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 ENDOSCOPES Internal surface of a brand new endoscope biopsy channel (Teflon ) 4µm

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

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

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

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 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

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…

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

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 training Advanced reprocessors needs trained nurses Cost Cost of the machine + cost per cycle + maintenance cost Water quality Hardness, flow, temperature, prefiltration…

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

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

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

In Asia Olympus OER

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

Automatic endoscope reprocessors 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 products n°1 : SOLUSCOPE 3

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)

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

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)

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

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.

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

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

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

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 2003 n°1 in Europe and Australia

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

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,

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

Easy to use Two irrigation circuit at two different pressure Red: big channels Blue 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 reductions reached with SOLUSCOPE 3 using : PAA 550 ppm 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) 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 104321 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

A choice between both solutions Peracetic acid Glutaraldehyde Wide 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 Water Air Suction Waterjet Leack test Code : 2XX Biopsy

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

Soluscope 3 validation ticket 1 Soluscope S3SolD: 3108/ Prog Vers: 2.71 Cycle 1 / counter cycle: 1823 Start: 03-11-05 17:49:37 Operator: Max Patient: Tony Gao 167 Gast FU 12785643 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

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

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

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 72-301 (spectre 4) Escherichia coli Enterococcus faecium 20, 25, 30, 35, 40 & 45°C > 5 40°C Soluscope C 0.005% NF T 72-300 (spectre 5) Mycobacterium smegmatis Clean conditions : 0.3% serum + 300 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

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 72-170 (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 72-300 pH 6 serum (5%) & hard water (340 ppm) 5,94 5,6 > 6,94 pH 8 (340 ppm) 6,07

PAA active concentration MYCOBACTERICIDAL STUDIES on PAA or Glutaraldehyde Standards & Strains PAA active concentration Contact time T° conditions Log reduction results NF T 72-300 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 72-301 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 965.12 0.15% 5 min 45 °C Carrier test (340 ppm) Mycobactericidal 7.5 min 10 min

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 72-300 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 72-190 0,1 % pH 6 Carrier test > 6,2 NF T 72-300 pH 10 4,9 5,4 pH 8 5,6

VIRUCIDAL STUDIES on PAA or Glutaraldehyde Standards & Strains PAA active concentration Contact time T° conditions Log reduction results NF T 72-180 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 72-180 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 72-181 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 1052-85 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

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 72-230 Clostridium sporogenes Bacillus subtilis 500 ppm 15 min 20°C Distilled water > 5 625 ppm 1000 ppm NF T 72-301 5 min 40°C Bacillus cereus NF T 72-300 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 72-230 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