1. Failures of Current Hand Hygiene, and the Search for Solutions
Colette Cozean, PhD

2. Summary Promise of Alcohol Sanitizers Failure of Alcohol Sanitizers
Reasons for Failure
The Ideal Product
Potential Solutions

3. Promise of Alcohol Sanitizers
Alcohol Sanitizer showed more complete kill against bacteria than soap and water
Alcohol is much more convenient, with the potential to decrease time spent while increasing compliance

4. Results of Alcohol Sanitizers
After more than 10 years of alcohol sanitizer use, 5% of patients get an HAI, 90,000 deaths
Studies – 7 comparison studies between handwashing and alcohol sanitizer in medical
4 Studies show alcohol increases infections
2 Studies report improvement in HAIs with alcohol
1 Study shows no difference in surgical site infections
Fendler et al, The Impact of hand sanitizer use on infection rates in an extended care facility, AJIC, 30:4, , 2002
Hilburn et al, Use of alcohol hand sanitizer as an infection control strategy in an acute care facility, AJIC, 31:2, , 2003
Rupp M et al, Prospective, Controlled, Cross‐Over Trial of Alcohol‐Based Hand Gel in Critical Care Units, Infection Control and Hospital Epidemiology; 29:1, 2008
Larsen E et al, Effect of Antiseptic Handwashing vs Alcohol Sanitizer on Health Care–Associated Infections in Neonatal Intensive Care Units, Arch Pediatr Adolesc Med. 2005;159(4):

5. University of Iowa Study
3 ICUs, crossover (multiple) study, 3,000+ pts, compared CHG handwash vs. alcohol sanitizer, sponsored by Calgon-Vestal
Shown significant increase in HAIs with alcohol
Change with Alcohol
Overall
+33.4%
UTI
+40.0%
Skin Infections
+93.0%
GI Infections
+436%
Doebbeling BN, Stanley GL, Sheetz CT, et al. Comparative efficacy of alternative handwashing agents in reducing nosocomial infections in intensive care units, New England Journal of Medicine, 1992; 327: 88-93

6. New York Presbyterian Hospital Study
Nearly 3,000 pts, 2 NICUs, crossover, comparison with 2% CHG handwash
Increase in HAIs of 27.3% overall, and in 4/5 categories, sponsored by 3M (Avagard)
Change with Alcohol
Overall
+27.3%
Bloodstream
+23.0%
Pneumonia
+29.4%
Skin Infections
+77.4%
CNS
+6.0%
Conjunctivitis
-15.8%
Larsen E et al, Effect of Antiseptic Handwashing vs Alcohol Sanitizer on Health Care–Associated Infections in Neonatal Intensive Care Units, Arch Pediatr Adolesc Med. 2005;159(4):

7. University of Nebraska
Two-year study, 2 ICUs, crossover, monitored compliance and HAIs, sponsored by GOJO, compared against PCMX soap
No improvement noted with addition of alcohol sanitizer
Worse than baseline in 4/6 categories, equivalent in 1/6, improvement in 1/6.
Rupp M et al, Prospective, Controlled, Cross‐Over Trial of Alcohol‐Based Hand Gel in Critical Care Units, Infection Control and Hospital Epidemiology; 29:1, 2008

8. Surgical Site Infection Study
Study in 6 surgical centers, randomized, crossover (multiple) 4,000+ pts
Compared alcohol vs. CHG or iodine as a surgical scrub in between patients, when hands were not visibly soiled
No difference between handwashing and alcohol rub (2.48% vs. 2.44%), concluded alcohol was equivalent.
Sponsored by Rivardis Laboratories
Parienti JJ et al, Hand-rubbing with an aqueous alcoholic solution vs. traditional surgical hand-scrubbing and 30-day surgical site infection rates: a randomized equivalence study, JAMA, 2002; 288:

9. Extended Care Facility Study
Showed a 30% decrease, sponsored by GOJO
Compared against a PCMX soap, not CHG or other top-tier antimicrobial
No crossover design
Significant differences between control and experimental groups
Exp. group only in residential wards
Control group on main floor, with cafeteria, dialysis, recreation/activity area, and rehab room – all common areas where germs can be transmitted
Control group (1:8.5 staff/pt), Exp. group (1:4.5)
Fendler et al, The impact of alcohol hand sanitizer use on infection rates in an extended care facility, AJIC, 30:4, , 2002

10. Ortho Surgery Study Showed 36% decrease, sponsored by GOJO
Also compared against PCMX soap
No crossover design
Gave additional education to staff, including in-service, posters, brochures, and reminders, that were not given to controls
Gave patients individual bottles of hand sanitizer and additional education
Only performed in orthopedic surgery suite, not in general ward (SS infections and UTIs)
Hillburn et al, Use of alcohol hand sanitizer as an infection control strategy in an acute care facility, AJIC, 31:2, , 2003

11. Results in Hospitals Improves compliance and skin condition
No improvement in HAIs
Never shown in any trial to be better than top-tier antiseptic handwashes (CHG, iodine, etc.), only PCMX
“PCMX had the weakest immediate and residual activity of any of the agents studied…studies (2) demonstrated the immediate and residual activity of PCMX was inferior to both CHG and povidone- iodine.” – CDC Hand Hygiene Guidelines, 2002

12. Other Medical Trials
Study of 61 long-term care facilities, sponsored by the CDC, largest multi-center look at medical infections ever done.
Showed that facilities that rely on alcohol sanitizers were six times more likely to have an illness outbreak (Norovirus) than ones relying on soap and water alone.
Only study unfunded by sanitizer company, and truly “real-world” situation
Blaney D et al, Use of alcohol-based hand sanitizers as a risk factor for norovirus outbreaks in long-term care facilities in northern New England: December 2006 to March 2007, American Journal of Infection Control, 39 (4) , 2011
CDC, Vessel Sanitation Program,

13. Reasons for Failure
Alcohol sanitizers kill bacteria faster and more completely than soap and water. They are more convenient and more widely used.
Why have we not seen the anticipated drop in infection and illness?

14. FDA Tentative Final Monograph, 1994
Persistence
“Antiseptic handwash….[should be] broad- spectrum, fast-acting, and if possible persistent.”
CDC Guidelines, 2002
“Persistence, defined as prolonged activity, is a valuable attribute that assures antimicrobial activity during the interval between washings, and is important to a safe and effective healthcare personnel handwash”
FDA Tentative Final Monograph, 1994

15. CDC Hand Hygiene Guidelines, 2002
1. Lack of Persistence
“Alcohols are rapidly germicidal when applied to the skin, but they have no appreciable persistent (i.e., residual) activity.”
CDC Hand Hygiene Guidelines, 2002
Kills the bacteria on the skin, but hands can immediately become recontaminated by the next surface or patient touched.
Compliance has to be perfect in order to eliminate risk of transmission

16. CDC Hand Hygiene Research Agenda
Determine if preparations with persistent antimicrobial activity reduce infection rates more effectively than do preparations whose activity is limited to immediate effect CDC Hand Hygiene Guidelines, 2002, “Hand Hygiene Research Agenda”

17. 2. Lack of Compliance
Because HCWs <health care workers> may wash their hands….as many as 30 times per shift, the tendency of products to cause skin irritation and dryness is a substantial factor that influences acceptance, and ultimate usage CDC Hand Hygiene Guidelines, 2002

18. 2. Lack of Compliance
Studies show that healthcare workers only comply with hand hygiene protocols 40-50% of the time
CDC studies have shown that 25% of HCWs have contact dermatitis from their hand hygiene products. Other studies put this number closer to 50%. Overall, 85% of HCWs have reported skin problems
Without persistence, each failure leaves the patient and worker open to pathogen transmission.
Erasmus V et al. Systematic Review of Studies on Compliance with Hand Hygiene Guidelines in Hospital Care, Infection Control and Hospital Epidemiology, 31(3) 2010
CDC Guidelines for Hand Hygiene, 2002

19. 3. Lack of efficacy against viruses
Approximately 22% of HAIs are viral, though we typically think of them as bacterial
Alcohol sanitizers are relatively ineffective against non-enveloped viruses

20. 3. Lack of efficacy against viruses
Researchers at Emory University showed that rinsing the hands with water alone was more effective than using an alcohol sanitizer against Norovirus

21. Failures of Alcohol Sanitizers
Lack of Persistence
Every failure to use product leaves HCW exposed
Lack of Compliance
Drying effects of alcohol cause skin irritation, reducing usage and compliance
Lack of Efficacy against Viruses
Viruses cause 22% of HAIs, and a high percentage of visitor illnesses (flu, colds, stomach flu, etc.). Alcohol sanitizers less effective than water rinse against many non-enveloped viruses

22. The Ideal Sanitizer Ideal Sanitizer Alcohol Sanitizer Fast-acting
Effective against bacteria
Effective against viruses
Less effective than water rinse
Persistent
No persistence
Non-irritating (compliance)
40-50% compliance % of HCWs report contact dermatitis

23. Other Alternatives
Non-alcohol sanitizers
Alcohol-plus sanitizers

24. CHG
“Immediate efficacy occurs more slowly than that of alcohols” – CDC Guidelines
“It has in-vivo efficacy against enveloped viruses…but substantially less activity against non-enveloped viruses” - CDC
High skin irritation
Some persistence
HibiClens
(4% CHG)*
Acinetobacter baumannii
1 min
Bacteroides fragilis
10 minutes
Enterococcus faecalis
Enterococcus faecium
Staphylococcus aureus
Staphylococcus epidermis
3 min
Staphylococcus saprophyticus
Streptococcus pyogenes

25. Triclosan
Serious health concerns, lawsuits against FDA and Dial, unable to pass the new FDA regulations governing soaps
Slower immediate activity than alcohol
Relatively ineffective against gram-negative bacteria, even resulting in contamination
High skin irritation
Persistent

26. QATs Slow-killing (2+ minutes)
Relatively weak against gram-negative bacteria
Good antiviral activity
Persistent
Well-tolerated on the skin

28. Skin Irritation

29. Non-alcohol sanitizers
Ideal
Alcohol
CHG
Triclosan
QATs
Fast-acting
Bacteria
Viruses
Persistence
Non-irritating

30. Alcohol-Plus Products
Use a combination of alcohol (immediate kill) and another antimicrobial (persistence)
Avagard (61% ethanol, 1% CHG), ChloraPrep (70% isopropyl alcohol, 2% CHG)
Surgicept (70% alcohol, BZK, CHG)
Typically used only as surgical scrubs, increase skin irritation (alcohol + additional irritating ingredient)

31. Overall Comparison Fast-acting Bacteria Viruses Persistence
Ideal
Alcohol
Non-alcohol
Alcohol + (CHG, QAT)
Fast-acting
Bacteria
Viruses
Persistence
Non-irritating

32. CDC Recommendations
“Selection committees must consider factors that can affect the overall efficacy of such products, including the relative efficacy of antiseptic agents against various pathogens and acceptance of hand hygiene products by personnel. Because HCWs may wash their hands….as many as 30 times per shift, the tendency of products to cause skin irritation and dryness is a substantial factor that influences acceptance, and ultimate usage” “An antiseptic…(should be) broad-spectrum, fast-acting, and if possible, persistent.”