Related Experiment Video

Updated: Feb 4, 2026

The Supraclavicular Fossa Ultrasound View for Central Venous Catheter Placement and Catheter Change Over Guidewire
07:47

The Supraclavicular Fossa Ultrasound View for Central Venous Catheter Placement and Catheter Change Over Guidewire

Published on: December 23, 2014

20.1K

Clinical and Regulatory Considerations for Central Venous Catheters for Hemodialysis

Douglas M Silverstein1, Scott O Trerotola2, Timothy Clark3

  • 1Center for Devices and Radiological Health, Division of Reproductive, Gastro-Renal, and Urological Devices, Renal Devices Branch, US Food and Drug Administration, Silver Spring, Maryland.

Clinical Journal of the American Society of Nephrology : CJASN
|October 13, 2018
PubMed

Insights

Central venous catheters are crucial for hemodialysis patients. This workgroup identified key design and regulatory challenges to foster innovation and improve patient outcomes.

Area of Science:

  • Nephrology
  • Medical Devices
  • Regulatory Science

Background:

  • Central venous catheters (CVCs) are essential for maintenance hemodialysis access.
  • Clinical and regulatory landscapes for CVCs are complex and evolving.
  • Stakeholders include patients, healthcare providers, industry, and regulatory bodies.

Purpose of the Study:

  • To identify major design considerations for hemodialysis CVCs.
  • To address clinical and regulatory challenges associated with hemodialysis CVCs.
  • To foster innovation and improve patient outcomes in maintenance hemodialysis.

Main Methods:

  • Convened a workgroup with representatives from academia, industry, and the US Food and Drug Administration (FDA).
  • Focused on identifying key design, clinical, and regulatory aspects of CVCs for hemodialysis.
  • Aimed to create a foundation for strategies promoting CVC innovation.

Main Results:

  • Identified critical design considerations for hemodialysis CVCs.
  • Outlined significant clinical challenges impacting CVC use.
  • Highlighted key regulatory hurdles affecting CVC development and approval.
  • Emphasized the need for transparent regulatory review to stimulate innovation.

Conclusions:

  • Improved understanding of CVCs is necessary for better patient care.
  • Collaborative efforts are vital to address design and regulatory challenges.
  • Fostering innovation in CVC technology can lead to enhanced outcomes for hemodialysis patients.

Keywords:
chronic dialysisdialysis accessend stage kidney diseasehemodialysishemodialysis access

More Related Videos

A Protocol to Set Up Needle-Free Connector with Positive Displacement on Central Venous Catheter in Intensive Care Unit09:57

A Protocol to Set Up Needle-Free Connector with Positive Displacement on Central Venous Catheter in Intensive Care Unit

Published on: July 13, 2019

13.8K
Use of a Central Venous Line for Fluids, Drugs and Nutrient Administration in a Mouse Model of Critical Illness09:17

Use of a Central Venous Line for Fluids, Drugs and Nutrient Administration in a Mouse Model of Critical Illness

Published on: May 2, 2017

9.4K

Related Concept Videos

Venous Thrombosis II: Clinical Manifestations and Diagnostic Studies01:20

Venous Thrombosis II: Clinical Manifestations and Diagnostic Studies

The key difference between Superficial Vein Thrombosis (SVT) and Deep Vein Thrombosis (DVT) lies in their location and severity.Clinical ManifestationsSVT typically presents with localized pain, tenderness, and redness along the course of a superficial vein, often accompanied by a palpable, cord-like structure under the skin. This condition is usually less dangerous than DVT but can be uncomfortable and may lead to complications such as cellulitis or, rarely, a clot extension into the deep...
345
Cis-regulatory Sequences02:02

Cis-regulatory Sequences

Cis-regulatory sequences are short fragments of non-coding DNA that are present on the same chromosomes as the genes that they regulate. These fragments serve as binding sites for transcriptional regulators, proteins that are responsible for controlling gene transcription and differential gene expression across cell types in eukaryotes. Cis-regulatory sequences can be close to the gene of interest or thousands of bases away in the DNA sequence; however, those sequences that are further away are...
11.8K
Hemodialysis I: Introduction01:25

Hemodialysis I: Introduction

Hemodialysis (HD) is a medical treatment that artificially removes waste products, excess fluids, and toxins from the blood when the kidneys are no longer able to perform these functions effectively. In this process, blood is filtered through a semipermeable membrane, allowing for the selective removal of waste while preserving necessary components like blood cells and proteins. Hemodialysis is typically performed in patients with end-stage renal disease (ESRD) or severe kidney...
1.7K
Hemodialysis II: Procedure and Complications01:24

Hemodialysis II: Procedure and Complications

DialyzersA hemodialysis (HD) dialyzer is a plastic cartridge containing thousands of parallel hollow fibers, which serve as semipermeable membranes. These fibers are typically made from cellulose-based or other synthetic materials. During HD, blood is pumped into the top of the cartridge and distributed among these fibers. Simultaneously, dialysis fluid, known as dialysate, is introduced into the bottom of the cartridge, bathing the outside of the fibers. Across the semipermeable membrane,...
821
Hemodialysis III: Nursing Management01:25

Hemodialysis III: Nursing Management

The nursing management of a patient undergoing hemodialysis includes several critical steps, starting with a thorough assessment before the procedure.Before the Hemodialysis ProcedureFirst, record the patient's vital signs—blood pressure, heart rate, respiratory rate, and temperature—to establish a baseline. This baseline is essential for detecting conditions such as hypotension that could impact the patient's response to dialysis. Document the patient's pre-dialysis weight, as this...
884
Design Consideration01:22

Design Consideration

Designing a structure involves a series of considerations, primarily the material's ultimate strength, calculated through tests that measure changes under increased force until the material reaches its breaking point or limit. The ultimate load, where the material breaks, is divided by its original cross-sectional area, resulting in the ultimate normal stress or strength. The ultimate shearing stress is another significant factor taken into account.
The factor of safety is another key...
576