Efficacy of Sporicidal Wipes - Cardiff University
Efficacy of Sporicidal Wipes - Cardiff University
Efficacy of Sporicidal Wipes - Cardiff University
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Sporicides<br />
Disinfectants / <strong>Wipes</strong><br />
do they really work?!<br />
Dr Jean-Yves Maillard!<br />
Welsh School <strong>of</strong> Pharmacy!<br />
<strong>Cardiff</strong> <strong>University</strong>!<br />
Wales!
MICROBIAL SUSCEPTIBILITY/RESISTANCE!<br />
INTRINSIC RESISTANCE TO BIOCIDES !<br />
High-level!<br />
!<br />
!<br />
!<br />
!<br />
Level <strong>of</strong> resistance!<br />
!<br />
!<br />
!<br />
!<br />
!<br />
Low-level!<br />
!<br />
- prions!<br />
- bacterial spores!<br />
- protozoal cysts!<br />
- mycobacteria!<br />
- naked viruses!<br />
- vegetative Gram-negative!<br />
- fungi!<br />
- protozoa!<br />
- vegetative Gram-positive !<br />
- enveloped viruses!<br />
SPORICIDE!<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
SPORE STRUCTURE AND SUSCEPTIBILITY!<br />
SPORE COATS!<br />
- lysozymes!<br />
DEGRADATION!<br />
(superoxide dismutase)!<br />
- hypochlorites!<br />
- chlorine dioxide!<br />
- GTA!<br />
- iodine!<br />
EXOSPORIUM!<br />
- highly reactive biocides (?)!<br />
- hydrogen peroxide!<br />
- chlorhexidine !<br />
- ethylene oxide (?)!<br />
- ozone!<br />
INACCESSIBILITY OF TARGET SITES!<br />
INACCESSIBILITY OF TARGET SITES!<br />
CORTEX!<br />
- alkali!<br />
- hypochlorites!<br />
- chlorine dioxide!<br />
- GTA(?)!<br />
- iodine!<br />
- chlorhexidine (?)!<br />
- ozone (?)!<br />
SPORE CORE!<br />
- dehydration!<br />
- SASPs (hydrogen peroxide)!<br />
INACCESSIBILITY OF TARGET SITES!<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
SPORULATION-GERMINATION AND ACTIVITY!<br />
SPORISTATIC<br />
ACTIVITY!<br />
SPORULATION!<br />
GERMINATION!<br />
SPORICIDAL<br />
ACTIVITY!<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
SPORICIDAL AND SPORISTATIC ACTIVITIES!<br />
SPORICIDAL ACTIVITY!<br />
Ethylene oxide!<br />
Glutaraldehyde!<br />
Formaldehyde!<br />
ortho-phthalaldehyde!<br />
SPORISTATIC ACTIVITY!<br />
Hydrogen peroxide!<br />
Peracetic acid!<br />
Chlorine dioxide!<br />
Ozone!<br />
Phenols and cresols !!<br />
Quaternary ammonium compounds!<br />
Biguanides!<br />
Organic acids and esters!<br />
Alcohols!<br />
Sodium hypochlorite!<br />
Sodium dichlororisocyanurate!<br />
Chloramine-T!<br />
Calcium hypochlorite!<br />
!<br />
Iodine and iodophors!<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
FACTORS AFFECTING SPORICIDAL ACTIVITY!<br />
FACTORS! IMPORTANCE FOR EFFICACY! PREDICTABILITY!<br />
Concentration! +++" Concentration exponent (η) "<br />
Type <strong>of</strong> surface!<br />
!<br />
++" Roughness"<br />
Hydrophobicity "<br />
Charge"<br />
Porosity"<br />
Organic load! +++" Chemical nature <strong>of</strong> active"<br />
Soiling (blood, faeces, etc.) "<br />
Temperature! + " Q 10 "<br />
pH! ++ " Chemical nature <strong>of</strong> active"<br />
Contact time! +++" Continuous release (reservoir)"<br />
Relative humidity! ++" Gaseous biocides"<br />
Formulation! ++" Depend on excipients"<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
SPORICIDE EFFICACY AGAINST C. DIFFICILE!<br />
BIOCIDE (spore concentration)" CONCENTRATION" LOG<br />
REDUCTION"<br />
Glutaraldehyde "<br />
TIME<br />
(min)"<br />
"(~105 ) ![ Wavicide-200]"<br />
20000 ppm "<br />
>4.1" 30"<br />
Liquid hydrogen peroxide - Surface test!<br />
"(107 ) "[Virox STF]" 70000 ppm" ≥ 6" 5-10"<br />
Liquid chlorine dioxide – surface test!<br />
!(6 x 107 ) "BHI growth" 600 ppm" ≥ 6" 30"<br />
"(1 x 107 ) "CB growth"<br />
Peracetic acid– suspension test"<br />
≥ 6" 10"<br />
!(~105 ) "[ Perasafe ® ]"<br />
3500 ppm (3% soiling)" >4" 5"<br />
" ""<br />
Sodium dichloroisocyanurate surface test – !<br />
" "Stainless steel"<br />
" "PVC"<br />
"<br />
2600 ppm"<br />
Maillard J-Y. J Hosp Infect 2011; 77:204-9. "<br />
"<br />
6"<br />
1000 ppm"
SPORICIDE EFFICACY AGAINST C. DIFFICILE!<br />
BIOCIDE (spore concentration)! CONCENTRATION! LOG<br />
REDUCTION!<br />
Bleach – surface test"<br />
! ! ! (10 7 ) "[acidified bleach]"<br />
! ! !(10 7 ) ![regular bleach]"<br />
! ! !(5 x 10 7 ) ![regular bleach]"<br />
Bleach – surface test!<br />
" " "(10 6 - 10 7 )"<br />
5000 ppm"<br />
1000 ppm"<br />
5000 ppm"<br />
"<br />
5000 ppm"<br />
Maillard J-Y. J Hosp Infect 2011; 77:204-9. "<br />
≥ 6"<br />
≥ 6"<br />
≥ 6"<br />
TIME<br />
(min)!<br />
Accelerated hydrogen peroxide! 4.5% " 6" 10"<br />
"<br />
6"<br />
3"<br />
~25"<br />
~10"<br />
"<br />
10"<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
SPORICIDAL – SPORISTATIC ACTIVITY AND CLAIM!<br />
LABEL CLAIMS - wipes!<br />
WIPES! INGREDIENT DISCLOSED ON LABEL! CLAIM ON LABEL!<br />
Clinell®<br />
sporicidal wipe"<br />
Inorganic peroxygen generator, tetra acetyl ethylenediamine,<br />
surfactants"<br />
Trigene Advance "
STANDARD EFFICACY TEST PROTOCOLS!<br />
PURPOSE OF EFFICACY TEST PROTOCOLS!<br />
!<br />
• End users can select a product that is appropriate for their use"<br />
"- provide reliable information on the efficacy <strong>of</strong> an antimicrobial product "<br />
• Ensure that the product specification from the manufacturer or supplier is accurate"<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
STANDARD EFFICACY TEST PROTOCOLS!<br />
Most common efficacy protocols used for determining sporicidal activity against C.<br />
difficile (from label claim and web information on specific sporicidal product)"<br />
!<br />
Phase 1, step 1 tests: the ability <strong>of</strong> a product to demonstrate bactericidal, fungicidal or sporicidal activity,<br />
without regard to specific conditions <strong>of</strong> intended use, is tested "<br />
!<br />
EN14347: Basic sporicidal activity"<br />
"Method developed by the Horizontal Working Group"<br />
"Temperature: 20ºC; contact time one <strong>of</strong> the following 30, 60, 120 min; no soiling (no C. difficile)"<br />
!<br />
!<br />
Phase 2, step 1 tests: tests are suspension tests to determine bactericidal, fungicidal, virucidal or<br />
sporicidal activity under laboratory conditions that simulate practical conditions. "<br />
!<br />
EN1276: "Bactericidal suspension test (no C. difficile)"<br />
"Method developed by the Food Hygiene and Domestic and Institutional use Working Group"<br />
"Temperature: 20ºC(4-40ºC); contact time: 5 min (1-60 min)"<br />
"<br />
EN13704: <strong>Sporicidal</strong> suspension test (no C. difficile)"<br />
" Method developed by the Food Hygiene and Domestic and Institutional use Working Group"<br />
"Temperature: 20ºC(4-40ºC); contact time: 5 min (1-60 min)"<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
INTERPRETING EFFICACY TEST PROTOCOLS!<br />
PRODUCT A!<br />
!<br />
“<strong>Sporicidal</strong>, kill Clostridium difficile (C.diff) spores (EN 1276 & EN 14347), started with<br />
15,300,000 c. diff spores and were reduced in one minute contact time to less than<br />
10 C. diff spores in both clean & dirty conditions” "<br />
EN1276!<br />
Bactericidal NOT sporicidal!<br />
EN14347!<br />
BASIC sporicidal test!<br />
NO soiling!<br />
PRODUCT B!<br />
!<br />
“ EN 1276: Campylobacter jejuni, E. coli, E. hirae, Klebsiella pneumoniae, Listeria<br />
monocytogenes, MRSA, Mycobacterium avium, Pseudomonas aeruginosa, Proteus<br />
vulgaris, Vibrio cholerae and Clostridium difficile (spores & vegetative)” "<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
INTERPRETING EFFICACY TEST PROTOCOLS!<br />
PRODUCT C!<br />
“Product C achieved a 100% kill <strong>of</strong> vegetative cells <strong>of</strong> Clostridium difficile ATCC 9689 (1.1<br />
x 10 7 ) dried out on a 12 inch square stainless steel test surface. (Wipe time: 30<br />
seconds)”"<br />
"<br />
Validation <strong>of</strong> Product C efficacy against Clostridium difficile ATCC 9689 – surface test"<br />
Methodology:"<br />
"<br />
“The test organism was inoculated into 9ml <strong>of</strong> cooked meat medium (Biomerieux) and<br />
incubated at 37 0 C for 48 hours to obtain a culture containing approximately 10 8 cells/ml<br />
(actual count = 1.1 x 10 8 /ml). A 12 inch square test surface was marked out on a<br />
stainless steel plate and one ml <strong>of</strong> inoculum was spread over the test surface and<br />
allowed to dry for 30 minutes. The Product C was wiped systematically over the test<br />
surface for 30 seconds. Suspensions were taken from the surface <strong>of</strong> the test site and<br />
from the wipe itself, plated out on HBA plates and incubated in an anaerobic jar for five<br />
days at 37 o C .”"<br />
NO MENTION THAT THE TEST WAS CONDUCTED ANAEROBICALLY!!!<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
TESTING SPORICIDAL WIPES ACTIVITY!<br />
Antimicrobial wipe usage!<br />
!<br />
! !!<br />
Wipe<br />
Number"<br />
Surface initially<br />
wiped"<br />
Time applied<br />
(seconds)"<br />
Number <strong>of</strong> consecutive surfaces wiped!<br />
(other surfaces)"<br />
1" Bed Rail" 4" 5 (bedside table, monitor X2, monitor stand)"<br />
2" Steel Trolley" 6" 2 (both shelves on the trolley wiped)"<br />
1" Monitor" 4" 5 (monitors, two keypads, monitor stand)"<br />
2" Bed rail" 7" 4 (table, monitor, keypad)"<br />
3" Bedside table" 10" 4 (folder, two bed rails) "<br />
Williams et al. J Hosp Infect 2007; 67: 329-35!<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
TESTING SPORICIDAL WIPES ACTIVITY!<br />
SPORICIDAL EFFICACY – efficacy testing against C. difficile NCTC12727!<br />
<strong>Wipes</strong>! Bacterial Removal !<br />
(log 10 cfu/disk ± SD)!<br />
500 g surface pressure!<br />
Bacterial transfer following 10 s wiping<br />
time at 500 g surface pressure!<br />
Negative control" 1.13 (± 0.36)" 5 consecutive transfers. TNTC"<br />
Hypochlorite soaked wipe" 2.02 (± 0.21)" 5 consecutive transfers. TNTC"<br />
Clinell® sporicidal wipe" 4.09 (± 0.79)" No spore transferred"<br />
Siani et al. AJIC 2011; 39(3):212-8. "<br />
TriGene Advance " 0.22 (± 0.07)" 5 consecutive transfers. From 0 to TNTC "<br />
AzoMaxActive TM " 1.30 (± 0.33)" 5 consecutive transfers. From 0 to TNTC "<br />
Sani-Cloth® Rapid " 0.57 (± 0.07)" 5 consecutive transfers. From 1 to TNTC "<br />
Activ8 TM " +0.08 (± 0.08)" 5 consecutive transfers. TNTC"<br />
SuperNova ® " 1.14 (± 0.65)" 5 consecutive transfers. From 83 to TNTC"<br />
Tuffie " 0.67 (± 0.11)" 5 consecutive transfers <strong>of</strong> ≤43 bacteria"<br />
Enduro Patient wipes " 0.88 (± 0.13)" 5 consecutive transfers. From 2 to TNTC"<br />
NewGenn " 0.84 (± 0.66)" 5 consecutive transfers. From 40 to TNTC"<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
TESTING SPORICIDAL WIPES ACTIVITY!<br />
SPORICIDAL EFFICACY – efficacy testing against C. difficile NCTC12727!<br />
<strong>Wipes</strong>! Claim on label! <strong>Sporicidal</strong> effect (log 10 reduction ±SD)!<br />
Clinell® sporicidal<br />
wipe"<br />
10 s contact time! 5 min contact time!<br />
<strong>Sporicidal</strong>" 0.11<br />
<strong>Sporicidal</strong>!<br />
(± 0.15)" 1.54 (± 0.84)"<br />
TriGene Advance " <strong>Sporicidal</strong>" 0.04 (± 0.05)" +0.84 (± 0.03)"<br />
AzoMaxActive TM " Bactericidal claim and claim against<br />
Clostridium difficile on label"<br />
1.41 (± 0.14)" +0.92 (± 0.15)"<br />
Sani-Cloth® Rapid " <strong>Sporicidal</strong>" 1.77 (± 0.27)" 0.01 (± 0.44)"<br />
Activ8TM " <strong>Sporicidal</strong>"<br />
Sporistatic!<br />
0.99 (± 0.14)" +0.70 (± 0.15)"<br />
SuperNova ® " <strong>Sporicidal</strong>" 1.96 (± 0.09)" +0.66 (± 0.13)"<br />
Tuffie " <strong>Sporicidal</strong>" 0.37 (± 0.23)" +0.50 (± 0.19)"<br />
Enduro Patient<br />
wipes "<br />
<strong>Sporicidal</strong>" 0.41 (± 0.10)" +0.66 (± 0.10)"<br />
NewGenn " No sporicidal claim on label" 0.31 (± 0.15)" +0.82 (± 0.14)"<br />
Hypochlorite soaked<br />
wipe"<br />
Siani et al. AJIC 2011; 39(3):212-8. "<br />
5000 ppm" +0.14 <strong>Sporicidal</strong>!<br />
(± 0.49)" 5.39 (± 0.00)"<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
TESTING SPORICIDAL WIPES ACTIVITY!<br />
SPORE ASSOCIATION WITH WIPE MATERIALS!<br />
Siani et al. AJIC 2011; 39(3):212-8. "<br />
Electron micrographs <strong>of</strong> inoculated with C. difficile R20291 ribotype 027 !<br />
Control!<br />
Inoculated!<br />
Clinell® sporicidal wipe! TriGene Advance ! Tuffie !<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
SPORICIDE EFFICACY AGAINST C. DIFFICILE<br />
Biocides efficacy against the transmission <strong>of</strong> C. difficile<br />
<strong>Sporicidal</strong> test: suspension test<br />
Murine model – disinfection <strong>of</strong> cages (15 mL for 10 min)<br />
BIOCIDES! COMPOSITION! LOG<br />
REDUCTION!<br />
TRANSMISSION!<br />
70% ethanol" Alcohol"
SPORICIDES AND SURFACE DISINFECTION IN SITU!<br />
ALCOHOL-BASED HAND RUBS!<br />
TRIAL! STUDY DESIGN! POPULATION! RESULTS!<br />
Gopal Rao et al.<br />
J Hosp Infect<br />
2002; 50:42-7"<br />
Gordin et al.<br />
Infect Control<br />
hosp Epidemiol<br />
2005; 26:650-3"<br />
Interventional<br />
before-after non<br />
randomized<br />
historical control"<br />
Interventional<br />
before-after non<br />
randomized<br />
historical control"<br />
Patients hospital<br />
wide (ages not<br />
specified)"<br />
Adult patients<br />
hospital wide"<br />
Hsu et al. Am J Gastroenterol 2010;105:2327-2339"<br />
Pre-intervention! Post-intervention!<br />
11.5 cases per<br />
1000 admissions"<br />
3.24 cases per<br />
10000 patient<br />
care days"<br />
9.5 cases per<br />
1000 admissions<br />
(P=0.02)"<br />
3.38 cases per<br />
10000 patient<br />
care days<br />
(P=0.78)"<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
SPORICIDES AND SURFACE DISINFECTION IN SITU!<br />
HYPOCHLORITE DISINFECTANTS!<br />
TRIAL! STUDY DESIGN! POPULATION! RESULTS!<br />
Mayfield et al. Clin Infect<br />
Dis 2000; 31:995-1000"<br />
Wilcox et al. J Hosp<br />
Infect 2003:54:109-14"<br />
McMullen et al. Infect<br />
Control Hosp Epidemiol<br />
2007; 28:205-7"<br />
Interventional beforeafter;<br />
historical control"<br />
Non randomized<br />
cross-over control"<br />
Interventional beforeafter;<br />
Outbreak"<br />
Adult patients in the<br />
bone marrow<br />
transplant unit, the<br />
neurosurgical<br />
intensive care unit<br />
and a general<br />
medicine unit"<br />
Elderly patients on<br />
two elected medicine<br />
wards"<br />
Medical and surgical<br />
intensive care units"<br />
Hsu et al. Am J Gastroenterol 2010;105:2327-2339"<br />
Pre-intervention! Post-intervention!<br />
8.6 cases per 1000<br />
patient days"<br />
8.9 cases per 100<br />
admissions"<br />
MICU: 16.6 cases per<br />
1000 patient days"<br />
"<br />
SICU: 10.4 cases per<br />
1000 patient days"<br />
3.3 cases per 1000<br />
patient days"<br />
5.3 cases per 100<br />
admissions (P
SPORICIDES AND SURFACE DISINFECTION IN SITU!<br />
HYDROGEN PEROXIDE VAPOUR!<br />
TRIAL! STUDY DESIGN! POPULATION! RESULTS!<br />
Boyce et al.<br />
Infect Control<br />
Hosp Epidemiol<br />
2008; 29:723-9"<br />
Prospective<br />
interventional<br />
before-after"<br />
Five inpatient<br />
units"<br />
" " All room vacated<br />
by patients"<br />
Hsu et al. Am J Gastroenterol 2010;105:2327-2339"<br />
Pre-intervention! Postintervention!<br />
2.28 cases per 1.28 cases per<br />
1000 patient 1000 patient<br />
days"<br />
days (P=0.047)"<br />
1.89 cases per<br />
1000 patient<br />
days"<br />
0.88 cases per<br />
1000 patient<br />
days (P=0.047)"<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
SURFACE DISINFECTION AND SPORICIDES!<br />
ARHAI/HIS task force on sporicidal disinfectants!<br />
Wilcox et al. J Hosp Infect 2011; 77: 187-188 "<br />
"<br />
“A taskforce has now been formed with representatives from the Department <strong>of</strong><br />
Health's Advisory Committee on Antimicrobial Resistance and Healthcare<br />
Associated Infection (ARHAI), the Hospital Infection Society (HIS) HIS, the<br />
Department <strong>of</strong> Health (England) and the Health Protection Agency. "<br />
"<br />
AIMS:!<br />
1. to develop an accepted standard for laboratory testing <strong>of</strong> disinfectants which<br />
claim to have activity against C. difficile spores; "<br />
2. to develop a network <strong>of</strong> laboratories with capability to perform in vitro assays <strong>of</strong><br />
sporicidal activity <strong>of</strong> disinfectants"<br />
3. to explore the creation <strong>of</strong> a national quality assessment scheme for laboratories<br />
which perform in vitro assays <strong>of</strong> sporicidal activity <strong>of</strong> disinfectants.”"<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
SURFACE DISINFECTION AND WIPES!<br />
The selection and use<br />
<strong>of</strong> disinfectant wipes<br />
RCN guidance<br />
Contents<br />
Executive summary and recommendations 2<br />
Introduction 4<br />
Principles <strong>of</strong> wipe usage 5<br />
Why is it important to consider wipe selection? 6<br />
Terminology 6<br />
How do wipes work? 7<br />
Current standards for selecting disinfectant wipes<br />
and their ingredients 8<br />
Disinfectants used in wipes 10<br />
Tests used to assess ecacy <strong>of</strong> wipes 10<br />
Selecting a wipe or wipes for trial 13<br />
Managing wipes in everyday use 14<br />
Selection and use <strong>of</strong> wipes checklist 15<br />
Further reading 16<br />
Additional resources 16<br />
Glossary 17<br />
The selection and use <strong>of</strong> disinfectant wipes<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!<br />
1
THANK YOU!<br />
Lovleen Joshi!<br />
<strong>Sporicidal</strong> wipes!<br />
!<br />
- Harsha Siani!<br />
- Callum Cooper!<br />
Infection Prevention Society, <strong>Cardiff</strong> 2011!
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