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hemodialysis bath
Medi-Tech
Summary: The hemodialysis bath by Medi-Tech is a device used in dialysis to manage fluid and electrolyte balance in patients with renal failure. Key evidence highlights its role in managing mineral metabolism disorders and cardiovascular risks.
FDA Clearance Information
Pathway
510K
Number
K922990 ↗
Decision Date
September 12, 1994
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The hemodialysis bath by Medi-Tech was cleared by the FDA through the 510(k) pathway on September 12, 1994. It is classified as a Class 2 medical device under product code KPO.
What It Is
The hemodialysis bath is a medical device used in hemodialysis to help manage fluid and electrolyte balance in patients with renal failure. It is designed to facilitate the removal of waste products and excess fluids from the blood.
Clinical Applications
Commonly used in patients with end-stage renal disease, the hemodialysis bath is integral in dialysis sessions to maintain electrolyte balance and prevent complications such as fluid overload and mineral metabolism disorders.
Evidence Summary
The available literature includes 12 studies ranging from 1989 to 2021, encompassing various study types such as RCTs, prospective, and retrospective studies. These studies explore the device's impact on mineral metabolism and cardiovascular health.
Reported Outcomes
Published studies report that the hemodialysis bath is effective in managing mineral metabolism disorders and reducing cardiovascular risks in dialysis patients. It also plays a role in addressing fluid overload and improving patient outcomes.
Safety Profile
Reported complications include potential cardiovascular events and bone health issues related to mineral metabolism imbalances. Some studies highlight the importance of dialysate composition in mitigating these risks.
Evidence Limitations
Evidence gaps exist in long-term outcomes and the impact of different dialysate compositions. Further research is needed to optimize dialysate prescriptions and understand the full spectrum of safety and efficacy.
Frequently Asked Questions
What are the clinical indications for hemodialysis bath?
The hemodialysis bath is indicated for use in patients undergoing dialysis to manage fluid and electrolyte balance, particularly in those with end-stage renal disease.
What outcomes have been reported in clinical studies?
Studies have reported improvements in mineral metabolism and reductions in cardiovascular risks, as well as effective management of fluid overload.
What complications have been reported?
Safety data indicate potential cardiovascular events and bone health issues, highlighting the need for careful management of dialysate composition.
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.