Endoscope Reprocessing: regulatory and technological development in Europe and in the US Introduction to SOLUSCOPE’s products

Endoscope Reprocessing: regulatory and technological development

in Europe and in the US

Introduction to SOLUSCOPE’s products

Difficulty of cleaning and disinfecting endoscopes

• Due to the endoscope material the endoscope is build with :

no heat sterilization

• Due to the hospital practice and habits

• Due to the endoscope design

BIOFILM AND

ENDOSCOPESInternal surface of a brand new endoscope biopsy channel (Teflon )

4µm

BIOFILM AND

ENDOSCOPESInternal surface of an endoscope biopsy channel after 300 exams (Teflon)

20µm

BIOFILM AND


4µm

BIOFILM AND


4µm

Where do we come from ?

• Cleaning only the distal part of the endoscope

because endoscopes were not waterproof

because the contamination risk was ignored

• The only thing the doctors cared about was :

the reprocessing time between two patients

not to damage their endoscopes

New awareness of the contamination risk

Changes in the types of germs

Changes in the legal responsibility

Changes in the types of patients

Hepatitis, Aids, multi resistant mycobacteria, SARS, Creutzfeld Jacob (mad cow)….

Elderly people, Immunodepressed patients….

The doctor and the hospital can be sued

New awareness of the chemical risk

Skin, eyes and respiratory toxicity: allergy, asthma

For the nurse

For the patient

For the environment

Colitis due to improper rinse of the endoscope

Non biodegradable disinfectant kills the bacteria used in sewage plants

New risk management for the hospital

More endoscopes

Writing and implementation of protocols

Respect of protocols

Evaluation, improvement of these protocols

Need for :

In one word : Quality and safety for the patient

Traceability

New risk management in general

New Chemistry

New Guidelines & Regulatory

New Technologies

Need for :

New guidelines & regulatory

The evolution came from the US

• Guidelines for the manual reprocessing The soaking time in 2% glut changed over the years from 5 to 90 min, for most glutaraldehyde products!

• FDA approved disinfectantsAOAC tests for bactericidal, virucidal, fongicidal and sporicidal efficacy

Stability and toxicity tests

• The US focus on the disinfectant in vitro efficacy• And not on the overall process efficacy

New Chemistry

• Disinfectants

2% Glutaraldehyde : world standard– Replaced alcohol, quaternary ammonium….

Today attempt to replace glutaraldehyde by– Peracetic acid, Chlorine dioxide, Cidex OPA….

• Cleaners– Enzymatic cleaners– Cleaners with proven efficacy

New technologies

• Endoscopes– Waterproof, – Without elevator channel, – Possibility to brush the water channel, – and tomorrow maybe single use endoscopes !

• Reprocessors– Semi-automatic reprocessors

• Pumps• Fume cabinet

– Automatic reprocessors• With validated process• Traceability• Single shot chemistry• Channel control

Limitations of the manual procedure

The cleaning : No monitoring of the channel flushing,nor of the cleaning solution concentration, temperature, contact time

The rinsing : No monitoring of the rinse efficacy and bacteriological quality

You cannot guaranty the efficacy of :

The disinfection : No monitoring of :• the temperature, • the concentration : disinfectant recycling leads to a loose of

efficacy after each use (dilution, pollution, etc.)• the amount of disinfectant flushed in the channels• the contact time…

Limitations of the manual procedure

Time consumingA good manual procedure is 10 min cleaning, 20 min disinfecting + leakage test + rinsing…

= 40 min.

Toxic for the nurse

No good traceability

It is not reproducible,

therefore it cannot be validated

A quick look at semi-automatic machines

An “opened machine”, The user can modified

temperature, contact time, concentrations, and even the

chemicals !

No controls No validation

No reproducibility No traceability

What is an automatic endoscope reprocessor ?

Fully automatic and reproducible : It is a whole system, a global process

• The cleaner,• The disinfectant • The temperature,• The contact time,• The irrigation flow and pressure

………………………cannot be modified by the user

• Traceability• Validated process• Self-disinfection cycle

It must have :

Advantages of the automatic procedure

Reproducibility

Temperature

Concentration

Reliable Leak test

Traceability

Time saving

Freedom for the nurse

Safety for the nurse

etc….

Better Cleaning

Monitoring of :

Better Rinsing

Contact time

Limitations of machines

Maintenance

User trainingAdvanced reprocessors needs trained nurses

CostCost of the machine + cost per cycle + maintenance cost

Water qualityHardness, flow, temperature, prefiltration…

A good manual procedure is better than

a bad automatic reprocessor

A good automatic reprocessor is good only• with the full validation :

in vitro tests on chemicals+ Simulated-use test + clinical-use tests

+ Self-disinfection validation (machine and water treatment)• with a proper maintenance • if used by qualified nurses

As a conclusion

Automatic endoscope reprocessors

In the USA

n°1 : MEDIVATORSsold in the US by OLYMPUS

n°2 : STERIS


Olympus/ Miele ETD 2 & 3

N°2 in Europe

In Asia

Olympus OER


Soluscope 2 & 3

N°1 in Europe

In Europe up to 2002

n°3 : BELIMED n°4 : LANCER


In Europe in 2003

Only 2 machines fully comply with the European standard :

n°2 : WASSEMBURG machine+ JOHNSON & JOHNSON productsn°1 : SOLUSCOPE 3

Because of :

the blood contamination scandal

the Creutzfeld Jacob disease (mad cow)

• Banning of manual reprocessing and glutaraldehyde

• Reprocessors complying with the European standard (that will become an ISO standard)

Today’s evolution comes from France & UK

The new European standard

A reprocessor should automatically :

• Leak test, Clean, Rinse, Disinfect, Rinse, Dry

• Check the flow in the endoscope channels

• Use single-shot chemistry

• Provide with traceability

• Have a validated self-disinfection cycle

• Provide with a water treatment system that can be disinfected

• Have 2 sensors for each critical parameters

The French regulation

The European Standard

+

No glutaraldehyde (to avoid protein fixation)

+

One endoscope at a time (to avoid cross contamination)

+

Double cleaning step (to limit the risk of prion transmission)

Why is the channel control so important ?

• During each step of the cycle,

• The reprocessor checks :– That no channel is blocked– That all channel are connected– That the proper amount of chemistry and rinse water

is flushed through each and every channel

O,2 µm filter

Non disinfected zone

Water

Why is the self-disinfection cycle so important ?

Disinfected Reprocessor

What happens if you have a back flow contamination in the non disinfected zone?

Every time you flush water, you will contaminate the machine.A biofilm will grow that will be difficult to get rid of.

3 answers for the self-disinfection cycle :

STERIS : Injection of the disinfectant through the filter

SOLUSCOPE 2 : backflow of the disinfectantfrom the machine to the filter

SOLUSCOPE 3

includes the water treatment

Water tank disconnected from the hospital water supply

Prefiltration

The SOLUSCOPE companies

Marseilles

Created in 1993, based in Marseilles, FRANCESOLUSCOPE holding company : Endotech manufactures the machines

Medlore manufactures the chemistry and markets the machines

SOLUSCOPE Company :

specialized in endoscope reprocessing

• SOLUSCOPE is the only European Company that manufactures both :

– the chemistry and the reprocessor.

• Over 1 500 SOLUSCOPE machine running in more than 25 countries.

In 2003n°1 in Europe and Australia

The SOLUSCOPE solutions :

Soluscope 2 and Soluscope 3

Soluscope 2

Existing Soluscope 2New generation (February 2004)

Compact, Odourless : can be used in the examination room

Safe, Reliable, Easy to use, Easy to install

Complete system and validated processContinuous leakage test, self-disinfection cycle, printerSingle use chemistry: Soluscope E enzyme cleanerSoluscope D glutaraldehyde concentrated formulation used at 0.2%, 45°C,

Soluscope 2 : the fastest endoscope reprocesor15 min Cycle

Temperature and low concentration

0.15% 45°C is better than 2% 20°C

Glutaraldehyde in vitro efficacy against Mycobacterium bovis : relation between concentration and temperature

-7

-6

-5

-4

-3

-2

-1

0

0 5 10 15 20 25 30 35 40 45 50

time (min)lo

g re

duct

ion

Soluscope D 0,15% 45°C

Soluscope D 2% 22°C

Easy to use

Two irrigation circuit at two different pressure

Red: big channelsBlue small channels

Soluscope 3 : the ultimate answer

• The most advanced endoscope reprocessor

• Channel control• Integrated water treatment• Bar code reader• Peracetic acid or

glutaraldehyde version• Self-disinfection including the

water treatment• Marketed in France, UK,

Germany• To be introduced in the US in

2005 Glut PAA

Easy connection & bar code reading

Soluscope 3 unique channel control

• Individual channel irrigation • Patented volumetric systems: measurement of the duration to empty a

calibrated volume in each channel.

- Too short : non connected channel- Too long : Blocked channel

Each channel is controlled during cleaning, disinfection and final rinse

The Disinfectant SOLUSCOPE PA

The disinfectant Soluscope PA is a mix of 2 patented formulations :• A 5% peracetic acid solution : Soluscope P • and an anticorrosive product : Soluscope A

Both solutions are extemporaneously diluted and mixed in the bowl, just before increasing temperature to 40°C.

No decrease of PAA concentration induced by the anticorrosive chemical

But a synergy between Soluscope P and stabilizers + tensioactives involved in Soluscope A

And of course the protective effect of Soluscope A

Soluscope 3 : a validated global Process

with a choice of 2 disinfectant solutions

BIOTECH GERMANDE Laboratory : simulated-use test Microbiological validation of the cycle 1 (standard cycle), one cleaning step

Required minimal

log reduction

Strains

Mean log reductionsreached with SOLUSCOPE 3 using :

PAA 550 ppmPAA 550 ppm GLUTA 0.2% GLUTA 0.2%

Pseudomonas aeruginosa CIP 103467

8.9 ± 0.1(8.5 < mean red < 9.0)

9.3 ± 0.6(8.8 < mean red < 10.0) 7 log

Aspergillus niger CIP 1431-83

6.6 ± 0.1(6.3 < mean red < 6.6)

6.8 ± 0.7(5.6 < mean red < 7.5)

6 log

Bacillus subtilis ATCC 9372

6.6 ± 0.5(5.8 < mean red < 7.2)

6.5 ± 0.4(5.9 < mean red < 7.1)

6 log

Bacillus cereus CIP 78.3

6.5 ± 0.1(6.2 < mean red < 6.6)

6.2 ± 0.3(5.7 < mean red < 6.6)

6 log

Mycobacterium terrae CIP 104321

7.7 ± 0.2(7.4 < mean red < 8.0)

7.5 ± 0.3(7.0 < mean red < 8.0)

5 logBiotech-Germande Lab., Marseilles, is an internationally recognized laboratory in microbiological evaluations of AERs efficacy and of their products in vitro

A choice between both solutions

Peracetic acid GlutaraldehydeWide antimicrobial efficacy ++ +Speed +++ ++Toxicity ++ -Ecotoxicity ++ -Compatibility +/- ++Odour + -Cost - ++Cleaning properties +/- -

Soluscope other features

Automatic sampling of endoscope channels•Suction•Water•Air•Biopsy•Additional channel•All channels

Prion inactivation cycle with 2% chlorine

Product control

- Bottle shape

- Cap diameter

- Cap height

- Cap connector

- Color code

- Product counter

A water treatment

• 0,2µ HIMA terminal filtration• 1µm & 0,6/0,2 µm prefiltration• Water Disconnection from

hospital water network• Water booster pump• Daily self disinfected

Endoscope identification

• Scopes are classified :• - by type : gastro, colo, duodéno, broncho…scope• - by number & type of channel to irrigate

Scopes are grouped as follow :• - Groupe 1 : 4 channels scopes (gastro)• - Groupe 2 : 5 channels scopes (Gastro/Colo)• - Groupe 3 : Scopes with elevator channel• - Groupe 4 : Scopes without air / water channel

• Ex : 0315 = group 3, endoscope N°15• All connectors irrigated (even if not connected)

Type of connection

• Biopsy channel

• Leak test

• Suction channel

• Code : 4XX

Type of connection

• Air• Suction • Leack test

• Code : 2XX

Water

Waterjet

Biopsy

Type of connection

• Leak test

• Air

• water

• Suction

• Code : 1XX

Biopsy channel

Soluscope 3 validation ticket 1 Soluscope S3SolD: 3108/ Prog Vers: 2.71Cycle 1 / counter cycle: 1823Start: 03-11-05 17:49:37Operator: MaxPatient: Tony Gao167 Gast FU 12785643 Endoscope: 105Time to inflate the endoscope: 4,7 sTemperature: 25,3 CCleaning stageFilling: 64 s 17:52:47: Sol C injectedFilling: 84 s Temperature reached: 35,0 C within 260 sAdd Channel 1: 5,8 s Suction: 11,1 s Air: 5,8 sBiopsy: 11,0 sWater: 5,8 s Add channel 2: 3,0s Add channel 1: 5,7s Number of controls: 1 Temperature: Min 35,0 C Max 36,0CContact time: 101,9 sDynamic rince1 B/S: 6,2 sA/w: 5,1 sAdd Channel : 6,2 s Temperature: 25,9 C

• AER Id• Cycle #• Date & time• Operateur ID• Patient ID• Scope’s identification• Leak test • Temp control • Cleaner injection • Filling flow • Channel control • Cleaning duration• Scope connection control• Dynamic rinse

Temperature: 25,9 CDisinfection stage Filling: 71 s 18:03:06: Sol D injectedFilling: 86 sTemperature reached: 45°C within 450 sAdd Channel 1: 5,4s Add channel 2: 3,0 s Air:5,7 sBiopsy: 10,9 sWater: 5,7 sSuction: 11 sAdd channel 1: 5,6 sAdd channel 2: 3,1 sSuction: 10,8 sAir: 5,5sBiopsy: 10, 9 sWater: 5,8 sAdd channel 1: 5,6 sAdd channel 2: 3,0 sWater: 5,7 sBiopsy: 10,9 s Air: 5,5 sSuction: 10,8 sNumber of controls: 3Temperature: Min 45,0C, Max 45,6 CDisinfection time: 301,8 s

Soluscope 3 validation ticket 2

DisinfectionTime to reach the temperature

3 channel controls

Disinfection time

Soluscope 3 validation ticket 3

B/S6,2 sA/W: 5,1s Add channel : 5,6 s Dynamic rinse 1 Dynamic rinse2Temperature: 26,2 CStatic rinseFilling: 63sDrying18:22:01 Cycle completed succesfully in 32m 41s

Scope connection control

2 Dynamic rinses

1 static rinse

Drying

Standards & StrainsPAA active

concentration Contact

timeT° conditions

Log reduction results

NF EN 1040 Pseudomonas aeruginosa

125 ppm

5 min 20°C Distilled water

> 5.18

250 ppm > 5.18

500 ppm > 5.18

Staphylococcus aureus

125 ppm


> 5.20

250 ppm > 5.20

500 ppm > 5.20

NF T 72-301 (spectre 4)Staphylococcus aureus

Pseudomonas aeruginosaEscherichia coli

Enterococcus faecium

500 ppm 5 min20, 25,

30, 35, 40 & 45°C

Distilled water

> 5> 5> 5> 5



Enterococcus faecium

500 ppm 5 min 40°CSoluscope C

0.005%

> 5> 5> 5> 5



Enterococcus faeciumMycobacterium smegmatis

500 ppm 5 min 40°C

Clean conditions :

0.3% serum + 300 ppm CaCO3

> 6.38> 6.28 > 6.185.93 > 6




500 ppm 5 min 40°C

Dirty conditions :

5% serum + 400 ppm CaCO3

> 6.34> 6.04> 6.43> 6.45> 6.04

BACTERICIDAL STUDIES on BACTERICIDAL STUDIES on Peracetic acidPeracetic acid

Standards & StrainsGLUTA active concentration

Contact time T° conditions Log reduction results

NF EN 1040Pseudomonas aeruginosa 0,1 % & 0,2 % 5 min 20°C pH 6,6 > 5

Staphylococcus aureus 0,1 % & 0,2 % 5 min 20°C pH 6,6 > 5

Selon NF EN 1040Pseudomonas aeruginosa

0,05 %,0,1 % & 0,2 %

5 min 45°C pH 6,6 > 5

Staphylococcus aureus 0,05 %,0,1 % & 0,2 %

5 min 45°C pH 6,6 > 5




0,1 % 5 min 20°C

pH 6,6albumine (1%)& hard water

(300 ppm)

> 6,03> 6,34 > 6,17> 5,95 5,70




0,1 % 10 min 20°C


(300 ppm)

5,73> 6,34 > 6,17> 5,95 5,99




0,1 % 5 min 45°C


(300 ppm)

> 6,03> 6,34> 6,17 > 5,95> 5,99




0,1 % 10 min 45°C


(300 ppm)

> 6,03> 6,34> 6,17 > 5,95> 5,99

Selon NF T 72-300 Escherichia coli

Staphylococcus aureusEnterococcus faecium

0,1 % 5 min 45°C

pH 6serum (5%)

& hard water (340 ppm)

5,94 5,6

> 6,94

Selon NF T 72-300 Escherichia coli

Staphylococcus aureusEnterococcus faecium

0,1 % 5 min 45°C

pH 8serum (5%)

& hard water (340 ppm)

> 6,94 6,07> 6,94

BACTERICIDAL STUDIES on BACTERICIDAL STUDIES on GlutaraldehydeGlutaraldehyde



D Value (selon Ascenzi & al)Mycobacterium bovis var BCG

0,10 % 6 min

45°C

pH 6Hard water (400 ppm)

& serum (5%)

> 6

0,15 % 4 min > 6

AOAC 965.12Mycobacterium bovis var BCG

0.15%

5 min

45 °C

pH 6Carrier testHard water (340 ppm)

& serum (5%)

Mycobactericidal

7.5 min Mycobactericidal

10 min Mycobactericidal

Standards & Strains PAA active concentration Contact time

T° conditions Log reduction results

NF T 72-300Mycobacterium avium

470 ppm,535 ppm,640 ppm

5 min 40°CCDirty conditions :


5.635.655.79

NF T 72-301 Mycobacterium aviumMycobacterium terrae

500 ppm 5 min 40°CDirty conditions :


> 6.80> 5.49

TB rate of kill Test (Ascenzi & al)Mycobacterium bovis var BCG

500 ppm 1 min

40°C serum (5%)

> 6

1000 ppm 1 min > 6

MYCOBACTERICIDAL STUDIES on MYCOBACTERICIDAL STUDIES on PAAPAA or Glutaraldehyde

FUNGICIDAL STUDIES on FUNGICIDAL STUDIES on PAAPAA or Glutaraldehyde

Standards & Strains PAA active concentration Contact time T° conditions Log reduction results

NF EN 1275Candida albicans

125 ppm


> 4.32

250 ppm > 4.32

500 ppm > 4.32

NF EN 1275Aspergillus niger

625 ppm15 min 20°C Distilled water

> 4.04

1250 ppm > 4.04

NF T 72-300Candida albicans Aspergillus niger

500 ppm 5 min 40°CDirty conditions :

5% serum +400 ppm CaCO3

> 5.41> 4.08




0,10 %5 min 45°C pH 6,6

> 4

0,20 % > 4


0,10 %5 min 45°C pH 6,6

> 4

0,20 % > 4


0,10 %10 min 45°C pH 6,6

> 4

0,20 % > 4


0,10 %10 min 45°C pH 6,6

> 4

0,20 % > 4

NF T 72-190Candida albicans

0,1 % 5 min 45°CpH 6

Carrier test> 6,2

NF T 72-300Aspergillus niger

0,1 % 5 min 45°C pH 10 4,9

NF T 72-300Candida albicans

0,1 % 5 min 45°CpH 6 5,4

pH 8 5,6

VIRUCIDAL STUDIES on VIRUCIDAL STUDIES on PAAPAA or Glutaraldehyde

Standards & Strains GLUTA active concentration Contact time T° conditions Log reduction results

NF T 72-180Enterovirus polio 1

Human Adenovirus type 5Vaccine Orthopoxvirus

0.125% 15 min 45°C pH 7,2> 4,2> 4,2

4,02

NF T 72-180Enterovirus polio 1

Human Adenovirus type 5Vaccine Orthopoxvirus

0.25% 15 min 45°C pH 7,2> 4,2> 4,2> 4,2

NF T 72-181Bacteriophage T2 / E. coli

Bacteriophage MS2 / E. coliBacteriophage X 174 / E. coli

0.125% 10 min 45°C pH 6,6> 5,35 5,04> 4,50

NF T 72-181Bacteriophage T2 / E. coli

Bacteriophage MS2 / E. coliBacteriophage X 174 / E. coli

0.125% 15 min 45°C pH 6,6> 5,35 5,9

> 4,50

According to ASTM 1052-85Adenovirus type 2

0.15%

5 min

45°C

Carrier testpH 6


Complete viral inactivation

Herpes simplex virus type 1 5 minComplete viral

inactivation

Polio virus type 12.5 min, 5 min

& 7.5 minComplete viral

inactivation


NF T 72-180Enterovirus Polio1

500 ppm 5 min 40°C Distilled water > 5.6

SPORICIDAL STUDIES on SPORICIDAL STUDIES on PAAPAA or Glutaraldehyde


NF T 72-230Clostridium sporogenes

Bacillus subtilis

500 ppm


> 5

625 ppm > 5

1000 ppm > 5

NF T 72-301Clostridium sporogenes

Bacillus subtilis

500 ppm


> 5

625 ppm > 5

1000 ppm > 5

NF T 72-301Bacillus cereus 1000 ppm 15 min 40°C Distilled water > 5

NF T 72-300Clostridium sporogenes 500 ppm

5 min40°C

Dirty conditions :5% serum +

400 ppm CaCO3

> 5.58

Bacillus subtilis 10 min > 5.65

D ValueBacillus cereus 500 ppm 60 min 40°C


400 ppm CaCO3

> 6

D ValueBacillus cereus 1000 ppm 10 min 40°C


400 ppm CaCO3

> 6

Standards & Strains GLUTA active concentration


D Value, according to NF T 72-230

Bacillus subtilis0.25% 1 à 5 h 45°C

pH 65% serum +

340 ppm CaCO3

> 6 within 3 to 5 h

End-point analysisaccording to AOAC966.04

Clostridium sporogenes 0.15% 2 à 8 h 45°C

Carrier tests(on penicylinders)


Sporicidal within 5 h

Bacillus subtilis Sporicidal within 7 h

D End-point analysisaccording to AOAC966.04

Clostridium sporogenes 0.15% 2 à 16 h 45°C

Carrier tests(on silk suture loops)


Sporicidal within 8 h

Bacillus subtilis Sporicidal within 13h

Documents

Endoscope Reprocessing: regulatory and technological development in Europe and in the US Introduction to SOLUSCOPE’s products