📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Filtration of blood or blood components during transfusion.
- Reduction of leukocyte contamination in transfused blood products.
- Use in a transfusion administration system when blood filtration is indicated by the product labeling or institutional protocol.
Clinical Applications
- Filtering whole blood or blood components during transfusion.
- Reducing leukocyte contamination before blood enters the patient.
- Use during perioperative transfusion when leukocyte-reduced blood filtration is indicated.
- Use for patients receiving transfusions for anemia, blood loss, or other conditions requiring blood-component support.
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.
Practical Considerations
- Confirm the filter's labeled blood-component compatibility, flow rate, priming requirements, and maximum capacity before use.
- Use only with compatible transfusion tubing, connectors, blood products, and administration equipment.
- Inspect the package for damage and follow institutional procedures for priming, air removal, monitoring, and disposal.
- This is a blood-administration filter, not an implantable device; it is generally used for one transfusion episode and then discarded.
- The available record does not establish MRI compatibility, so the device should not be taken into an MRI environment unless current labeling confirms its status.
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.