Presentation is loading. Please wait.

Presentation is loading. Please wait.

Stabimed & Helizyme Manual Instrument Cleaning and Disinfection Taiwan April 16, 2013.

Similar presentations


Presentation on theme: "Stabimed & Helizyme Manual Instrument Cleaning and Disinfection Taiwan April 16, 2013."— Presentation transcript:

1 Stabimed & Helizyme Manual Instrument Cleaning and Disinfection Taiwan April 16, 2013

2 OPM - Infection Control | Martin Madrid | Stabimed | Page2 International Standards for Reprocessing of Medical Devices Cleaning DisinfectionSterilization Cleaning Disinfection / Sterilization Cleaning Disinfection Critical Items: Medical devices that penetrate sterile tissue, cavity, or blood (e.g. surgical instruments, cardiac catheters) Semi-Critical Items: Medical devices that come in contact with intact non-sterile mucous membranes (e.g. endoscopes) Non-Critical Items: Medical devices that come in contact with intact skin (e.g. EKG leads, non-invasive ultrasound probes) Methods: Steam (Autoclave) Ethylene Oxide H202 Gas/Plasma Ozone STEPS: SPAULDING’S CLASSIFICATION > Enzyme Cleaner> Liquid Chemical Germicide > Enzyme Cleaner> Liquid Chemical Germicide for heat sensitive > Enzyme Cleaner> Liquid Chemical Germicide where USA & EU are different! (includes dental devices)

3 OPM - Infection Control | Martin Madrid | Stabimed | Page3 USED INSTRUMENT >Potentially contaminated = DANGEROUS MethodResult Cleaning and DisinfectionReduced number of pathogens, proteins are removed Safe for handling = safety for the staff Inspection and careInstrument is proper functioning SterilizationSafe for use = Safety for the patient

4 OPM - Infection Control | Martin Madrid | Stabimed | Page4 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 OPM - Infection Control | Martin Madrid | Stabimed | Page5 Detergents – How they work  reduce the surface tension of water  support softening, loosening and detaching of dirt  disperse dirt (bind dirt in the solutions, preventing recontamination) Soil Instrument surface

6 OPM - Infection Control | Martin Madrid | Stabimed | Page Danger – Bacterial replication in a cleaning solution without disinfection properties 6 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 OPM - Infection Control | Martin Madrid | Stabimed | Page7 20 min. 2 Bacteria 40 min. 4 1 hr.8E.Coli or 2 hrs. 64Salmonella 3 hrs. 512double their number 4 hrs.4.096every 5 hrs minutes 6 hrs hrs. 40 min Bacteria Bacterial replication is fast Disinfection is needed immediately before the bacteria grows to a dangerous number!

8 OPM - Infection Control | Martin Madrid | Stabimed | Page Cleaning and Disinfection of Instruments starting point cleaning before disinfection reduces visible blood to zero disinfection with aldehydes or alcohol before cleaning settles and bleaches protein Surface of instrument blood germs invisible 8

9 OPM - Infection Control | Martin Madrid | Stabimed | Page Aldehydes e. g. Formaldehyde, Glutaraldehyde, Phthalaldehyde, Aldehyde releasing compounds Efficacy:bactericidal, fungicidal, tuberculocidal, virucidal (enveloped and non-enveloped viruses), sporicidal Application area: surface and instrument disinfection (in particular flex. endoscopes) 9 ProCons Effective, even in the presence of blood Irritates skin and respiratory tract Easily biodegradableMay cause allergies, contact allergies Material compatibleFormaldehyde is categorized as cancerogenic World standard for high-level disinfection of flexible endoscopes Protein fixing => no longer used for heat-resistant instruments

10 OPM - Infection Control | Martin Madrid | Stabimed | Page10 Aldehydes and Protein-fixing Aldehydes contaminated with blood after machine cleaning after manual disinfection after steam sterilization

11 OPM - Infection Control | Martin Madrid | Stabimed | Page11 SHEA: Society for Healthcare Epidemiology of America (2010)

12 OPM - Infection Control | Martin Madrid | Stabimed | Page12 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 OPM - Infection Control | Martin Madrid | Stabimed | Page13 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 effective Conclusion: Aldehydes are no longer recommended for reprocessing heat resistant (134°C) surgical instruments!

14 OPM - Infection Control | Martin Madrid | Stabimed | Page14 Aldehyde free disinfectants prevent protein-fixing Aldehydes Alkylamines & Phenols prevent protein-fixing BETTER ALTERNATIVE: contaminated with blood after machine cleaning after manual disinfection after steam sterilization

15 OPM - Infection Control | Martin Madrid | Stabimed | Page Alkylamines Active Ingredients with Excellent Cleaning Property Cocospropylene diamine 15

16 OPM - Infection Control | Martin Madrid | Stabimed | Page16

17 OPM - Infection Control | Martin Madrid | Stabimed | Page Microbicidal Efficacy of an Alkylamine Based Disinfectant (Stabimed) 17 EN 14653

18 OPM - Infection Control | Martin Madrid | Stabimed | Page18 New DGHM-Test quantitative carrier test / EN 14653:2008 vgl. Hyg. Med. 27. Jahrgang 2002 – Heft 10, Test germ M. terrae Organic load e.g. 0,3% albumin and sheep erythrozyts Old: quantitative suspension test New: quantitative carrier test Disinfectant solution

19 OPM - Infection Control | Martin Madrid | Stabimed | Page19 Active ingredients can attack germs form all directions Active ingredients can attack from one direction, only! Diffusion Surface tension Chemical structure of active ingredient Suspension test vs. Practical Carrier test In the practical carrier test the efficacy of a product can be approved, even if there is visible contamination !

20 OPM - Infection Control | Martin Madrid | Stabimed | Page20 EN 14653:2008 : Active Ingredients in Instrument Disinfectants

21 OPM - Infection Control | Martin Madrid | Stabimed | Page21 Standards for re-processing flexible endoscopes (heat sensitive) Disinfectant must be also be capable of inactivating some bacterial spores Disinfectant must be able to pass Practical Carrier Test and inactivate Mycobacteria

22 OPM - Infection Control | Martin Madrid | Stabimed | Page22 Microbicidal Efficacy of Alkylamine Based Disinfectant (Stabimed) HLDs: kill some spores Destroys ALL spores

23 OPM - Infection Control | Martin Madrid | Stabimed | Page23 High Level Disinfectant - an agent that kills all microbial organisms but not necessarily large numbers of bacterial spores Used 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) Definitions: American National Standard for Reprocessing of Medical Devices (ANSI/AAMI ST79:2010)

24 OPM - Infection Control | Martin Madrid | Stabimed | Page Limitations of Gluteraldehyde (‘high level disinfectant’) 24

25 OPM - Infection Control | Martin Madrid | Stabimed | Page Limitations of Gluteraldehyde (‘high level disinfectant’) They are ineffective against Clostridial Endospores such as Clostridium Tetani (Tetanus) and Clostridium Perfringens (Gangrene) 25

26 OPM - Infection Control | Martin Madrid | Stabimed | Page FROM J&J CIDEX Instruction For Use: 26

27 OPM - Infection Control | Martin Madrid | Stabimed | Page27 Effective Marketing Talk !

28 OPM - Infection Control | Martin Madrid | Stabimed | Page Risk of Infection: Are HLDs really necessary for flexible endoscopes? Are bacterial spores really a threat? 28 REFERENCES :

29 OPM - Infection Control | Martin Madrid | Stabimed | Page Risk of Infection: Are HLDs really necessary for flexible endoscopes? Are bacterial spores really a threat? FROM CDC 2008 REPORT: 29

30 OPM - Infection Control | Martin Madrid | Stabimed | Page So which is the real threat to patients? BACTERIAL SPORES PRIONS 30

31 OPM - Infection Control | Martin Madrid | Stabimed | Page31 Cleaning and disinfection in one step! To minimize risks in case of sharp injuries

32 OPM - Infection Control | Martin Madrid | Stabimed | Page Stabimed Video 32

33 OPM - Infection Control | Martin Madrid | Stabimed | Page33 EUROPE Cleaning and Disinfection in one step (Alkylamines) vs. USA 1 st Precleaning 2 nd Disinfection 2.4% activated Gluteraldehyde 15 minutes 45 minutes (acc. to FDA*, 2009) 15 minutes 10 minutes avoidable RISK Efficacy against Mycobacteria:

34 OPM - Infection Control | Martin Madrid | Stabimed | Page34 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 recommendations of the manufacturer) Open jointed instruments Immerse instruments completely Wait until the contact time has fully elapsed Use brushes as recommended by the manufacturer

35 OPM - Infection Control | Martin Madrid | Stabimed | Page35 Which Process Do You Prefer? Cleaning – not safe for the staff Risk of infection by sharp injuries Cleaning and disinfection in one step a) Time needed: 55 minutes b) Time needed: 15 minutes (at 2% concentration) Disinfection in 2.4% Glutardialdehyde solution

36 OPM - Infection Control | Martin Madrid | Stabimed | Page Stabimed® : For cleaning and disinfection in one step of surgical instruments, medical devices, rigid and flexible endoscopes Occupational Health and Safety 36

37 OPM - Infection Control | Martin Madrid | Stabimed | Page37 Stabimed Dosing table 15 mins30 mins60 mins

38 OPM - Infection Control | Martin Madrid | Stabimed | Page38 Preparation of 2 litres of 2 % disinfectant solution 1‘960 mlcold water +40 mlconcentrate =2‘000 mltotal volume

39 OPM - Infection Control | Martin Madrid | Stabimed | Page Concentrates are economic: 1 Litre of concentrate gives 50 liters of a 2% ready-to-use working solution liters

40 OPM - Infection Control | Martin Madrid | Stabimed | Page40 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 basis 2% concentration: may be less cost effective than ready-to-use solutions of high volume manual reprocessing of instruments 1% 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 OPM - Infection Control | Martin Madrid | Stabimed | Page One Step Method: Cost Savings start at 1% & 0.5% 41

42 OPM - Infection Control | Martin Madrid | Stabimed | Page42 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 OPM - Infection Control | Martin Madrid | Stabimed | Page COST SAVINGS: (Stabimed as a Disinfectant) 43 = (50 Liters or gallons of Cidex) (1 liter of Stabimed) 40ml per 2 liters of water

44 OPM - Infection Control | Martin Madrid | Stabimed | Page COST SAVINGS: (Stabimed as a Disinfectant) 44

45 OPM - Infection Control | Martin Madrid | Stabimed | Page Manual Instrument Reprocessing 45 Contact mainly with diluted ready-to-use working concentration

46 OPM - Infection Control | Martin Madrid | Stabimed | Page Helizyme: Enzymatic Cleaner 46

47 OPM - Infection Control | Martin Madrid | Stabimed | Page Helizyme: Enzymatic Cleaner 47

48 OPM - Infection Control | Martin Madrid | Stabimed | Page Helizyme for effective cleaning of flexible endoscopes 48

49 OPM - Infection Control | Martin Madrid | Stabimed | Page 49

50 OPM - Infection Control | Martin Madrid | Stabimed | Page50 Stabimed Dosing Aid = CONVENIENCE OF USE

51 OPM - Infection Control | Martin Madrid | Stabimed | Page Material compatibility + validated cleaning result 51 STABIMED is recommended by Aesculap for its devices

52 OPM - Infection Control | Martin Madrid | Stabimed | Page52 Stabimed is safe for staff

53 OPM - Infection Control | Martin Madrid | Stabimed | Page 53 Stabimed is biodegradable

54 OPM - Infection Control | Martin Madrid | Stabimed | Page Does Stabimed Meet User Requirements? Aldehyde-free, so no protein-fixing Excellent material compatibility: recommended by Aesculap Broad efficacy spectrum: bactericidal (incl. MRSA and mycobacteria-TbB), fungicidal, virucidal against enveloped viruses and effective against Rota-Polyoma- and Adenoviruses Short re-processing time (2% - 15 mins) Cost-effective (dilutable concentrate) Safe for the staff (passed patch test) Safe for the environment (biodegradable) 54


Download ppt "Stabimed & Helizyme Manual Instrument Cleaning and Disinfection Taiwan April 16, 2013."

Similar presentations


Ads by Google