the testing and evaluation of chemical disinfectants by the

1

The Testing and Evaluation of Chemical Disinfectants by the Association for Applied

Hygiene (VAH) in Germany

J. Gebel and M. Exner

Department of Hygiene and Public Health of Bonn University

Disinfectant Committee in theAssociation for Applied Hygiene (VAH)

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Disinfection in Germany

Medical Applications – Public Facilities:Prophylactic disinfection → DGHM now VAHInfection Control Law (§18 paragraph 1, 2) → RKI (Robert Koch-Institut)

Virus Disinfection → DVV (German Society for the Control of Viral Diseases) + RKI (in future also VAH)Veterinary and Food Sector → DVG (German Society for Veterinary Medicine)

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Desinfectant-Commission in the VAH16 Members:

Prof. Borneff-Lipp, Dr. Christiansen, Prof. Exner, Dr. Gebel, Prof. Heeg, Prof. Hingst, Prof. Kramer, Prof. Martiny, Prof. Eikmann, PD Dr. Pitten, Dr. Schrader, Prof. Schubert, Dr. Steinmann, Prof. Wendt, Prof. Wolff

3 Guests: Dr. Burghardt (BW)Prof. Klein (DVG)Dr. Schwebke (RKI)

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Members and Partners in the VAH

DGKH*GHUP*Doctors in the ÖGD*BDH* DGHM*

BW (Guest in the DC)DVV (Guest in the DC)DVG RKI (Guest in the DC)VHD

* bereits Mitglied

Possible international Cooperations

ÖGHMPSGSH SFHH société francaise d´hygiène hospitalière

Cooperation with the Industry

BPIIHO

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StructureVAH as parent organizationDisinfectant Committee

19 independent membersDGHM, federal authorities, DGKH, GHU, DVV and invited guests from RKI and DVG

Head office (Secretary, Assistant)Administration - Coordination - Information for Users

Laboratory (MTA) Research - Efficacy control tests - Training courses

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4+4-Working group:

Members:4 Members out of the Disinfectant Commission of VAH:Dr. Christiansen, Prof. Heeg, Dr. Gebel, Prof. Martiny

4 Industrial Participants: C. Ostermeyer (Bode), Dr. Goroncy-Bermes (Schülke&Mayr), Dr. Meyer (Ecolab), Dr. Rödger (Lysoform)

RKI as Guest: Dr. Schwebke

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Tasks of the Committee

Prophylactic disinfection of hands, skin, surfaces, instruments and linen in various application areas as e.g.:

HospitalsMedical and dental surgeriesAmbulatory health careSchools, daycare centres, nursing homesHair dressers, tattoo studios, swimming pools

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Tasks of the Committee

National body of experts Analysis and discussion of questions relating to the microbiological testing and application of disinfectantsAdaptation of disinfectant testsCompiling the certificates of effective disinfectants in a list

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Head Office

Tasks: Ensuring a smooth and rapid certification process for disinfectants Coordination of control tests of disinfectants already on the marketOrganisation or multicentre studies in cooperation with other test laboratoriesHeadquarters and information centre for disinfectant manufacturers and users

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Certification and Listing1959 first list with 51 disinfectant proceduresListing after testing the conformity of two independent expert reports on the efficacy of the product with the DGHM guidelines by experts from the CommitteeThree year validity of certificatesRecommended by

The guideline for hospital hygiene and infection control issued by RKI Federal infection control ordinancesUVV - accident prevention regulations in health care

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Standardmethods and Requirements of DGHM

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VAH List of Disinfectants 2006

Issued as of 1.1.2006, English/German with 838 commercial products 6 Application domains:

Hygienic handwash (previously: decontamination of hands)Hand disinfection (hygienic - surgical)Skin disinfection (antisepsis)Surface disinfectionInstrument disinfectionLinen disinfection

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3a. Flächendesinfektion/Surface Disinfection

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4a. Instrumentendesinfektion/Instrument Disinfection

4b. Instrumentendesinfektion/Instrument Disinfection

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Disinfection in Germany

In the event of epidemics §18 paragraph 1,2 of the Infection Control Law → RKI List (issued by Robert Koch-Institut)

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Instrument disinfection - RKI

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Linen disinfectionMob disinfectionDisinfection of excrements –RKI

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Hygienic handrub - RKI

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Surface disinfection - DVG

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Guidelines of the DGHM for testing chemical disinfectants

Testing since 1959 in 2 stepsin-vitro teststests unter 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)

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Determination of neutralizer / MIC / qualitative suspension test – testorganisms – VAH/DGHM

S. aureus ATCC 6538E. coli K12 NCTC 10538E. hirae ATCC 8043P. aeruginosa ATCC 15442P. mirabilis ATCC 14153C. albicans ATCC 10231

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38

5 mL

M

5 mL

x %

PLC*

doppelt konz. doppelt konz..

5 mL

M

5 mL

WSH

WC*

doppelt konz.

5 mL

MM

5 mL

WSH

C*

konz.

M

x %

M M M

y % z % WSH

P

je 0,1 mL

M

x %

M M M

y % z % WSH

P M

x %

M M M

y % z % WSHx %

M

y % z % WSH

PP

Inkubation

AC*MN

A. bidest.CSL ohne bzw. mit NMischungNeutralisationsmittel

OPPLPV

organische BelastungPrüfsuspensionProduktprüflösungPrüfsuspension für die Validierung

SVW

SpülflüssigkeitVerdünnungsmittel, ggf. mit NWSH

M


OPPLPV


SVW




OPPLPV



SVW


VW


MIC and suitable Neutralizer

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40

x %

PL PL PL W

y % z % WSH

P

je 0,1 mL

Inkubation

C* C* C* C*

je 0,1 mLnach der Einwirkzeit (t)

je 10 mL

je 10 mL

AC*MN


OPPLPV


SVW


Qualitative suspension test

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Qualitative suspension test – requirements VAH/DGHM

No growing during 48 h incubation at 36°CCondition for performing the quantitative suspensiontestSearching for the most resistant gram-negative testorganism used in the quantitative suspensiontest

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Quantitative suspension test

0,5 mL M

nach derEinwirkzeit(t)

nach der

0,5mL M

nach 5 minNeutralisationszeit

0,5 mL M

0,5 mL

4,5 mL

M

VV

a) ohne Belastung / WSH-Kontrolle

...weiter s. oben

b) bzw. c) mit Belastung / Test

...weiter s. oben

b) bzw. c) mit Belastung / WSH-Kontrolle

...weiter s. oben

1 mL 0,1 mL 0,1 mL 0,1 mL

Prüfneutralisationsgemisch = 100

0,5 mL

4,5 mL

M

V

10-1-

0,5 mL

4,5 mL

M

V

10-2

0,5 mL

4,5 mL

M

V

M

V

-

a) ohne Belastung / Test

1 mL

8 mL

P

PL

W1 mL1 mL

8 mL

1 mL

1 mL

8 mL

P

W

W1 mL1 mL

8 mL

P

PL

O1 mL1 mL

8 mL

1 mL

1 mL

8 mL

P1 mL

W

O

sofort

Inkubation

AC*MN


OPPLPV


SVW


.

ggf

..

ggf

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Qualitative and quantitative suspension test – test conditions – VAH/DGHM

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Qualitative and quantitative suspension test – spectrum – VAH/DGHM

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Qualitative and quantitative suspension test – spectrum – VAH/DGHM

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Quantitative test under practical conditions – spectrum VAH/DGHM

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Quantitative test under practical conditions –requirements – VAH/DGHM

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51

1 mL

9 mL

O

P

1 mL

9 mL

O

P

0,1 mL

(max. 60 min)trocknen

. 60 min)

nach der Einwirkzeit (t)Überführen des

Keimträgers in C*und 2 min schütteln

nach der Einwirkzeit (t)Überführen des

Keimträgers in C*und 2 min schütteln

0,5 mL

nach dem Schütteln

0,1 mL

Inkubation

0,5 mL

0,1 mL

Inkubation

0,5 mL

0,1 mL

InkubationInkubation

0,2 mL

PL

Testfläche

C*

10 mL0,5 mL

4,5 mL

M

V

10-1

0,5 mL

4,5 mL

M

V

10-1

0,5

Prüfneutralisationsgemisch(mit Glasperlen)

mL

4,5 mL4,5 mL

M

V

M

V

10-1

AC*MN


OPPLPV


SVW


Carrier test – Surface Disinfection

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1 mL

9 mL

O

P

0,05 mL

PL

10 mL

C*10 mL

trocknen (max. 60 min)

und

überführenin PL

nach der Einwirkzeit (t)überführen des Keimträgersin C* und 15 s schütteln

Schüttelröhrchen

0,5 mL

4,5 mL

M

V

10-2

0,1 mL

0,5 mL

4,5 mL

10-2

4,5 mL

-

0,5 mL

4,5 mL

M

V

10-1

0,5 mL

4,5 mL

-

0,1 mL

0,5 mL M

sofort

0,5 mL

nach demSchütteln

0,5 mL

0,1 mL

InkubationInkubation

Carrier test – Instrument disinfectionAC*MN


OPPLPV


SVW


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Quantitative carrier test – requirements –VAH/DGHM

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CEN TC 216Chemical Disinfectants and Antiseptics

Sekretariat: AFNORTC 216 / HWG NAMed / NAL

Horizontal Working Group GemeinschaftsausschußAFNOR Desinfektionsmittel und Antiseptika

TC 216 / WG 1 NAMed / D7Human Medicine Desinfektionsmittel im Bereich der

DIN HumanmedizinTC 216 / WG 2 NAL / DT

Veterinary Desinfektionsmittel im Bereich derBSI Tierhaltung

TC 216 / WG 3 NAL / DLFood hygiene Desinfektionsmittel im

AFNOR Lebensmittelbereich

Disinfectant Testing in Europe

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Disinfectant Testing in Europe - Three-Phase-Modell

phase 1: basistestphase 2 / step 1: quant. suspension testphase 2 / step 2: quant. carrier testphase 3: field trials

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CEN TC 216 – Standards - basics and phase 1 (2007)

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Integration of European Standards VAH/DGHM

Preservation of test organisms used for determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity (EN 12353) Hygienic handwash - phase 2/step 2 (EN 1499)Hygienic handrub - phase 2/step 2 (EN 1500)Surgical handrub - phase 2/step 2 (EN 12791)

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Integration of European Standards VAH/DGHM

Quantitative suspension test – Instruments bactericidal, fungicidal, mycobactericidal – phase 2/step 1 (EN 13727, EN 13624, EN 14348)Quantitative carrier test – Surfaces - bactericidal -phase 2/step 2 (EN 13697)Quantitative carrier test – Instruments – bactericidal, fungicidal, mycobactericidal - phase 2/step 2 (EN 14561, EN 14562, prEN 14563)

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EditorsProf. Dr. M. Borneff-Lipp,

Halle-WittenbergProf. Dr. M. Exner, BonnProf. Dr. P. Gastmeier, HannoverProf. Dr. J.P. Guggenbichler,

ErlangenProf. Dr. P. Heeg, Tübingen,Prof. Dr. V. Hingst, ErlangenProf. Dr. A. Kramer, Greifswald

Chief EditorDr. J. Gebel, BonnPD Dr. C. Wendt, Heidelberg

Editorial staffDr. P. Mailänder

Official Journal

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Bündelung der Kräfte im Bereich "Desinfektion - Antiseptik - Aufbereitung„

„Verbund für Angewandte Hygiene“ (VAH)

[email protected]

http://www.vah-online.de/

the testing and evaluation of chemical disinfectants by the

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