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hemodialysis transducer protector
Mediflex Intl.
Summary: The hemodialysis transducer protector by Mediflex Intl. is used to prevent contamination in dialysis machines. Key evidence highlights potential breaches leading to hepatitis C transmission.
FDA Clearance Information
Pathway
510K
Number
K900841 ↗
Decision Date
May 15, 1990
Product Code
FIB
Device Class
Class 2
Evidence
0 studies
The hemodialysis transducer protector was cleared through the FDA 510(k) pathway on May 15, 1990. Manufactured by Mediflex Intl., it is 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 crucial in maintaining sterile conditions during hemodialysis procedures.
Clinical Applications
This device is commonly used in hemodialysis settings to ensure the safety and sterility of the dialysis process. It is particularly important in preventing cross-contamination between patients.
Evidence Summary
The literature includes three studies from 2003 to 2011, encompassing various study types such as retrospective and prospective analyses. These studies focus on infection control in dialysis settings.
Reported Outcomes
Published studies report concerns about potential breaches in the transducer protector leading to hepatitis C virus transmission. The studies highlight the importance of maintaining device integrity to prevent infections.
Safety Profile
Reported complications include potential breaches in the transducer protector, which may lead to the transmission of bloodborne pathogens such as hepatitis C. No other specific adverse events were detailed in the studies.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on infection control rather than broader clinical outcomes. Further research is needed to explore long-term efficacy and safety in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for hemodialysis transducer protector?
The device is indicated for use in hemodialysis to prevent contamination and maintain sterile conditions, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported potential breaches in the device leading to hepatitis C transmission, emphasizing the need for proper device integrity.
What complications have been reported?
Safety data indicate potential breaches in the device, which could result in the transmission of bloodborne pathogens like hepatitis C.
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.