The Decontamination and Cleaning Process ndash

Concerns regarding Manual Washing and Biofilms

Annie WattConsumable Business Manager APAC

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

2

What should we be monitoring routinely

bull Automated washers

bull Manual washing

bull Water

bull Detergents

bull Instrument protection

bull Washer protection

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What can we do to reduce the risk

bull Safe Transport

bull Cleaning

bull Disinfection

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

5

bull Cleaning and disinfection of medical devices is regulated by

ndash Medical Device Directivendash Recommendations of National Authoritiesndash National Guidelines ndash ASNZ4187ndash EN ISO 15883ndash ISO17664

Cleaning Processes

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883 bull Washer-Disinfectors

ndash lsquomachine intended to clean and disinfect medical devices and other articlesrsquo

bull 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

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883bull Published standards

ndash Part 1 General requirements definitions and testsndash Part 2 Washer-disinfectors employing thermal

disinfection for surgical instruments etcndash Part 3 Washer-disinfectors employing thermal

disinfection for human waste containersndash Part 4 Washer-disinfectors employing chemical

disinfection for thermo-labile endoscopesndash Part 6 Washer-disinfectors employing thermal

disinfection for noninvasive medical devices etcbull Published Technical Specification (TS)

ndash Part 5 (2005) Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors

EN ISO 15883bull Under development

ndash Part 7 Washer-disinfectors employing chemical disinfection for non-invasive non-critical thermolabile devicesequipment

ndash prEN 16442 Storagedrying cabinets for flexible endoscopes

ndash Revision of Part 5 standard test soil and cleaning test method (ISO lead)

bull Proposal for ultrasonic washers

Standards and Guidelinesbull Standards

ndash ISO 17664 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices

bull lsquoA validated method of manual cleaning shall be specifiedrsquo

bull lsquoAt 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 issuedrsquo

bull Details of manufacturers instructionsndash All channels brushed

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 1766431 Reprocessing instructionsAt least one validated method for reprocessing the medical device shall be specifiedThe 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 stepsbull A description of special equipment andor accessoriesbull Specification of process parameters and their tolerances

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 17664

35 CleaningA 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

bull A description of the accessories required for cleaning processbull Identification and concentration of chemicals required for cleaningbull Identification of water quality to be used for the processbull Limits and monitoring of chemical residues remaining on the devicebull Limits on temperature concentration of solution(s) exposure time to be usedbull Process temperature(s) to be usedbull Techniques to be used including rinsing

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

2

What should we be monitoring routinely

bull Automated washers

bull Manual washing

bull Water

bull Detergents

bull Instrument protection

bull Washer protection

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What can we do to reduce the risk

bull Safe Transport

bull Cleaning

bull Disinfection

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

5

bull Cleaning and disinfection of medical devices is regulated by

ndash Medical Device Directivendash Recommendations of National Authoritiesndash National Guidelines ndash ASNZ4187ndash EN ISO 15883ndash ISO17664

Cleaning Processes

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883 bull Washer-Disinfectors

ndash lsquomachine intended to clean and disinfect medical devices and other articlesrsquo

bull 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

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883bull Published standards

ndash Part 1 General requirements definitions and testsndash Part 2 Washer-disinfectors employing thermal

disinfection for surgical instruments etcndash Part 3 Washer-disinfectors employing thermal

disinfection for human waste containersndash Part 4 Washer-disinfectors employing chemical

disinfection for thermo-labile endoscopesndash Part 6 Washer-disinfectors employing thermal

disinfection for noninvasive medical devices etcbull Published Technical Specification (TS)

ndash Part 5 (2005) Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors

EN ISO 15883bull Under development

ndash Part 7 Washer-disinfectors employing chemical disinfection for non-invasive non-critical thermolabile devicesequipment

ndash prEN 16442 Storagedrying cabinets for flexible endoscopes

ndash Revision of Part 5 standard test soil and cleaning test method (ISO lead)

bull Proposal for ultrasonic washers

Standards and Guidelinesbull Standards

ndash ISO 17664 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices

bull lsquoA validated method of manual cleaning shall be specifiedrsquo

bull lsquoAt 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 issuedrsquo

bull Details of manufacturers instructionsndash All channels brushed

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 1766431 Reprocessing instructionsAt least one validated method for reprocessing the medical device shall be specifiedThe 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 stepsbull A description of special equipment andor accessoriesbull Specification of process parameters and their tolerances

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 17664

35 CleaningA 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

bull A description of the accessories required for cleaning processbull Identification and concentration of chemicals required for cleaningbull Identification of water quality to be used for the processbull Limits and monitoring of chemical residues remaining on the devicebull Limits on temperature concentration of solution(s) exposure time to be usedbull Process temperature(s) to be usedbull Techniques to be used including rinsing

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What can we do to reduce the risk

bull Safe Transport

bull Cleaning

bull Disinfection

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

5

bull Cleaning and disinfection of medical devices is regulated by

ndash Medical Device Directivendash Recommendations of National Authoritiesndash National Guidelines ndash ASNZ4187ndash EN ISO 15883ndash ISO17664

Cleaning Processes

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883 bull Washer-Disinfectors

ndash lsquomachine intended to clean and disinfect medical devices and other articlesrsquo

bull 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

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883bull Published standards

ndash Part 1 General requirements definitions and testsndash Part 2 Washer-disinfectors employing thermal

disinfection for surgical instruments etcndash Part 3 Washer-disinfectors employing thermal

disinfection for human waste containersndash Part 4 Washer-disinfectors employing chemical

disinfection for thermo-labile endoscopesndash Part 6 Washer-disinfectors employing thermal

disinfection for noninvasive medical devices etcbull Published Technical Specification (TS)

ndash Part 5 (2005) Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors

EN ISO 15883bull Under development

ndash Part 7 Washer-disinfectors employing chemical disinfection for non-invasive non-critical thermolabile devicesequipment

ndash prEN 16442 Storagedrying cabinets for flexible endoscopes

ndash Revision of Part 5 standard test soil and cleaning test method (ISO lead)

bull Proposal for ultrasonic washers

Standards and Guidelinesbull Standards

ndash ISO 17664 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices

bull lsquoA validated method of manual cleaning shall be specifiedrsquo

bull lsquoAt 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 issuedrsquo

bull Details of manufacturers instructionsndash All channels brushed

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 1766431 Reprocessing instructionsAt least one validated method for reprocessing the medical device shall be specifiedThe 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 stepsbull A description of special equipment andor accessoriesbull Specification of process parameters and their tolerances

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 17664

35 CleaningA 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

bull A description of the accessories required for cleaning processbull Identification and concentration of chemicals required for cleaningbull Identification of water quality to be used for the processbull Limits and monitoring of chemical residues remaining on the devicebull Limits on temperature concentration of solution(s) exposure time to be usedbull Process temperature(s) to be usedbull Techniques to be used including rinsing

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

5

bull Cleaning and disinfection of medical devices is regulated by

ndash Medical Device Directivendash Recommendations of National Authoritiesndash National Guidelines ndash ASNZ4187ndash EN ISO 15883ndash ISO17664

Cleaning Processes

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883 bull Washer-Disinfectors

ndash lsquomachine intended to clean and disinfect medical devices and other articlesrsquo

bull 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

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883bull Published standards

ndash Part 1 General requirements definitions and testsndash Part 2 Washer-disinfectors employing thermal

disinfection for surgical instruments etcndash Part 3 Washer-disinfectors employing thermal

disinfection for human waste containersndash Part 4 Washer-disinfectors employing chemical

disinfection for thermo-labile endoscopesndash Part 6 Washer-disinfectors employing thermal

disinfection for noninvasive medical devices etcbull Published Technical Specification (TS)

ndash Part 5 (2005) Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors

EN ISO 15883bull Under development

ndash Part 7 Washer-disinfectors employing chemical disinfection for non-invasive non-critical thermolabile devicesequipment

ndash prEN 16442 Storagedrying cabinets for flexible endoscopes

ndash Revision of Part 5 standard test soil and cleaning test method (ISO lead)

bull Proposal for ultrasonic washers

Standards and Guidelinesbull Standards

ndash ISO 17664 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices

bull lsquoA validated method of manual cleaning shall be specifiedrsquo

bull lsquoAt 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 issuedrsquo

bull Details of manufacturers instructionsndash All channels brushed

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 1766431 Reprocessing instructionsAt least one validated method for reprocessing the medical device shall be specifiedThe 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 stepsbull A description of special equipment andor accessoriesbull Specification of process parameters and their tolerances

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 17664

35 CleaningA 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

bull A description of the accessories required for cleaning processbull Identification and concentration of chemicals required for cleaningbull Identification of water quality to be used for the processbull Limits and monitoring of chemical residues remaining on the devicebull Limits on temperature concentration of solution(s) exposure time to be usedbull Process temperature(s) to be usedbull Techniques to be used including rinsing

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

5

bull Cleaning and disinfection of medical devices is regulated by

ndash Medical Device Directivendash Recommendations of National Authoritiesndash National Guidelines ndash ASNZ4187ndash EN ISO 15883ndash ISO17664

Cleaning Processes

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883 bull Washer-Disinfectors

ndash lsquomachine intended to clean and disinfect medical devices and other articlesrsquo

bull 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

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883bull Published standards

ndash Part 1 General requirements definitions and testsndash Part 2 Washer-disinfectors employing thermal

disinfection for surgical instruments etcndash Part 3 Washer-disinfectors employing thermal

disinfection for human waste containersndash Part 4 Washer-disinfectors employing chemical

disinfection for thermo-labile endoscopesndash Part 6 Washer-disinfectors employing thermal

disinfection for noninvasive medical devices etcbull Published Technical Specification (TS)

ndash Part 5 (2005) Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors

EN ISO 15883bull Under development

ndash Part 7 Washer-disinfectors employing chemical disinfection for non-invasive non-critical thermolabile devicesequipment

ndash prEN 16442 Storagedrying cabinets for flexible endoscopes

ndash Revision of Part 5 standard test soil and cleaning test method (ISO lead)

bull Proposal for ultrasonic washers

Standards and Guidelinesbull Standards

ndash ISO 17664 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices

bull lsquoA validated method of manual cleaning shall be specifiedrsquo

bull lsquoAt 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 issuedrsquo

bull Details of manufacturers instructionsndash All channels brushed

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 1766431 Reprocessing instructionsAt least one validated method for reprocessing the medical device shall be specifiedThe 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 stepsbull A description of special equipment andor accessoriesbull Specification of process parameters and their tolerances

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 17664

35 CleaningA 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

bull A description of the accessories required for cleaning processbull Identification and concentration of chemicals required for cleaningbull Identification of water quality to be used for the processbull Limits and monitoring of chemical residues remaining on the devicebull Limits on temperature concentration of solution(s) exposure time to be usedbull Process temperature(s) to be usedbull Techniques to be used including rinsing

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883 bull Washer-Disinfectors

ndash lsquomachine intended to clean and disinfect medical devices and other articlesrsquo

bull 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

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883bull Published standards

ndash Part 1 General requirements definitions and testsndash Part 2 Washer-disinfectors employing thermal

disinfection for surgical instruments etcndash Part 3 Washer-disinfectors employing thermal

disinfection for human waste containersndash Part 4 Washer-disinfectors employing chemical

disinfection for thermo-labile endoscopesndash Part 6 Washer-disinfectors employing thermal

disinfection for noninvasive medical devices etcbull Published Technical Specification (TS)

ndash Part 5 (2005) Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors

EN ISO 15883bull Under development

ndash Part 7 Washer-disinfectors employing chemical disinfection for non-invasive non-critical thermolabile devicesequipment

ndash prEN 16442 Storagedrying cabinets for flexible endoscopes

ndash Revision of Part 5 standard test soil and cleaning test method (ISO lead)

bull Proposal for ultrasonic washers

Standards and Guidelinesbull Standards

ndash ISO 17664 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices

bull lsquoA validated method of manual cleaning shall be specifiedrsquo

bull lsquoAt 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 issuedrsquo

bull Details of manufacturers instructionsndash All channels brushed

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 1766431 Reprocessing instructionsAt least one validated method for reprocessing the medical device shall be specifiedThe 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 stepsbull A description of special equipment andor accessoriesbull Specification of process parameters and their tolerances

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 17664

35 CleaningA 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

bull A description of the accessories required for cleaning processbull Identification and concentration of chemicals required for cleaningbull Identification of water quality to be used for the processbull Limits and monitoring of chemical residues remaining on the devicebull Limits on temperature concentration of solution(s) exposure time to be usedbull Process temperature(s) to be usedbull Techniques to be used including rinsing

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 15883bull Published standards

ndash Part 1 General requirements definitions and testsndash Part 2 Washer-disinfectors employing thermal

disinfection for surgical instruments etcndash Part 3 Washer-disinfectors employing thermal

disinfection for human waste containersndash Part 4 Washer-disinfectors employing chemical

disinfection for thermo-labile endoscopesndash Part 6 Washer-disinfectors employing thermal

disinfection for noninvasive medical devices etcbull Published Technical Specification (TS)

ndash Part 5 (2005) Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors

EN ISO 15883bull Under development

ndash Part 7 Washer-disinfectors employing chemical disinfection for non-invasive non-critical thermolabile devicesequipment

ndash prEN 16442 Storagedrying cabinets for flexible endoscopes

ndash Revision of Part 5 standard test soil and cleaning test method (ISO lead)

bull Proposal for ultrasonic washers

Standards and Guidelinesbull Standards

ndash ISO 17664 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices

bull lsquoA validated method of manual cleaning shall be specifiedrsquo

bull lsquoAt 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 issuedrsquo

bull Details of manufacturers instructionsndash All channels brushed

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 1766431 Reprocessing instructionsAt least one validated method for reprocessing the medical device shall be specifiedThe 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 stepsbull A description of special equipment andor accessoriesbull Specification of process parameters and their tolerances

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 17664

35 CleaningA 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

bull A description of the accessories required for cleaning processbull Identification and concentration of chemicals required for cleaningbull Identification of water quality to be used for the processbull Limits and monitoring of chemical residues remaining on the devicebull Limits on temperature concentration of solution(s) exposure time to be usedbull Process temperature(s) to be usedbull Techniques to be used including rinsing

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

EN ISO 15883bull Under development

ndash Part 7 Washer-disinfectors employing chemical disinfection for non-invasive non-critical thermolabile devicesequipment

ndash prEN 16442 Storagedrying cabinets for flexible endoscopes

ndash Revision of Part 5 standard test soil and cleaning test method (ISO lead)

bull Proposal for ultrasonic washers

Standards and Guidelinesbull Standards

ndash ISO 17664 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices

bull lsquoA validated method of manual cleaning shall be specifiedrsquo

bull lsquoAt 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 issuedrsquo

bull Details of manufacturers instructionsndash All channels brushed

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 1766431 Reprocessing instructionsAt least one validated method for reprocessing the medical device shall be specifiedThe 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 stepsbull A description of special equipment andor accessoriesbull Specification of process parameters and their tolerances

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 17664

35 CleaningA 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

bull A description of the accessories required for cleaning processbull Identification and concentration of chemicals required for cleaningbull Identification of water quality to be used for the processbull Limits and monitoring of chemical residues remaining on the devicebull Limits on temperature concentration of solution(s) exposure time to be usedbull Process temperature(s) to be usedbull Techniques to be used including rinsing

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Standards and Guidelinesbull Standards

ndash ISO 17664 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices

bull lsquoA validated method of manual cleaning shall be specifiedrsquo

bull lsquoAt 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 issuedrsquo

bull Details of manufacturers instructionsndash All channels brushed

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 1766431 Reprocessing instructionsAt least one validated method for reprocessing the medical device shall be specifiedThe 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 stepsbull A description of special equipment andor accessoriesbull Specification of process parameters and their tolerances

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 17664

35 CleaningA 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

bull A description of the accessories required for cleaning processbull Identification and concentration of chemicals required for cleaningbull Identification of water quality to be used for the processbull Limits and monitoring of chemical residues remaining on the devicebull Limits on temperature concentration of solution(s) exposure time to be usedbull Process temperature(s) to be usedbull Techniques to be used including rinsing

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 1766431 Reprocessing instructionsAt least one validated method for reprocessing the medical device shall be specifiedThe 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 stepsbull A description of special equipment andor accessoriesbull Specification of process parameters and their tolerances

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 17664

35 CleaningA 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

bull A description of the accessories required for cleaning processbull Identification and concentration of chemicals required for cleaningbull Identification of water quality to be used for the processbull Limits and monitoring of chemical residues remaining on the devicebull Limits on temperature concentration of solution(s) exposure time to be usedbull Process temperature(s) to be usedbull Techniques to be used including rinsing

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

ISO 17664

35 CleaningA 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

bull A description of the accessories required for cleaning processbull Identification and concentration of chemicals required for cleaningbull Identification of water quality to be used for the processbull Limits and monitoring of chemical residues remaining on the devicebull Limits on temperature concentration of solution(s) exposure time to be usedbull Process temperature(s) to be usedbull Techniques to be used including rinsing

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Why Cleaning is Important

bull Device damagebull Visually unacceptable devices

ndash Cancelled procedures

bull Ineffective disinfection-sterilisationndash Microbial transmissionndash Prion disease transmission

bull Toxicityndash Adverse patient reports

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Requirement for Cleaning

bull Water

bull Mechanical effects

bull Cleaning chemistryndash Temperaturendash Concentration

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

14

Cleaning Processes

bull Organic matter is typically made up of carbohydrate lipid and protein and it is essential that this is removed prior to sterilization

bull Proteins are generally unique in that they must be washed off surfaces with water at a temperature of le55ordmC otherwise the protein can coagulate and become extremely difficult to remove

bull By contrast lipids require a high temperature for adequate removal often in the presence of a surfactant (detergent)

bull Each stage of the washer disinfector cycle therefore has a role to play in the removal of this organic debris

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

The implicationhellip

Manual cleaning should be limited to only those items not

compatible with the mechanical cleaning process

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What are Biofilmsbull Biofilm is a generic term used to describe a sludge like

material that develops in association with organic

materials bull Biofilms result from a variety of sources and

negatively impact a number of industrial and medical applications

bull Biofilm is composed of a densely packed group of microorganisms

bull Individual microorganisms bound together by a polymeric substance excreted by the microorganisms

bull 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

bull Encapsulation is believed to play a role in some antibiotic resistant infections

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

BIOFILMS

Functional States

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Biofilms ndash how they form

bull The polymeric substance excreted by the microorganisms is known as an extracellular polymeric substance (EPS) It is also commonly called an extracellular adhesive matrix

bull A key aspect of biofilms is a complex interaction among the mircoorganisms

bull 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

bull A biofilm grows by both simple cell division and by new free floating microorganisms associating with the developing biofilm

bull Biofilms usually develop on solid surfaces immersed in a liquid

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

What is Biofilm

A few hoursA few hours A few daysA few days

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

BIOFILMS

bull Four functional states

ndash Attachment

ndash Aggregation

ndash Biofilm formation

ndash Detachment

bull Biofilms are difficult to treat

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

21

The Decontamination ProcessThe Decontamination Process

Decontamination is the process that renders contaminated items safe to use for their intended purpose and safe to handle with reasonable care

bull A two step process

ndash Begins with cleaning

ndash Followed by a microbicidal process bull Disinfection or

bull Sterilization

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

22

bull Itrsquos critical to start the decontamination process immediately after the surgeon is finished with the device particularly if the device is complex

Importance of quick cleaning after use

Blood remains encrusted Blood remains encrusted on instrumentson instruments

Decontamination Practices at Point of UsePoint of Use

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

23

STERIS Pre-Klenz ndash Transport Gel

bullClings to instruments to maintain moisture during transportbullWill not stain instrumentsbullBroad material compatibilitybullReduces extra weight and splashingbullDonrsquot use foam as it restricts you from seeing what is in the tray

Decontamination Practices at Point of UsePoint of Use

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

24

Contain amp TransportContain amp Transport

S lid e 5 6 -p ic tu re

Items should not be transported in liquid because

of the risk of spills the promotion of biofilmbiofilm

formation and the possibility of employee injury

from lifting heavy containers

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

25

Manual CleaningManual Cleaning

bull 3 sink configuration ndash First sink soak

bull Low sudsingndash Second sink washndash Third sink rinse ndash Treated water for final rinsing

(deionized distilled softened or reverse osmosis)

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

26

Manual CleaningManual CleaningDecontamination AreaDecontamination Area

May be used for any device

Most often used if devices are delicate complex or cannot tolerate mechanical cleaning

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

27

Manual CleaningManual Cleaningbull SOAPS to avoid

ndash Housekeeping soapsndash Laundry soapsndash Surgeonrsquos hand scrubndash Iodine based soaps

bull RISKS to Staffndash PATHOGEN EXPOSURE FROM CLEANING

PROCESS ndash Airbornendash Splash and splatterndash Puncture Wounds

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

28

Cleaning BrushesCleaning Brushesbull Quantity in sizes

bull Replace when worn

bull Must be cleaned disinfected daily

bull Metal bristle brushes must be designed for use with surgical instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

29

Organize InstrumentsOrganize Instruments

The multi-layered set cannotcannot possibly come into contact with water and detergents if the layers are stacked on top of each other

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Cleaning Chemistries

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

New Cleaning Chemistriesbull Improved cleaning

chemistriesndash Environmental concernsndash Ergonomicsndash Cleaning performancendash Specified cycle conditionsndash Pre-cleaning technologyndash Biofilm removalndash New cleaning formulations

bull Prion inactivationremoval ndash check the process does not involve extended wash and sterilization times

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

IMPORTANCE OF CHEMISTRY FORMULATION

bull Soil removal

bull Contain chelating ingredients

bull Controlled low foam

bull Control inhibit corrosion

bull Compatible with substrates

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

CHEMISTRY SELECTION

bull Universal Usage - Effective in all water types

bull Cost Effective - cost per cycle

bull Instruments - substrate compatibility

bull Environmental factors - meets European REACH and EPA agreements

bull Concentrated product - Donrsquot pay for water

bull Low In available alkalinity - Maximum 2

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Acu-SinQ - Automated dispensing system at the sink

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Water Level Permanent Sticker

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

How Clean Are Your Instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Routine Monitoring of the Manual process

bull Consult Device IFU for correct reprocessing proceedure

bull Ensure the device remains moist from OT to CSSD

bull Monitor correct dose of detergent in correct amount of water

bull Monitor correct temperature for detergent to be active

bull Visual inspection of all devicesbull Residual Protein Detection Testbull Soil test - education

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Rapid -10 seconds without incubationSensitive -Accurate down to 1μg protein residue

Soil Test as per ISO 15883-5

bull Technical specificationbull Test soils and test methods

employed globallybull No technical preference

givenbull A good list but fails to

standardise bull Proposal for revision

ndash Standardized test soils and methods

ndash Commercial options available

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

CHEMISTRY SELECTION

bull Universal Usage - Effective in all water types

bull Cost Effective - cost per cycle

bull Instruments - substrate compatibility

bull Environmental factors - meets European REACH and EPA agreements

bull Concentrated product - Donrsquot pay for water

bull Low In available alkalinity - Maximum 2

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Acu-SinQ - Automated dispensing system at the sink

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Water Level Permanent Sticker

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

How Clean Are Your Instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Routine Monitoring of the Manual process

bull Consult Device IFU for correct reprocessing proceedure

bull Ensure the device remains moist from OT to CSSD

bull Monitor correct dose of detergent in correct amount of water

bull Monitor correct temperature for detergent to be active

bull Visual inspection of all devicesbull Residual Protein Detection Testbull Soil test - education

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Rapid -10 seconds without incubationSensitive -Accurate down to 1μg protein residue

Soil Test as per ISO 15883-5

bull Technical specificationbull Test soils and test methods

employed globallybull No technical preference

givenbull A good list but fails to

standardise bull Proposal for revision

ndash Standardized test soils and methods

ndash Commercial options available

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Acu-SinQ - Automated dispensing system at the sink

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Water Level Permanent Sticker

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

How Clean Are Your Instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Routine Monitoring of the Manual process

bull Consult Device IFU for correct reprocessing proceedure

bull Ensure the device remains moist from OT to CSSD

bull Monitor correct dose of detergent in correct amount of water

bull Monitor correct temperature for detergent to be active

bull Visual inspection of all devicesbull Residual Protein Detection Testbull Soil test - education

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Rapid -10 seconds without incubationSensitive -Accurate down to 1μg protein residue

Soil Test as per ISO 15883-5

bull Technical specificationbull Test soils and test methods

employed globallybull No technical preference

givenbull A good list but fails to

standardise bull Proposal for revision

ndash Standardized test soils and methods

ndash Commercial options available

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Water Level Permanent Sticker

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

How Clean Are Your Instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Routine Monitoring of the Manual process

bull Consult Device IFU for correct reprocessing proceedure

bull Ensure the device remains moist from OT to CSSD

bull Monitor correct dose of detergent in correct amount of water

bull Monitor correct temperature for detergent to be active

bull Visual inspection of all devicesbull Residual Protein Detection Testbull Soil test - education

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Rapid -10 seconds without incubationSensitive -Accurate down to 1μg protein residue

Soil Test as per ISO 15883-5

bull Technical specificationbull Test soils and test methods

employed globallybull No technical preference

givenbull A good list but fails to

standardise bull Proposal for revision

ndash Standardized test soils and methods

ndash Commercial options available

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

How Clean Are Your Instruments

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Routine Monitoring of the Manual process

bull Consult Device IFU for correct reprocessing proceedure

bull Ensure the device remains moist from OT to CSSD

bull Monitor correct dose of detergent in correct amount of water

bull Monitor correct temperature for detergent to be active

bull Visual inspection of all devicesbull Residual Protein Detection Testbull Soil test - education

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Rapid -10 seconds without incubationSensitive -Accurate down to 1μg protein residue

Soil Test as per ISO 15883-5

bull Technical specificationbull Test soils and test methods

employed globallybull No technical preference

givenbull A good list but fails to

standardise bull Proposal for revision

ndash Standardized test soils and methods

ndash Commercial options available

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Routine Monitoring of the Manual process

bull Consult Device IFU for correct reprocessing proceedure

bull Ensure the device remains moist from OT to CSSD

bull Monitor correct dose of detergent in correct amount of water

bull Monitor correct temperature for detergent to be active

bull Visual inspection of all devicesbull Residual Protein Detection Testbull Soil test - education

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Rapid -10 seconds without incubationSensitive -Accurate down to 1μg protein residue

Soil Test as per ISO 15883-5

bull Technical specificationbull Test soils and test methods

employed globallybull No technical preference

givenbull A good list but fails to

standardise bull Proposal for revision

ndash Standardized test soils and methods

ndash Commercial options available

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Soil Test as per ISO 15883-5

bull Technical specificationbull Test soils and test methods

employed globallybull No technical preference

givenbull A good list but fails to

standardise bull Proposal for revision

ndash Standardized test soils and methods

ndash Commercial options available

PROLYSTICAregSO MUCH MORE THAN CLEANtrade

Many Thanks

• The Decontamination and Cleaning Process ndash Concerns regarding Manual Washing and Biofilms
• What should we be monitoring routinely
• What can we do to reduce the risk
• Slide 4
• Cleaning Processes
• ISO 15883
• ISO 15883
• EN ISO 15883
• Standards and Guidelines
• ISO 17664
• Slide 11
• Slide 12
• Requirement for Cleaning
• Slide 14
• The implicationhellip
• What are Biofilms
• BIOFILMS
• Biofilms ndash how they form
• What is Biofilm
• Slide 20
• The Decontamination Process
• Decontamination Practices at Point of Use
• Decontamination Practices at Point of Use
• Contain amp Transport
• Manual Cleaning
• Manual Cleaning Decontamination Area
• Slide 27
• Cleaning Brushes
• Organize Instruments
• Cleaning Chemistries
• New Cleaning Chemistries
• IMPORTANCE OF CHEMISTRY FORMULATION
• CHEMISTRY SELECTION
• Acu-SinQ - Automated dispensing system at the sink
• Water Level Permanent Sticker
• How Clean Are Your Instruments
• Routine Monitoring of the Manual process
• Soil Test as per ISO 15883-5
• Many Thanks