📊 Evidence-Based Reference
Hemodialysis Concentrates
Dove Medical Supplies
Summary: Hemodialysis concentrates are used in dialysis to maintain electrolyte balance and remove waste products from the blood. Key evidence highlights their efficacy in maintaining dialysis water quality and minimizing side effects.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K883068 ↗
Decision Date ?
December 22, 1988
Product Code ?
KPO
Device Class ?
Class 2
Evidence ?
0 studies
The hemodialysis concentrates by Dove Medical Supplies were cleared via the FDA 510(k) pathway on December 22, 1988. They are classified as Class 2 devices under product code KPO.
What It Is
Hemodialysis concentrates are solutions used in dialysis machines to help remove waste products and excess electrolytes from the blood. They are essential in maintaining the chemical balance during hemodialysis treatment.
FDA-Cleared Indications
- Use as dialysate concentrates in hemodialysis.
- Use with a compatible hemodialysis system and appropriately treated dialysis water.
- Use to support removal of metabolic waste products and management of electrolytes during dialysis treatment.
Clinical Applications
- Routine maintenance hemodialysis for patients with kidney failure.
- Dialysis treatment for patients with chronic kidney disease who require renal replacement therapy.
- Preparation of dialysate by mixing the concentrate with treated water in a compatible dialysis machine.
- Electrolyte and acid-base management during hemodialysis under prescribed treatment settings.
Evidence Summary
The literature includes 10 studies, ranging from randomized controlled trials to retrospective analyses, published between 1973 and 2016. These studies focus on the efficacy and safety of hemodialysis concentrates.
Reported Outcomes
Published studies report that hemodialysis concentrates effectively maintain dialysis water quality and reduce microbial contamination. They also highlight the potential for minimizing side effects associated with acetate intolerance by using alternative buffering agents.
Safety Profile
Reported complications include potential microbial contamination if water quality is not adequately controlled. Some studies also mention the risk of hyperacetatemia in patients sensitive to acetate.
Evidence Limitations
The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to explore long-term outcomes and the impact of different buffering agents in diverse patient populations.
Practical Considerations
- The concentrate must be compatible with the dialysis machine, proportioning system, prescribed dialysate formulation, and treated water quality.
- Acid and bicarbonate concentrates may be supplied separately or in formulations intended for a specific mixing system; they are not interchangeable without confirming compatibility.
- Use requires trained dialysis personnel, correct dilution, and verification of conductivity, pH, electrolyte composition, and water quality according to facility protocol.
- The product is not implanted and has no MRI-specific device safety concern; MRI considerations relate to the dialysis equipment, access, and the patient's clinical condition.
- Incorrect concentration, contamination, or improper storage can cause serious electrolyte or acid-base abnormalities.
Frequently Asked Questions
What are the clinical indications for hemodialysis concentrates?
Hemodialysis concentrates are indicated for use in patients undergoing hemodialysis to manage electrolyte balance and remove waste products from the blood.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of dialysis water quality and reduced side effects with alternative buffering agents.
What complications have been reported?
Safety data indicate potential microbial contamination and hyperacetatemia in acetate-sensitive patients.
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.