1. Nguyen OB, Shugart A, Lines C, Shah AB, Edwards J, Pollock D, Sievert D, Patel PR. National healthcare safety network (NHSN) dialysis event surveillance report for 2014. Clin J Am Soc Nephrol 12(7), 1139-1146, 2017.
2. United States Renal Data System. 2018 USRDS annual report: Epidemiology of kidney disease in the Unites States. National Institutes of Health, Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2018.
3. Zimlichman, E et al. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013;173(22):2039-2046.
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5. Hymes, JL et al. Dialysis catheter-related bloodstream infections: a cluster-randomized trial of the ClearGuard HD antimicrobial barrier cap. Am J Kidney Dis. 2017 Feb;69(2)220-227.
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FDA Broadens ClearGuard HD Antimicrobial Barrier Cap Indications
Pursuit Vascular Inc., manufacturer of ClearGuard HD Antimicrobial Caps, the leading antimicrobial device for catheter-based dialysis patients, said the U.S. Food and Drug Administration (FDA) granted clearance for a broader indication of the company’s ClearGuard HD caps to include reduction in the incidence of central-line associated bloodstream infection (CLABSI) in hemodialysis patients with central venous catheters (CVCs). The safety and efficacy of the ClearGuard technology is well established, and ClearGuard HD caps were first cleared for use with hemodialysis catheters in 2013. The expanded clearance was based on post-market clinical surveillance data.
Bloodstream infection is the leading cause for hospitalizations and the second leading cause of death in hemodialysis patients, and catheters cause 70 percent of these infections. The ClearGuard HD cap is the first and only device cleared for sale in the United States that kills infection-causing bacteria inside a long-term catheter. The caps are simple to use, yet highly effective and clinically shown to reduce bloodstream infection.
The expanded clinical indications are a result of a recent study published in the April 2018 Journal of the American Society of Nephrology. The study, conducted by DaVita Clinical Research, demonstrated that use of ClearGuard caps vs. Tego Connector plus Curos caps, lowered the rate of BSIs in hemodialysis patients using CVCs. The study builds on prior research conducted by Frenova Renal Research (Fresenius Kidney Care), published in 2017 in the American Journal of Kidney Diseases, demonstrating that use of ClearGuard HD caps vs. standard CVC caps lowered the rate of BSIs in hemodialysis patients using CVCs.
“Bloodstream infections can have a devastating effect on patients and contribute significantly to healthcare costs for insurers and patients,” said Doug Killion, president and CEO of Pursuit Vascular. “Dialysis patients are particularly vulnerable to infections, and ClearGuard HD caps represent a lifesaving tool that have a real impact on these patients’ lives.”
The ClearGuard HD Antimicrobial Barrier Cap is the first and only device cleared for sale in the United States that kills infection-causing bacteria inside a long-term hemodialysis catheter. The caps are simple to use and clinically shown to reduce central line-associated bloodstream infection. This simple, yet revolutionary single-use device is protected by seven issued U.S. patents, and several other U.S. patents pending. Foreign patents issued and pending.
Headquartered in Maple Grove, Minn., Pursuit Vascular Inc. is developing a family of products designed to protect patients from acquiring life-threatening infections associated with long-term catheter and port use, while reducing the costs of healthcare.
ClearGuard HD Antimicrobial Barrier Cap (ICU Medical) is a central venous catheter (CVC) cap for haemodialysis catheters. The cap includes a rod that extends into the CVC hub. The rod and cap threads are coated with chlorhexidine acetate, a broad-spectrum antimicrobial agent. Chlorhexidine acetate is intended to reduce the presence of pathogenic organisms in the CVC lock to reduce the risk of catheter-related bloodstream infections (CRBSI). When the ClearGuard HD cap is inserted into the liquid-filled catheter, chlorhexidine acetate is released from the rod into the catheter lock solution. The antimicrobial agent is held inside the catheter hub in between treatments using the existing catheter clamp. ClearGuard HD caps are used in place of a standard cap or connector and need to be replaced every dialysis session. The recommended maximum use time for the cap is 3 days.
The ClearGuard HD cap is intended to replace the need to clean the connector port with 2% chlorhexidine in 70% alcohol and then have to wait for it to air dry. This could save time for healthcare staff and potentially reduce the risk of CRBSI.
Current care pathway
The current standard care makes recommendations about minimising infection risk for vascular access devices. This includes decontaminating the injection port or vascular access device catheter hub before and after accessing the system using 2% chlorhexidine gluconate in 70% alcohol. The hub should be cleaned for 15 seconds and allowed to dry before access. If the manufacturer's recommendations prohibit the use of alcohol with their catheter, an aqueous solution of chlorhexidine gluconate should be considered. The recommendations also state that antibiotic lock solutions and systemic antimicrobial prophylaxis should not be used routinely to prevent CRBSI.
The following publications have been identified as relevant to this care pathway:
Population, setting and intended user
ClearGuard HD is intended for use in people who need haemodialysis using CVCs. This device would be used mainly by vascular access specialist nurses in dialysis clinics as well as in home dialysis. Users of the ClearGuard HD caps are trained using videos available on the company website. Further training can be requested at no additional cost. Healthcare professionals may need awareness training regarding chlorhexidine allergy according to national audit projects (NAP) 6: perioperative anaphylaxis.
The cost of a pair of ClearGuard caps is £4 per pair of caps. Haemodialysis would normally be needed 3 times a week and the caps would need to be replaced at each dialysis session, leading to a cost of £12 a week. The company have estimated that haemodialysis patients would need a CVC for an average of 132 days (estimated by the company based on Kwak et al., 2012, Crowley et al., 2017 and Hymes et al., 2017) until a more permanent form of vascular access is established. This would lead to a cost of £226 per person over this period.
Costs of standard care
The cost of a standard CVC cap is around £0.30 to £0.40 per cap. The cap would be disinfected with an alcohol wipe, which costs around £0.02 per wipe (including those containing 2% chlorhexidine gluconate).
The ClearGuard HD could be used as a replacement to a standard CVC cap, without an overall change in the care pathway. The ClearGuard cap may reduce healthcare professional time by removing the need to clean the connector port. The cap is thought to lower the incidence of CRBSIs, which would reduce the cost and time needed to treat infections.
Caps clearguard hd
.ClearGuard™ HD Antimicrobial Barrier Caps - ICU Medical
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