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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
Colette Cozean, PhD
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Promise of Alcohol Sanitizers
Failure of Alcohol Sanitizers
Reasons for Failure
The Ideal Product
Potential Solutions
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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
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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 Fendler et al, The Impact of hand sanitizer use on infection rates in an extended
care facility, AJIC, 30:4, 226-33, 2002
Hilburn et al, Use of alcohol hand sanitizer as an infection control strategy in an
acute care facility, AJIC, 31:2, 109-116, 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):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?
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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
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
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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)
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):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.
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
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)
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)
Hillburn et al, Use of alcohol hand sanitizer as an infection control
strategy in an acute care facility, AJIC, 31:2, 109-166, 2003
Randomized
/Crossover
Confounding
Factors
Valid
Comparison
Product
Sponsor
Result
Doebbeling
Yes
No
Yes
CalgonVestal
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 povidoneiodine.” – CDC Hand Hygiene Guidelines, 2002
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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
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, 2011
CDC, 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?
“Antiseptic handwash….[should be] broadspectrum, 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
“Alcohols are rapidly germicidal when applied
to the skin, but they have no appreciable
persistent (i.e., residual) activity.”
CDC Hand Hygiene Guidelines, 2002
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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
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”
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
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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.
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
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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
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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
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Lack of Persistence
◦ Every failure to use product leaves HCW exposed
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Lack of Compliance
◦ Drying effects of alcohol cause skin irritation,
reducing usage and compliance
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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
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.
25-50% of HCWs report
contact dermatitis
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Non-alcohol sanitizers
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Alcohol-plus sanitizers
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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
HibiClens
(4% CHG)*
Some persistence Acinetobacter baumannii
1 min
Bacteroides fragilis
Enterococcus faecalis
Enterococcus faecium
Staphylococcus aureus
Staphylococcus epidermis
Staphylococcus saprophyticus
Streptococcus pyogenes
10 minutes
10 minutes
10 minutes
10 minutes
3 min
3 min
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
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Slow-killing (2+ minutes)
Relatively weak against gram-negative
bacteria
Good antiviral activity
Persistent
Well-tolerated on the skin
Dermal Moisture after 100 Uses
10
5
0
-5
-10
-15
-20
-25
Day 1
Day 2
Day 3
Day 4
Day 5
Skin Irritation after 5 Day
Dermal Test
3.5
1
1
1
CHG (0.75%)
PCMX (1.0%)
Triclosan (0.3%)
0
BZT (0.2%)
CHG (4.0%)
Ideal
Fast-acting
Bacteria
Viruses
Persistence
Non-irritating
Alcohol
CHG
Triclosan
QATs
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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)
Ideal
Fast-acting
Bacteria
Viruses
Persistence
Non-irritating
Alcohol
Nonalcohol
Alcohol +
(CHG, QAT)
“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.”