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. 2018 Dec 7;13(12):1924-1932.
doi: 10.2215/CJN.14251217. Epub 2018 Oct 11.

Clinical and Regulatory Considerations for Central Venous Catheters for Hemodialysis

Douglas M Silverstein  1 , Scott O Trerotola  2 , Timothy Clark  3 , Garth James  4 , Wing Ng  5 , Amy Dwyer  6 , Marius C Florescu  7 , Roman Shingarev  8 , Stephen R Ash  9   10   11 ; Kidney Health Initiative HDF Workgroup
Affiliations

Clinical and Regulatory Considerations for Central Venous Catheters for Hemodialysis

Douglas M Silverstein et al. Clin J Am Soc Nephrol. .

Abstract

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.

Keywords: chronic dialysis; dialysis access; end stage kidney disease; hemodialysis; hemodialysis access.

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Figures

Figure 1.
Figure 1.
Comparison of overall design of various CVC for acute hemodialysis shows direction of flow and side hole location. Spaces indicate side holes. (A) Shaldon catheters. (B) Uldall concentric catheter. (C) Mahurkar DD catheter.
Figure 2.
Figure 2.
Comparison of the overall design of various CVC for maintenance hemodialysis, with axial cross-section of the catheters shows the locations of side holes and ports. Circles, squares, and spaces indicate side holes or ports. (A) Quinton PermCath (20 French oval cross-section). (B) Mahurkar catheter, single body, DD design. (C) Canaud and Tesio twin catheters. (D) Ash split-tip catheter. (E) Symmetric-tip catheter by Tal. (F) Self-centering catheter (arrowhead indicates position of a self-sealing hole to allow the catheter to be threaded over a single guide-wire or stylet).
See this image and copyright information in PMC

References

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