Disinfection: Germany - CEN - rudolf-schuelke-stiftung.de … · Classification of Disinfectants...
Transcript of Disinfection: Germany - CEN - rudolf-schuelke-stiftung.de … · Classification of Disinfectants...
Disinfection: Germany - CEN
Schülke-Stiftung 26th and 27th November 2015
Dr. Jürgen Gebel
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 1
Current Disinfection Practices:
Laws and regulations with regard to disinfection
• Disinfection in outbreak situations laid down in German Infection
Protection Act (IfSG § 18): Usage of disinfectants tested and
listed by Robert Koch-Institute is mandatory
• Recommendations by KRINKO (Commission for Hospital
Hygiene and Infection Prevention at Robert Koch-Institute
(RKI)): Usage of VAH-certified products ensures quality
assurance
• State infection control regulations for occupations apart from
medical professionals (e.g. tattoo, hairdressing, podology)
describe necessary disinfection measures
• Mandatory surveillance of healthcare-acquired infections (HAI)
with resistances (IfSG)
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 2
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 3
RKI-Guideline: Surface Cleaning and Disinfection
Certification of Disinfectants
• Medical applications – public facilities:
VAH for routine and prophylactic disinfection,
certification by VAH, products published with exposure
time/concentration ratios in VAH List of Disinfectants
RKI for disinfection measures issued by health authorities
according to the Infection Protection Act (IfSG §18), products
suitable for this purpose published with exposure
time/concentration ratios in RKI List of Disinfectants
• Veterinary applications, foods sector:
DVG (German Veterinary Society)
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 4
Classification of Disinfectants
• Hygienic handwash: cosmetics
• Hand disinfectants or skin antiseptics: Pharmaceuticals (regulation from BfArM – Federal Institute for Drugs and Medical Devices)
• Surface disinfectants: Biocides (regulation from BAUA – Federal Institute for Occupational Safety and Health)
• Surface disinfectants for medical devices, instrument
disinfectants, chemothermal textile disinfection: Medical devices (CE-mark)
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 5
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 6
Association for Applied Hygiene
•consolidation of competence in applied hygiene
•elaboration of test protocols and evaluation standards for
decontamination, disinfection, antisepsis and sterilization
procedures
•exchange of ideas and multidisciplinary cooperation with the
relevant medical and non-medical disciplines
•national and international harmonization of efforts with regard to
indication, toxicological and ecological aspects of products and
procedures employed for preventing infections
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VAH Disinfectants-Commission
Members:
Dr. Christiansen, PD Dr. Eggers, Prof. Exner, Dr. Gebel,
Prof. Heeg, Prof. Hingst, Dr. Hunsinger, Prof. Kramer,
Prof. Martiny, Prof. Eikmann, PD Dr. Pitten,
Dr. Steinmann, PD Dr. Suchomel, Prof. Vossebein,
Prof. Wendt, Prof. Wolff
Guests:
Dr. Burghardt (BW)
Prof. Truyen (DVG)
Dr. Schwebke (RKI)
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 7
4+4-Working Group
• Members:
– 4 Members out of the Disinfectant Commission of VAH:
Dr. Christiansen, Dr. Gebel, Prof. Martiny,
Prof. Vossebein
– 4 Members of Disinfectant Suppliers:
Ms C. Ostermeyer (Bode),
Dr. Goroncy-Bermes (Schülke),
Dr. Meyer (Ecolab), Dr. Rödger (Lysoform)
– RKI as Guest: Dr. Schwebke
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 8
VAH List of Disinfectants 2015
• Issue 1 April 2015, English/German
with 1.200 commercial products
• Online and brochure
• 6 Application domains:
– Hygienic handwash
– Hand disinfection (hygienic - surgical)
– Skin antisepsis
– Surface disinfection
– Instrument disinfection
– Linen disinfection
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 9
Certification and Listing
• Certification and listing after approving the conformity of two
independent expert reports on the efficacy of the product with
the DGHM/VAH guidelines on testing disinfectants by scientific
experts from the Commission
• Three-year validity of certificates
• Issuance of certificate and inclusion in VAH List of Disinfectants
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 10
Dr. Jürgen Gebel, Verbund für Angewandte Hygiene e.V.
Institut für Hygiene und Öffentliche Gesundheit, Universitätsklinikum Bonn 11
Spectrum of microbicidal acitivity
• Bactericidal (obligatory)
• Levurocidal (obligatory – except hyg. handwash)
• Fungidical (optional)
• Tuberculocidal (optional)
• Mycobactericidal (optional)
• Virucidal (optional)
(conformity assessment according to DVV –
German Association for Controlling Viral Diseases)
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Testing the activity against bacteria, moulds (C. albicans), fungus
• The VAH-listed procedures are active against
the gram-positive testorganism S. aureus and E. hirae and
against the gram-negative testorganism E. coli, P. aeruginosa
and P. mirabilis and against the mould C. albicans.
• Activity against tuberculosis (tuberculocidal) has to be shown
with M. terrae.
• Activity against atypical mycobacteria (mycobactericidal) has to
be shown with M. terrae and M. avium.
• Fungicidal activity is shown with tests against A. brasiliensis.
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 12
Conformity Evaluation
Standard Methods and Requirements of VAH
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 13
DGHM/VAH Guidelines for
Testing Chemical Disinfectants
• Testing since 1959 in 2 steps
in-vitro tests
tests under practical conditions
• Determination of MIC and suitable neutralizer
• Qualitative suspension test
• Quantitative suspension test
• Quantitative test under practical conditions (hands and skin)
• Quantitative carrier test (surface, instruments, linen)
The standard methods and requirements have been revised by the VAH Disinfectants Commission and will be published at the end of 2014
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 14
Disinfectant Testing according to
CEN-TC 216 – EN 14885 - 3-Phase-Model
• Phase 1: Basis test
• Phase 2 / Step 1 Suspension test
• Phase 2 / Step 2 Carrier test
• Phase 3: Field trials
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 15
CEN TC 216 – Chemical Disinfectants and Antiseptics –
developement of standards in Europe
founded in 1990
2012: 32 member states
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 16
EN-Standards CEN TC 216 WG1 – November 2015
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 17
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 18
Fungicidal Mycobactericidal Tuberculocidal
2 / 1 EN 12054EN 13727
enlargem.**
WI 216039
(stopped)
EN 13624
enlargem** ** EN 14476
EN 14476
(reduced
activity)
2 / 2 ** ** **
2 / 1 EN 12054EN 13727
enlargem**
WI 216039
(stopped)
EN 13624
enlargem
EN 14348
enlargem.?** EN 14476
EN 14476
(reduced
activity)
2 / 2 ** ** **
2 / 1 EN 12054EN 13727
enlargem**
WI 216039
(stopped)
EN 13624
enlargem** **
2 / 2 ** ** **
2 / 1 *EN 13727
enlargem
EN 13624
enlargemEN 14348 EN 14348
WI 216032
(erazed)
draft N 352
April 2004
2 / 2WI 216019
(stopped)
draft N 438
(April 2007) * * *
WI 216037
(erazed)
draft N 395
Sep 2005
2 / 1 EN 13624 EN 14348 EN 14348WI 216032
(erazed)
draft N 352
April 2004
2 / 2 EN 14562 prEN 14563 prEN 14563WI 216037
(erazed)
draft N 395
Sep 2005
2 / 1
2 / 2
Chemical-thermal linen 2 / 1
2 / 2draft N 443
April 2007
draft N 443
April 2007
* No work items are yet approved but relevant standards may become available in the future
** No intention to develop a test
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draft N 443 April 2007
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WI 216036 (withdrawn)
prEN 13623 April 2008
(only L. pneumophila)Water treatment against
Legionella
EN 14562
Instrument disinfection, clean
and dirty conditions
EN 13727 EN 14476
EN 14561
EN 13624
EN 14476
EN 1499
EN 1500
EN 12791
EN 13624 enlargem
draft N 443 April 2007
Hygienic hand wash
Hygienic hand rub
Surgical hand rub and
surgical hand wash
Surface disinfection, clean
and dirty conditions
Standard test methods to be used to substantiate claims for disinfectant products - April 2008
Type and/or Purpose of
productPhase / Step
Activity claims
Bactericidal Virucidal SporicidalYeasticidal
EN-Standards CEN TC 216 WG1 – April 2008
Integration of EN Standards in VAH Methods
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 19
Challenges for
Surface Disinfection
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 20
By the new
biocidal product
directive many
active ingredients
will not be
available
anymore.
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 21
Requirements for Surface Cleaning and
Disinfection Procedures
• No increase of cfu and no dissemination of pathogens into the
patient environment
• Proven antimicrobial effectivity
• Fast acting antimicrobial effectivity
• Broad antimicrobial spectrum of activity to prevent selection of
pathogens
• Ecologically friendly
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 22
Idealisierte schematische Darstellung von Reinigung, Desinfektion unddesinfizierender Reinigung
Reinigung Desinfektiondesinfizierende
Reinigung
Ubiquitäre Umweltkeime
Pathogene oder fakultativ-pathogene Keime
Schmutz
Cleaning Disinfection Cleaning and
Disinfection
dirt
Ubiquitious microorganisms
Pathogens
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 23
Choosing a Disinfectant
• If possible, surface disinfection should be done using mechanical
action – as scrub-wipe-process.
• Compatibility between the disinfectant and the wipe should be
checked by the manufacturer (for example: 4-Field Test =
EN 16615. Disinfectants in the VAH-List are tested as liquids,
not as a procedures with wipes/utensils.
• Adsorption to disinfection utensils/fabrics may especially pose a
problem for pre-wetted wipes.
• Effect of organic soils (organic load/contamination) must be
taken into consideration for choosing the correct
concentration/exposure time ratio.
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 24
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 25
Surface Disinfection Test – phase 2 – step 2
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 26
volume-ratio ml/m2 product inoculum carrier-area cont. surface covered surface
OECD ~ 666 50 µl 10 µl 0,79 cm2
(1 cm ) ~ 0,25 cm2 ~ 0,75 cm2
EN 13697
without
mechanical
action
~ 333 100 µl 50 µl 3,14 cm2
(2 cm ) ~ 1 cm2 ~ 3 cm2
DGHM with
mechanical
action ~ 95 200 µl 100 µl
25 cm2
(5x5 cm) ~ 9 cm2 ~ 21,16 cm2
(4,6x4,6 cm)
4-field test
prEN 16615 ~ 13
16 ml in
the wipe (app. 800 µl on
the surface)
50 µl 1000 cm2
(20x50 cm) 25 cm2 ~ 600 cm2
wiped (app. 13x45 cm)
Surface Disinfection Tests – volume
Surface Disinfection – 4-Field Test Method
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 27
Surface Disinfection: 4-Field Test Method
0 1 2 3 4 5 6
1
2
3
4
Fie
ld
Factors
RC
AF
RF
Δ to max
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 28
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 29
Choosing Pre-Wetted Wipes
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 30
Critical control points which need to monitored
• Disinfectant solution for dispenser system is
contaminated
• Wipes are not compatible with the disinfectant
• Prolonged reuse periods (longer than 28 d)
• Wipes are dried out
• Contamination of wipes hanging outside the dispenser
• Multiplication of Gram-negative bacteria in the bucket
(threshold values 0 cfu/10 ml and for airborne spore formers
3 cfu/10 ml)
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 31
Monitoring of critical control points
• Rapid detection of contamination of disinfectant
solution during filling procedure
• Expert report on the compatibility of wipe material and
disinfectant
• Expert report for extended reuse periods
• Tight closure of the dispenser
• Adequate reprocessing of dispensers before refilling
• Laboratorory examination during outbreaks
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Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 32
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 33
Thanks for your attention!!!
26th-27th November 2015
Dr. Jürgen Gebel, Association for Applied Hygiene e.V.
Institute for Hygiene and Public Health, University-Hospital Bonn 34
2017
A list of procedures issued by
the Disinfectants Commission
in the Association for Applied
Hygiene (VAH) in collaboration
with the Scientific Societies
and Professional Associations
in Europe tested according to
the CEN TC 216 Standard
Methods for Testing Chemical
Disinfection Processes and
deemed to be effective for
prophylactic disinfection and
hygienic handwash
European List of Disinfectants
My vision: Bactericidal, levurocidal,
antiviral, sporicidal products in the