Autoclave Hygiene

Presentation summary on Sterilization
1. Infection control
> > > > > Why reinforce hygiene and prevent infection in the surgery? Major infectious diseases Factors that contribute to the risk of infection in a surgery Who is contagious? - When is a risk a real risk? Bioburden. Universal precautions!
2. Prevention of cross infection

> Hand hygiene: Transient and resident flora > Hygiene protocol (tips and ideas)
3. Sterilization
> Type of sterilizer (gravity vacuum) > EN13060: load / cycle description / test methods > Maintenance of sterilizers
4. Legal point of view

> Quality system log book > Traceability by Brandon Ding Division Manager, Amedix Sdn Bhd.
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Major infectious diseases
> Tuberculosis > Hepatitis B
2000 million 350 million (Dentists with the highest HBV infection)
1/10th of l of blood (invisible) contains enough viral particles of HBV to cause infection.
> Hepatitis C
> HIV / AIDS
170 million
> 60 million
(5 million new cases in 2001)
World Health Organization 2002
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Leading causes of death

> Cardiovascular diseases
> Infectious diseases > Cancer
30%
30% 13%
> Injuries
> Respiratory and digestive > Others
9%
9% 9%
World Health Organization 2005
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Who is contagious?
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Who is contagious?
Quantity of micro-organisms (infectious agents) in the body Concentration of antibodies against infectious agents in the body
Period with infectious agents in the body.
Individuals are infected
Disease symptom period B
Infected individuals can be identified

(examination or laboratory tests)
Time A C Period from infection until first symptoms of disease (Colonization / Incubation period). Individuals are free of symptoms but most contagious cannot be identified. Over 90% of transmitted infectious diseases are from such individuals (unknown cases)
When is a risk a real risk ?
all infected patients cannot be identified by medical history, physical examination, or laboratory tests.
Center of Desease Control : 1988 37(24) and 1993 (RR-8)
Every patient MUST be treated as a patient at risk!
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Potential targets?
> The dentist > Dental assistant > The secretary > Dental technician > The patient > Their respective families
Infection control
Why reinforce hygiene and prevent infection in the surgery?

To protect the patients, the staff and their families To protect oneself To protect oneself against lawsuits To provide a positive image of the dental practice To guarantee the surgerys income
Factors which contribute

to the risk of infection in a surgery
> Succession of numerous patients

who not always look after their health and hygiene.
> Various and numerous manipulations

which are part of the daily routine in a surgery.
> Treatments are often invasive

as cavities are colonised with blood and saliva.
> Equipment and organisation of the surgery

are not always functional.
> Lack of training of the dental team

concerning hygiene, infection control and devices.
Bioburden
Bioburden is the number of micro-organisms with which an object is contaminated. Amount and type of biological load (micro-organisms, proteins, dirt)
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Bioburden
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Bioburden
IMPORTANT !
Soil, debris, blood cells, saliva, etc. will not be removed by sterilizing
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Bioburden
Soil, debris, blood cells, saliva, etc. will not be removed by sterilizing
only by proper cleaning !
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Bioburden
100 x
New, never used endo file
Used, not cleaned, sterilized
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Hygiene protocol
HANDS Your most valuable instruments!
Bacterial counts on hands of medical personnel, transient and resident flora: 3.9x104 to 4.6x106 CFU/cm2 > Gloves do not prevent the need to clean and disinfect hands. > Change gloves between patients/acts. > Infections complicate 8-12 of every 100 hospital admissions. > Micro-lesions in the skin which are open doors to microbes.
Hygiene protocol
Cleaning
Contaminated instruments
Proper cleaning is the basis of the whole reprocessing cycle and is indispensable for safe sterilisation.
Pre - disinfection Cleaning Rinsing - Drying
Only clean instruments can be sterilized!

Hygiene protocol
Cleaning
Contaminated instruments
Proper cleaning is the basis of the whole reprocessing cycle and is indispensable for safe sterilisation.
Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

Hygiene protocol
Soaking / pre-disinfection
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage
> 10-15 min
Prevents debris, blood, saliva residues from drying. Prevents bacterial growth and biofilm.
Hygiene protocol
TIPS & IDEAS!

> Soak instruments immediately after use.
> Respect the concentration, time and temperature for which the liquid was tested. > Hard (tap) water containing large amounts of minerals reduces the efficiency of certain disinfecting substances. > Tap water can contribute to instrument deterioration. Use distilled or demineralized water. > The presence of chlorine (100 mg/l) favours corrosion. > Temperature <30C, prevents the fixing of proteins and also limits evaporation of the solution.
Hygiene protocol
TIPS & IDEAS!

> Renew bath regularly. Don't mix liquids which could impair efficiency. > Place scissors, forceps... in open position. > Dismantle instruments when possible. > Check full immersion of hollow instruments. > Rinse abundantly with tap water and then with distilled or demineralized water.
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Hygiene protocol
Manual cleaning
Transportation
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Hygiene protocol
Manual cleaning
TIPS & IDEAS!
> Clean under running water.

> Replace mask frequently or when humid. > Use soft brushes.
Protection against aerosol contamination

Hygiene protocol
Automated cleaning
Preferred solution!
Ultrasonic cleaner
Washer Disinfector
Hygiene protocol
Automated cleaning
TIPS & IDEAS! Ultra-sonic cleaner > Efficient on hollow items (single / double ended open). > Ideal for rough surfaces, which tend to retain germs; less > > > >
on plastic components which absorb vibrations. Respect instructions on liquid type, dosage, temperature and cycle duration provided by the manufacturer. Cover in order to avoid splashes and evaporation. Rinse abundantly with tap water and then with distilled or demineralized water. Challenge the unit once a week. (hmark.com)
Hygiene protocol
Automated cleaning
TIPS & IDEAS!
Washer disinfector > One cycle: cleans, rinses, disinfects, rinses and "dries". > Ideal automated method which can be checked/validated. > Gives the assistant time for other tasks eg. assist Doctor. > Combines mechanical (aspersion) and chemical actions
for cleaning, amplified by heat (60/90C). Helps drying.
> Thermal-disinfection with water at 80for 10' or 95for3-5'.

or with chemicals.
> Efficiency and drying on hollow instruments must be proven.

Hygiene protocol
Automated cleaning
TIPS & IDEAS!
Washer disinfector > Loading method of highest importance. Do not overload. > Use of softened water is indispensable. Ideally, the device
should connect to water treatment system (RO).
> Water softener as well as detergent dosage systems to be

adequately adjusted on site by engineer.
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Hygiene protocol
Packing
Trust is good checking is better!
> > > > >
Check the cleanliness of the instruments.
Check integrity of instruments.

Check dryness of the load (esp. hollow). Lubricate prior to packing. Prevent sharp edges from damaging bags (pre-post vac.)
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Hygiene protocol
Packing
Dental containers are ideal for storing sterile goods to the point of use.
Hygiene protocol
Packing
TIPS & IDEAS! Bags > Test self sealing bags when used in vacuum sterilizers. > Minimum seal width of 8 mm. > Adapt the length of the bag to the instrument. Don't fold. > Follow instructions about how to place bags on trays. > Don't pile bagged instruments. > Never re-use bags. > Use perforated light-weight trays. > Make sure the cassette filters are replaced regularly. > Clean, disinfect, rinse and dry new instruments
Hygiene protocol
Sterilization
Refers to a set of methods and means which are used to eliminate ALL living microorganisms in any form including spores.
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Hygiene protocol
Sterilization
Chamber loading > Do not overload the chamber. > Do not pile bagged instruments (nylon/paper).
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Hygiene protocol
Sterilization
Chamber loading > Place U shaped recipients upside down
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Hygiene protocol
Storage
> > > > > >
Check cycle parameters, printouts, alarms or indications. Check for absence of condensation when opening door. Check dryness of each item, bag and cassette. Check integrity of the packaging. Re-bag/wrap and re-process non dried items. Re-bag/wrap and re-process bags that have popped open.
Hygiene protocol
Storage
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Hygiene protocol
Storage
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Hygiene protocol
Storage
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Hygiene protocol
Sterilization
Moist heat in the form of saturated steam under pressure, is by far the most reliable medium, known for the destruction of all forms of microbial life. Steam sterilization, is the most economical and effective method for sterilization.
Nagpal AK. et al. Health Popul Perspect Issues 1978 Jan-Mar;1(1):40-50 Hammond L. Aust Fam Physician 1990 May;19(5):693
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Hygiene protocol
Why is moist heat the most efficient sterilization method?

T
180C 60 min
Dry heat
160C 90 min
Steam
134C 3 min
121C
100C
15 min
Exposure time
Saturated steam: steam required for sterilization excellent heat conductor EN 15882
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Hygiene protocol

Steam has the ability to accumulate energy and to release it to the instruments (latent heat)
C 100
1 litre
100 Kcal
20
(air 20Kcal)
530 kcal
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time
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Saturated steam: steam required for sterilization excellent heat conductor EN 15882
Hygiene protocol

Pressure (bar)
2.5 COLD STEAM
(air/steam mixture)
2.0 SATURATED STEAM Max efficiency (100% water vapour)
1.5
1.0
SUPER-HEATED STEAM
(dry air)
0.5
atm
Temperature (C)
100
110
121
130
134
140
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Saturated steam : vapour in a state of equilibrium between Datum Seite condensation and evaporation. (EN 15882)
Which sterilizer to buy?
? ? ?
? ? ?
Chamberland 1880
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So we have all purchased a new Television
1955
2005
Like buying a new computer
1981
2011
1880
2011
Air displacement technology
LOAD
WATER INJECTION
Solenoid valve HEATING

Step 1 : Water injected into the chamber + heating
LOAD
Large amount of residual air HEATING
Solenoid valve
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Cycle profile
POSITIVE PRESSURE
DURATION NEGATIVE PRESSURE
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Hollow load
Large amount of residual air HEATING
Solenoid valve
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Incomplete Air Removal

The presence of residual air in the sterilization chamber is considered the greatest impediment to steam sterilization. Steam penetration can be impeded by this residual air, which can result in inadequate temperature and moisture conditions.
Common causes for the presence of residual air:
Inadequate initial vacuum. Poor quality steam containing trapped air. Clogged or obstructed steam traps that may prevent adequate air removal at the start of the steam sterilization cycle. Presence of large packs containing absorbent material. Presence of container systems and devices with long lumens. Performance of Various Steam Sterilization 14.11.2013 Datum
Indicators Under Optimum and Sub-Optimum Exposure Conditions
Seite 75 B.S., Philip M. Schneider, M.S., Robert R. Reich, M.S. *, Steven S. Kirckof, William G. Foltz, B.S. 3M Health Care, St. Paul, MN *Pharmaceutical Systems, Inc., Mundelein, IL
Load description (EN 13060)
Solid instruments Hollow product B Hollow product A Small porous item Small porous load Full porous load
Solid instruments
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Few examples
= 2 mm
= 200
mm
L= 100 mm
= 50 mm
L= 100 mm
L= 100 mm
L= 2 mm
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= 0.5 mm
2/0.5 = 4
100/200=0.5
100/50 = 2 ( > 5 mm)
100/2 = 50 (L < 1500 mm)
NOT HOLLOW
HOLLOW B
HOLLOW A
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Hollow items ?
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Hollow instruments
Scissors and forceps?
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Hollow items
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Porous loads
Wrapped products / cassettes, gauze, bibs, gowns..
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Pre-vacuum cycles
...number of evacuation cycles necessary highly depends on the degree of vacuum in relation to the no of vacuum pulses.
Only one vacuum pulse is in general insufficient for

wrapped/hollow/porous loads. ...steam sterilisation of hollow instruments and porous objects
requires pre-vacuum.....
For steam sterilisation of objects with long and narrow lumens, procedures with several pre-vacuum pulses to a defined (=pre
set) vacuum level must be used.

Peters J., et al., Hyg Med 1997;22 (9): 444-462
BZB CareSystems AB
Education & Development
Dr. Mikael Zimmerman 29-31 March 2004 Bergamo, Italy

Air removal phase for Hollow and porous loads
FRACTIONATED PRE-VACUUM
Less than 0.1% residual air
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UNWRAPPED 1 Solid 2 Hollow A 3 Hollow B 4 Small porous items 7 8
SINGLE WRAPPED Solid
DOUBLE WRAPPED 13 14 Solid Hollow A
9 10
11 12
Which cycle Hollow A is appropriate Hollow B for my load?

Small porous items
Small porous load Full porous load
15 16
17 18
Hollow B Small porous items

Small porous load Full porous load
5 Small porous load

6 Full porous load
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Cycle types description (EN

13060)
CYCLE
No vacuum, not wrapped, not hollow ONLY for Naked solid instruments
S CYCLE
Cycles designed for Specific products For those declared by the manufacturer
B CYCLE
Medical grade cycle (Big sterilizer (EN 285) ) Designed for ALL types of load
Australian/New Zealand Standard

AS/NZS 4815:2006 Steam sterilizers manufactured in Europe are being widely distributed on the Australian market The choice of sterilizer and selected sterilization cycles may be inappropriate for particular items or types of loads.
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Typical B Type cycle profile

Pressure
Time
End
-0.80
-0.90
PV1
PV2 PP1 PP2
PV3
PPh
PR
VEN
DVs
DVe
LEV
STERILIZATION PLATEAU
VACUUM PULSED DRYING 14.11.2013 Datum

Seite 91
Other S N Type cycles profile

Pressure
Time
End
-0.80
-0.90
PV1
PV2 PP1 PP2
PV3
PPh
PR
VEN
DVs
DVe
LEV

Seite 92
Typical B Type cycle profile

Why is drying of highest importance?
" the bio-barrier must be considered penetrated..."
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Cycle table to be provided

Pre-purchase information
The user instructions shall include: the performance capabilities of each available sterilization cycle as described in annex D (EN 13060)
It is the users responsibility

to ensure that the cycle selected is suitable for the types of load to be sterilized.
Not all sterilizers/cycles are appropriate for all types of load.
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Pre-purchase information
The user instructions shall include: the performance capabilities of each available sterilization cycle as described in annex D EN 13060
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EXAMPLES
N Solid
Bagged / wrapped
S1
YES
NO YES
S2
YES
YES
S3
YES
YES
S4
YES
NO
B
YES
YES
YES
Hollow A
Bagged / wrapped
NO
NO
NO
NO
NO
NO
YES
YES
(YES)
NO
YES
YES
Hollow B
Bagged / wrapped
NO
NO
NO
NO
YES
YES
YES
YES
YES
NO
YES
YES
Small porous item

Bagged / wrapped
NO
NO
NO
NO
YES
YES
YES
YES
NO
NO
YES
YES
Small porous load

Bagged / wrapped
NO
NO
NO
NO
NO
NO
YES
YES
NO
NO
YES
YES
Full porous load

Bagged / wrapped
NO
NO
NO
NO
NO
NO
NO
NO
NO
YES
YES
14.11.2013 Datum NO Seite 98

N1 S1 S2 S3 S4
WRAPPED S1, S2 ?
STERILIZER
HOLLOW B, S1, S2, S3 ?
HOLLOW S3,S4 ? or B,?
SOLID N1, N2 ??
DAILY USED INSTRUMENTS IN A DENTAL SURGERY
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99
SAFEST !
B 134 2.1 Bar Solid
Bagged / wrapped
B 121 1.1 Bar

YES
YES YES
YES YES
Bagged / wrapped YES
Hollow A Hollow B
Bagged / wrapped
YES
YES
YES
YES
YES
YES
Small porous item

Bagged / wrapped
YES
YES
YES
YES
Small porous load

Bagged / wrapped
YES
YES
YES
YES
Full porous load

Bagged / wrapped
YES
YES
YES Datum
Seite
YES
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Final control - works test & validation

series of tests performed at the manufacturer's works to demonstrate compliance of each sterilizer with its specification (EN13060)
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Final control: Process Challenge

Devices
Pressure
Time
End
-0.80
-0.90
PV1
PV2 PP1 PP2
PV3
PPh
PR
VEN
DVs
DVe
LEV

Seite 104

Devices
Initial air (100%)
HELIX TEST
1.5 m
Residual air (10%)
Residual air (1%)
Residual air (< 0,1%)
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Process Challenge Devices

BOWIE & DICK TEST
Before
Processed Processedwith withan anN Btype typecycle cycle

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Devices
Pressure
Time
End
-0.80
-0.90
PV1
PV2 PP1 PP2
PV3
PPh
PR
VEN
DVs
DVe
LEV

Seite 112

Dryness test for solid load: max. overweight 0.2 %
Example: 4500gr Before
4509gr After sterilization
Before: 4538.1 gr
After: 4535.4 gr Datum

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Final control - summary
Vacuum test (air leakage) Empty chamber Helix test (Hollow A) Bowie & Dick (Small porous load) Dryness: full solid load Dryness: full porous load
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Awareness about "Quick" or "flash" cycles!
P (bar)
B Cycle?
15 min
Tempo (min) 0
D10
Duration of B type cycle : 30-40 min

FRACTIONATED PRE-VACUUM STERILIZATION PLATEAU
14.11.2013 Datum VACUUM PULSED DRYING Seite 116

Documentation
03-0249
EN 13060
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Regular maintenance
STERILIZER
N1 S1 S2 S3 S4 B
Drain water tanks if not used for more than 3 days. Clean water tanks regularly (every 3-6 months). Replace the bacteriological filter periodically (vac. ster.). Clean chamber surface regularly (every 10 cycles). Clean racks and trays (weekly). Challenge cycle process on a daily / weekly basis.
Run periodic cleaning cycles (re-use water)
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Process indicators
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ISO 11140 - Class 1 indicators

This type of indicator is used as an external indicator (pack, pouch, or cassette) to indicate that the item has been processed through a heat sterilizer. This helps prevent the accidental clinical use of unprocessed items. These indicators do not show whether sterilization has been achieved.
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Effectiveness of air removal from hollow instruments and wrapped items or packs If air is not removed, steam penetration is not guaranteed
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Single parameter indicators (e.g. temperature)

Used internally Accuracy 2C and 25% on time
Provide only single point information. Eg. dry heat sterilizers (160C)
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2 parameter indicators (time and temperature) Inside packages or cassettes Accuracy 2 and 25% on time
Most widely used indicators for water steam sterilizers on a routine basis.
It changes from clear to dark in a slow and gradual way.
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Unexposed
Exposed
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Multi-parameter indicators (time, steam and temperature) Inside packages or cassettes Accuracy 1C and 15% on time
3min 134C
Called integrating emulators:

They take information (time, temp. and exposure to steam) and manage it in a way that resembles the spore tests. They change gradually. Low cost and reliable.
> 3.5 min
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not used
> 1 min
Emulating indicators / cycle verification (time, steam and temperature) Inside packages or cassettes Accuracy 1C and 5% on time Most widely used indicators for water steam sterilizers. Compared to Class 5 indicators, they change very quickly.
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Class 6 indicators interpretation

BEFORE USE unprocessed
One or more process criteria not achieved. Items should be considered suspect and must be reprocessed with a new indicator
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Process indicators
Conclusion
ISO 15882 No indicator can prove, guarantee and confirm that sterilization occurred. It is dangerous and wrong to believe that if the indicator changed colour that the item is sterile.
It must be considered that indicators are part of the quality 14.11.2013 Datum management system. Seite 134
Conclusion
The life-time cost of effective infection control is far less than a malpractice.
Terezhalmy GT., et al Dental Clin North Am 1998;42(4):629-42
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Autoclave Hygiene

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Autoclave Hygiene

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Presentation summary on Sterilization

2. Prevention of cross infection

4. Legal point of view

Major infectious diseases

> Tuberculosis > Hepatitis B

World Health Organization 2002

Leading causes of death

World Health Organization 2005

Period with infectious agents in the body.

Individuals are infected

Disease symptom period B

Infected individuals can be identified

When is a risk a real risk ?

Every patient MUST be treated as a patient at risk!

Why reinforce hygiene and prevent infection in the surgery?

Factors which contribute

> Succession of numerous patients

> Various and numerous manipulations

> Treatments are often invasive

> Equipment and organisation of the surgery

> Lack of training of the dental team

only by proper cleaning !

New, never used endo file

Used, not cleaned, sterilized

Pre - disinfection Cleaning Rinsing - Drying

Only clean instruments can be sterilized!

Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

> 10-15 min

TIPS & IDEAS!

TIPS & IDEAS!

TIPS & IDEAS!

> Clean under running water.

Protection against aerosol contamination

TIPS & IDEAS!

> Thermal-disinfection with water at 80for 10' or 95for3-5'.

> Efficiency and drying on hollow instruments must be proven.

TIPS & IDEAS!

> Water softener as well as detergent dosage systems to be

Trust is good checking is better!

> > > > >

Check the cleanliness of the instruments.

Check integrity of instruments.

Chamber loading > Place U shaped recipients upside down

Trust is good checking is better!

> > > > > >

Why is moist heat the most efficient sterilization method?

Why is moist heat the most efficient sterilization method?

Why is moist heat the most efficient sterilization method?

2.0 SATURATED STEAM Max efficiency (100% water vapour)

Which sterilizer to buy?

Which sterilizer to buy?

So we have all purchased a new Television

Which sterilizer to buy?

Like buying a new computer

Which sterilizer to buy?

Air displacement technology

Solenoid valve HEATING

Step 1 : Water injected into the chamber + heating

Air displacement technology

Large amount of residual air HEATING

Air displacement technology

DURATION NEGATIVE PRESSURE

Air displacement technology

Large amount of residual air HEATING

Incomplete Air Removal

Common causes for the presence of residual air: