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

2. 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

5. BIOFILM AND ENDOSCOPES
Internal surface of a brand new endoscope biopsy channel (Teflon )
4µm

6. BIOFILM AND ENDOSCOPES
Internal surface of an endoscope biopsy channel after 300 exams (Teflon)
20µm

7. BIOFILM AND ENDOSCOPES
Internal surface of an endoscope biopsy channel after 300 exams (Teflon)
4µm

8. BIOFILM AND ENDOSCOPES
Internal surface of an endoscope biopsy channel after 600 exams (Teflon)
4µm

9. 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

10. 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

11. 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

12. New risk management for the hospital
Need for :
More endoscopes
Writing and implementation of protocols
Evaluation, improvement of these protocols
Respect of protocols
Traceability
In one word : Quality and safety for the patient

13. New risk management in general
New Chemistry
New Guidelines & Regulatory
New Technologies
Need for :

14. 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 disinfectants
AOAC 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

15. 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

16. 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

17. 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…

18. therefore it cannot be validated
Limitations of the manual procedure
Time consuming
A 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

19. 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

20. 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 :

21. 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

22. Limitations of machines
Maintenance
User training
Advanced reprocessors needs trained nurses
Cost
Cost of the machine + cost per cycle
+ maintenance cost
Water quality
Hardness, flow, temperature, prefiltration…

23. As a conclusion 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

24. Automatic endoscope reprocessors
In the USA
n°1 : MEDIVATORS
sold in the US by OLYMPUS
n°2 : STERIS

25. Automatic endoscope reprocessors
Olympus/ Miele ETD 2 & 3
N°2 in Europe

26. In Asia
Olympus OER

27. Automatic endoscope reprocessors
Soluscope 2 & 3
N°1 in Europe

28. Automatic endoscope reprocessors
In Europe up to 2002
n°3 : BELIMED
n°4 : LANCER

29. In Europe in 2003
Only 2 machines fully comply with the European standard :
n°2 : WASSEMBURG machine
+ JOHNSON & JOHNSON products
n°1 : SOLUSCOPE 3

30. Today’s evolution comes from France & UK
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)

31. 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

32. No glutaraldehyde (to avoid protein fixation) One endoscope at a time
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)

33. 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

34. Why is the self-disinfection cycle so important ?
O,2 µm filter
Disinfected Reprocessor
Water
What happens if you have a back flow contamination in the non disinfected zone?
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.

35. 3 answers for the self-disinfection cycle :
STERIS :
Injection of the disinfectant through the filter
SOLUSCOPE 2 :
backflow of the disinfectant
from the machine to the filter

36. includes the water treatment
SOLUSCOPE 3
includes the water treatment
Water tank disconnected
from the hospital water supply
Prefiltration

37. The SOLUSCOPE companies
Created in 1993, based in Marseilles, FRANCE
SOLUSCOPE holding company : Endotech manufactures the machines
Medlore manufactures the chemistry
and markets the machines
Marseilles

38. SOLUSCOPE Company : specialized in endoscope reprocessing
SOLUSCOPE is the only European Company that manufactures both :
the chemistry and the reprocessor.
Over SOLUSCOPE machine running in more than 25 countries.
In 2003
n°1 in Europe and Australia

39. The SOLUSCOPE solutions : Soluscope 2 and Soluscope 3
Existing Soluscope 2
New generation (February 2004)

40. Soluscope 2 : the fastest endoscope reprocesor 15 min Cycle
Compact, Odourless :
can be used in the examination room
Safe, Reliable, Easy to use, Easy to install
Complete system and validated process
Continuous leakage test, self-disinfection cycle,
printer
Single use chemistry:
Soluscope E enzyme cleaner
Soluscope D glutaraldehyde concentrated formulation used at 0.2%, 45°C,

41. Temperature and low concentration
 0.15% 45°C is better than 2% 20°C

42. Easy to use Two irrigation circuit at two different pressure
Red: big channels
Blue small channels

43. 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

45. Easy connection & bar code reading

46. 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

47. 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

48. 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 reductions
reached with SOLUSCOPE 3 using :
PAA 550 ppm
GLUTA 0.2%
Pseudomonas aeruginosa CIP
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
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)
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)
Mycobacterium terrae CIP
7.7 ± 0.2
(7.4 < mean red < 8.0)
7.5 ± 0.3
(7.0 < mean red < 8.0)
5 log
Biotech-Germande Lab., Marseilles, is an internationally recognized laboratory
in microbiological evaluations of AERs efficacy and of their products in vitro

49. A choice between both solutions
Peracetic acid
Glutaraldehyde
Wide antimicrobial efficacy ++ +
Speed
+++
Toxicity -
Ecotoxicity
Compatibility
+/-
Odour
Cost
Cleaning properties

50. Soluscope other features
Automatic sampling of endoscope channels
Suction
Water
Air
Biopsy
Additional channel
All channels
Prion inactivation cycle with 2% chlorine

51. Product control Bottle shape Cap diameter Cap height Cap connector
Color code
Product counter

52. 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

53. 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)

54. Type of connection
Biopsy channel
Leak test
Suction channel
Code : 4XX

55. Type of connection Water Air Suction Waterjet Leack test Code : 2XX
Biopsy

56. Type of connection Leak test Air water Biopsy channel Suction
Code : 1XX
Biopsy
channel

57. Soluscope 3 validation ticket 1
Soluscope S3SolD: 3108/ Prog Vers: 2.71
Cycle 1 / counter cycle: 1823
Start: :49:37
Operator: Max
Patient: Tony Gao
167 Gast FU
Endoscope: 105
Time to inflate the endoscope: 4,7 s
Temperature: 25,3 C
Cleaning stage
Filling: 64 s
17:52:47: Sol C injected
Filling: 84 s
Temperature reached: 35,0 C within 260 s
Add Channel 1: 5,8 s
Suction: 11,1 s
Air: 5,8 s
Biopsy: 11,0 s
Water: 5,8 s
Add channel 2: 3,0s
Add channel 1: 5,7s
Number of controls: 1
Temperature: Min 35,0 C Max 36,0C
Contact time: 101,9 s
Dynamic rince1
B/S: 6,2 s
A/w: 5,1 s
Add 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

58. Soluscope 3 validation ticket 2
Temperature: 25,9 C
Disinfection stage
Filling: 71 s
18:03:06: Sol D injected
Filling: 86 s
Temperature reached: 45°C within 450 s
Add Channel 1: 5,4s
Add channel 2: 3,0 s
Air:5,7 s
Biopsy: 10,9 s
Water: 5,7 s
Suction: 11 s
Add channel 1: 5,6 s
Add channel 2: 3,1 s
Suction: 10,8 s
Air: 5,5s
Biopsy: 10, 9 s
Water: 5,8 s
Air: 5,5 s
Number of controls: 3
Temperature: Min 45,0C, Max 45,6 C
Disinfection time: 301,8 s
Disinfection
Time to reach the temperature
3 channel controls
Disinfection time

59. Soluscope 3 validation ticket 3
B/S6,2 s
A/W: 5,1s
Add channel : 5,6 s
Dynamic rinse 1
Dynamic rinse2
Temperature: 26,2 C
Static rinse
Filling: 63s
Drying
18:22:01
Cycle completed succesfully in 32m 41s
Scope connection control
2 Dynamic rinses
1 static rinse
Drying

60. PAA active concentration
BACTERICIDAL STUDIES on Peracetic acid
Standards & Strains
PAA active concentration
Contact time T°
conditions
Log reduction results
NF EN 1040
Pseudomonas aeruginosa
125 ppm
5 min
20°C
Distilled water
> 5.18
250 ppm
500 ppm
Staphylococcus aureus
> 5.20
NF T (spectre 4)
Escherichia coli
Enterococcus faecium
20, 25, 30, 35, 40 & 45°C
> 5
40°C
Soluscope C 0.005%
NF T (spectre 5)
Mycobacterium smegmatis
Clean conditions :
0.3% serum ppm CaCO3
> 6.38
> 6.28
> 6.18
5.93
> 6
Dirty conditions :
5% serum +
400 ppm CaCO3
> 6.34
> 6.04
> 6.43
> 6.45

61. GLUTA active concentration
BACTERICIDAL STUDIES on Glutaraldehyde
Standards & Strains
GLUTA active concentration
Contact time T°
conditions
Log reduction results
NF EN 1040
Pseudomonas aeruginosa
0,1 % & 0,2 %
5 min
20°C
pH 6,6
> 5
Staphylococcus aureus
Selon NF EN 1040
0,05 %,
45°C
NF T (spectre 5)
Escherichia coli
Enterococcus faecium
Mycobacterium smegmatis
0,1 %
albumine (1%)
& hard water
(300 ppm)
> 6,03
> 6,34
> 6,17
> 5,95
5,70
10 min
5,73
5,99
> 5,99
Selon NF T
pH 6
serum (5%)
& hard water (340 ppm)
5,94
5,6
> 6,94
pH 8
(340 ppm)
6,07

62. PAA active concentration
MYCOBACTERICIDAL STUDIES on PAA or Glutaraldehyde
Standards & Strains
PAA active concentration
Contact
time T°
conditions
Log reduction results
NF T
Mycobacterium avium
470 ppm,
535 ppm,
640 ppm
5 min
40°CC
Dirty conditions :
5% serum +
400 ppm CaCO3
5.63
5.65
5.79
NF T
Mycobacterium terrae
500 ppm
40°C
> 6.80
> 5.49
TB rate of kill Test
(Ascenzi & al)
Mycobacterium bovis var BCG
1 min
serum (5%)
> 6
1000 ppm
Standards & Strains
GLUTA active
concentration
Contact time T°
conditions
Log reduction results
D Value (selon Ascenzi & al)
Mycobacterium bovis var BCG
0,10 %
6 min
45°C
pH 6
Hard water
(400 ppm)
& serum (5%)
> 6
0,15 %
4 min
AOAC
0.15%
5 min
45 °C
Carrier test
(340 ppm)
Mycobactericidal
7.5 min
10 min

63. PAA active concentration GLUTA active concentration
FUNGICIDAL STUDIES on PAA or Glutaraldehyde
Standards & Strains
PAA active concentration
Contact time T°
conditions
Log reduction results
NF EN 1275
Candida albicans
125 ppm
5 min
20°C
Distilled water
> 4.32
250 ppm
500 ppm
Aspergillus niger
625 ppm
15 min
> 4.04
1250 ppm
NF T
40°C
Dirty conditions : 5% serum +
400 ppm CaCO3
> 5.41
> 4.08
Standards & Strains
GLUTA active concentration
Contact time T°
conditions
Log reduction results
NF EN 1275
Aspergillus niger
0,10 %
5 min
45°C
pH 6,6
> 4
0,20 %
Candida albicans
10 min
NF T
0,1 %
pH 6
Carrier test
> 6,2
NF T
pH 10
4,9
5,4
pH 8
5,6

64. VIRUCIDAL STUDIES on PAA or Glutaraldehyde
Standards & Strains
PAA active concentration
Contact time T°
conditions
Log reduction results
NF T
Enterovirus Polio1
500 ppm
5 min
40°C
Distilled water
> 5.6
Standards & Strains
GLUTA active concentration
Contact time T°
conditions
Log reduction results
NF T
Enterovirus polio 1
Human Adenovirus type 5
Vaccine Orthopoxvirus
0.125%
15 min
45°C
pH 7,2
> 4,2
4,02
0.25%
NF T
Bacteriophage T2 / E. coli
Bacteriophage MS2 / E. coli
Bacteriophage X 174 / E. coli
10 min
pH 6,6
> 5,35
5,04
> 4,50
5,9
According to ASTM
Adenovirus type 2
0.15%
5 min
Carrier test
pH 6
5% serum +
340 ppm CaCO3
Complete viral inactivation
Herpes simplex virus type 1
Polio virus type 1
2.5 min, 5 min & 7.5 min

65. PAA active concentration GLUTA active concentration
SPORICIDAL STUDIES on PAA or Glutaraldehyde
Standards & Strains
PAA active concentration
Contact time T°
conditions
Log reduction results
NF T
Clostridium sporogenes
Bacillus subtilis
500 ppm
15 min
20°C
Distilled water
> 5
625 ppm
1000 ppm
NF T
5 min
40°C
Bacillus cereus
NF T
Dirty conditions :
5% serum +
400 ppm CaCO3
> 5.58
10 min
> 5.65
D Value
60 min
> 6
Standards & Strains
GLUTA active concentration
Contact time T°
conditions
Log reduction results
D Value,
according to NF T
Bacillus subtilis
0.25%
1 à 5 h
45°C
pH 6
5% serum +
340 ppm CaCO3
> 6
within 3 to 5 h
End-point analysis
according to AOAC966.04
Clostridium sporogenes
0.15%
2 à 8 h
Carrier tests
(on penicylinders)
400 ppm CaCO3
Sporicidal within 5 h
Sporicidal within 7 h
D End-point analysis
2 à 16 h
(on silk suture loops)
Sporicidal within 8 h
Sporicidal within 13h