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)







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)




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)







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

7

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)




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




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




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




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)


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.




Conformity Evaluation

Standard Methods and Requirements of VAH




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




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




CEN TC 216 – Chemical Disinfectants and Antiseptics –

developement of standards in Europe

founded in 1990

2012: 32 member states




EN-Standards CEN TC 216 WG1 – November 2015







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

**

**

**

**

**

**

*

**

**

**

**

draft N 443 April 2007

*

**

**

**

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




Challenges for

Surface Disinfection




By the new

biocidal product

directive many

active ingredients

will not be

available

anymore.

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




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




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.







Surface Disinfection Test – phase 2 – step 2




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




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







Choosing Pre-Wetted Wipes

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)




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




Thanks for your attention!!!




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

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