FACTS

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FACTS

• Fibrin Analysis Catheter Testing System

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Background CRBSICatheter Related Blood Stream
Infections

• The high incidence of CRBSIs, and the potential
  for morbidity and mortality related to CVC use,
  have put the prevention of central line
  infections at the forefront of US national health
  care (1).
• It is one of the six initiatives implemented by
  the Institute of Healthcare Improvements 100,000
  Lives Campaign.

1. CDC.(2002).Guidelines for the prevention of
intravascular catheter related infections.
Morbidity and Mortality
Weekly Report,51.
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Background CRBSICatheter Related Blood Stream
Infections

• Approximately 250,000 cases of CRBSI are
  estimated to occur in the US with attributable
  mortality estimated at 12-25 for each
  infection, and cost to the healthcare system is
  estimated to be 25,000 per episode (1).
• Bottom line, approx. 3,200 50,000 deaths per
  year can be attributed to CRBSIs.

1. CDC.(2002).Guidelines for the prevention of
intravascular catheter related infections.
Morbidity and Mortality
Weekly Report,51.
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Background CRBSICatheter Related Blood Stream
Infections

• Infections occur during insertion or use
• 80,000 patients annually in the ICU will develop
  a CRBSI
• Complications will occur in 10 of these patients

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Background CRBSICatheter Related Blood Stream
Infections

• Approximately 20 of CVCs removed for suspicion
  of catheter related blood stream infections
  (CRBSIs) are actually the source of infection (2).

2. Mermel,L.A.,et al.(2001) Guidelines for
management of intravascular catheter-related
infections. Journal of Infusion Nursing, 24(3).
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Treatment for CRBSIs

• Treatment for CRBSI or catheter related sepsis
  (CRS) traditionally is to remove the central line
  and replace it.

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CDC INITIATIVES

• Maximum sterile barriers with insertion
• Proper catheter insertion site selection
• Follow CDC recommendations for catheter care
• CDC guidelines include not replacing catheters
  routinely for prevention of infection or for
  fever alone (1). DO NOT replace CVC for fever
  alone
• DO NOT routinely replace CVCs

1. CDC.(2002).Guidelines for the prevention of
intravascular catheter related infections.
Morbidity and Mortality
Weekly Report,51.
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CURRENT TESTING OF CVCS FOR INFECTION

• Pull line upon suspicion and send tip to lab for
  analysis
• Samples of outer portion of catheter to be
  included
• Blood cultures
• Results in 24-48 hours

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As a Result

• Lines are removed unnecessarily
• Costly to reinsert CVC (if able)
• Blood cultures are NOT conclusive
• Potential for complications with reinsertion

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A New Alternative for Testing CVCs for Catheter
Related Blood Stream Infections

• The FDA-approved FACTS procedure offers a simple
  and economical way to test a CVC for sepsis while
  it remains in-situ (in the patient), preventing
  the unnecessary removal and replacement of
  central venous catheters thus reducing costs and
  improving patient outcomes (3).

3. Catton, J.,et.al.2002. Quantitative culture of
through line blood is an accurate method for the
diagnosis of central venous catheter-related
bloodstream infection without catheter
removal.26th Clinical Congress of Nutrition
Practice.
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FACTS Endoluminal Brush

• A sterile nylon bristled brush in a sterile
  polyurethane sheath
• Attaches to the hub of a CVC, is advanced through
  the line and swabs the biofilm and fibrin in the
  catheter, then is removed with the samples to be
  cultured.
• Determines if the CVC itself is infected prior to
  removal and replacement

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Here is how FACTS works

• The sheath is attached to the catheter hub
  through the slip luer and the brush is introduced
  into the catheter lumen through the hub

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• As the brush passes through the catheter it
  effectively samples the entire internal surface.
  Brushes are available in sizes to accommodate all
  standard CVC specifications.

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• The brush is withdrawn into the sterile sheath
  which is then capped. The brush is never
  contaminated by external contact.

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• 10 ml of blood is withdrawn and the brush and
  blood are sent to the laboratory for testing.
  Standard laboratory techniques (acridine orange
  leukocyte cytospin) provide results within 60
  minutes.

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BENEFITS

• The CVC remains in place
• The entire brush assembly and blood sample are
  sent to the lab
• Results in 60 Minutes (24-48 hrs for blood)
• Catheter is pulled only if positive for
  infection.
• Eliminates the need to remove and reinsert a CVC
  on suspicion of infection.
• Patient morbidity is reduced due to decreased
  insertion of CVCs.
• Reduces the costs of healthcare.
• The procedure can be administered by RNs or MDs.
• The endoluminal brush used in the Fibrin Analysis
  Catheter Testing System is FDA-approved

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• Thank You for Your attention
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