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

Stabimed & HelizymeManual Instrument Cleaning and Disinfection

Taiwan April 16, 2013

OPM - Infection Control | Martin Madrid | Stabimed |

International Standards for Reprocessing of Medical Devices

Cleaning Disinfection Sterilization

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:

STEPS:

STEPS:

SP

AU

LD

ING

’S C

LA

SS

IFIC

AT

ION

> 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)

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USED INSTRUMENT > Potentially contaminated = DANGEROUS

Method Result

Cleaning and Disinfection Reduced number of pathogens, proteins are removedSafe for handling = safety for the staff

Inspection and care Instrument is proper functioning

Sterilization Safe for use = Safety for the patient


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.


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)

SoilInstrument surface

Instrument surface

Instrument surface

OPM - Infection Control | Martin Madrid | Stabimed | Page

Danger – Bacterial replication in a cleaning solution without disinfection properties

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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.


20 min. 2 Bacteria40 min. 41 hr. 8 E.Coli or 2 hrs. 64 Salmonella3 hrs. 512 double their number4 hrs. 4.096 every5 hrs. 32.768 20 minutes6 hrs. 262.1446 hrs. 40 min. 1.048.576 Bacteria

Bacterial replication is fast

Disinfection is needed immediately before the bacteria grows to a dangerous number!


Cleaning and Disinfection of Instruments

starting point

cleaning beforedisinfection reduces visible blood to zero

disinfection with aldehydes or alcoholbefore cleaning settles and bleaches protein

Surface of instrument



blood

blood

germs

germs

germs

invisible

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Aldehydese. 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)

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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

http://www.google.com.my/imgres?imgurl=http://www.amawebs.com/storage/photos/n19bi29afjnm.jpg&imgrefurl=http://sites.amarillasinternet.com/gamedical/productos_3m.html&usg=__GMrbXv8u53sKhTwyDZvDLbxtHZY=&h=375&w=224&sz=12&hl=en&start=2&zoom=1&tbnid=jo1lDhaF_rgCvM:&tbnh=122&tbnw=73&ei=Hi43UIKcCJGsrAfBlYAw&prev=/search?q=3M+Glutarex&um=1&hl=en&gbv=2&tbm=isch&um=1&itbs=1

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http://www.google.com.my/imgres?imgurl=http://www.mwdental.com/media/catalog/product/cache/1/thumbnail/1000x1000/9df78eab33525d08d6e5fb8d27136e95/3/0/300-1205.jpg&imgrefurl=http://www.mwdental.com/supplies/infection-control/cidex-opa-disinfecting-solution-gallon.html&usg=__BV6Ln_HzPxaJcjfi04ilrTPP2f4=&h=1000&w=1000&sz=62&hl=en&start=7&zoom=1&tbnid=jkLqWmjtzTvAzM:&tbnh=149&tbnw=149&ei=fjA3UIvKDsTrrQf0uoDADA&prev=/search?q=cidex+opa&um=1&hl=en&gbv=2&tbm=isch&um=1&itbs=1


Aldehydes and Protein-fixing

Aldehydes

contaminated with blood

after machine cleaning

after manual disinfection

after steam sterilization


SHEA: Society for Healthcare Epidemiology of America (2010)



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.

http://en.wikipedia.org/wiki/File:Histology_bse.jpg


Patient Risks: Facts about Prions / CJD UK: Instruments must be discarded and burned after use for surgery on known

CJD-patients! Þ 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!


Aldehyde free disinfectants prevent protein-fixing

Aldehydes

Alkylamines & Phenolsprevent

protein-fixing

BETTER ALTERNATIVE:

contaminated with blood

after machine cleaning

after manual disinfection

after steam sterilization


AlkylaminesActive Ingredients with Excellent Cleaning Property

Cocospropylene diamine

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Microbicidal Efficacy of an Alkylamine Based Disinfectant (Stabimed)

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EN 14653



New DGHM-Test quantitative carrier test 1.9.2001 / EN 14653:2008vgl. Hyg. Med. 27. Jahrgang 2002 – Heft 10, 384-386

Test germM. terrae

Organic loade.g. 0,3% albumin and sheep erythrozyts

Old: quantitative suspension test

New: quantitative carrier test

Disinfectant solution



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 !



EN 14653:2008 : Active Ingredients in Instrument Disinfectants

Efficacy without

Phase 2 Step 2 Class of Active Ingredient

Efficacy incl. TbB Phase 2 Step 2

Aldehydes

Phenols

Alkylamines

- QAC, Biguanides

Combination of Alkylamins,

QAC



www.cdc.gov/biosafety/publications/bmbl5/bmbl5_appendixb.pdf

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



OPM - Infection Control | Martin Madrid | Stabimed | Page 23

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)



Limitations of Gluteraldehyde (‘high level disinfectant’)

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Limitations of Gluteraldehyde (‘high level disinfectant’)

• They are ineffective against Clostridial Endospores such as Clostridium Tetani (Tetanus) and Clostridium Perfringens (Gangrene)

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Effective Marketing Talk !


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

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REFERENCES:



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

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So which is the real threat to patients?

BACTERIAL SPORES PRIONS

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Cleaning and disinfection in one step!

To minim

ize risks in

case

of sharp in

juries



Stabimed Video

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EUROPECleaning and Disinfection in one step (Alkylamines)

vs.

USA1st Precleaning

2nd Disinfection 2.4% activated Gluteraldehyde

15 minutes 45 minutes (acc. to FDA*, 2009)

15 minutes

10 minutes

avoidable RISK

Efficacy against Mycobacteria:




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


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


Stabimed® : For cleaning and disinfection in one step of surgical instruments, medical devices, rigid and flexible endoscopes

Occupational Health and

Safety

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Stabimed Dosing table15 mins30 mins60 mins


Preparation of 2 litres of 2 % disinfectant solution

1‘960 ml cold water+ 40 ml concentrate

= 2‘000 ml total volume


Concentrates are economic: 1 Litre of concentrate gives 50 liters of a 2% ready-to-use working solution

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10 liters

10 liters

10 liters

10 liters

10 liters


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


One Step Method: Cost Savings start at 1% & 0.5%

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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


COST SAVINGS: (Stabimed as a Disinfectant)

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=

(50 Liters or 13.15 gallons of Cidex)

(1 liter of Stabimed)40ml per 2 liters of water

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COST SAVINGS: (Stabimed as a Disinfectant)

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Manual Instrument Reprocessing

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Contact mainly with diluted ready-to-use working concentration


Helizyme: Enzymatic Cleaner

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Helizyme: Enzymatic Cleaner

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Helizyme for effective cleaning of flexible endoscopes

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Stabimed Dosing Aid = CONVENIENCE OF

USE


Material compatibility

+validated

cleaning result

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STABIMED is recommended by Aesculap for its devices


Stabimed is safe for staff


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Stabimed is biodegradable


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)

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

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