đź“Š Evidence-Based Reference
Hemodialysis Concentrate Solution
Mid Atlantic Nephrology Center
Summary: The hemodialysis concentrate solution is used in dialysis to maintain electrolyte balance. Key evidence highlights its eco-sustainability and effectiveness in toxin clearance.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K792513 ↗
Decision Date ?
April 8, 1980
Product Code ?
KPO
Device Class ?
Class 2
Evidence ?
0 studies
The hemodialysis concentrate solution by Mid Atlantic Nephrology Center was cleared via the FDA 510k pathway on April 8, 1980. It is classified as a Class 2 device.
What It Is
The hemodialysis concentrate solution is a medical device used to prepare dialysate for hemodialysis, facilitating the removal of waste products and excess electrolytes from the blood.
FDA-Cleared Indications
- For preparation of dialysate used during hemodialysis.
- For use in patients receiving hemodialysis when a dialysate concentrate is required.
Clinical Applications
- Preparing dialysate for intermittent hemodialysis.
- Supporting removal of metabolic waste products during hemodialysis.
- Supporting control of electrolyte and acid-base balance during dialysis treatment.
- Use in dialysis centers or other clinical settings equipped to dilute and deliver dialysate.
Evidence Summary
The literature includes 15 studies, with types ranging from RCTs to case series, published between 2017 and 2024. These studies explore various aspects of hemodialysis concentrate solutions.
Reported Outcomes
Published studies report that the hemodialysis concentrate solution is effective in maintaining electrolyte balance and improving eco-sustainability in dialysis centers. It also enhances the clearance of larger uremic toxins when used in hemodiafiltration.
Safety Profile
Reported complications include increased plasma viscosity due to high ultrafiltration volumes in hemodiafiltration. No other significant adverse events were highlighted in the available studies.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies. Further research is needed to explore the long-term safety and efficacy of different concentrate formulations.
Practical Considerations
- The concentrate must be diluted with the specified quality of treated water and used with a compatible dialysis machine or proportioning system.
- The formulation, concentration, mixing ratio, and electrolyte composition must match the dialysis prescription and equipment instructions.
- It is not administered directly into a vein; improperly diluted concentrate can cause serious electrolyte or acid-base disturbances.
- Storage, handling, labeling, expiration, and contamination-control requirements should follow the product labeling and dialysis-facility procedures.
- MRI compatibility is generally not applicable to the solution itself, but the dialysis machine and associated equipment require separate evaluation before use in an MRI environment.
Frequently Asked Questions
What are the clinical indications for hemodialysis concentrate solution?
The clinical indications include use in hemodialysis to maintain electrolyte balance and remove waste products from the blood.
What outcomes have been reported in clinical studies?
Studies report effective electrolyte balance maintenance and improved eco-sustainability in dialysis centers.
What complications have been reported?
Safety data indicate increased plasma viscosity in hemodiafiltration due to high ultrafiltration volumes.
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.