Presentation on theme: "International Standards for Reprocessing of Medical Devices"— Presentation transcript:
1 Stabimed & Helizyme Manual Instrument Cleaning and Disinfection Taiwan April 16, 2013
2 International Standards for Reprocessing of Medical Devices (includes dental devices)Critical Items: Medical devices that penetrate sterile tissue, cavity, or blood (e.g. surgical instruments, cardiac catheters)STEPS:CleaningDisinfectionSterilization> Enzyme Cleaner> Liquid Chemical GermicideMethods:Steam (Autoclave)Ethylene OxideH202 Gas/PlasmaOzoneSemi-Critical Items: Medical devices that come in contact with intact non-sterile mucous membranes (e.g. endoscopes)SPAULDING’S CLASSIFICATIONSTEPS:CleaningDisinfection / Sterilization> Enzyme Cleaner> Liquid Chemical Germicide for heat sensitivewhere USA & EU are different!Non-Critical Items: Medical devices that come in contact with intact skin (e.g. EKG leads, non-invasive ultrasound probes)STEPS:CleaningDisinfection> Enzyme Cleaner> Liquid Chemical Germicide
3 USED INSTRUMENT > Potentially contaminated = DANGEROUS Method ResultCleaning and Disinfection Reduced number of pathogens, proteins are removed Safe for handling = safety for the staffInspection and care Instrument is proper functioningSterilization Safe for use = Safety for the patient
4 The Cleaning Process:1st step: Softening. This is a prerequisite for cleaning effectively. This is based on general state-of-the-art principles by means of special liquids/detergents that may loosen dirt, biofilm a little and/or dissolve any bacteria that are present.2nd step: Loosening. Loosening the softened dirt is part of the detachment process. At this stage, the softening process is not yet complete over the whole area. This means that parts of instrument are still coated with dirt.3rd step: Detachment. Once the softening/loosening is complete, it becomes possible to detach any dirt coating the surface, for example by means of rinsing, possibly supported by brushing or other recognized procedures (e.g. water jets or ultrasound techniques).4th step: Removal. As a final step removal of dirt is ensured by rinsing off residues. Recontamination of the instrument must be avoided. The instrument must be protected form recontamination of dirt which was previously removed from the same or other instruments.
5 Detergents – How they work reduce the surface tension of watersupport softening, loosening and detaching of dirtdisperse dirt (bind dirt in the solutions, preventing recontamination)SoilInstrument surfaceInstrument surfaceInstrument surface
6 Danger – Bacterial replication in a cleaning solution without disinfection properties Bacteria double their number every X minutes. After certain hours bacteria can grow to a dangerous number.A reliable disinfectant kills bacteria and prevents bacterial growth in the bath.
7 Bacterial replication is fast 20 min. 2 Bacteria40 min. 41 hr. 8 E.Coli or2 hrs Salmonella3 hrs double their number4 hrs every5 hrs minutes6 hrs6 hrs. 40 min BacteriaDisinfection is needed immediatelybefore the bacteria growsto a dangerous number!
8 Cleaning and Disinfection of Instruments bloodgermsstarting pointcleaning before disinfection reduces visible blood to zerodisinfection with aldehydes or alcohol before cleaning settles and bleaches proteinSurface of instrumentinvisiblegermsSurface of instrumentbloodgermsSurface of instrument
9 Aldehydes Pro Cons Effective, even in the presence of blood e. g. Formaldehyde, Glutaraldehyde, Phthalaldehyde, Aldehyde releasing compoundsEfficacy: bactericidal, fungicidal, tuberculocidal, virucidal (enveloped and non-enveloped viruses), sporicidalApplication area: surface and instrument disinfection (in particular flex. endoscopes)ProConsEffective, even in the presence of bloodIrritates skin and respiratory tractEasily biodegradableMay cause allergies, contact allergiesMaterial compatibleFormaldehyde is categorized as cancerogenicWorld standard for high-level disinfection of flexible endoscopesProtein fixing => no longer used for heat-resistant instruments
10 Aldehydes and Protein-fixing contaminated with bloodafter machine cleaningafter manual disinfectionafter steam sterilizationAldehydes
11 SHEA: Society for Healthcare Epidemiology of America (2010)
12 Patient Risks: Facts about Prions & CJD (Creutzfeldt-Jakob Disease) Prions are infectious agents composed of protein in a misfolded form.When a prion enters a healthy organism, it induces existing, properly folded proteins (found most abundantly in the brain) to convert into the disease-associated, prion/misfolded form; the prion acts as a template to guide the misfolding of more proteins into prion form.The abnormal folding of the prion proteins leads to brain damage and the characteristic signs and symptoms of the disease. Prion diseases are usually rapidly progressive and always fatal.Creutzfeldt-Jakob Disease (CJD) is a human prion disease. It is a neurodegenerative disorder that is rapidly progressive and always fatal. Infection with this disease leads to death usually within 1 year of onset of illness.
13 Patient Risks: Facts about Prions / CJD UK: Instruments must be discarded and burned after use for surgery on known CJD-patients!Instrument tracking becomes more and more relevant.Prions can withstand heat e.g. autoclaving 121 °C – 21min. Therefore steam sterilisation at 134 °C is recommended.Prions / Proteins are stabilized on metal surfaces of surgical instruments by protein fixing agents such as Aldehydes, Alcohols or heat.after decontamination with aldehydes autoclaving even 134 °C / 18 minutes is not effectiveConclusion: Aldehydes are no longer recommended for reprocessing heat resistant (134°C) surgical instruments!
17 Microbicidal Efficacy of an Alkylamine Based Disinfectant (Stabimed) EN 14653
18 New DGHM-Test quantitative carrier test 1. 9. 2001 / EN 14653:2008 vgl New DGHM-Test quantitative carrier test / EN 14653:2008 vgl. Hyg. Med. 27. Jahrgang 2002 – Heft 10,Test germ M. terraeOrganic load e.g. 0,3% albumin and sheep erythrozytsDisinfectant solutionOld: quantitative suspension testNew: quantitative carrier test
19 Suspension test vs. Practical Carrier test Active ingredients can attack germs form all directionsActive ingredients can attack from one direction, only!DiffusionSurface tensionChemical structure of active ingredientIn the practical carrier test the efficacy of a product can be approved, even if there is visible contamination !
20 EN 14653:2008 : Active Ingredients in Instrument Disinfectants
21 Standards for re-processing flexible endoscopes (heat sensitive) Disinfectant must be also be capable of inactivating some bacterial sporesDisinfectant must be able to pass Practical Carrier Test and inactivate Mycobacteria
22 Microbicidal Efficacy of Alkylamine Based Disinfectant (Stabimed) Destroys ALL sporesHLDs: kill some spores
23 American National Standard for Reprocessing of Medical Devices (ANSI/AAMI ST79:2010) Definitions:High Level Disinfectant - an agent that kills all microbial organisms but not necessarily large numbers of bacterial sporesUsed as an acceptable alternative to Sterilization for reprocessing heat sensitive SEMI-CRITICAL medical devices such as flexible endoscopes.Some capable of Chemical Sterilization when reusable medical devices are soaked for longer periods of time (5 to 12 hours)---only as last resort and not to be performed if other sterilization methods capable of being biologically monitored are available (e.g. steam, ethylene oxide, hydrogen peroxide gas plasma)
24 Limitations of Gluteraldehyde (‘high level disinfectant’)
25 Limitations of Gluteraldehyde (‘high level disinfectant’) They are ineffective against Clostridial Endospores such as Clostridium Tetani (Tetanus) and Clostridium Perfringens (Gangrene)
33 Efficacy against Mycobacteria: EUROPECleaning and Disinfection in one step (Alkylamines)vs.USA1st Precleaning2nd Disinfection 2.4% activated Gluteraldehyde15 minutes10 minutes45 minutes (acc. to FDA*, 2009)15 minutesavoidable RISK
34 Disinfection by Immersion Modern instrument disinfectants (in particular amines e.g. Cocospropylene diamine) clean and disinfect in one step.Process:Disassemble complex instruments (according to the recommendationsof the manufacturer)Open jointed instrumentsImmerse instruments completelyWait until the contact time has fully elapsedUse brushes as recommended by the manufacturer
35 Which Process Do You Prefer? a) Time needed: 55 minutesCleaning – not safe for the staff Risk of infection by sharp injuriesDisinfection in 2.4% Glutardialdehyde solutionb) Time needed: 15 minutes (at 2% concentration)Cleaning and disinfection in one step
36 Occupational Health and Safety Stabimed® : For cleaning and disinfection in one step of surgical instruments, medical devices, rigid and flexible endoscopesOccupational Health and Safety
38 Preparation of 2 litres of 2 % disinfectant solution 1‘960 ml cold water+ 40 ml concentrate= 2‘000 ml total volume
39 Concentrates are economic: 1 Litre of concentrate gives 50 liters of a 2% ready-to-use working solution10 liters10 liters10 liters10 liters10 liters
40 Limitations of Stabimed One Step Method (vs. ready to use solutions) Basin of solution for one-step solution needs to be replaced on a daily basis2% concentration: may be less cost effective than ready-to-use solutions of high volume manual reprocessing of instruments1% and 0.5% concentration: more cost effective than ready-to-use solutions however immersion times are longer, thus extending reprocessing times (1% = 30 mins; 0.5% = 60 mins)Need to do workflow studies to balance off cost and turn-around time requirements
41 One Step Method: Cost Savings start at 1% & 0.5%
42 Two Step Method with Stabimed: For fast processing time at lowest possible costs for high volume manual instrument reprocessing:Helizyme for Cleaning 1% (5 mins)Stabimed for Disinfection 2% (15 mins)Total time: 20 mins
43 COST SAVINGS: (Stabimed as a Disinfectant) =(1 liter of Stabimed)40ml per 2 liters of water(50 Liters or gallons of Cidex)
54 Does Stabimed Meet User Requirements? Aldehyde-free, so no protein-fixingExcellent material compatibility: recommended by AesculapBroad efficacy spectrum: bactericidal (incl. MRSA and mycobacteria-TbB), fungicidal, virucidal against enveloped viruses and effective against Rota-Polyoma- and AdenovirusesShort re-processing time (2% - 15 mins)Cost-effective (dilutable concentrate)Safe for the staff (passed patch test)Safe for the environment (biodegradable)