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hemodialysis transducer protector
Membrana
Summary: The hemodialysis transducer protector by Membrana is used to prevent contamination in dialysis machines. Key evidence highlights potential breaches leading to infection risks.
FDA Clearance Information
Pathway
510K
Number
K812162 ↗
Decision Date
September 24, 1981
Product Code
FIB
Device Class
Class 2
Evidence
0 studies
The hemodialysis transducer protector was cleared by the FDA via the 510k pathway on September 24, 1981. It is manufactured by Membrana and classified as a Class 2 device.
What It Is
The hemodialysis transducer protector is a device designed to prevent blood contamination in dialysis machines by acting as a barrier. It is used in clinical settings to ensure the safety and efficacy of hemodialysis procedures.
Clinical Applications
This device is commonly used in hemodialysis centers to protect patients from potential infections during dialysis. It is particularly important in settings with high patient turnover and shared equipment.
Evidence Summary
The available literature includes three studies, ranging from 2003 to 2011, focusing on infection risks associated with hemodialysis. Study types include retrospective and prospective analyses.
Reported Outcomes
Published studies report concerns about infection transmission, particularly hepatitis C, due to potential breaches in the transducer protector. These studies highlight the importance of maintaining device integrity to prevent disease spread.
Safety Profile
Reported complications include potential breaches leading to hepatitis C virus transmission in dialysis settings. These incidents underscore the need for rigorous device maintenance and monitoring.
Evidence Limitations
The evidence is limited by a small number of studies and a focus on infection risks without comprehensive data on other potential complications. Further research is needed to explore long-term outcomes and device efficacy.
Frequently Asked Questions
What are the clinical indications for hemodialysis transducer protector?
The device is indicated for use in hemodialysis to prevent contamination and infection transmission.
What outcomes have been reported in clinical studies?
Studies have reported infection risks, particularly hepatitis C, due to potential breaches in the device.
What complications have been reported?
Safety data indicate potential breaches leading to hepatitis C transmission in dialysis settings.
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.