1. Consumable Business Manager APAC
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The Decontamination and Cleaning Process – Concerns regarding Manual Washing and Biofilms
Annie Watt
Consumable Business Manager APAC

2. What should we be monitoring routinely?
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What should we be monitoring routinely?
Automated washers
Manual washing
Water
Detergents
Instrument protection
Washer protection

3. What can we do to reduce the risk?
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What can we do to reduce the risk?
Safe Transport
Cleaning
Disinfection
Sterilization
Universal Precautions
These are Universal Precautions that we all need to follow to ensure we can reduce the risk of infections from contaminated instruments or scopes.

4. PROLYSTICA®
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5. Cleaning and disinfection of medical devices is regulated by:
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Cleaning Processes
Cleaning and disinfection of medical devices is regulated by:
Medical Device Directive
Recommendations of National Authorities
National Guidelines – AS/NZ4187
EN ISO 15883
ISO17664

6. ISO 15883 Washer-Disinfectors
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ISO 15883
Washer-Disinfectors
‘machine intended to clean and disinfect medical devices and other articles’
Performance requirements for washer-disinfectors and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice

7. ISO 15883 Published standards Published Technical Specification (TS)
Part 1: General requirements, definitions and tests
Part 2: Washer-disinfectors employing thermal disinfection for surgical instruments, etc.
Part 3: Washer-disinfectors employing thermal disinfection for human waste containers
Part 4: Washer-disinfectors employing chemical disinfection for thermo-labile endoscopes
Part 6: Washer-disinfectors employing thermal disinfection for noninvasive medical devices etc.
Published Technical Specification (TS)
Part 5 (2005): Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors

8. EN ISO 15883 Under development Proposal for ultrasonic washers
Part 7: Washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile devices/equipment
prEN Storage/drying cabinets for flexible endoscopes
Revision of Part 5: standard test soil and cleaning test method (ISO lead)
Proposal for ultrasonic washers

9. Standards and Guidelines
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Standards and Guidelines
Standards
ISO 17664: Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
‘A validated method of manual cleaning shall be specified.’
‘At least one validated automated method using a washer-disinfector shall also be specified unless the medical device cannot withstand any such process, in which case a warning should be issued’
Details of manufacturer's instructions
All channels brushed?
ISO is a standard for re sterilizable devices however we believe this standard should also be followed for HLD. Good practice and standards need to be applied to HLD if we are to be successful.
If brushing is so important then why do we only brush one lumen?? Do we really need to brush at all if the WD has a validated cleaning method?

10. ISO 17664 3.1 Reprocessing instructions
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ISO 17664
3.1 Reprocessing instructions
At least one validated method for reprocessing the medical device shall be specified.
The following information shall be stated where it is critical to the maintenance of the intended function of the medical device and the safety of the user(s) and the patient:
Details of process steps;
A description of special equipment and/or accessories;
Specification of process parameters and their tolerances.

11. PROLYSTICA®
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ISO 17664
3.5 Cleaning
A validated method of manual cleaning shall be specified. At least one validated automated method using a washer-disinfector shall also be specified unless the medical device cannot withstand any such process, in which case a warning should be issued.
Where appropriate, at least the following information shall be included:
A description of the accessories required for cleaning process
Identification and concentration of chemicals required for cleaning
Identification of water quality to be used for the process
Limits and monitoring of chemical residues remaining on the device
Limits on temperature, concentration of solution(s), exposure time to be used
Process temperature(s) to be used
Techniques to be used including rinsing

12. Why Cleaning is Important
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Why Cleaning is Important
Device damage
Visually unacceptable devices
Cancelled procedures
Ineffective disinfection-sterilisation
Microbial transmission
Prion disease transmission
Toxicity
Adverse patient reports
Visually accepted devices – it’s not what you can see that should worry you it’s what you can’t see
Infection leads to toxicity which leads to more damage to the patient

13. Requirement for Cleaning
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Requirement for Cleaning
Water
Mechanical effects
Cleaning chemistry
Temperature
Concentration
Requirement for cleaning is not just flowing liquid through a tube as this is NOT good cleaning
Before the no brushing technique was introduced brushing was the mechanical effect for cleaning. So if we are to remove the brushing then we need some power or vortex in the water to replace brushing as the mechanical component

14. PROLYSTICA®
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Cleaning Processes
Organic matter is typically made up of carbohydrate, lipid and protein and it is essential that this is removed prior to sterilization.
Proteins are generally unique in that they must be washed off surfaces with water at a temperature of ≤55ºC otherwise the protein can coagulate and become extremely difficult to remove.
By contrast, lipids require a high temperature for adequate removal, often in the presence of a surfactant (detergent).
Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

15. The implication…
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Manual cleaning should be limited to only those items not compatible with the mechanical cleaning process

16. What are Biofilms?
Biofilm is a generic term used to describe a sludge like
material that develops in association with organic
materials.
Biofilms result from a variety of sources, and
negatively impact a number of industrial and medical applications.
Biofilm is composed of a densely packed group of microorganisms
Individual microorganisms bound together by a polymeric substance excreted by the microorganisms.
The polymeric substance forms an adhesive matrix that holds the biofilm together, allows it to attach to surfaces, and protects the colony forming the biofilm.
Encapsulation is believed to play a role in some antibiotic resistant infections.

17. Functional States BIOFILMS
This picture helps to illustrate how biofilms are formed. Bacteria grow naturally on surfaces as biofilms. To form a biofilm, bacteria bind to a surface, multiply, form a matrix that protects the bacteria from the environment, including disinfectants, and then can mature by binding other microorganisms or release parts of the biofilm to form new biofilms. They essentially become a reservoir for bacterial growth. Biofilms have been implicated in healthcare acquired infections (HAI) due to contaminated washer-disinfectors and medical devices.

18. Biofilms – how they form?
The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS). It is also commonly called an extracellular adhesive matrix.
A key aspect of biofilms is a complex interaction among the mircoorganisms.
A biofilm forms when individual microorganisms cease to exhibit individual, free floating behaviour, and begin to associate with each other, and a surface, and begin to act in concert with each other.
A biofilm grows by both simple cell division, and by new free floating microorganisms associating with the developing biofilm.
Biofilms usually develop on solid surfaces immersed in a liquid.

19. What is Biofilm?
What is Biofilm explanation
A few hours
A few days

20. Four functional states
BIOFILMS
Four functional states
Attachment
Aggregation
Biofilm formation
Detachment
Biofilms are difficult to treat
The existence of biofilms has been recognized for years. Their development is typically a progression through four functional states:
Freely mobile, known as “planktonic” bacteria, recognize and attach to a surface.
Once attached, the bacteria aggregate and form into micro-colonies.
Chemical signals are then released within and between micro-colonies and biofilm formation, including what is known as exopolysaccharide encasement, begins.
Once biofilm is formed, a natural pattern of programmed detachment of planktonic bacteria occurs and the process starts over in a new location.
It’s important to understand that freely floating planktonic bacteria, unshielded by protective excretions, are generally susceptible to antibodies and antibiotics. However, once encased in a biofilm, the bacteria are generally not susceptible to either, making them difficult or impossible to treat with antimicrobial agents.

21. The Decontamination Process
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The Decontamination Process
Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care.
A two step process
Begins with cleaning
Followed by a microbicidal process
Disinfection or
Sterilization

22. Decontamination Practices at Point of Use
Importance of quick cleaning after use
It’s critical to start the decontamination process immediately after the surgeon is finished with the device, particularly if the device is complex.
Blood remains encrusted
on instruments.

23. Decontamination Practices at Point of Use
STERIS Pre-Klenz – Transport Gel
Clings to instruments to maintain moisture during transport
Will not stain instruments
Broad material compatibility
Reduces extra weight and splashing
Don’t use foam as it restricts you from seeing what is in the tray

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Contain & Transport
Items should not be transported in liquid because of the risk of spills, the promotion of biofilm formation, and the possibility of employee injury from lifting heavy containers.

25. Manual Cleaning 3 sink configuration Low sudsing
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Manual Cleaning
3 sink configuration
First sink: soak
Low sudsing
Second sink: wash
Third sink: rinse
Treated water for final rinsing
(deionized, distilled, softened, or reverse osmosis)
Decontamination area sinks should be large enough to contain large utensils and instruments, and there should be enough sinks to accommodate concurrent soaking, washing, and rinsing. Treated water (deionized, distilled or reverse osmosis) should be available for final rinsing.
An ideal decontamination sink is a three sink configuration that is approximately 36 inches from the floor, 10 inches deep, and wide and long enough to allow a tray or container basket of instruments to be placed flat for pretreatment or manual cleaning.
All cleaning should be done under the water line to prevent exposure to microorganisms through aerosolization, especially when brushes are used to clean lumens. The detergent should be low foaming so that the worker can see into the sink to identify all instruments and prevent injuries from sharp objects.

26. Manual Cleaning Decontamination Area
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Manual Cleaning Decontamination Area
May be used for any device
Most often used if devices are delicate, complex or cannot tolerate mechanical cleaning

27. Manual Cleaning SOAPS to avoid RISKS to Staff Housekeeping soaps
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Manual Cleaning
SOAPS to avoid
Housekeeping soaps
Laundry soaps
Surgeon’s hand scrub
Iodine based soaps
RISKS to Staff
PATHOGEN EXPOSURE FROM CLEANING PROCESS: 
Airborne
Splash and splatter
Puncture Wounds

28. X Cleaning Brushes Quantity in sizes Replace when worn
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Cleaning Brushes
Quantity in sizes
Replace when worn
Must be cleaned, disinfected daily
Metal bristle brushes must be designed for use with surgical instruments X
Brushes need to be the correct size and not damaged to prevent damage to the instrument. The device manufacturer should provide recommendation for the cleaning method most appropriate depending on the device’s size, fragility, immersibility, complexity, working parts, sensitivity to the cleaning agents , and other properties. Wire brushes should never be used unless they are specifically designed for cleaning surgical instruments.

29. PROLYSTICA®
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Organize Instruments
These are poorly loaded and organized trays for processing through an automated washer. The multi-layered set cannot possibly come into contact with water and detergents if the layers are stacked on top of each other. The other try is overloaded, the hinged instruments are not opened, and the basin on top of the instruments could potentially damage the instruments below it, as well as deflect water and detergents from coming into contact with the tray contents.
The multi-layered set cannot possibly come into contact with water and detergents if the layers are stacked on top of each other.

30. Cleaning Chemistries All Different PROLYSTICA®
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Cleaning Chemistries
All Different

31. New Cleaning Chemistries
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New Cleaning Chemistries
Improved cleaning chemistries
Environmental concerns
Ergonomics
Cleaning performance
Specified cycle conditions
Pre-cleaning technology
Biofilm removal
New cleaning formulations
Prion inactivation/removal – check the process does not involve extended wash and sterilization times

32. IMPORTANCE OF CHEMISTRY FORMULATION
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IMPORTANCE OF CHEMISTRY FORMULATION
Soil removal
Contain chelating ingredients
Controlled / low foam
Control / inhibit corrosion
Compatible with substrates
– Maintaining the useful life, function, and appearance of instruments depends on the attributes of the cleaning compounds that are used on them. It is particularly important to pay attention to some of the more technical aspects of these attributes, for example, chelating ability. All soap is not created equal and price should not be the only thing that matters.
Soils that are left on instrument surfaces can harbor microorganisms that interfere with decontamination and sterilization. When these instruments are subjected to the heat or pressure of the sterilization process, instrument degradation (deterioration in instrument finish) is accelerated. In order to avoid this, the cleaning compound selected must be able to remove organic substances, such as blood and other body tissues. The product must also be able to remove inorganic substances, such as hard water deposits, that may cause the instrument to rust.
Chelating ability refers to the chemical ability to tie up water hardness ions or minerals such as calcium or magnesium and keep them in solution. Without agents to keep them in the solution, minerals will settle on the instruments. The better a product is able to counteract adverse water conditions, the better the surfactants in that product will be able to clean.

33. CHEMISTRY SELECTION Universal Usage - Effective in all water types
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CHEMISTRY SELECTION
Universal Usage - Effective in all water types
Cost Effective - cost per cycle
Instruments - substrate compatibility
Environmental factors - meets European REACH and EPA agreements
Concentrated product - Don’t pay for water
Low In available alkalinity - Maximum 2%
UNIVERSAL USAGE – The product should be designed to be used in both ultrasonic and washer/disinfectors. In the washer/disinfector, the cleaner should be able to perform within the parameters of time, temperature, concentration, and pressure. In the ultrasonic, the cleaner should be able to enhance the ultrasonic process. By using one cleaner in both the ultrasonic and the washer/disinfector, a cost savings can be realized through reduction in inventory.
COST EFFECTIVENESS – Cost, of course, is always a major consideration. However, you should consider the actual cost in use of a product before making a decision about cleaner A comparison of active ingredients and concentrations often lead to the discovery that a significantly larger quantity of the less expensive product would be required to achieve the same cleaning results. Differences in ingredients also point out the reasons why some products actually do perform better than others.
PRICE PER INSTRUMENT CLEANED – If the wrong cleaner is used, the lives of the instruments cleaned will be shortened. The wise selection of cleaning chemicals can prevent problems in the long run. The proper cleaner can eliminate spotting, staining, and corrosion problems.
DILUTION RATES – Check to see how the price compares once the product is diluted as per label instructions. More expensive products are frequently more concentrated and make up more gallons of solution than their less expensive counterparts.

34. Acu-SinQ - Automated dispensing system at the sink!
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35. Water Level Permanent Sticker
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36. How Clean Are Your Instruments?
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How Clean Are Your Instruments?
The top picture shows a scope after cleaning which looks very clean to me.
However the second picture is using the same scope which has had a special staining technique added to the scope which picks up soil. As you can see this is more than enough soil remaining on this scope to pass on a C Diff or Prion infection

37. Routine Monitoring of the Manual process
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Routine Monitoring of the Manual process
Consult Device IFU for correct reprocessing proceedure
Ensure the device remains moist from OT to CSSD
Monitor correct dose of detergent in correct amount of water
Monitor correct temperature for detergent to be active
Visual inspection of all devices
Residual Protein Detection Test
Soil test - education
Rapid -10 seconds without incubation
Sensitive -Accurate down to 1μg protein residue

38. Soil Test as per ISO 15883-5 Technical specification
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Soil Test as per ISO
Technical specification
Test soils and test methods employed globally.
No technical preference given
A good list, but fails to standardise
Proposal for revision
Standardized test soils and methods
Commercial options available

39. Many Thanks!