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Reprocessing of flexible endoscopes

Rudolf Glasmacher

Manager Technical Service Research & Development

Health Care Division Europe Middle East Africa

Mar. 2009


Removal of all visible contamination� Cleaning

Removal of all microbiological/virological contaminati on� disinfection and sterilisation

Useful life of Instruments� Material compatibility against chemistry /

temperature / mechanical influences

Claims for reprocessing of instruments


Source: ESGE-ESGENA guideline: Cleaning and disinfec tion in gastrointestinal endoscopy (Update 2008); Endoscopy 2008;40:939-957

Overview reprocessing possibilities of flexible endoscopes


HYGEA Study*

German Survey about Flexible Endoscope Reprocessing

Performed in: 1999 - 2000

Participation: • 25 hospitals • 30 private endoscopy units

Target: Check Quality status of endoscope reprocessing at 2 phases

* Lit.:


ResultsPhase 1 / Survey ResultsPhase 2 / Survey following Questionnaire and Training

7 7

8 4

5 8

9 6

4 25

3 25

0% 20% 40% 60% 80% 100%

Manual: P1 (n=14)

Manual: P1 (n=12)

Semi-automatic: P1 (n=13)

Semi-automatic: P1 (n=15)

Automatic: P1 (n=29)

Automatic: P1 (n=28)

Results „Not OK“ Results „OK“


Conclusions of Study

No significant difference between Phase 1 and Phase 2

Manual and semi-automatic reprocessing less effective than automatic reprocessing

Consequence in Germany:Automated processes will be required from Health insuran ce


Statement of

Robert Koch Institute (RKI) a Federal Institute with in the portfolio of the Federal Ministry of Health in Germany:

Automated processes possibility of validation

Manual processes only if automated not possible and than with aStandard Operating Procedure (SOP)


Application

Pre-cleaning

Cleaning

Taking

Storage

Sterilization(thermo stable )

Final disinfection(thermo unstable )

Circle of reprocessing of instrumentsCircle of reprocessing of instruments

Manual Reprocessing


Pre-cleaning still connected with light source

• Wipe the insertion tube with a tissue soak with Cleaning solution Detergentwith good cleaning power

• Insertion of scope specific value for cleaning

• Rinse channels with a sufficient volume (200 - 500 ml) of disinfection solution Detergent• Operation of Air-/water feeding for several seconds

• Disconnection of scope from light source

Cleaning on reprocessing workplace• Insertion of scope in disinfection solution with good cleaning power Detergent

• Leakage test according scope manufacturer

• Brush of channels with cleaning brushes from Manufacturer

Wipe all outer surfaces of scope with a lint-free cloth

• Rinse Channels with disinfectant solution, special hand pump from scope manufacturer

• Remove scope from solution, rinse outside of scope with a water shower and the channels with the Pump

• Dry roughly channels by rinsing of air with manual pump

• Dry roughly outer surfaces with a cloth

Pre-Cleaning and cleaningManual Reprocessing - SOP


Detergents can be divided in two main groups:

with enzymatic and/or alkaline boosters

with antimicrobial active substances


present situation

Region Pre-cleaning final disinfection

Central Detergent with antimicrobial disinfectant, concentrated Europe substances products; antimicrobial

substances (mixture of aldehydes, Peracetic acid)

France Two cleaning steps required disinfectant (ready to use)- 1st have to be detergent with (PAA, OPA, Glutaraldehyde)

actives substances- slight alkaline detergent

USA, some Detergent with enzymes disinfectant (Ready to use) European C. (PAA, OPA, Glutaraldehyde )

Manual Reprocessing

Reprocessing of flexible endoscopesDetergents with antimicrobial agents / disinfectantDetergents with antimicrobial agents / disinfectant

Activ agent Advantages DisadvantagesQAC (Quaternary ammonium compounds)

Glucoprotamin/Aminderivates

Peracids / Salts of peracids

•alkaline pH

•neutral pH

• No smell

• Good material compatibility

• Residues

• Limited microbiological efficacy

• high effectiveness

• high cleaning activity• high ecological disintegration

• no activity against polio viruses• material compatibility limited for some silicon elastomer

• Discoloration with aldehydes

• high cleaning activity

• odourless

• good cleaning power• high effectiveness• Efficacy against Clostridiumdefficile spores

• good material compatibility• better smell than pure PAA

• lower material compatibility

(e.g. anodized aluminium, plated instruments-chromium layer)

• material compatibility limited for

instruments with chromium layer, if layer is damaged, copper, brass)


Use of detergent

• Prepare right use concentration of the disinfecting sol ution� For powdered products, fill in water at first,

add powder and then insert instruments

• Take care of complete wetting (hollow spaces)

• Application of detergent solution at room temperatur e

• For hygienically reasons detergent solution without an timicrobial actives should be single use.

Detergent with antimicrobial actives should be change d at least on a daily basis or in case of visible contamination immediately

• Rinse thoroughly with running water

Manual Reprocessing


Manual Reprocessing


Cleaning with ultrasonic bathfor some accessories

4444 Use of suited detergent agents

4444 Temperature of cleaning solution > 40°C

4444 Sort in instruments correctly - sonic shadows have to be avoided

4444 Keeping of sonic times (3-5 minutes at least 35 kHz )

4444 Solution in the sonic bath has to be renewed in reg ular intervals

Manual Reprocessing


Soiling of a PESoiling of a PE--forcesforcesbetween leader wire and coatbetween leader wire and coat

Scale 1:40 Scale 1:5

Manual Reprocessing


Application

Pre-cleaning

Cleaning

Taking

Storage

Sterilization(thermo stable )

Final disinfection(thermo unstable )

Circle of reprocessing of instrumentsCircle of reprocessing of instruments

Manual Reprocessing


• Immersion of scope in disinfection solution Instrument-DisinfectantConcentration of disinfectantshort contact time conc.

• Fill channels with pump (disconnect pump after filling)

Disinfection

• Thoroughly rinsing of all surfaces of endoscope outside and channels water of minimum drinking water quality (better sterile desalinate water

Rinsing

Drying• Accurate drying of outer surfaces and channels (if air-pistol used pressure max. 0.5 bar)

• Control part and optic glasses can be wiped with germ-free alcohol Ethanol / Isopropanol (70%ig)

• Accessories, vales etc. are cleaned and disinfected seperatly, if possible sterilisation

Manual Reprocessing - SOP


Manual Reprocessing – active substances


present situation

Region Pre-cleaning Final disinfection

Central Detergent with antimicrobial disinfectant, concentratedEurope substances products; antimicrobial

substances (mixture of aldehydes, Peracetic acid)

France Two cleaning steps required disinfectant (ready to use)- 1st have to be detergent with (PAA, OPA, Glutaraldehyde)

actives substances- slight alkaline detergent

USA, some Detergent with enzymes disinfectant (Ready to use) European C. (PAA, OPA, Glutaraldehyde)

Manual Reprocessing


Manual Reprocessing – active substances

Selection of disinfectant

Excellent Efficacy

Good Material Compatibility

Less Toxicological Risk for user

Biodegradability of ingredients


a) Phase 1 (Basic-Suspension test, 2 different germs, 3 times) every disinfectant have to be effective latest in 60 min.log-reduction > 5

b) Phase 2 / Step 1Specific suspension test; different test models dependent from kind of application of disinfectant

c) Phase 2 / Step 2Carrier test; different test models dependent from kind of application of disinfectant

European Test Norms (CEN)

Manual Reprocessing – microbiological test methods

Final disinfection: Clean conditionsPre-Cleaning/Cleaning: Dirty for cleaning)


Manual Reprocessing – microbiological test methods


Phase 2Step 1

Phase 2Step 2

Manual Reprocessing – microbiological test methodsEquivalence of German test methods with EN standards

Reprocessing of flexible endoscopesManual Reprocessing – disinfection



Most of endoscope manufacturers have improved their material to get a sufficient

material compatibility with PAA.

PAA becomes more and more the standard for disinfection of flexible endoscopes.

Manual Reprocessing – disinfection



AutomatedAutomated ReprocessingReprocessing

DIN EN ISO 15883 standard for Washer disinfectors.Part 4 „Requirements and tests for washer-disinfect ors

employing chemical disinfection for thermolabile end oscopes (ISO 15883-4:2008)” in force since 08.2008



Overview reprocessing possibilities of flexible endoscopes


Pre-cleaning still connected with light source

• Wipe the insertion tube with a tissue soak with Cleaning solution Detergentwith good cleaning power

• Insertion of scope specific value for cleaning

• Rinse channels with a sufficient volume (200 - 500 ml) of disinfection solution Detergent• Operation of Air-/water feeding for several seconds

• Disconnection of scope from light source

Cleaning on reprocessing workplace• Insertion of scope in disinfection solution with good cleaning power Detergent

• Leakage test according scope manufacturer

• Brush of channels with cleaning brushes from Manufacturer

Wipe all outer surfaces of scope with a lint-free cloth

• Rinse Channels with disinfectant solution, special hand pump from scope manufacturer

• Remove scope from solution, rinse outside of scope with a water shower and the channels with the Pump

• Dry roughly channels by rinsing of air with manual pump

• Dry roughly outer surfaces with a cloth

Pre-Cleaning and cleaningManual cleaning – before WD


EN 15883 ( Requirements Washer / Disinfectors)Part 1:

General Requirements, Terms, Definitions and Tests for all WD

Part 4:Special Requirements and Tests for WD for thermo-labile endoscopes Check whether correct outcome quality is obtained - with all endoscope types - under particular circumstances at the user's place

Part 5: Test Methods to be used for Type Tests and Validatio n checking Cleaning and Disinfecting Performance


Quality Management System acc. to EN15883

Type TestsSeparate Analysis of each ProcessParameters and Components

=> Conformity of WD with EN ISO 15883Validation

Check of Pre-requisites at HospitalInstallation-, Operational- & Performance – Qualifica tion

=> Assure proper Installation and Function of WDRoutine Tests

Evaluation of outcome qualityTesting of Endoscope, WD + Water

=> Assure continuous proper Function of WD


Consequences out of EN 15883 for:Endoscopy Staff (Nurses, Reprocessing Professionals, etc)Manufacturers of Endoscopes, WD & Chemicals

Effects:Increase Quality AssuranceIncrease Patient SafetyReduce Liability Risks


Glutaraldehyde process


PerAcetic Acid (PAA) process

35°C


ChemicalsNeutral detergent, low foaming

With / without enzymes

DisinfectantGlutaraldehydePeracetic acid + pH - booster

Disinfectant used in the washer have to fulfill in-vi tro-tests under conditions (minimum concentration, minimum temperatur and Minimum contact) in washer process according EN standards for:

bacteria and yeast > 6 log mycobacteria > 5 logfungal spores > 4 log


More information will also give the guideline from ESGE-ESGENA

Other ESGE-ESGENA publications in that field:

ESGE/ESGENA Guideline for process validation an d r outine testing for reprocessing endoscopes in Washer-disinfectors, according to the European standard prEN 15883 parts 1, 4 and 5. (Endoscopy 2007; 39: 85-94)

ESGE-ESGENA guideline for quality assurance in repr ocessing: Microbiological surveillance testing in endoscopy. (Endoscopy 2007; 39: 175-181)

Published in: Endoscopy 2008;40:939-957


Summary

� HYGEA Study showed preferences for Automated Reprocessi ng

� Manual processing has still great importance

� Manual reprocessing should be done according SOPs

� PAA got great importance in last years as detergent fo r pre-cleaning/cleaning and disinfectant for manual and au tomated reprocessing

� EN standard 15883 finished for washer disinfectors for flexible endoscopes in August 2008, standard gives requirements , terms, definitions and tests. Standard gives methods for typ e testing, validation and routine testing


Thank you very much for attention

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