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Hemodialysis Blood Tubing Set
National Medical Care, Medical Products Div.
Summary: The hemodialysis blood tubing set is used in dialysis to facilitate blood flow between the patient and the dialysis machine. Key evidence highlights immune responses and iron loss during hemodialysis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K920797 ↗
Decision Date ?
September 21, 1992
Product Code ?
FJK
Device Class ?
Class 2
Evidence ?
0 studies
The hemodialysis blood tubing set was cleared by the FDA through the 510(k) pathway on September 21, 1992. It is manufactured by National Medical Care, Medical Products Division and is classified as a Class 2 device.
What It Is
The hemodialysis blood tubing set is a medical device used to connect the patient's vascular access to the dialysis machine, allowing for the removal of waste products from the blood. It is essential in the process of hemodialysis, which is used to treat patients with renal failure.
FDA-Cleared Indications
- Used as blood tubing for extracorporeal blood circulation during hemodialysis.
- Used to connect the patient's vascular access to the hemodialysis machine and dialyzer.
Clinical Applications
- Hemodialysis for patients with chronic kidney disease and kidney failure.
- Hemodialysis for patients with acute kidney injury when extracorporeal blood circulation is required.
- Connection of an arteriovenous fistula, arteriovenous graft, or dialysis catheter to the hemodialysis circuit.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs, prospective, retrospective, and case series. The studies span from 2008 to 2023, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the hemodialysis blood tubing set is effective in facilitating the dialysis process, although it may induce immune responses as noted in studies on neutrophil activation. Iron loss during hemodialysis is also documented, highlighting the need for monitoring iron levels in patients.
Safety Profile
Reported complications include hypersensitivity reactions associated with ethylene oxide sterilization and hemolysis due to tubing kinks. These findings underscore the importance of monitoring for adverse events during dialysis.
Evidence Limitations
The evidence is limited by the lack of large-scale, long-term studies specifically focused on the hemodialysis blood tubing set. Further research is needed to explore the long-term safety and efficacy of the device, as well as to develop strategies to mitigate reported complications.
Practical Considerations
- Tubing sets must be compatible with the dialysis machine, dialyzer, vascular access, anticoagulation system, and prescribed treatment flow rates.
- The set is sterile and intended for single use; it should be inspected for damage, leaks, particulate matter, or expired packaging before use.
- Correct connection of the arterial and venous limbs is essential to reduce the risk of blood loss, air entry, clotting, or inadequate dialysis.
- This external tubing is not an implanted device and is not independently evaluated as an MRI device; MRI safety depends on the complete dialysis setup and whether the machine and circuit can be removed from the scanner environment.
- Potential complications include bleeding, air embolism, blood loss, clotting, infection, hemolysis, and inaccurate monitoring if the tubing is incorrectly connected or handled.
Frequently Asked Questions
What are the clinical indications for hemodialysis blood tubing set?
The device is indicated for use in hemodialysis to facilitate blood flow between the patient and the dialysis machine, primarily for patients with renal failure.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of dialysis, with noted immune responses and iron loss as key outcomes.
What complications have been reported?
Safety data indicate hypersensitivity reactions and hemolysis as potential complications during use.
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.