Dr. Colette Cozean
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Transcript of Dr. Colette Cozean
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PhD in BioMedical Engineering (Ohio St.), Masters in Electrical Engineering (Ohio St.), J.D. (Concord Law School)
Senior management positions with Pfizer, Baxter, American Hospital Supply
Author of more than 100 peer-reviewed papers, holds more than 50 patents
Reviewer for National Institute of Health
Dr. Colette Cozean
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Failures of Current Hand Hygiene, and the Search for
SolutionsColette Cozean, PhD
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Promise of Alcohol Sanitizers Failure of Alcohol Sanitizers Reasons for Failure The Ideal Product Potential Solutions
Summary
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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
Promise of Alcohol Sanitizers
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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
Results of Alcohol Sanitizers
Fendler et al, The Impact of hand sanitizer use on infection rates in an extended care facility, AJIC, 30:4, 226-33, 2002Hilburn et al, Use of alcohol hand sanitizer as an infection control strategy in an acute care facility, AJIC, 31:2, 109-116, 2003Rupp M et al, Prospective, Controlled, Cross‐Over Trial of Alcohol‐Based Hand Gel in Critical Care Units, Infection Control and Hospital Epidemiology; 29:1, 2008Larsen 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):377-383
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Is it blinded? Is it randomized? Is it a crossover design? Are there any potential confounding
factors? Is it large enough to be statistically
significant? Who sponsored the study?
Evaluating Clinical Trials
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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
University of Iowa Study
Change with AlcoholOverall +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
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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)
New York Presbyterian Hospital Study
Change with AlcoholOverall +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):377-383
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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.
University of Nebraska
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
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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
Surgical Site Infection Study
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; 288:722-727
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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)
Extended Care Facility Study
Fendler et al, The impact of alcohol hand sanitizer use on infection rates in an extended care facility, AJIC, 30:4, 226-233, 2002
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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)
Ortho Surgery Study
Hillburn et al, Use of alcohol hand sanitizer as an infection control strategy in an acute care facility, AJIC, 31:2, 109-166, 2003
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Randomized/Crossover
Confounding Factors
Valid Comparison Product
Sponsor Result
Doebbeling Yes No Yes Calgon-Vestal
Increase of 33%
Larsen Yes No Yes Avagard Increase of 27%
Parienti Yes No Yes Rivardis No difference
Rupp Yes No No GOJO Slight increase
Fendler No Yes No GOJO Decrease of 30%
Hillburn No Yes No GOJO Decrease of 36%
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Improves compliance and skin condition No improvement in HAIs Never shown in a crossover study to offer
improvement 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
Results in Hospitals
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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
Other Medical Trials
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) 296-301, 2011CDC, Vessel Sanitation Program, http://www.cdc.gov/nceh/vsp/surv/gilist.htm
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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?
Reasons for Failure
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“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
Persistence
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“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
1. Lack of Persistence
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Determine if preparations with persistent antimicrobial activity reduce infection rates
more effectively than do preparations whose activity is limited to immediate effectCDC Hand Hygiene Guidelines, 2002,
“Hand Hygiene Research Agenda”
CDC Hand Hygiene Research Agenda
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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
2. Lack of Compliance
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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.
2. Lack of Compliance
Erasmus V et al. Systematic Review of Studies on Compliance with Hand Hygiene Guidelines in Hospital Care, Infection Control and Hospital Epidemiology, 31(3) 2010CDC Guidelines for Hand Hygiene, 2002
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Approximately 22% of HAIs are viral, though we typically think of them as bacterial
Alcohol sanitizers are relatively ineffective against non-enveloped viruses
3. Lack of efficacy against viruses
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Researchers at Emory University showed that rinsing the hands with water alone was more effective than using an alcohol sanitizer against Norovirus
3. Lack of efficacy against viruses
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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
Failures of Alcohol Sanitizers
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The Ideal SanitizerIdeal
SanitizerAlcohol
SanitizerFast-acting
Effective against bacteria
Effective against viruses Less effective than water rinse
Persistent No persistence
Non-irritating (compliance) 40-50% compliance. 25-50% of HCWs report contact dermatitis
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Non-alcohol sanitizers
Alcohol-plus sanitizers
Other Alternatives
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“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
CHG
HibiClens (4% CHG)*
Acinetobacter baumannii 1 minBacteroides fragilis 10 minutesEnterococcus faecalis 10 minutesEnterococcus faecium 10 minutesStaphylococcus aureus 10 minutesStaphylococcus epidermis 3 minStaphylococcus saprophyticus
3 min
Streptococcus pyogenes 10 minutes
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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
Triclosan
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Slow-killing (2+ minutes) Relatively weak against gram-negative
bacteria Good antiviral activity Persistent Well-tolerated on the skin
QATs
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BZT (0.2%)
Iodine (7.5%)
CHG (0.75%)
PCMX (1.0%
)
CHG (4.0%)
Triclosan (0.3%)
-25
-20
-15
-10
-5
0
5
10
Dermal Moisture after 100 Uses
Day 1 Day 2 Day 3 Day 4 Day 5
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Skin Irritation
BZT (0.2%) CHG (0.75%) PCMX (1.0%) Triclosan (0.3%) CHG (4.0%)0
1 1 1
3.5
Skin Irritation after 5 Day Dermal Test
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Non-alcohol sanitizersIdeal Alcohol CHG Triclosa
nQATs
Fast-actingBacteriaVirusesPersistenceNon-irritating
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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)
Alcohol-Plus Products
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Overall Comparison
Ideal Alcohol Non-alcohol
Alcohol + (CHG, QAT)
Fast-actingBacteriaVirusesPersistenceNon-irritating
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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.”