Decontamination is an entry-level program for new entrants to the field of decontamination and sterilization in a hospital, dental or ambulatory clinic setting. In this module, we will discuss about reusable medical device reprocessing, the facilities required to carry out this function, and how the life cycle of a reusable medical device fits in.

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

2. Introduction to
decontamination
Project presentation
Overview of Central Service Supply Department
Talal Albudayri

3. Introduction
Decontamination is an entry-level program for new
entrants to the field of decontamination and sterilization in
a hospital, dental or ambulatory clinic setting.
In this module, we will discuss about reusable medical
device reprocessing, the facilities required to carry out
this function, and how the life cycle of a reusable medical
device fits in.

4. General overview of CSSD

5. I want to know what I am entering?...
What is CSSD?
Central Sterile Service Department
(CSSD) is a place in hospitals or
healthcare facilities that performs
reprocessing of reusable medical
devices used by health workers in the
operating room for surgical and
other patient procedures.
This department is sometimes called
the sterile processing department
(SPD), central supply department
(CSD) and central decontamination
unit (CDU). Any of these or other
variations will be referred to as
CSSD in this program
Manufacturing
Manufacturing is the term most
commonly applied to industrial
production, where raw materials are
transformed into finished goods on a
large scale. Cars, electronics, appliances,
and furniture are examples of items we
buy that are manufactured with
standards to ensure they are reliable and
safe for use. Most consumables we
purchase in supermarkets are also
manufactured, and need to be produced
in a consistent safe process to ensure no
harm to consumers. With RMD,
producing quality results is especially
important as they will be used on
patients with compromised health.

6. Medical Device Manufacturing
Medical devices are defined by
international regulatory bodies, such
as the US Food and Drug
Administration (FDA) and the
European Medical Devices Directive,
as any object or component used in
the diagnosis, treatment, prevention,
or cure of medical conditions or
diseases, or affects body structure or
function through means other than
chemical or metabolic reaction to
humans or animals.
This includes all medical tools,
excluding drugs, ranging from tongue
depressors, to surgical instruments
and radiology treatments.
Most medical procedures require
the use of medical supplies, surgical
instruments and equipment.
Some of these items are single use
and used once then discarded,
while many are designed for reuse.
RMD must be thoroughly cleaned,
disinfected, inspected, packaged
and sterilized before they can be
safely reused on another pati

7. Element
33.3%
Element
16.7%
Element
16.7%
Element
16.7%
Element
16.7%
In healthcare, CSSD is where the critical function of
reprocessing reusable medical devices occurs.
In a hospital setting, reusable medical devices and
surgical instruments are more commonly used than
disposable ones, as it is more cost effective and creates
less environmental waste.
This is especially true for surgical procedures in
operating rooms where 50 or more surgical instruments
are commonly used.

8. AAMI-Association for the Advancement
of Medical Instrumentation ST79-
Comprehensive guide of steam
sterilization and sterility assurance
WHO- world Health Organization
Decontamination and Reprocessing of
Medical Devices for Healthcare Facilities
IAHCSMM- International Association of
Healthcare Central Service Material
Management Technical Manual
CBSPD-Certification Board for Sterile Processing
and Distribution The Basics of Sterile Processing
AORN-Association of perioperative Registered
Nurses Recommended Practices for Cleaning and
Care of Surgical Instruments (HTM 01-01)
UK DH-Decontamination of Surgical Instruments
(HTM 01-01)
IE HSE-Ireland Health Service Executive Standards
and recommended practices for Central
Decontamination Units

9. There is such a wide variety of equipment classified as reusable medical
devices, that regulatory agencies have no single standard, but they do have
an international standard:
ISO 17664, that specifies what all manufacturers must do to create
procedures or Professional groups and associations use research and
evidence-based practice to define minimum standards used to help set
guidelines for standard practices and procedures for reusable medical device
reprocessing.
These and other similar professional bodies are used to ensure policies and
procedures will produce safe, high quality and reliable RMD.

10. I want Know why?
The Sterile Processing Department
What are some of the differences between a hospital and a hotel?
They both want a nice entrance, friendly and calming environments, and return visits.
They also have individual guest rooms with attached bathrooms.
The biggest difference is the role that sterile processing plays in the health of patients,
employees, and the building.
Without it, surgeries would be much more dangerous, with lasting debilitating results and effects.

11. What is the Value of the SPD in the Facility?
The Sterile Processing Department
The SPD plays an integral role within a healthcare facility by providing
sterile surgical instrumentation to the OR as well as all other areas that
require sterile goods.
The infection control practices within the department prevent the onset
and spread of infectious diseases such as HIV, Hepatitis A & B, TB, etc.
The SPD is the department within a healthcare facility that processes and
controls medical supplies, devices, and equipment, sterile and non-
sterile, for patient care areas of the facility. (Per AAMI, Association for the
Advancement of Medical Instrumentation)

12. Workflow of the Sterile Processing Department
The Sterile Processing Department
The shown 3-D diagram on the following slide is a
representation of a sterile processing department.
This example is a new trend in the U.S. market that has become
a standard in Europe. They divide each of the cleaning stages
into separate zones.
Typically in the United States we see the packing department
in the same area as the sterilization room. A fourth area that in
shown in this diagram is the sterile storage and staging area.
Here materials and instruments are pulled, packed, and
organized onto carts for specific scheduled operations.

13. Workflow of the Sterile Processing Department
Soiled Return Decontamination
Sterilization
Prep and Pack
Sterile
Storage
The Sterile Processing Department

14. Workflow of the Sterile Processing Department
The Sterile Processing Department
Note the separating walls for each of the above areas.
During the course of this presentation: A red floor will designate the
decontamination/dirty area. Blue will represent the prep/pack area and green will be for
sterilization and sterile storage.
In some of the larger hospitals in the U.S. a 3 zone department is
being established because of its uni-directional flow, cutting down on the possibility of
cross- contamination.
We are going to step through the SPD starting in the Disinfection
area.

15. Our Main Customer
1.Operating Room
2.Out Patient
Departments
3.Emergency Department
4. Wards
5.Dental Clinics
6.Respiratory Therapy
Department
7.Endoscopy Department
8. Pharmacy
9.Maternity Department

16. (For Contaminated Medical Devices)
End-User
CSSD
1.The essential requirements in treating the
instruments must strictly followed in the following
(AORN):
2. Must notify any contamination
of instruments needing strict and
extra precautions for handling
When transporting contaminated
items back to CSSD from the point
of use the following requirements
need to be reviewed and defined:
a.Pre cleaning
b.During the Procedure
c.Before transportation
d.Pre-cleaning
e. Transport
containers f. Spill kit
g.Transport carts
h. Handling

17. (For Sterilized Items)
End-User
CSSD
1.Verify the sterility of an item by Internal Chemical
Indicator
2.Notify CSSD for any wetness seen in the set of
instrument received
3.Participates in the Recall Process
4.Inform any Discrepancies related to:
Checklist
Missing instruments
Damages
5. Participates in Maintaining Sterile items
for Storage.
5.Ensures adequate dryness, Verifies Sterilizer Parameters and
External indicators before release of an item
6.Transport Contaminated items using covered cart/trolley
7.Send items using any transport methodology as per hospital
policy

18. Decontamination Life Cycle
The decontamination life cycle
model shows the critical steps
required for reprocessing reusable
medical devices, and the pathway
through the whole organization.
This model will be referenced
throughout this program, to details
how to safety meet standards and
keep patients safe.

22. Decontamination Design
Before the CSSD, the critical role of design, construction
and equipping of the zone areas were often neglected,
but are now recognized as significant factors in ensuring
safe practices in the reprocessing of RMD.
Ensuring a proper one-way flow is a key part of safe
reprocessing of reusable medical devices. Separating
dirty, clean, and sterile items avoids routes and workflows
that could re-contaminate processed reusable medical
devices.
In CSSD this is achieved by using walls to separate the
work areas into three primary functional zones.
Some building design resources are:
HBN 13-Health Building Note: Sterile
Services Department—Department of
Health UK AAMI-Building for the Future
AIA-Guidelines for Design and
Construction in Health Care Facilities

24. Automated Cleaning Manual Cleaning
Decontamination Cleaning & Drying
The washer disinfector renders its load (i.e.
washed goods, surgical instruments, etc.)
safe to handle
Disinfection and cleaning of non- critical
goods prevents hospital acquired infections
Staff safety-cleaning process takes place in
a closed chamber which means no risk for
splashes and thereby contamination
Correct drying after cleaning can easily be
arranged and integrated into the process
No automated disinfection of
instruments and utensils,
increases the risk of
contaminations and infections.
Contamination risk for staff due
to exposure to soil and liquids.
Wet goods may cause re-
contamination
The Sterile Processing Department

25. What is Prep & Pack?
Today most sterilizers can be found in the prep/pack room, but as
mentioned before, this trend is changing. You can think of this area
as being the ‘clean room’.
During a typical site visit, you as the visitor would ‘gown-up’ and
enter the prep/pack area first.
Why would this be?
The Sterile Processing Department

26. What is Prep & Pack?
They must check surfaces for:
Remaining soils, determine if the instrument is functioning properly – does it need sharpening? is it
bent? is it worn and needs to be replaced?
Insure that instrument sets and trays are assembled
Wrapped and placed into the sterilizers correctly
Catalogue and pull instruments
Track and trace instruments and setsVerify the sterilizers performed their cycles correctly each and
every time.

27. What is Prep & Pack?
The main reason is to eliminate the possibility of cross contamination.
If you were to enter via the ‘dirty’ decontamination door then into the
prep/pack the hospital runs the risk of you carrying a potential ‘bug’ with
you that could invade, attach, or contaminate a disinfected or sterilized
instrument.
The professionals in prep and pack must pay close attention to details. Each
instrument must be visually examined for quality.

28. Let’s ask these questions of ourselves:
1.If I have a splinter in my finger that needs to be removed and I light a match and hold
a needle in its flame for 10 seconds, is the needle sterilized?
2.No, the needle would contain trace amounts of residues/ash.
3.If I had a knife and used it to cut a cucumber, would the knife be sterilized if I dipped
it in rubbing alcohol for 30 second?
4.No, there would be bio-burden on the blade. – It must be clean to be sterilized
5.If I am standing in line at the local buffet and I pick up a clean hot plate from the plate
cart, is the plate sterilized?
6.No, and it may not be completely disinfected if you find food particles on it – like
melted cheese.
The Sterile Processing Department
What is Sterilization?

29. What is Sterilization?
The Sterile Processing Department
So what is sterilization?
Sterilization is the process used to render a product free from all forms of viable
micro- organisms (bacteria, spores, fungi, and viruses)
Sterilization is required because not all micro-organisms have been completely
destroyed during the decontamination process.
Within the SPD, the sterilization area is where sterilizers (steam, and/or low
temperature processes), are located including the space for loading, unloading, and
cooling. This can be accommodated by a two or three zone system.

30. What is Sterile Storage?
Sterile storage is the OR instrumentation and equipment
warehouse typically for the entire hospital.
If a product is disinfected and/or sterilized it will have a home in
this department or in another sterile storage location. Like a
warehouse, orders are packed and sent to other locations for
use on specific patients undergoing specific procedures.

31. Introduction to decontamination
Part 2
Overview of Central Service Supply Department

32. Introduction to
decontamination
part 2
Project presentation
Overview of Central Service Supply Department
Talal Albudayri

33. Decontamination Zone
Decontamination is the combination of processes (including cleaning,
disinfection and sterilization) used to render reusable medical devices
safe for handling by staff and for use on patients.
All reusable medical devices returned to the decontamination zone are
considered contaminated and potentially infected.
You, as a decontamination specialist, must have an in-depth knowledge
of microbiology, infection control and safe cleaning practices to ensure
safety for yourself and for patients.
Ideally this zone is defined by specific rooms or at minimum segregated
areas to ensure safety to staff and a unidirectional flow of reusable
medical devices

34. What is the Decontamination Process?
So what is decontamination?
Here is the definition as provided by OSHA:
“The use of physical or chemical means to remove, inactivate or
destroy blood borne pathogens on a surface or item to the point
where they are no longer capable of transmitting infectious particles
and the surface or item is safe for handling, use or disposal.”
(OSHA CFR 1910.1030)
The Sterile Processing Department

35. What is the Decontamination Process?
In the surgical environment hospitals must be very cognizant of all types of
contamination. This does not only include dust, lint, paint chips, metal shavings, hair,
but also microscopic soils that are invisible to the eye that can and will cause
infection in the surgical incision.
First are the organics, mainly comprised of blood, tissue, fats, feces, grease, and
proteins.
Second are the inorganics such as water deposits – lime, rust and types of scale. Each of
these can cause and infection in a surgical wound leading to more serious complications.
Therefore, what types of soils on surgical instrumentation are we
removing?
The Sterile Processing Department

36. Contaminated Returns Room—
provides outside staff with secure and
controlled access into the zone,
allowing delivery of contaminated
containers and trolleys
Gowning room—provides controlled
entry and exit to the wash area, space
for changing into PPE, a hand wash sink
for hand hygiene, and an eye wash
station in case of eye splash
Wash room—space to carry out
preparation, cleaning and
disinfection of contaminated
reusable medical devices
Environmental cleaner room—
dedicated to cleaning only the
decontamination room

37. With the wide variety of surgical
specialties and procedures, there is an
extensive range of complex reusable
medical devices being used.
In order to clean these specialized
reusable medical devices, processes and
appropriate tools are required such as:
• Hand wash sink– with liquid soap and
paper towels
• Instrument cleaning sink— with two
or three basins
• Brushes
• Air guns
• Water guns
To ensure safety and prevent
exposure to pathogens and other
contaminants, decontamination
specialists must wear personal
protective equipment such as:
• Cover gown with sleeves
• Face mask
• Eye protection
• Gloves
• Shoe covers or alternative shoes or
boots
• Head cover

38. • Magnifiers
• Additional lighting
• Detergents
• Disinfectants
• Lubricants
• Ultrasonic washers
• Automated washer disinfectors
• Cart washer
• Automated endoscope re-processer
• Environmental monitors—
temperature, humidity and pressure
• Spill kits

39. In the decontamination zone:
• PPE is worn to ensure specialist safety
• Reusable medical devices received are checked for missing parts,
manually pre-cleaned and prepared for automated washing
• Reusable medical devices not compatible with automated
washers are manually cleaned and disinfected

40. What is the Purpose of an Ultrasonic Cleaner?
The next basin is the rinse
sink… Ultrasonic
For instruments that are heavily covered
in bio burden or have hard to clean
surfaces an ultrasonic cleaner is used.
This machine creates vibration or
cavitation waves that shear soils from
instruments. An example of a hard to
clean instrument would be a reamer, due
to its sharp fluted surfaces.
Equipment, Design Layout and Workflow for Decontamination

41. What is the Purpose of an Ultrasonic Cleaner?
Ultrasonic is a type of specialized unit that is used
to remove debris from difficult to reach areas of
surgical instruments such as box locks, and
serrations.
Instruments are submersed in a liquid detergent
bath.
The passage of Ultrasonic waves cause cavitations
(vibration).
The vibrations create mechanical energy which
removes debris from the surfaces.
The detergent traps the loose debris from settling
on
the instruments.
Equipment, Design Layout and Workflow for Decontamination

42. The washer-disinfectors effectively cleans, thermally
disinfects, and dries moisture from temperature stable
utensils, surgical instruments, anesthesia materials and
glassware prior to any necessary sterilization.
What do we mean when we say thermal disinfection? What is
the
boiling point of water?
We know that water boils at 212 degrees F at sea level.
We also know that when we say boil it also means water is
turning into steam.
At these extreme temperatures most organic organism will
meet
their demise. So when we say thermal disinfection we are
speaking about the temperature and exposure time these
organisms have in the water.
What Does a Washer-Disinfector Accomplish?
Equipment, Design Layout and Workflow for Decontamination

43. What Does a Washer-Disinfector Accomplish?
What about drying? What does ‘bone dry’ mean in the SPD environment?
Death Valley is a very hot place. Almost all forms of life would have an extremely hard
time surviving there for any long duration of time. Just as an oak tree transplanted
from North Carolina to the desert would not survive, the same can be said of a micro
organism in a high temperature dryer. Heat and high temperatures kill them off.
One way to determine the effectiveness of a washer disinfector is to submit it to a
TOSI
(Test Object Surgical Instrument) test. A description of the test sample is described
below.
A ‘test soil’ is engineered to have the same attributes as human blood. Blood has
many properties that make it adhere to surfaces. This makes it a good test media for
determining the washers effectiveness. cont…

44. Contents
Inspection
Assembly
Packaging
(IAP)
zone

45. After cleaning and disinfection, reusable medical devices are received in
the Inspection, Assembly and Packaging zone to prepare for
sterilization.
Reusable medical devices are now safe for handling and extra care must
be taken to ensure that they are not re-contaminated. Strict hand
hygiene must be maintained and personal protective
equipment must be used at all times.
Ideally this zone is defined by specific rooms or at minimum segregated
areas to ensure safety to staff and ensure a unidirectional flow.

46. Identified rooms
Inspection, assembly and packing (IAP)
room — this room is restricted only to
specialists who inspect, assemble and
package cleaned RMD to prepare for
sterilization. Sterilizers are frequently
located in this room.
Gowning room— provides controlled
entry and exit to the IAP zone, allows for
changing into personal protective
equipment, and a hand wash sink for hand
hygiene to protect clean instrumentation
from the risk of contamination
Materials transfer room- maintains
an air-lock to bring raw materials in
and out of the IAP zone
Environmental cleaner room-
dedicated to cleaning materials and
equipment for use only in the IAP
zone
Sterilization room— in newer CSSD
designs sterilization equipment is
located in a room separate from IAP
and Storage to further reduce
contamination risks to unwrapped
RMD

47. The extensive range of complex instrumentation
requires specialized processes and appropriate tools
for inspection and packing such as:
• Packing tables
• Chairs
• Magnifiers
• Additional task lighting
• Wrappers and containers
• View pack pouches
In the Inspection, Assembly and Packaging
zone, surgical instruments are unloaded from
automated washers or pass through hatches
(if manually cleaned) and:
• Visually checked to ensure cleanliness
• Manually inspected against a checklist to
ensure items are correct and functional
• Packaged in appropriate materials and
labelled
• Sterilized with the correct process or passed
to a sterilization room if separate from IAP

48. The extensive range of complex instrumentation requires
specialized processes and appropriate tools for
inspection and packing such as:
• Surgical instrument tip protectors
• Tray liners
• Air guns
• Pass through hatchs
• Drying cabinets
• Sterilizers—high temperature
• Sterilizers—low temperature
• Biological incubators
• Environmental monitors
temperature, humidity and pressure

49. Return
Conveyor
Pass Thru Window Prep and
Pack Tables
Steam Sterilizers
RO
Water
System
Good Work Flow for Prep, Pack, and Sterilization

50. Used for the sorting, inspection, and packaging of decontaminated
goods prior to sterilization.
Task lights, monitors, instrument tracking system, sterile wrap, heat
shrink units, etc.
What is the Use and What Would I Find on a Prep and Pack Table?

51. What is a Pass Through Window Used For?
A pass through window is used to move
clean items into prep and pack area and
items that need to be reprocessed back
to decontaminated area.
Equipment, Design Layout and Workflow for Prep, Pack and Sterilization

52. Contents
Sterilization
Sterilization
Sterilization
Sterilization

53. What Does a Sterilizer Achieve?
Sterilization is the process used to destroy all remaining
microbial life.
The sterilizing agent can be steam, plasma, ozone, EO Gas, or
other low temperature solutions.
Steam is the most widely used and cost effective solution, and
typical applications include wrapped and unwrapped, porous
and non-porous hard goods, towel packs, and liquids.
Low temperature sterilizers are used
with temperature sensitive goods.

54. What Does a Sterilizer Achieve?
How do we know if the sterilizer is killing microbial life?
Sterilizers kill the remaining microbial life left on surgical instruments.
How do we know if the sterilizer is working properly?
Biological indicators monitor the effectiveness of the steam sterilization process.
Sterilizers are tested using a Bowie-Dick test. A Bowie-Dick tests for air leaks, inadequate air
removal and steam penetration for vacuum-assisted steam sterilizers.

55. What Does a Sterilizer Achieve?
How do we know if a pack has been sterilized?
Once an item has been sterilized it is considered 100% free of
organics and inorganics.
Remember, it must be clean first to be sterilized! An
unclean item can not be sterilized.
Chemical indicator tape gives the sterilizer operator assurance that each pack
or item has been exposed to the sterilization process. Hatch marks on the tape
turn black when exposed at the correct temperature and time in a sterilizer.

56. Sterile Storage Zone
CSSD requires a safe storage zone for sterile and clean supplies used in
production.
Sterile reusable medical devices are packaged, and stored safely in an
environmentally monitored (temperature, humidity and pressure) room using:
• Washable, round-edged shelving designed to avoid damage to packaging
• Transport carts
• Workstations
In the Sterile Storage zone processed reusable medical devices are:
• Transferred from the sterilizer to this room where they will either be kept
until required or staged for end-user delivery
• Removed from shipping boxes and containers before being transferred
here for storage or staged for end-user delivery

57. Sterile storage

58. Contents
Sterile
Storage
Sterile
Storage

59. The area of the healthcare facility designed to store clean and
sterile items before their selection and distribution for use in
procedures (AAMI).
Includes items supplied from SPD as well as pre-packed clean/sterile
items from outside vendors.
You would find instrument tracking, sterile storage carts, racks,
case carts, and shelving systems in this area.
Many hospitals require a positive airflow from sterile storage out
into other areas. This provides more assurance that the temperature
and humidity stay constant within the sterile storage room.
What is Sterile Storage?

60. What Do I Need to Know About Sterile Storage?
It should be located near a dock for the receiving of materials.
Consideration of elevator placement for best material flow efficiency.
Proper square footage must be allocated for storage and material break-out.
Sufficient space allocation for instrument tracking system.
Equipment, Design Layout and Workflow for Sterile Storage

61. Additional CSSD Support Areas
The CSSD is segregated into three primary zones and additional areas are required to support the safety of
specialists and surgical instruments.
Staff Facilities—Changing, Toilets, and Showers
• Male and female toilets and areas to change
from outdoor to working clothing
• Lockers to accommodate storage of specialist
belongings
• Showers located close to the decontamination
area to ensure quick access in case of a
workplace spill or contamination incident
• Hand hygiene station
• Mirrors to check PPE
Staff Rest Room
• Facilities to prepare hot and cold drinks for
staff breaks • Area for eating and drinking
(restricted to this area)
Materials Storage
• Separate segregated area for bulk storing of
production materials
• Sufficient stock levels of materials to ensure
smooth operations
• Not used to store sterile processed items
Education, Training and Meeting Rooms
• Separate from the work area and provides
space for teaching materials and work samples
• Support for important regular training and
education for all grades of staff
Central Detergent Dosing Room
• Adjacent room for detergent replacement
without entering the contaminated area,
reducing the opportunity for automated
washer contamination

62. General CSSD Requirements
The unit is used exclusively for reprocessing reusable medical devices, must be physically
separated from other work areas and never used as a thoroughfare to other units.
Unit Access. Due to the critical nature of this
unit, access is restricted to authorized
personnel and trained specialists.
Lighting The light is kept at a brightness and
color balance for good working practices and
visual examination of reusable medical devices.
Additional task lighting and magnification are
available in decontamination and IAP areas.
Temperature Room temperature is controlled
between 18–25°C (64–77°F) and kept at a
relative humidity of 30–60% depending on
the activities carried out in the area.
Air Pressure Air pressure is regulated to
prevent cross contamination of airborne
pathogens between each zone.
A ventilation system is used to either exhaust
air out of a room, creating negative air
pressure, or vent air into the room, creating
positive air
pressure.
Work Surfaces
• Walls are smooth, non-shedding, water
resistant and withstand frequent cleaning.
• Floors are a washable non-slip material and
have no exposed seams or openings.
• All tables, workstations and shelving are
made of easily cleanable materials with non-
glare surfaces. Adequate spacing allows for
staff and equipment movement.

64. Thanks
CSSD Telegram channel
Talal Albudayri