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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)
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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
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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
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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.
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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.
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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!


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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


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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.
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Hygiene protocol
Soaking / pre-disinfection
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

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.
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Hygiene protocol
Soaking / pre-disinfection
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

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
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

Transportation

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Hygiene protocol
Manual cleaning
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

TIPS & IDEAS!

> Clean under running water.


> Replace mask frequently or when humid. > Use soft brushes.

Protection against aerosol contamination


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Hygiene protocol
Automated cleaning
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

Preferred solution!

Ultrasonic cleaner

Washer Disinfector
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Hygiene protocol
Automated cleaning
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

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)
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Hygiene protocol
Automated cleaning
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

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.


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Hygiene protocol
Automated cleaning
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

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
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

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
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

Dental containers are ideal for storing sterile goods to the point of use.
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Hygiene protocol
Packing
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

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
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Hygiene protocol
Sterilization
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

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
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

Chamber loading > Do not overload the chamber. > Do not pile bagged instruments (nylon/paper).

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Hygiene protocol
Sterilization
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

Chamber loading > Place U shaped recipients upside down

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Hygiene protocol
Storage
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

Trust is good checking is better!

> > > > > >

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.
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Hygiene protocol
Storage
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

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Hygiene protocol
Storage
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization Storage

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Hygiene protocol
Storage
Contaminated instruments Pre - disinfection Cleaning Rinsing - Drying Packing Sterilization 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

Why is moist heat the most efficient sterilization method?


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

Why is moist heat the most efficient sterilization method?


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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Which sterilizer to buy?

So we have all purchased a new Television

1955

2005
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Which sterilizer to buy?

Like buying a new computer

1981

2011
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Which sterilizer to buy?

1880

2011
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Air displacement technology

LOAD

WATER INJECTION

Solenoid valve HEATING


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Step 1 : Water injected into the chamber + heating

Air displacement technology

LOAD

Large amount of residual air HEATING

Solenoid valve

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Air displacement technology


Cycle profile

POSITIVE PRESSURE

DURATION NEGATIVE PRESSURE

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Air displacement technology

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
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Load description (EN 13060)

Solid instruments

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Load description (EN 13060)

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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Load description (EN 13060)


Hollow items ?

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Load description (EN 13060)


Hollow instruments

Scissors and forceps?

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Load description (EN 13060)


Hollow items

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Load description (EN 13060)


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
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BZB CareSystems AB

Education & Development

Dr. Mikael Zimmerman 29-31 March 2004 Bergamo, Italy

Load description (EN 13060)


Air removal phase for Hollow and porous loads

FRACTIONATED PRE-VACUUM

Less than 0.1% residual air

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Load description (EN 13060)

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
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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

FRACTIONATED PRE-VACUUM

STERILIZATION PLATEAU

VACUUM PULSED DRYING 14.11.2013 Datum


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Other S N Type cycles profile


Pressure

Time

End

-0.80
-0.90

PV1

PV2 PP1 PP2

PV3

PPh

PR

VEN

DVs

DVe

LEV

FRACTIONATED PRE-VACUUM

STERILIZATION PLATEAU

VACUUM PULSED DRYING 14.11.2013 Datum


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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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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

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Cycle table to be provided

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

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Cycle table to be provided


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

Cycle table to be provided

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

FRACTIONATED PRE-VACUUM

STERILIZATION PLATEAU

VACUUM PULSED DRYING 14.11.2013 Datum


Seite 104

Final control: Process Challenge


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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Final control: Process Challenge


Devices
Pressure

Time

End

-0.80
-0.90

PV1

PV2 PP1 PP2

PV3

PPh

PR

VEN

DVs

DVe

LEV

FRACTIONATED PRE-VACUUM

STERILIZATION PLATEAU

VACUUM PULSED DRYING 14.11.2013 Datum


Seite 112

Final control - works test & validation


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

Final control - works test & validation


Documentation

03-0249

EN 13060

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Regular maintenance
Trust is good checking is better!

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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ISO 11140 - Class 2 indicators

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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ISO 11140 - Class 3 indicators

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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ISO 11140 - Class 4 indicators

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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ISO 11140 - Class 4 indicators

Unexposed

Exposed

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ISO 11140 - Class 5 indicators

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

ISO 11140 - Class 6 indicators

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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ISO 11140 - Class 6 indicators

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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