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:
Cleaning
Disinfection
Sterilization
> Enzyme Cleaner
> Liquid Chemical Germicide
Methods:
Steam (Autoclave)
Ethylene Oxide
H202 Gas/Plasma
Ozone
Semi-Critical Items: Medical devices that come in contact with intact non-sterile mucous membranes (e.g. endoscopes)
SPAULDING’S CLASSIFICATION
STEPS:
Cleaning
Disinfection / Sterilization
> Enzyme Cleaner
> Liquid Chemical Germicide for heat sensitive
where 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:
Cleaning
Disinfection
> Enzyme Cleaner
> Liquid Chemical Germicide

3. USED INSTRUMENT > Potentially contaminated = DANGEROUS
Method Result
Cleaning and Disinfection Reduced number of pathogens, proteins are removed Safe for handling = safety for the staff
Inspection and care Instrument is proper functioning
Sterilization 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 water
support softening, loosening and detaching of dirt
disperse dirt (bind dirt in the solutions, preventing recontamination)
Soil
Instrument surface
Instrument surface
Instrument 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 Bacteria
40 min. 4
1 hr. 8 E.Coli or
2 hrs Salmonella
3 hrs double their number
4 hrs every
5 hrs minutes
6 hrs
6 hrs. 40 min Bacteria
Disinfection is needed immediately
before the bacteria grows
to a dangerous number!

8. Cleaning and Disinfection of Instruments
blood
germs
starting point
cleaning before disinfection reduces visible blood to zero
disinfection with aldehydes or alcohol before cleaning settles and bleaches protein
Surface of instrument
invisible
germs
Surface of instrument
blood
germs
Surface of instrument

9. Aldehydes Pro Cons Effective, even in the presence of blood
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)
Pro
Cons
Effective, even in the presence of blood
Irritates skin and respiratory tract
Easily biodegradable
May cause allergies, contact allergies
Material compatible
Formaldehyde is categorized as cancerogenic
World standard for high-level disinfection of flexible endoscopes
Protein fixing => no longer used for heat-resistant instruments

10. Aldehydes and Protein-fixing
contaminated with blood
after machine cleaning
after manual disinfection
after steam sterilization
Aldehydes

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 effective
Conclusion: Aldehydes are no longer recommended for reprocessing heat resistant (134°C) surgical instruments!

14. Aldehyde free disinfectants prevent protein-fixing
contaminated with blood
after machine cleaning
after manual disinfection
after steam sterilization
Aldehydes
BETTER ALTERNATIVE:
Alkylamines & Phenols prevent protein-fixing

15. Alkylamines Active Ingredients with Excellent Cleaning Property
Cocospropylene diamine

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. terrae
Organic load e.g. 0,3% albumin and sheep erythrozyts
Disinfectant solution
Old: quantitative suspension test
New: quantitative carrier test

19. Suspension test vs. Practical Carrier test
Active ingredients can attack germs form all directions
Active ingredients can attack from one direction, only!
Diffusion
Surface tension
Chemical structure of active ingredient
In 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 spores
Disinfectant must be able to pass Practical Carrier Test and inactivate Mycobacteria

22. Microbicidal Efficacy of Alkylamine Based Disinfectant (Stabimed)
Destroys ALL spores
HLDs: 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 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)

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)

26. FROM J&J CIDEX Instruction For Use:

27. Effective Marketing Talk !

28. Risk of Infection: Are HLDs really necessary for flexible endoscopes
Risk of Infection: Are HLDs really necessary for flexible endoscopes? Are bacterial spores really a threat?
REFERENCES:

29. Risk of Infection: Are HLDs really necessary for flexible endoscopes
Risk of Infection: Are HLDs really necessary for flexible endoscopes? Are bacterial spores really a threat?
FROM CDC 2008 REPORT:

30. So which is the real threat to patients? BACTERIAL SPORES PRIONS

31. Cleaning and disinfection in one step!
To minimize risks in case of sharp injuries

32. Stabimed Video

33. Efficacy against Mycobacteria:
EUROPE
Cleaning and Disinfection in one step (Alkylamines)
vs.
USA
1st Precleaning
2nd Disinfection 2.4% activated Gluteraldehyde
15 minutes
10 minutes
45 minutes (acc. to FDA*, 2009)
15 minutes
avoidable 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 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. Which Process Do You Prefer?
a) Time needed: 55 minutes
Cleaning – not safe for the staff Risk of infection by sharp injuries
Disinfection in 2.4% Glutardialdehyde solution
b) 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 endoscopes
Occupational Health and Safety

37. Stabimed Dosing table
60 mins
30 mins
15 mins

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 solution
10 liters
10 liters
10 liters
10 liters
10 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 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. 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)

44. COST SAVINGS: (Stabimed as a Disinfectant)

45. Manual Instrument Reprocessing
Contact mainly with diluted ready-to-use working concentration

46. Helizyme: Enzymatic Cleaner

47. Helizyme: Enzymatic Cleaner

48. Helizyme for effective cleaning of flexible endoscopes

50. Stabimed Dosing Aid = CONVENIENCE OF USE

51. STABIMED is recommended by Aesculap for its devices
Material compatibility + validated cleaning result

52. Stabimed is safe for staff

53. Stabimed is biodegradable

54. 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)