Center for Devices and Radiological Health, Division of Reproductive, Gastro-Renal, and Urological Devices, Renal Devices Branch, US Food and Drug Administration, Silver Spring, Maryland.
Interventional Radiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
Clin J Am Soc Nephrol. 2018 Dec 7;13(12):1924-1932. doi: 10.2215/CJN.14251217. Epub 2018 Oct 11.
Central venous catheters remain a vital option for access for patients receiving maintenance hemodialysis. There are many important and evolving clinical and regulatory considerations for all stakeholders for these devices. Innovation and transparent and comprehensive regulatory review of these devices is essential to stimulate innovation to help promote better outcomes for patients receiving maintenance hemodialysis. A workgroup that included representatives from academia, industry, and the US Food and Drug Administration was convened to identify the major design considerations and clinical and regulatory challenges of central venous catheters for hemodialysis. Our intent is to foster improved understanding of these devices and provide the foundation for strategies to foster innovation of these devices.
中心静脉导管仍然是接受维持性血液透析患者的重要选择。对于这些设备的所有利益相关者，都有许多重要且不断发展的临床和监管方面的考虑因素。对这些设备进行创新和透明、全面的监管审查至关重要，这有助于激发创新，帮助接受维持性血液透析的患者获得更好的治疗效果。一个由学术界、工业界和美国食品和药物管理局代表组成的工作组被召集起来，以确定用于血液透析的中心静脉导管的主要设计考虑因素和临床及监管挑战。我们的目的是促进对这些设备的更好理解，并为促进这些设备创新的策略提供基础。
