o Describe why policies and procedures are required for an effective decontamination unit. Describe international standards available for decontamination units.

1. ALL YOU NEED
TO KNOW ABOUT
CENTRAL
STERILE SUPPLY
DEPARTMENT

2. Introduction to The Decontamination area
(Zone 1)
Day 1
Presented by Talal Albudayri

3. Learining Outcomes
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o Describe why policies and procedures are required for an
effective decontamination unit.
Describe international standards available for decontamination units.
Describe the function of a decontamination unit and key
requirements for unit design.

4. Decontamination (Zone 1)
o
oCombination of process which are cleaning and disinfection to
make RMD safe for handling by staff and safe to use on patient.
The returned RMD to the decontamination area are
considered potentially infected and contaminated.

5. Personal Protective Equipment (PPE)
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Cover gown with
sleeves. Face mask.
Eye protection.
Gloves.
Shoe covers.
Headcover.

6. Requirements tool for cleaning
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Instrument cleaning sinks.
Brushes.
Air and water guns.
Detergents. (Enzymatic Detergents).
Cart washer.
Ultrasonic washer and automated washer
disinfectors. Disinfectants.
Environmental monitors.
Spill kit.

7. Decontamination (Zone 1)
All RMDs that come into contact with the patient or surgical field should be
systematically decontaminated after each surgical procedure.
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The reusable medical devices reprocessed to a level appropriate for their intended use.
Depends on the body sites where the device will be used and the risk associated with a
particular procedure.
The minimum levels of processing based on three risk categories of use, are shown in a
classifications system called the Spaulding classification system.
In the reprocessing world, Spaulding Classification is the standard from which we learn what
to disinfect or sterilize and how much to do it.

8. The appropriate level of decontamination will depend on the
body sites where the device will be used and the risk
associated with the procedure.

9. The History of Spaulding Classification
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Spaulding Classification goes way back to 1939 when a microbiologist named
Earle Spaulding wrote a paper for Temple University.
In it, he proposed a system for determining which patient care items needed
disinfection or sterilization. Spaulding separated patient care items into three
categories: non-critical, semi-critical, and critical.
He also recognized three levels of germicidal activity: high, intermediate, and
low. By 1957, this system was called the Spaulding Criteria and was widely being
used to further establish these norms.
The CDC currently defines Spaulding Classification as, “a strategy for
sterilization or disinfection of inanimate objects and surfaces based on
the degree of risk involved in their use.”

10. Critical
Ø A medical device that comes into contact with the vascular system
or sterile tissue and that shall be sterile at the time of use.
Clean as soon as possible after using.
Sterilize by moist heat after cleaning.
If RMD is heat or moisture sensitive, sterilize suing an alternative process,
e.g. automated low temperature chemical sterilizing process, liquid
chemical sterilizing process.
Process:
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11. Semi-Critical
Ø A medical device that comes into contact with mucous
membranes or nonintact skin.
Clean as soon as possible after using.
Sterilize by moist heat after cleaning.
If RMD will not tolerate moist heat sterilization use a low temperature
sterilization process or disinfection using a high level instrument grade
.
Process:
chemical disinfectant
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12. Non-Critical
Ø
Clean as necessary with detergent solution.
If further treatment is necessary,
A medical device that only comes into contact with intact skin
but not mucous membranes.
Process:
disinfect with compatible low level or
intermediate level instrument grade disinfectant after cleaning.
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13. Surgical Instrument Processing Steps

14. Keeping items Moist

15. Dirty instruments returned to the
OR Why we should keep it moist ?!

16. Sorting and Disassembly of Contaminated RMD
Ø
The manufacturer’s instructions for cleaning.
1. Manual cleaning process .
2. Automated cleaning process, and there two types:
To ensure the device is not damaged and is cleaned adequately.
Reusable medical device decontamination must be carried out in a
timely manner.
Are followed:
DEPENDS ON:
Washer Disinfectors.
Ultrasonic Cleaners.
RMD Sorted according to :
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17. Disassembly of RMD
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Open all reusable medical device box locks.
Place the medical devices in a mesh basket in a way
that ensures effective cleaning of the device.
Do not place reusable medical devices on top of
one another.
Arrange medical devices in an orderly fashion in
mesh trays so that all surfaces are exposed to the
cleaning action when using an automated cleaner.
Overloaded baskets will result in ineffective cleaning.

18. Disassembly of RMD
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If extra mesh baskets are required
for cleaning a device set,
in the extra basketsto identify the
set name and number.
Place heavy retractors and other
heavy medical devices on the
bottom or in a separate tray.
Place each jointed medical device in
the open position in the mesh basket.
a marker is placed

19. Disassembly of RMD
o Secure small and light items with
a hold down screen or by other
means, to ensure they are not
free to move around during the
cleaning process. Place scissors,
light-weight medical devices, and
microsurgical devices next.

20. Disassembly of RMD
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Receivers and gallipots (bowl-shaped items) must not be placed
over any other reusable medical devices, as they may cause
shadowing and interfere with the cleaning process .
Separate all sharp devices from general devices. This is to ensure
ease of identification for personnel assembling the devices after
cleaning, in order to prevent sharps injury.

21. Disassembly of RMD
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Open, flush and brush taps that do not come apart.
Stylets are used to unblock devices during use. Remove them, and
flush and brush the devices.
Open ratcheted devices for cleaning to ensure the box joints and
jaws are being cleaned thoroughly and all debris removed.
Dismantle any devices with valves, ports or multiple parts as far as
possible for cleaning, following manufacturer’s instructions.
For medical devices with one or more lumens (tubes), connect each
lumen to the appropriate flushing system provided for that purpose.
Ensure the tips of devices align and meet at the tip, and are not
hooked or snagged—items that are misaligned, damaged or worn
need to be sent for repair.

22. Camera Head Laying on top of Flex scope tip

23. As we have learned
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In other words--if the item can't be cleaned, it can't be
disinfected or sterilized .
cleaning is an essential prerequisite for all effective disinfection and
sterilization processes, as organic residue may prevent the
disinfectant or sterilant from contacting the surfaces of the item being
processed and may also bind and inactivate chemical disinfectants.
cleaning is the initial and most crucial step in breaking the chain of
disease transmission.

24. Summery of the Decontamination (Zone 1)
Q: So, how do I know I am choosing the right method
of decontamination for the devices I’m dealing with?
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Always remember—the appropriate level of decontamination will depend on the
body sites where the device will be used and the risk associated with the
procedure.
So for a device that enters the body, like surgical scissors, it is considered a
critical
risk and must be sterilized.
An endoscope, that comes in contact with intact skin or mucous membranes, is
considered a semi-critical risk, and a high level of disinfection is needed.
A blood pressure cuff that comes in contact with healthy skin, is considered non-
critical, and a good cleaning is needed.

25. Manual Cleaning
Day 2
Presented by Talal Albudayri

26. Manual Cleaning
Ø The use of manual cleaning methods for washing certain delicate or
complex devices, for example when:
Medical devices cannot be immersed in water ,power tools.
Medical devices have an operating temperature lower than is achieved in
automated washing.
Mechanical damage may result from the impact of the water jets or other items
in the load.
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27. IN Manual Cleaning
o Carefully wash and rinse these devices according to the
manufacturer’s instructions. Non-immersion manual cleaning
methods are appropriate for certain devices like electrical tools
that may be compromised by soaking in wet solutions.

28. Immersion Method Essential Requirements
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Always use brushes under water to avoid splashing and aerosols.
After cleaning
Place devices in
Sinkor a receptacle which will hold enough water and detergent to fully immerse the item
to be cleaned.
Detergentand a validated method of dispensing a measured quantity, following
manufacturers’ instructions for dilution and temperature of warm detergent solution.
Temperature controlin the wash and rinse sinks (usually <40C), thermostatic mixer
taps are preferred.
Brushesa selection of non-damaging brushes in a range of diameters and lengths for
cleaning both the external surfaces and The internal surfaces of devices. Single-use is
desirable,If not using single-use, there must be a protocol in place to decontaminate the
brushes at least daily.
, dry the manually washed devices.
a drying cabinet . W here a drying cabinet is not available use a clean,
disposable lint-free, absorbent wipe to dry the devices.

29. To ensure effective manual cleaning, follow written
procedures
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Specifically designed to clean RMD.
Household soap must never be used.
A mild detergent is preferred for manual cleaning (pH range 8.0–11.5).
Follow the
Fill the sink with water to a predetermined level, at the specified temperature and
with the appropriate amount of detergent .
It is recommended to use three sinks-washing, potable or tap water rinse, and
purified water rinse.
Use detergents:
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ü
manufacturer’s instructions and local policies and procedures for
detergent dilution and water TEMP.

30. The gloves IN each stage IT must be changed

31. THE STEPS
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o Inspect devices and equipment to establish that they are
clean before further processing or storage.
Immerse the item, carefully, in the solution in order to displace
trapped air—it is important to ensure that the cleaning solution
reaches all surfaces including those of lumened (tubed) devices.
Remove all visible soiling, including lumens and valves. Remove
stubborn staining by using inside non-abrasive scouring pad or
soaking in an approved stain-removing solution.
Dry mechanically in a drying cabinet or hand dry with a
clean, lint- free cloth and single use.
Note:items should not be left to dry in ambient air .
Flush all lumened devices with a jet-gun (discharge under
water to avoid splashing and aerosols).
Rinse the item finally in warm-to-hot water.
Ø

32. o
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Take special care when you are
rinsing your instruments.
Here's a note of caution:
If not rinsed properly, low pH detergents may
breakdown the stainless protective surface and
cause black staining. High pH detergents may cause
surface deposits of brown stains, which can
interfere
with the smooth operation of the instrument.
Ø
o A mild detergent is preferred for manual
cleaning (pH range 8.0–11.5).
THE STEPS

33. o
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Name of device or device set.
Name of processor.
Date.
Type of cleaning.
Type of detergent and detergent dilution used.
Keep a record of each device and device set that has been manually
cleaned. The records should contain, at a minimum:
§
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§
§
§
THE STEPS

34. Automated Cleaning
(Including Pre-Cleaning)
Day 2
Presented by Talal Albudayri

35. Automated Cleaning (Including Pre-Cleaning)
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As we have learned, cleaning is an essential prerequisite for all effective
disinfection and sterilization processes.
if the item can’t be cleaned, it can’t be disinfected or sterilized.
cleaning is the initial and most crucial step in breaking the chain of disease
transmission.
The advantage of using automated cleaning equipment is that it provides an
efficient, validated, reproducible process which is more easily controlled than
manual methods. always reproduces the same result.
Automated processes are generally more convenient and also provide
protection for the user in reducing exposure to contaminated devices and
chemicals.

36. o
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Ideally, manual cleaning
should be used only where
no pre-treatment has been
carried out by the user, and
gross soiling remains on
the device.
All soiling must be removed
before automated cleaning
takes place.
Automated Cleaning (Including Pre-Cleaning)

37. Washer-Disinfectors
o All washer-disinfectors used for
decontamination of reusable medical
devices conform to the medicines and
healthcare products regulatory
authority (MHRA) requirements, are
compliant with EU legislation and
have
CE Marking (Conformité Européene),
and are approved by the US Food and
Drug Administration (FDA) or an
equivalent competent authority.

38. Questions to consider when Determining if the Device
is Compatiaable with the washer-disinfector included
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What does the manufacturer’s IFU indicate?
Is it water submersible?
What is the maximum operating temperature?
Will mechanical damage occur from the impact of the water jets or other items in the load?
Is the device compatible with the process chemicals?

39. When ready to load the reusable medical devices there
are a few key points to note
4. Use the load carrier and racks for items they
were designed to hold.
1. Ensure the washer-disinfector and all
services are operational.
2. The washer-disinfector should not start if
any anomalies are present including blocked or
occluded spray arms.
3. Wearing PPE, load the rack or machine ensuring that
the arrangement of devices does not get in the way of the
cleaning process, and the rotary spray arms can rotate.

40. 6.Load the load carrier into the washer-disinfector.
7.Secure the door (if fitted), and select and
start the appropriate cycle.
8.When the cycle is done, make sure that all
stages and parameters have been achieved.
9.When the automated cleaning process is complete,
inspect the processed devices.
5.Keep a record of each device and device set processed
in each washer-disinfector, and each cycle in order to
trace them through the decontamination process.
When ready to load the reusable medical devices there
are a few key points to note

41. Phases of a Typical Cycle
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Drying –this phase purges the load and chamber with filtered heated air to remove
residual moisture.
Record information for each washer-disinfector cycle.
Cold flushing/pre-rinsing–chamber is filled with cold water (<40C), to prevent coagulation
of blood and protein, soil fixation-devices are rinsed to remove gross soil before the
chamber drains.
Warm washing –chamber fills again with warm fresh water plus detergent and is heated to
about 60C-this wash removes any remaining soil with the physical and chemical action of
detergent and again drains when completed.
Rinsing –chamber fills again, but this time with filtered or reverse osmosis (RO) water to
rinse and remove any chemical residues from the previous cleaning phase-in many washers
this phase is repeated a second time.
Disinfection –the chamber is filled for a final time again with filtered or RO water but this
time the temperature is raised to 80-93C and held for a predetermined time (usually 90C for
5 minutes) to ensure effective disinfection.

42. Documentation is required for every washer-disinfector
cycle and at a minimum should contain the following
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Operator’s name.
Date and time of start of cycle.
Washer-disinfector identification number Type of washer-
disinfector.
Type of cycle used.
Cycle number.
Load contents, for example: general device set, stitch set, mayo
scissors.
Critical parameters for the specific washer-disinfector cycle.
Results of washer-disinfector process.
Signature of a qualified person (decontamination) confirming
whether or not the process cycle was within recommended
parameters.
Any notes or observation for the process cycle.
Document aborted cycles in a log book, recording the reasons and
actions taken.

43. Ultrasonic Cleaners
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The Ultrasonic cleanser is used to
remove fine soil from surgical devices
after they have been manually cleaned
and before they are sterilized.
materials cannot be successfully
processed by this method:
Plastics and other similar materials.
Cemented glass syringes and lenses will
be damaged if repeatedly subjected to
this process.
Ø
Ø

44. General Guidelines
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Water temperature is usually <35C
Thermal disinfection option-temperatures between 80C -93C with holding time >20
seconds to 10 minutes.
Document, scan and record all cycles and processes—preferably using automated
track and trace systems
Follow the manufacturer’s IFUs and standard operating procedures (SOP) Older
machines - de-gas time is between 5 and 15 minutes (de-gas is the removal of air from
the water to allow the ultrasonic waves to pass more freely).
Cycle time depends on the machine, cycle program and how much soil is on the Medical
device.

45. How Ultrasonic cleaners Works?!
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o The high-frequency energy causes microscopic bubbles to form on the surface
of the devices and as the bubbles implode, minute vacuum areas are created,
drawing out the tiniest particles of debris from the crevices of the devices, This
process is called cavitation.
Converting high-frequency sound waves into mechanical vibrations that
free soil from the surface of devices.

46. How Ultrasonic cleaners Works?!

47. Thank you