Clinical and regulatory considerations for central venous catheters for hemodialysis

Douglas M. Silverstein; Scott O. Trerotola; Timothy Clark; Garth James; Wing Ng; Amy Dwyer; Marius C. Florescu; Roman Shingarev; Stephen R. Ash

doi:10.2215/CJN.14251217

Clinical and regulatory considerations for central venous catheters for hemodialysis

Douglas M. Silverstein, Scott O. Trerotola, Timothy Clark, Garth James, Wing Ng, Amy Dwyer, Marius C. Florescu, Roman Shingarev, Stephen R. Ash

Research output: Contribution to journal › Article › peer-review

18 Scopus citations

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.

Original language	English (US)
Pages (from-to)	1924-1932
Number of pages	9
Journal	Clinical Journal of the American Society of Nephrology
Volume	13
Issue number	12
DOIs	https://doi.org/10.2215/CJN.14251217
State	Published - Dec 7 2018

ASJC Scopus subject areas

Epidemiology
Critical Care and Intensive Care Medicine
Nephrology
Transplantation

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AU - Shingarev, Roman

AU - Ash, Stephen R.

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Clinical and regulatory considerations for central venous catheters for hemodialysis

Abstract

ASJC Scopus subject areas

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