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The Decontamination and Cleaning Process – Concerns regarding Manual Washing and Biofilms Annie Watt Consumable Business Manager APAC PROLYSTICA® SO MUCH.

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Presentation on theme: "The Decontamination and Cleaning Process – Concerns regarding Manual Washing and Biofilms Annie Watt Consumable Business Manager APAC PROLYSTICA® SO MUCH."— Presentation transcript:

1 The Decontamination and Cleaning Process – Concerns regarding Manual Washing and Biofilms Annie Watt Consumable Business Manager APAC PROLYSTICA® SO MUCH MORE THAN CLEAN ™

2 2 What should we be monitoring routinely? Automated washers Manual washing Water Detergents Instrument protection Washer protection PROLYSTICA® SO MUCH MORE THAN CLEAN ™

3 What can we do to reduce the risk? Safe Transport Cleaning Disinfection Sterilization PROLYSTICA® SO MUCH MORE THAN CLEAN ™

4 PROLYSTICA® SO MUCH MORE THAN CLEAN ™

5 5 Cleaning and disinfection of medical devices is regulated by: –Medical Device Directive –Recommendations of National Authorities –National Guidelines – AS/NZ4187 –EN ISO –ISO17664 Cleaning Processes PROLYSTICA® SO MUCH MORE THAN CLEAN ™

6 ISO Washer-Disinfectors –‘machine intended to clean and disinfect medical devices and other articles’ Performance requirements for washer-disinfectors and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice PROLYSTICA® SO MUCH MORE THAN CLEAN ™

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

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

9 Standards and Guidelines Standards –ISO 17664: Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices ‘A validated method of manual cleaning shall be specified.’ ‘At least one validated automated method using a washer-disinfector shall also be specified unless the medical device cannot withstand any such process, in which case a warning should be issued’ Details of manufacturer's instructions –All channels brushed? PROLYSTICA® SO MUCH MORE THAN CLEAN ™

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

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

12 Why Cleaning is Important Device damage Visually unacceptable devices –Cancelled procedures Ineffective disinfection- sterilisation –Microbial transmission –Prion disease transmission Toxicity –Adverse patient reports PROLYSTICA® SO MUCH MORE THAN CLEAN ™

13 Requirement for Cleaning Water Mechanical effects Cleaning chemistry –Temperature –Concentration PROLYSTICA® SO MUCH MORE THAN CLEAN ™

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

15 The implication… Manual cleaning should be limited to only those items not compatible with the mechanical cleaning process PROLYSTICA® SO MUCH MORE THAN CLEAN ™

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

17 BIOFILMS Functional States

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

19 What is Biofilm? A few hours A few days

20 BIOFILMS Four functional states –Attachment –Aggregation –Biofilm formation –Detachment Biofilms are difficult to treat

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

22 22 It’s 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 on instruments. Point of Use Decontamination Practices at Point of Use

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

24 24 Contain & Transport biofilm Items should not be transported in liquid because of the risk of spills, the promotion of biofilm formation, and the possibility of employee injury from lifting heavy containers. PROLYSTICA® SO MUCH MORE THAN CLEAN ™

25 25 Manual Cleaning 3 sink configuration –First sink: soak Low sudsing –Second sink: wash –Third sink: rinse –Treated water for final rinsing (deionized, distilled, softened, or reverse osmosis) PROLYSTICA® SO MUCH MORE THAN CLEAN ™

26 26 Manual Cleaning Decontamination Area May be used for any device Most often used if devices are delicate, complex or cannot tolerate mechanical cleaning PROLYSTICA® SO MUCH MORE THAN CLEAN ™

27 27 Manual Cleaning SOAPS to avoid –Housekeeping soaps –Laundry soaps –Surgeon’s hand scrub –Iodine based soaps RISKS to Staff –PATHOGEN EXPOSURE FROM CLEANING PROCESS: –Airborne –Splash and splatter –Puncture Wounds PROLYSTICA® SO MUCH MORE THAN CLEAN ™

28 28 Cleaning Brushes Quantity in sizes Replace when worn Must be cleaned, disinfected daily Metal bristle brushes must be designed for use with surgical instruments PROLYSTICA® SO MUCH MORE THAN CLEAN ™

29 29 Organize Instruments cannot The multi-layered set cannot possibly come into contact with water and detergents if the layers are stacked on top of each other. PROLYSTICA® SO MUCH MORE THAN CLEAN ™

30 Cleaning Chemistries PROLYSTICA® SO MUCH MORE THAN CLEAN ™

31 New Cleaning Chemistries Improved cleaning chemistries –Environmental concerns –Ergonomics –Cleaning performance –Specified cycle conditions –Pre-cleaning technology –Biofilm removal –New cleaning formulations Prion inactivation/removal – check the process does not involve extended wash and sterilization times PROLYSTICA® SO MUCH MORE THAN CLEAN ™

32 IMPORTANCE OF CHEMISTRY FORMULATION Soil removal Contain chelating ingredients Controlled / low foam Control / inhibit corrosion Compatible with substrates PROLYSTICA® SO MUCH MORE THAN CLEAN ™

33 CHEMISTRY SELECTION Universal Usage - Effective in all water types Cost Effective - cost per cycle Instruments - substrate compatibility Environmental factors - meets European REACH and EPA agreements Concentrated product - Don’t pay for water Low In available alkalinity - Maximum 2% PROLYSTICA® SO MUCH MORE THAN CLEAN ™

34 Acu-SinQ - Automated dispensing system at the sink! PROLYSTICA® SO MUCH MORE THAN CLEAN ™

35 Water Level Permanent Sticker PROLYSTICA® SO MUCH MORE THAN CLEAN ™

36 How Clean Are Your Instruments? PROLYSTICA® SO MUCH MORE THAN CLEAN ™

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

38 Soil Test as per ISO Technical specification Test soils and test methods employed globally. No technical preference given A good list, but fails to standardise Proposal for revisionrevision –Standardized test soils and methodsmethods –Commercial options available PROLYSTICA® SO MUCH MORE THAN CLEAN ™

39 Many Thanks!


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