08/05/2015

Proses Pembersihan Peralatan Kesehatan;

Faktor Air, Deterjen dan Metode

The Importance of Cleaning!

Your Bowie Dick Test says : Pass
Your Type 6 Indicator says : Pass
Your Bio Indicator says : Pass
Do you think your load is sterile?

But when you open the package, you saw ...

Remember, Sterility Indicators assume
that your package is clean!

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The Importance of Cleaning!

Ensure that infectious microorganisms are removed together with the

organic matter that protect them!
Ensure better contact between the disinfectant and sterilant with any
remaining infectious microorganisms!
Ensure instrument functionality and longevity!
Ensure patient safety!

If it's not clean...

it can't be sterile
(Spaulding)
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Manufacturers recommendations according to

ISO 17664: 2004
Specifies the information to be provided by the medical device
manufacturer on the processing of medical devices claimed to be resterilizable, and medical devices intended to be sterilized. Safely
re-processing the medical device so that it will continue to meet its
performance specification.
Preparation at the point of use
Preparation, cleaning, disinfection
Drying
Inspection, maintenance and testing
Packaging
Sterilization
Storage
Source: ISO 17664: 2004

Key Factor- Cleaning Parameters

Action

Detergents

Water

Temperature

Time

Reasons for Manual Cleaning

Lack of mechanical equipment

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Reasons for Manual Cleaning

Instrument design and manufacturers recommendations
Essential for department cleaning protocols

Reasons for Manual Cleaning

Amount of soil and condition of soil on the instrument
Poor protocol at the point of use
Instruments that have been allowed to dry

Reasons for Manual Cleaning

National and local standards of practice
Prerequisite to mechanical cleaning

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Selecting a Detergent
Characteristics of a good detergent:

Worker safety
Material compatibility
Effective on multiple soil types
Low foaming
Ability to work in adverse water
Free rinsing
Environmentally friendly
Cost-effective
Standardisation

Manual Detergent Formulations

Water
Surfactants
Chelates
Sequestrates
Corrosion Inhibitors
Biocides
Solvents

Enzymes

Enzymes

Enzymes are specific in the type of soil they remove, e.g.

o Lipases: help to digest fats and oils.

o Cellulases: digest celluloses main ingredient of viscous ultrasonic and other
coupling gels that can affect thermal and chemical sterilisation steps
o Amylases: digest hard-to-dissolve starches.
o Proteases: digest proteins.

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Enzymes

Typically formulated in pH neutral

detergents
Enzymes are the most efficient
catalysts known to man; used
correctly they can increase a rate
of biochemical reactions up to
10,000 times compared to only
100 times by the best nonenzymatic detergents
Can deactivate Prions better than
Alkaline!

Key Factor- Water Quality

Principle component of cleaning, rinsing and steam sterilization

Major culprit in destruction of instrumentation and equipment
Anything in water that is not H2O is an impurity and needs to be regularly
observed and controlled by purification methods
Instrument and equipment damage can result from impurities found in
feed water used for washing and for steam sterilization

Water Elements

Water
H2O

Calcium
Ca2+

Fluoride
FPotassium
K+

Nitrate
NO3-

Sulfate
SO42-

Carbonate
CO32-

Aluminum
Al3+

Bicarbonate
HCO3-

Silicate
SiO2

Magnesium
Mg2+

Copper
Cu2+

Phosphate
PO43-

Iron
Fe2+

Sodium
Na+
Zinc
Zn2+

Hydroxide
OHChloride
Cl-

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Damage & Discoloration caused by Water

Water Quality

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Water Quality- Purification

Water Type

Characteristic

Potable

Drinking water that normally contains both

ionic & organic impurities

Softened

Removal of calcium & magnesium

Deionized

Removal of ionic impurities, but not all

organic contaminates

Reverse Osmosis

Removal of nearly all ionic & organic

impurities

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Concentration
Detergent Dosage

Soil type, amount and condition

Water quality
Confirm use for automated, manual
cleaning, low foaming
Confirm material compatibility/
manufacturers recommendation
Biofilm removal
Protein and/or Prion deactivation
Longevity

Action
Water Flow, impingement
and Brushing

Use instrument manufacturer

recommended brushes (size &
design) in order to clean efficiently
and prevent instrument damage
Brush under water level to avoid
aerosols
Impingement by washers or
ultrasound by ultrasonics

Temperature
Cleaning Temperature

Should be controlled throughout process

Water temperature for manual cleaning

typically 25 - 40C, automated at higher
temperatures

Slightly elevated temperatures important

for better detergent cleaning efficacy

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Time
Process Time

All other parameters are time

dependent

Detergent manufacturers
recommendations

Longer than recommended

contact time may damage
instrumentation, shorter may
mean improper cleaning

Manual Cleaning

The human factor cant be validated

Cleaning Methods
Mechanical

Automated, factory type tested,

validated cleaning cycles
(Reproducible)

Controlled Action (spray arm)

Controlled Temperatures
Controlled Concentration
Controlled Time
Disinfection (90 degrees)

Manual

Human dependent, can not be

validated and can vary from operator
and set up (un-reproducible)

Action (manual brushing)

Temperature can vary
Concentration (how is it dosed)
Time can vary
No Disinfection (steam)

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How to Assure Optimum Cleaning in Your

Department

What is Routine Monitoring?

Chronology of decontamination process

Washing
Sterilisation
Documentation
Routine monitoring of the entire process
Washing wash monitors / soil removal tests
and protein residue tests
Sterilisation Daily tests ( Bowie and Dick type
test), Cycle tests (Load-checks), In Pack tests (
chemical indicators)
Documentation Traceability and the results of
the above

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Helpful Accessories
Monitoring the Parameters of
Manual Cleaning
Basic to advanced

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International Advisory Bodies/ Standards

ISO15883:
For routine checks the operator must formulate a concept with regular
checks to verify whether impeccable functioning of the washer-disinfector is
still assured. It is recommended that additional checks, which are to be
used for routine monitoring, be integrated already at the time of validation and
revalidation in order to demonstrate correlation with other methods The
operator is responsible for drawing up a routine check plan. He determines
the scope and frequency of the individual tests as well as the quantity and
positioning of indicators.
A routine control concept can include:
Temperature-time curves
Visual inspection for cleanliness
Verification of the spray pattern
Testing with biological indicators
Spot checks for protein residues
Checking of water quality
Cleaning tests with cleaning indicators, test soils as per Annex B

Test Soil Both for Manual and Automated Cleaning

Synthetic test soil used to validate wash processes
Designed to meet the requirnments of EN ISO15883
To be used in accordance with local and international guidelines
Formula includes protein, lipids & polysaccharides to mimic surgical soils
Blindt Tests for Manual Cleaning

Ultrasonic Monitors
Ultrasonic monitor determines the cleaning
effectiveness of an ultrasonic bath
Designed to meet the requirements of EN ISO15883
Monitors multi-parameters
o Time, Temperature, Transducers, Cavitation &
Detergent
Recommended Use:
o As a daily machine release with an empty
machine
o As a load release to verify cleaning and to
train employees

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Ultrasonic Monitors Recommended Use

For daily machine release, The monitor and holder are

placed in the empty ultrasonic bath with detergent. The
blue diamond facing up, and a normal ultrasonic cycle is
conducted.
For load release: The monitor and holder are placed in
the cleaner on top of the instruments with the blue square
facing up.
Recommended use: Daily monitoring of ultrasonic
cleaners for machine release, and periodically throughout
the day for load release. In conjunction with
recommended foil test according to 15883

Why Ultrasonic Monitors Fail?

Basic problems that occur with ultrasonic cleaning

Overloaded baskets too many instruments will reduce cleaning
effectiveness
Transducer failure
Using the wrong detergent or incorrect amount
Not changing out detergent periodically
Low power

Wash Monitors
The test soil (red diamond) simulates
human blood and tissue debris
Designed to meet the requirements of
EN ISO15883
When the test is placed in the holder the
test soil is half obscured, simulating the
joint of a surgical instrument
The removal of all test soil indicates
effective cleaning
Austrian & German Studies

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Wash Monitor Recommended Use

The Wash Monitors are inserted in

the reusable holder and can be
placed face up in a basket. The
washer may be loaded or empty
Monitor every shelf on every
washer each morning for machine
release
Include a minimum of one monitor
per load for routine daily
monitoring. This way the
verification of cleanliness for that
load can be traced to the patient

Why Wash Monitors Fail?

Many Washer-Disinfectors fail

validation tests due to:
Spray arms clogged with dried
chemicals and/or debris
Loose or broken spray arms
Deficient or inefficient washing
solutions
Malfunctioning pumps and lines
Overloaded instrument trays
Insufficient pre-treatment when
needed

Wash Monitors F/R & U/L

The Wash Monitors F/R & U/L are

designed for monitoring the cleaning of
hollow instruments in a washerdisinfectors and ultra sonic baths

Both Wash Monitors F/R & U/L work with

the same Wash Monitor R (rigid) and F
(flexible)

Wash Monitor F/R

Wash Monitor U/L

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Wash Monitor F and R Holders

Wash Monitor F Holder

Wash Monitor R Holder

Protein Residual
Protein is a significant component of bio burden
Traces of protein indicate an unclean surface
and a likely source of cross contamination
What may look clean may in fact still be
contaminated
Recent issues with CJD Prion infective
denatured protein
The most efficient way to assure the cleaning
process is effective is to incorporate periodic
protein residual testing into the overall wash
monitoring protocol

Protein Tests
The Protein Tests detect residual proteins left behind
on the surfaces of:
o Surgical Instruments, Endoscopes
o Washer-Disinfectors, Ultrasonic Cleaners
o Surfaces
Meets EN ISO 15883 requirements
Some tests can detect protein residues down to 1 g
sensitivity
New tests are extremely fast results in 10 seconds
No incubation required
Its not an ATP (adenosine triphosphate) test and we
will show you some reasons why

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8-May-15

Name Name I Whats New Conference 2010 I Confidential

40

8-May-15

Name Name I Whats New Conference 2010 I Confidential

41

Summary

When performing manual cleaning always refer to the instrument

manufacturers recommendations and build them into the cleaning
protocol

Detergents are formulated to clean and protect instruments as well as

the healthcare worker and environment. Review your detergent usage
and ensure you have pH neutral and strong enzymatic detergents

Manual cleaning can not be validated, however the parameters of time,

temperature, action and concentration still need to be monitored (tools)
in order to achieve efficient cleaning. Automated cleaning can be
validated!

Good water quality is essential for cleaning and rinsing. A highly

purified final rinse water will help prevent surface staining and corrosion

Training and routine monitoring of the cleaning process can be achieved

with commercial test soil and protein residual tests

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Thank you!

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