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hemodialysis concentrate additives
Dana Laboratories
Summary: Hemodialysis concentrate additives by Dana Laboratories are used in dialysis machines to produce dialysis fluid. Key evidence highlights their role in maintaining acid-base balance and potential safety concerns with bisphenol A exposure.
FDA Clearance Information
Pathway
510K
Number
K851431 ↗
Decision Date
June 12, 1985
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The hemodialysis concentrate additives by Dana Laboratories were cleared via the FDA 510k pathway on June 12, 1985. They are classified as Class 2 devices under product code KPO.
What It Is
Hemodialysis concentrate additives are used to create dialysis fluid necessary for hemodialysis treatment. They help in maintaining electrolyte and acid-base balance in patients with renal failure.
Clinical Applications
These additives are commonly used in clinical settings for patients undergoing hemodialysis, particularly those with chronic kidney disease or end-stage renal disease, to ensure proper dialysis fluid composition.
Evidence Summary
The available literature includes 10 studies, comprising RCTs, prospective, and retrospective studies, published between 2016 and 2023. These studies explore various aspects of dialysis fluid composition and its clinical implications.
Reported Outcomes
Published studies report that hemodialysis concentrate additives play a crucial role in managing acid-base balance and electrolyte levels in patients. They also highlight the importance of proper fluid composition in preventing dyskalemia and other complications.
Safety Profile
Reported complications include potential exposure to bisphenol A, which may act as an endocrine disruptor and has been associated with cardiovascular events and carcinogenesis pathways. The safety of dialysis fluid composition is critical in minimizing these risks.
Evidence Limitations
Current evidence is limited by the variability in study designs and small sample sizes. Further research is needed to establish optimal fluid compositions and to explore long-term safety outcomes associated with these additives.
Frequently Asked Questions
What are the clinical indications for hemodialysis concentrate additives?
These additives are indicated for use in hemodialysis to maintain electrolyte and acid-base balance in patients with renal failure.
What outcomes have been reported in clinical studies?
Studies report that these additives help manage acid-base balance and prevent dyskalemia, with a focus on the importance of fluid composition.
What complications have been reported?
Safety data indicate potential risks from bisphenol A exposure, which may lead to endocrine disruption and cardiovascular issues.
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.