đź“Š Evidence-Based Reference
blood tubing lines for hemodialysis al series archloop blood tubing lines for hemodialysis c18 series
Nikkiso
Summary: The blood tubing lines for hemodialysis by Nikkiso are used in dialysis to transport blood between the patient and the dialysis machine. Key evidence highlights their role in preventing coagulation and ensuring biocompatibility.
FDA Clearance Information
Pathway
510K
Number
K230514 ↗
Decision Date
June 16, 2023
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The blood tubing lines for hemodialysis, manufactured by Nikkiso, received FDA clearance via the 510(k) pathway on June 16, 2023. They are classified as Class 2 medical devices.
What It Is
These blood tubing lines are components of the hemodialysis system, facilitating the circulation of blood between the patient and the dialysis machine. They are designed to be biocompatible and minimize the risk of coagulation.
Clinical Applications
Commonly used in chronic and acute hemodialysis settings, these tubing lines are essential for patients requiring renal replacement therapy. They are integral to the extracorporeal circuit in dialysis treatment.
Evidence Summary
The literature includes 15 studies, ranging from 2006 to 2024, encompassing RCTs, prospective, and retrospective analyses. These studies focus on coagulation prevention, biocompatibility, and safety of the tubing lines.
Reported Outcomes
Published studies report that the blood tubing lines effectively prevent coagulation during hemodialysis, with advancements in biocompatible materials enhancing patient outcomes. Optical and electrical characterizations have been explored to improve therapy customization.
Safety Profile
Reported complications include the formation of white thrombus in the tubing lines and potential leakage currents posing a safety risk, particularly in patients with central dialysis catheters.
Evidence Limitations
The evidence is limited by the small number of studies focusing on long-term outcomes and the need for more comprehensive safety evaluations. Further research is needed to explore the integration of advanced sensors in the tubing lines.
Frequently Asked Questions
What are the clinical indications for blood tubing lines for hemodialysis?
These tubing lines are indicated for use in hemodialysis to facilitate blood circulation between the patient and the dialysis machine.
What outcomes have been reported in clinical studies?
Studies have reported effective prevention of coagulation and improved biocompatibility of the tubing lines.
What complications have been reported?
Safety data indicate potential complications such as white thrombus formation and leakage currents, especially in patients with central dialysis catheters.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.