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平衡手术创新与风险:新兴技术、监管及全球可及性的叙述性综述

Balancing Surgical Innovation and Risk: A Narrative Review of Emerging Technologies, Regulation, and Global Access.

作者信息

Saroha Sarup, Patel Akash

机构信息

General Surgery, University College London, London, GBR.

Trauma & Orthopaedics, Royal Free Hospital, London, GBR.

出版信息

Cureus. 2025 Jul 14;17(7):e87957. doi: 10.7759/cureus.87957. eCollection 2025 Jul.

Abstract

Surgical innovation has significantly advanced patient care, enabling complex procedures and improving outcomes. However, the integration of new technologies presents challenges related to patient safety, regulatory oversight, cost-effectiveness, and equitable global access. The balance between fostering innovation and ensuring responsible implementation remains a critical issue in modern healthcare. This narrative review explores the evolution of surgical innovation, highlighting key historical advancements, regulatory frameworks, and emerging technologies such as artificial intelligence (AI) in intraoperative decision-making and virtual reality (VR) in surgical education, as illustrative examples of transformative technologies. It discusses financial and ethical considerations, including the impact of frugal innovation in low-resource settings and the role of tiered regulatory approaches in mitigating risk. Effective adoption of surgical innovations requires adaptable regulatory models, continuous training programmes, and a multi-stakeholder approach that includes policymakers, healthcare providers, and industry leaders. Addressing financial constraints and ethical dilemmas is essential to ensure that novel surgical technologies are accessible, safe, and sustainable. Future efforts should prioritise dynamic regulatory mechanisms, equitable innovation dissemination, and interdisciplinary collaboration to maximise the benefits of surgical advancements while minimising risks. A structured approach, balancing technological progress, patient safety, and global equity, is crucial to shaping the future of surgery.

摘要

外科创新显著推动了患者护理的发展,使复杂手术得以开展并改善了治疗效果。然而,新技术的整合带来了与患者安全、监管监督、成本效益以及全球公平可及性相关的挑战。在促进创新与确保负责任的实施之间取得平衡,仍然是现代医疗保健中的一个关键问题。本叙述性综述探讨了外科创新的演变,重点介绍了关键的历史进展、监管框架以及新兴技术,如术中决策中的人工智能(AI)和外科教育中的虚拟现实(VR),作为变革性技术的示例。它讨论了财务和伦理考量,包括节俭创新在低资源环境中的影响以及分层监管方法在降低风险中的作用。有效采用外科创新需要适应性强的监管模式、持续培训计划以及包括政策制定者、医疗保健提供者和行业领导者在内的多利益相关方方法。解决财务限制和伦理困境对于确保新型外科技术可及、安全且可持续至关重要。未来的努力应优先考虑动态监管机制、公平的创新传播以及跨学科合作,以在将外科进展的益处最大化的同时将风险最小化。一种平衡技术进步、患者安全和全球公平的结构化方法对于塑造外科手术的未来至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a2e/12351193/c7f5026e59c0/cureus-0017-00000087957-i01.jpg

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