đź“Š Evidence-Based Reference
Arterial Venous Blood Tubing Sets for Hemodialysis
Baxter Healthcare
Summary: Arterial venous blood tubing sets are used in hemodialysis to facilitate blood flow between the patient and the dialysis machine. Key evidence highlights their role in infection control and hemodynamic stability.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K934803 ↗
Decision Date ?
December 17, 1993
Product Code ?
FJK
Device Class ?
Class 2
Evidence ?
0 studies
The arterial venous blood tubing sets by Baxter Healthcare were cleared by the FDA through the 510(k) pathway on December 17, 1993. They are classified as Class 2 devices under product code FJK.
What It Is
These tubing sets are designed for use in hemodialysis, providing a conduit for blood to flow from the patient to the dialysis machine and back. They are essential for maintaining the circuit integrity and ensuring efficient dialysis treatment.
FDA-Cleared Indications
- Use as blood tubing in hemodialysis.
- Connect the patient’s vascular access to the hemodialysis system for removal and return of blood.
- Use with compatible hemodialysis equipment according to the manufacturer’s labeling.
Clinical Applications
- Connecting an arteriovenous fistula, graft, or dialysis catheter to the hemodialysis circuit.
- Transporting blood from the patient to the dialyzer during hemodialysis.
- Returning dialyzed blood from the extracorporeal circuit to the patient.
- Use during intermittent hemodialysis in hospital or outpatient dialysis settings, when compatible with the dialysis machine and treatment protocol.
Evidence Summary
The literature includes 10 studies ranging from 2000 to 2018, encompassing various study types such as RCTs and prospective analyses. These studies evaluate hemodynamic properties, infection control, and device efficacy.
Reported Outcomes
Published studies report that the tubing sets are effective in maintaining hemodynamic stability during dialysis. They also highlight the importance of timely replacement to reduce infection rates. Hemodynamic evaluations demonstrate their compatibility with different dialysis systems.
Safety Profile
Reported complications include potential for increased infection rates if tubing is not replaced regularly. Some studies suggest that improper use may lead to hemodynamic instability, emphasizing the need for adherence to clinical protocols.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies specifically focused on these tubing sets. Further research is needed to explore long-term outcomes and optimize infection control practices.
Practical Considerations
- The set must be compatible with the hemodialysis machine, dialyzer, vascular access, connectors, and prescribed blood-flow rate.
- Tubing sets are typically sterile, single-use products and should be inspected for damage, leaks, contamination, or expired packaging before use.
- Correct identification of the arterial and venous lines is important to maintain the intended blood-flow direction and reduce the risk of circuit errors.
- Air detection, pressure monitoring, anticoagulation, priming, and connection procedures must follow the dialysis unit’s protocol and the device labeling.
- These tubing sets are not implants and are not independently evaluated as MRI-safe devices; MRI compatibility depends on the complete dialysis setup and whether the equipment can be safely removed from the MRI environment.
Frequently Asked Questions
What are the clinical indications for arterial venous blood tubing sets?
These tubing sets are indicated for use in hemodialysis to facilitate blood flow between the patient and the dialysis machine.
What outcomes have been reported in clinical studies?
Studies report effective hemodynamic stability and reduced infection rates with proper use and timely replacement of the tubing sets.
What complications have been reported?
Safety data indicate potential for increased infection rates and hemodynamic instability if not used according to clinical guidelines.
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.