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 journalArticlepeer-review

1 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 languageEnglish (US)
Pages (from-to)1924-1932
Number of pages9
JournalClinical Journal of the American Society of Nephrology
Volume13
Issue number12
DOIs
StatePublished - Dec 7 2018

ASJC Scopus subject areas

  • Epidemiology
  • Critical Care and Intensive Care Medicine
  • Nephrology
  • Transplantation

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