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. Active Agents AlcoholPVP-ITincture of Iodine Aqueous CHG Broad Spectrum Rapid Activity Residual Activity Activity in Blood/Organic Non-Irritating Toxic/Minimal Absorption

9. Combination Products Chlorhexidine and alcohol (ChloraPrep) PVP-I and alcohol Tincture of Iodine

10. Active Agents CHG/ Alcohol Tincture of Iodine PVP-I/ Alcohol Broad Spectrum Rapid Activity Residual Activity Activity in Blood/Organic Non-Irritating Toxic/Minimal Absorption

11. 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

12. 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

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

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