Download How KTP is making an impact at GAMA Healthcare

How KTP is
making an
impact at
GAMA Healthcare
Harsha Siani
About Gama Healthcare
GAMA Healthcare Ltd. develops and
manufactures breakthrough antimicrobial
products under the Clinell brand.
Founded in 2004 the company focus is to
develop infection control products with an
emphasis on wet wipes.
Encompassing a wide range of wipe
products from skin decontamination and
surface cleaning to catheter care and
medical device disinfection.
CLINELL PRODUCTS
ARE SOLD TO OVER
450 NHS TRUSTS
ACROSS THE UK,
AND OVER
40 COUNTRIES
WORLDWIDE
Today the Clinell range is the number one
brand of antimicrobial wipes used in the
NHS
1
Cardiff University Expertise
– Efficacy testing of biocidal products
against micro-organisms (bacteria,
spores, fungi)
– Development of efficacy test protocols
(3-stage wipe test)
– Mechanisms of microbial resistance and
cross-resistance to antimicrobials
– Mechanisms of action of biocides
2
Cardiff – the home of ‘C. diff’ !
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Healthcare Associated Infections
4
Healthcare Associated Infections
– 1 in 16 patients are diagnosed with an
active HCAI.
– HCAIs cost the NHS ￡1 billion annually
(￡7000 per patient).
– 20-30% of HCAIs could be avoided.
– Enhanced cleaning practices can reduce
additional costs of HCAIs by 76%
Types of HCAIs, HPA, 2011
5
What is C. difficile?
– Gram-positive, spore forming
anaerobic bacteria.
– Patients excrete up to 107 C. difficile per g
liquid faeces.
– Primary virulence factors Toxin A and Toxin B.
– Spores persist on surfaces for >5 months.
– Infectious dose <7 spores/cm2.
– Mode of transmission –
Faecal oral route.
Johnson and Gerding, 2012
6
Wipes and Healthcare Associated
Infections
– Pre-prepared wipes are increasingly being
used for cleaning and disinfection.
STAGE 1
Removal of bioburden from a surface
– Wipes provide a convenient and quick
means of cleaning and disinfection.
STAGE 2
Bacterial transfer - Do the wipes transfer
survivors to other surfaces
– NHS market value for wet wipes is £15
million and growing by 10-20% per annum.
STAGE 3
Antimicrobial activity
– Current standard test methods are not
representative of in-use application.
– There is a poor level of evidence to support
the efficacy of disinfectant wipes.
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C. difficile Label Claims of Wipes
WIPES
INGREDIENT DISCLOSED ON LABEL
CLAIM ON LABEL
Wipe A
Inorganic peroxygen generator, tetra acetyl ethylenediamine,
surfactants
Sporicidal
Wipe B
Impregnated with low-level biocides,’’ 5% cationic surfactant,
amphoteric surfactant, EDTA
Sporicidal
Wipe C
1% cationic and nonionic surfactants, acidity modifiers
Bactericidal claim and
claim against C. difficile
Wipe D
1% polymeric biguanide hypochloride, alkyl di-methyl benzyl
ammonium chloride, didecyl dimethyl ammonium chloride
Sporicidal
Wipe E
QAC, polymeric biguanide and bronopol
Sporicidal
Wipe F
Didecyl dimethyl ammonium chloride 0.45%
Sporicidal
Wipe G
Composition not disclosed
Sporicidal
Wipe H
Didecyl ammonium chloride, laurakonium chloride,
polyaminoporopyl biguanide, 2-bromo-2-nitro-para1-3-diol
Sporicidal
Wipe I
Composition not disclosed
Sporicidal
Siani et al. AJIC 2011; 39(3):212-8.
Siani et al. AJIC 2011; 39(3):212-8
Efficacy of ‘sporicidal’ wipes against C. difficile
Wipes
Bacterial Removal (log CFU/disc ± SD) Bacterial transfer following 10 s wiping
500 g surface pressure
time at 500 g surface pressure
Negative control
1.13 (± 0.36)
5 consecutive transfers. TNTC
Hypochlorite soaked wipe
2.02 (± 0.21)
5 consecutive transfers. TNTC
Wipe A
4.09 (± 0.79)
No spore transferred
Wipe B
0.22 (± 0.07)
5 consecutive transfers. From 0 to TNTC
Wipe C
1.30 (± 0.33)
5 consecutive transfers. From 0 to TNTC
Wipe D
0.57 (± 0.07)
5 consecutive transfers. From 1 to TNTC
Wipe E
+0.08 (± 0.08)
5 consecutive transfers. TNTC
Wipe F
1.14 (± 0.65)
5 consecutive transfers. From 83 to TNTC
Wipe G
0.67 (± 0.11)
5 consecutive transfers of ≤43 bacteria
Wipe H
0.88 (± 0.13)
5 consecutive transfers. From 2 to TNTC
Wipe I
0.84 (± 0.66)
5 consecutive transfers. From 40 to TNTC
Siani et al. AJIC 2011; 39(3):212-8
9
KTP Aims
– Transfer knowledge and understanding
of biocide efficacy tests.
– Provide scientific support to sales and
marketing teams.
– Develop in-use simulated tests for new
and existing products.
– Develop in-house R&D facility.
– Assess efficacy of Clinell Sporicidal
wipes in a phase 3 clinical field trial.
10
HOW HAS KTP BENEFITED
GAMA HEALTHCARE?
HOW HAS KTP BENEFITTED
GAMA HEALTHCARE?
11
KTP and Gama Healthcare
Provides scientific credibility to Gama’s products
– Siani et al. AJIC 2011; 39(3):212-8
– Siani and Maillard, review to be submitted
Export Team
Conference presentations
– Infection Control Africa Network, South Africa, 2012 (speaker)
– Heamodialysis Technician Conference, Italy, 2012 (speaker)
– Infection Prevention Society, London, 2013 (poster)
Sales Team
– Invited speaker for Local Infection Control study days
– Scientific support for the dissemination of product data
Marketing Team
– Production of marketing material based on scientific literature ‘Protecting the Patient’ ,
‘Benefits of Wipes’, ‘QACs are not Sporicidal.’
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Assessing the efficacy of Clinell® Sporicidal
Wipes – A double cross over field trial
– 9 months study at the University Hospital Wales across 2 wards.
– Total aerobic and anaerobic counts.
– ATP and UV monitoring.
– Isolation of MRSA, VRE, CRE, ESBL and C. difficile.
– Generating >12000 data points.
Phase 1
Phase 2
Phase 3
Month
1
2
3
4
5
6
7
8
9
Ward 1
Cr
Cr
Cr
Sp
Sp
Sp
Cr
Cr
Cr
Ward 2
Cr
Cr
Cr
Cr
Cr
Cr
Sp
Sp
Sp
–Provides the first phase 3 clinical trial on the efficacy of wipes in in-use conditions.
13
KTP and Gama Healthcare
Research and Development
– Development of new products (Blood spill kit, Floor cleaner and 15 new formulas)
– Efficacy testing of existing products
– Review of competitor products and claims
– Interaction of wipe materials and bacteria
Cost Saving
£25,000.00
Cost
£20,000.00
£15,000.00
£10,000.00
£5,000.00
£0.00
Comercial Lab A
Comercial Lab B
KTP
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KTP and Gama Healthcare
Research and Development
– Development of new products (Blood spill kit, Floor cleaner and 15 new formulas)
– Efficacy testing of existing products
– Review of competitor products and claims
Net Profit (£)
– Interaction of wipe materials and bacteria
400000
350000
300000
250000
200000
150000
100000
50000
0
During KTP
Yr 1
Current customers
Yr 2
New customers
Yr 3
New products
15
What does it all mean?
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ANY QUESTIONS?
23/05/2017
Clostridium Difficile
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