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interface transfusion blood filter 30
Medical
Summary: The Interface Transfusion Blood Filter 30 is a medical device used to filter blood during transfusions. It is primarily used to reduce leukocyte contamination. Key evidence highlights its role in improving tissue remodeling and reducing adverse transfusion effects.
FDA Clearance Information
Pathway
510K
Number
K823261 ↗
Decision Date
January 7, 1983
Product Code
CAK
Device Class
Class 2
Evidence
0 studies
The Interface Transfusion Blood Filter 30 was cleared through the FDA 510(k) pathway on January 7, 1983. It is manufactured by Medical and classified as a Class 2 device.
What It Is
The Interface Transfusion Blood Filter 30 is designed to filter blood during transfusions, primarily to reduce leukocyte contamination. It is used in clinical settings to improve the safety and efficacy of blood transfusions.
Clinical Applications
This device is commonly used in scenarios where blood transfusions are required, such as during surgeries or in patients with blood disorders. It helps in reducing the risk of transfusion-related complications by filtering out leukocytes.
Evidence Summary
The available literature includes four studies, ranging from 1996 to 2017, encompassing various study types such as RCTs and case series. These studies focus on the device's efficacy in reducing leukocyte contamination and improving clinical outcomes.
Reported Outcomes
Published studies report that the Interface Transfusion Blood Filter 30 effectively reduces leukocyte contamination in platelet concentrates. It has been associated with improved tissue remodeling in certain surgical procedures and enhanced platelet yield during apheresis.
Safety Profile
Reported complications include the potential for platelet loss during filtration. However, the studies emphasize the device's role in minimizing adverse effects associated with leukocyte contamination in transfusions.
Evidence Limitations
The evidence is limited by the small number of studies and varying study designs. Further research is needed to establish long-term outcomes and optimize filtration techniques for different clinical scenarios.
Frequently Asked Questions
What are the clinical indications for interface transfusion blood filter 30?
The device is indicated for use in blood transfusions to reduce leukocyte contamination and associated adverse effects.
What outcomes have been reported in clinical studies?
Studies have reported improved tissue remodeling and reduced leukocyte contamination, enhancing the safety and efficacy of transfusions.
What complications have been reported?
Safety data indicate potential platelet loss during filtration, but overall reduction in transfusion-related adverse effects.
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.