approaches to surgery. Robotic-assisted surgery (RAS) offers enhanced 3D visualisation of the operative field and increased flexibility and agility of the instruments, amongst other benefits. However, robotic platforms are complex systems and there is evidence that they may be associated with increased patient risk, particularly in the initial learning curve of a surgeon's robotic training. To ensure the continued safe use of RAS, adequate governance policies must be in place to regulate training, ensure patient safety and maximise the benefits of RAS programs. This systematic review synthesises all available evidence on RAS governance structures internationally for the first time. It was conducted and reported per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. This systematic review identified, for the first time, three guidelines offering recommendations on the Governance Structures for RAS programs. We extracted the key recommendations to provide a holistic set of guidelines. Through consensus, we offer recommendations for the composition of a RAS governance committee, the frequency with which the committee should sit, and the remit of the committee, including training, granting of privileges, quality assurance and continued professional development. We also stress future research needs in RAS team credentialing and vendor-agnostic training pathways. These recommendations may serve as a template for establishing future RAS programs.
自2000年美国食品药品监督管理局批准首个用于人体的机器人平台以来,机器人手术方法的普及程度一直在稳步上升。机器人辅助手术(RAS)具有诸多优势,包括增强手术视野的3D可视化以及提高器械的灵活性和敏捷性等。然而,机器人平台是复杂的系统,有证据表明它们可能会增加患者风险,尤其是在外科医生机器人培训的初始学习曲线阶段。为确保RAS的持续安全使用,必须制定适当的管理政策来规范培训、确保患者安全并最大化RAS项目的益处。本系统评价首次综合了国际上关于RAS管理结构的所有现有证据。它是按照系统评价和Meta分析的首选报告项目声明进行并报告的。本系统评价首次确定了三项关于RAS项目管理结构的指南并提出建议。我们提取了关键建议以提供一套全面的指南。通过协商一致,我们就RAS管理委员会的组成、委员会开会的频率以及委员会的职责范围提出建议,包括培训、特权授予、质量保证和持续专业发展。我们还强调了RAS团队资质认证和供应商中立培训途径方面未来的研究需求。这些建议可作为建立未来RAS项目的模板。