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Hemodialysis Tubing Sets
Ofi Biomedica S.P.A.
Summary: Hemodialysis tubing sets by Ofi Biomedica S.P.A. are used in dialysis procedures. Key evidence highlights include studies on chemical leaching and particle spallation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K001971 ↗
Decision Date ?
May 24, 2001
Product Code ?
FIB
Device Class ?
Class 2
Evidence ?
0 studies
The hemodialysis tubing sets by Ofi Biomedica S.P.A. were cleared via the FDA 510(k) pathway on May 24, 2001. They are classified as Class 2 devices.
What It Is
Hemodialysis tubing sets are components used in dialysis to transport blood between the patient and the dialysis machine. They are designed to withstand repeated use and maintain sterility during the dialysis process.
FDA-Cleared Indications
- For use as tubing components in hemodialysis procedures.
- For transporting blood between the patient, the dialyzer, and the hemodialysis machine during extracorporeal treatment.
Clinical Applications
- Connecting the patient's vascular access to the hemodialysis circuit.
- Carrying blood from the patient to the dialyzer for filtration.
- Returning treated blood from the dialyzer to the patient.
- Supporting blood flow through the extracorporeal circuit during hemodialysis.
Evidence Summary
The literature includes three studies ranging from 1986 to 1994, focusing on chemical leaching and mechanical wear. Study types include retrospective analyses and safety evaluations.
Reported Outcomes
Published studies report the determination of cyclohexanone leaching from tubing and the rate of particle release due to pump-induced abrasion. These findings highlight the importance of material integrity in dialysis tubing.
Safety Profile
Reported complications include chemical leaching of cyclohexanone and particle spallation from tubing surfaces. These issues could potentially impact patient safety if not adequately controlled.
Evidence Limitations
The evidence is limited by the age of the studies and the focus on chemical and mechanical properties rather than clinical outcomes. Further research is needed to assess long-term safety and efficacy in diverse patient populations.
Practical Considerations
- The tubing set must be compatible with the dialysis machine, dialyzer, vascular access, connectors, and prescribed blood-flow rate.
- Tubing size and configuration vary by manufacturer and treatment setup; staff should confirm the labeled specifications before use.
- These sets are generally single-use sterile products unless the specific labeling states otherwise. They should be inspected for damage, leaks, particulate matter, or loss of package integrity before use.
- The circuit must be primed and connected using the dialysis unit's infection-control and anticoagulation procedures.
- MRI compatibility should not be assumed. Because the set is used with an extracorporeal circuit and dialysis equipment, MRI-related use requires review of the complete setup and the manufacturer's labeling.
Frequently Asked Questions
What are the clinical indications for hemodialysis tubing sets?
Hemodialysis tubing sets are indicated for use in dialysis procedures to facilitate blood transport between the patient and the dialysis machine.
What outcomes have been reported in clinical studies?
Studies have reported on the chemical leaching of cyclohexanone and the mechanical wear leading to particle spallation in tubing sets.
What complications have been reported?
Safety data indicate complications such as chemical leaching and particle spallation, which could affect patient safety.
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.