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Chlorhexidine & the Blood Donor

Chlorhexidine & the Blood Donor. Cynthia T Crosby TJ Smith December 12, 2002. OVERVIEW. Antiseptic Agents - QUICK REVIEW NDA submission Overview of DATA CHG in vascular access Blood Donor Facilities & the National Blood Service (UK) Q & A. Alcohol. Broad spectrum

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Chlorhexidine & the Blood Donor

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  1. Chlorhexidine & the Blood Donor Cynthia T Crosby TJ Smith December 12, 2002

  2. OVERVIEW • Antiseptic Agents - QUICK REVIEW • NDA submission • Overview of DATA • CHG in vascular access • Blood Donor Facilities & the National Blood Service (UK) • Q & A

  3. Alcohol • Broad spectrum • Denatures cell proteins and dissolves cell lipids • Concentration • Ideal at 70% to 90% • Quick dry time • Rapidity of action: immediate • Lack of residual property • Irritation • Flammability

  4. Iodophors • Iodine complexed with an inert polymer • Why? To Reduced skin irritation and sensitization • Effects are neutralized by blood • 2 to 3 minute dry time • Sensitivity and toxicity issue, especially infants

  5. Tincture of Iodine • Combination product • 1% or 2% free available iodine • Quick to dry • Irritation? • Mechanism: • Free iodine penetrates cell and replaces components • Effects are neutralized by organic material (blood)

  6. Chlorhexidine • Primary advantages: • Residual activity • Affinity to bind to the skin • Superior efficacy • Less skin irritation • Broad-spectrum • Activity in the presence of organic matter #1

  7. IDEAL Antiseptic PROPERTIES: • Broad spectrum • Rapid bactericidal activity • Persistent • Active in BLOOD/Organic • Non-irritating • Minimal absorption

  8. Combination Products • Chlorhexidine and alcohol (ChloraPrep) • PVP-I and alcohol • Tincture of Iodine * Convenience * Compliance

  9. NDA submission & DATA • ChloraPrep is a combination product • 2% chlorhexidine gluconate • 70% isopropyl alcohol • Clinical DATA • 2% CHG/70% IPA combination demonstrated a greater log reduction than • 10% PVP-I • 70% isopropyl alcohol • 2% aqueous CHG

  10. What Prep to Use? • Povidone-Iodine (2 step procedure) • Standard prep for donor prep (AABB) • Tincture of Iodine and CHG are superior to Povidone-Iodine • Tincture of Iodine (2 step procedure) • Proposed for “Standards of Blood Banking and Transfusion” • 2% Chlorhexidine-based (1-step procedure) • Equivalent to Tincture of Iodine • Proposed as an Alternative Prep • COMPLIANCE TO PROTOCOL

  11. New CDC Guidelines • Prevention of Intravascular Catheter-Related Infections • Education and dedicated resources • IV Teams • Phlebotomy Teams • Maximal Barriers • 2% chlorhexidine-based antiseptic

  12. Preventative measures are the highest quality in medical treatment and the most cost efficient!

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