Clinical and Regulatory Considerations for Central Venous Catheters for Hemodialysis

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.

Hemodialysis Catheters: Update on Types, Outcomes, Designs and Complications

“…As such, these catheters are described as tunneled or cuffed catheters. 4 In terms of design, the long-term HDC are made with side holes to maintain continuous blood flow during the dialysis process. 4 However, the presence of these side holes is associated with increased turbulence and subsequent intra-luminal thrombosis.…”

“…4 In terms of design, the long-term HDC are made with side holes to maintain continuous blood flow during the dialysis process. 4 However, the presence of these side holes is associated with increased turbulence and subsequent intra-luminal thrombosis. The use of dialysis catheters that have no side holes has been reported to have a lower catheter infection rate.…”

“…11 Optimal catheter tip positioning for IJV catheters is recommended to be within the right atrium, a location that decreases the fibrin cap formation. 4 It is well recognized that the use of HDC in dialysis population is associated with multiple catheter placement, exchange, and removal procedures leading to central venous stenosis and eventually thrombosis, which ultimately limit future vascular access options.…”

“…Starting within days of insertion, FS forms a sleeve that encase the catheter starting at the blood vessel entry point. 4 Once the catheter tip is involved, the FS act as one way valve, allowing catheter flushing and fluid administration, and preventing blood aspiration. The diagnosis is usually clinical and confirmed by injecting contrast under radiographic imaging (►Fig.…”

“…Currently, most of the HD catheters are dual-lumen and use the "DD" internal lumen design, which has low hydraulic resistance and small caliber. 4 HDCs provides vascular access for both short-term and long-term use and can be classified into two groups, nontunneled and tunneled (cuffed) catheters.…”