ClearGuard® HD End Caps for Hemodialysis Catheters
Catheter-related bloodstream infections (CRBSI) are the greatest threat to the safety of patients dialyzed through catheters. Cleaning and wiping techniques are not always enough.
The first and only device that kills infection-causing bacteria inside a long-term hemodialysis catheter
- Innovative device cleared for sale by FDA
- FDA created a new Product Code (PEH) for this novel technology “for use in hemodialysis catheters to reduce hub infection”
The ClearGuard HD end cap has an antimicrobial-coated rod that extends into the hemodialysis catheter hub. The rod and cap threads are coated with chlorhexidine, a well-known broad-spectrum antimicrobial agent.
How it Works
- Antimicrobial coating is activated when inserted into a liquid-filled catheter
- Coating dissolves to kill harmful microorganisms inside catheter
- Existing catheter clamp holds the antimicrobial agent inside the catheter
- Used in place of regular end cap for a single use
ClearGuard HD end caps effectively kill a broad spectrum of bacteria and fungi known to cause CRBSI*
*For more information regarding organisms associated with CRBSI, refer to Hidron AI, et al. Antimicrobial-Resistant Pathogens Associated With Healthcare-Associated Infections: Annual Summary of Data Reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2006-2007. NHSN Annual Update, Infection Control and Hospital Epidemiology November 2008, vol. 29, no. 11.
Chlorhexidine is a well-known antimicrobial agent with a long history of safety.
The dissolved antimicrobial agent is held inside the catheter by the existing catheter clamp.
The amount of chlorhexidine is controlled to ensure safety even if the clamp is opened.
+ EASY TO USE
ClearGuard HD is as simple to use as a regular end cap.
U.S. Patent Numbers 8,622,995; 8,622,996; 9,022,984; 9,072,868; 9,078,992; 9,352,142;
and other U.S. and foreign patents pending.
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Indications for Use
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.
The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter, and does not migrate to distal portions of the catheter.