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The Decontamination and
Cleaning Process –
Concerns regarding Manual
Washing and Biofilms
Annie Watt
Consumable Business Manager APAC
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What should we be monitoring routinely?
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Automated washers
Manual washing
Water
Detergents
Instrument protection
Washer protection
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What can we do to reduce the
risk?
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Safe Transport
Cleaning
Disinfection
Sterilization
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Cleaning Processes
• Cleaning and disinfection of
medical devices is regulated by:
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Medical Device Directive
Recommendations of National Authorities
National Guidelines – AS/NZ4187
EN ISO 15883
ISO17664
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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
ISO 15883
• Published standards
– 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
EN ISO 15883
• Under development
– Part 7: Washer-disinfectors employing chemical
disinfection for non-invasive, non-critical thermolabile
devices/equipment
– prEN 16442 Storage/drying cabinets for flexible
endoscopes
– Revision of Part 5: standard test soil and cleaning test
method (ISO lead)
• Proposal for ultrasonic washers
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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?
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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.
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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
Why Cleaning is
Important
• Device damage
• Visually unacceptable
devices
– Cancelled procedures
• Ineffective disinfectionsterilisation
– Microbial transmission
– Prion disease transmission
• Toxicity
– Adverse patient reports
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Requirement for Cleaning
• Water
• Mechanical effects
• Cleaning chemistry
– Temperature
– Concentration
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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
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The implication…
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Manual cleaning should be
limited to only those items not
compatible with the mechanical
cleaning process
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.
BIOFILMS
Functional States
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.
What is Biofilm?
A few hours
A few days
BIOFILMS
• Four functional states
– Attachment
– Aggregation
– Biofilm formation
– Detachment
• Biofilms are difficult to treat
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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
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Disinfection or
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Sterilization
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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.
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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
Slide 56-picture
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.
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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)
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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
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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
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– Puncture Wounds
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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
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Organize Instruments
The multi-layered set cannot possibly come into contact with
water and detergents if the layers are stacked on top of each
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other.
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Cleaning Chemistries
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New Cleaning Chemistries
• Improved cleaning
chemistries
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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
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IMPORTANCE OF CHEMISTRY
FORMULATION
• Soil removal
• Contain chelating ingredients
• Controlled / low foam
• Control / inhibit corrosion
• Compatible with substrates
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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%
Acu-SinQ - Automated dispensing
system at the sink!
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Water Level Permanent
Sticker
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How Clean Are Your
Instruments?
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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
Soil Test as per ISO
15883-5
• 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
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Many Thanks!