CSSD practices at Tata Medical Center, Kolkata

1

A standard workflow practice in a Central Sterile
Supply Department (TATA MEDICAL CENTER, KOLKATA)
https//tmckolkata.com/tmc/vision-tmc/infection-
control/ http//www.web.tmckolkata.com/page.php?pi
d4page_id96
2
History of healthcare sterilization
Joseph Lister (18271912) 1865 phenol (carbolic
acid) as bactericide
Ignaz Semmelweis (18181865) realized the
importance of cleaning hands before surgery
First container for steam sterilization Schimmel
busch-Drum developed by Surgeon Curt
Schimmelbusch (18601895)
Louis Pasteur (18221895) Micro-organisms
cannot emerge de novo. Discovered hot water as
good disinfecting agent.
Robert Koch (18431910) Scientific findings
about micro-organisms, causing illnesses in the
1880s. Development of steam sterilization
processes.
3
CSSD in India

• Safdarjung Hospital, New Delhi inaugurated their
  first CSSD in India in
• the year 1957
• Joslok Hospital in Mumbai starts CSSD operations
  in the year 1973
• In Kolkata, First CSSD in Kothari Medical Center
  in the year 1986-87
• CSSD functioning starts at Tata Medical Center,
  Kolkata in the year
• 2011 in 1st phase Hospital Building

4
Why C.S.S.D is required in a hospital

• Today more and more infectious diseases form a
  serious threat to peoples health.
• In olden days, the work of Sterilization was
  carried out in the Operation Theatre, with the
  help of sterilizers which were fitted in the OT
  itself.
• Many units had their own sterilizers.
• Due to concentrating on other work, the practice
  of Sterilization was neglected. Items were left
  in the sterilizer for longer periods of time and
  thus damaged by overheating, or kept for a
  shorter time and not properly sterilized
  resulting in the risk of infection.
• The operation of the Sterilizer was everyones
  business but no ones responsibility.
• Recommendation of NABH about CSSD in every
  hospital.

5
C.S.S.D Planning

• PHYSICAL PLANNING
• FUNCTIONAL PLANNING
• PERSONNEL PLANNING
• EQUIPMENT PLANNING
• FINANCIAL PLANNING
• QUALITY CONTROL
• PREVENTIVE MAINTENANCE

6
Objective of a CSSD in a healthcare institution

• The sterilized items should be reached to the
  user area at
• RIGHT TIME
• RIGHT PLACE
• RIGHT CONDITION

7
Design and Infrastructure

• Central Sterile Supply Department
• (Tata Medical Center)

8
Unidirectional layout (O.R and CSSD) (Red arrow
shows the unidirectional workflow inside CSSD)
(ST79, section 3.2.3)
RAW MATERIAL STORE
9
C.S.S.D area separation(Soil area ¼, Processing
area 2/4 , Sterile storage ¼)

• MAJOR AREAS 75 of total area
• Decontamination room (-ve pressure) (light
  required 500 lux)
• Preparation room (ve pressure) (light required
  1000 lux)
• Linen packing room (-ve pressure) (light required
  500 lux)
• Clean storage room (ve pressure) (light required
  300 lux)
• Support areas 25 of total area
• 1) C.S.S.D Officers room
• 2) Meeting room
• 3) Consumable store
• 4) Dress changing room with toilet facility

10
Size of different zone in TMC-CSSD Ratio
1hospital bed 10 Sq ft CSSD area
Sl. No Room Number Name of the zone L (ft) B (ft) Area (Sq. Ft.)
1 HL-206 Decontamination zone 1710 146 258.58
2 HL-207 CSSD Raw Material Store 185 98 178.03
3 HL-208 Packaging zone 34 302 1025.67
4 HL-209 Trolley Wash zone 10 6 60.00
5 HL-210 CSSD In-charge zone 610 64 43.28
6 HL-211 Linen zone 15 103 153.75
7 HL-212 Sterile zone 297 2510 764.24
8 HL-213 Changing zone 127 74 92.28
9 HL-214 CSSD Office 127 98 121.64
11
TOTAL CSSD EQUIPMENTS
SL .NO. NAME OF EQUIPMENTS QTY
1 TIVA-700 WASHER DISINFECTOR (TUTTNAUER) 2
2 DUAL CHAMBER ULTRASONIC RINSER (SONICLEAN) 1
3 D-500 DRYING CABINET (STERIDIUM) 1
4 ROTARY HEAT SEALER (GETINGE) 2
5 T-MAX8 STEAM STERILIZER (TUTTNAUER) 2
6 5075 HSG STEAM STERILIZER (TUTTNAUER) 1
7 STERIVAC-8XL ETHYLENE OXIDE STERILIZER (3M) 1
8 STERRAD 100S PLASMA STERILIZER (JOHNSON JOHNSON) 1
12
Control air flow in controlled environment(ST79,
section 3.3.6.4)

• Work and Material Dirty to Clean

• Air Clean to Dirty

• Pressure Positive to Negative

13
Essential requirements of CSSD

• Water quality R/O or DM-TDS 70 ppm
• Double R/O- TDS
  2-3 ppm
• Water pressure Minimum 4Kgs/cm2
• Electricity Uniformly or otherwise UPS
• Compressed Air quality Free from moisture
• Compressed Air pressure Minimum 5-7 Kgs/cm2

14
CSSD flooring(ST79, section 3.3.6.1)

• Floor
• Floors should be made in such a way that should
  facilitate easy cleaning
• Floors may be epoxy coated or vinyl flooring
• No such cracks and crevices on the floor that
  can accumulate dust
• Joints of floors and walls should be curved for
  maintaining better cleaning procedure

Epoxy flooring
15
CSSD ceiling and walls(ST79, section 3.3.6.2)

• Ceiling Wall
• Ceiling and wall should be made in such a way
  that should facilitate easy cleaning
• For ceiling, avoid gypsum board that can hold
  moisture
• Ceiling should be made up with stainless steel or
  aluminum based materials
• CSSD walls should be tiled for better cleaning
  procedure (except sterile storage area which is
  anti-fungal painting)

Ceiling Wall
16
Access control system for traffic
controlling(ST79, section 8.9.2)

• All CSSD doors should be access controlled
• Unauthorized entry should be restricted
• Wear clean cloths and slippers and use
  appropriate PPEs while entering inside the CSSD
  premises.
• CSSD should be far away from normal traffic area.

17
Staffing/Qualification/Experience Ratio 20
hospital bed 1 CSSD manpower
Sl. No. Designation Number Qualification Experience
1 Scientific Officer 1 Graduate or Master degree 5Yrs
2 Sr. Technologist (Graduate) 1 Graduate 3Yrs
3 Technologist 6 HS or Graduate 3Yr
4 Attendant Housekeeping (Out Sourced) 44 HS or Graduate Fresher
18
Standard work practices

• Central Sterile Supply Department
• (Tata Medical Center)

19
WORK FLOW
A reprocessing unit has some different functional
areas which serve a unique role.

20
DECONTAMINATION AREA
Equipments Accessories

• Accessories
• PPEs
• Washing Brushes
• Wire Mesh Baskets
• Cleaning Disinfection agents
• Loading carts for baskets
• Haz-Mat Cabinets
• Stainless Steel Furniture
• Jet Attachments
• Hand Wash Basins, soap, paper towels

• Equipments
• Washer Disinfector
• Ultrasonic Cleaner
• Disinfection Tank
• Air Water Jet Gun
• Wash basin with rotable tap
• Computer with barcode scanner

• Key Functions
• Receiving
• Disassembling Sorting
• Cleaning
• Disinfection
• Quality Control

21
Surgical instruments handover system(ST79,
section 7.2.1, 7.4.1)

• Instruments are primarily cleaned in user area
  and then transport to C.S.S.D by covering them.
• First distinguish set and separate instruments
  and then count the instrument as per checklist.
• Check the tip of sharp items like (Probe, Skin
  hook, Cats paw etc)
• Disassembled all the parts of the instruments for
  better cleaning
• Keep heavier and lighter instruments in different
  wire mesh baskets. Handling sharp instruments
  carefully.
• Powered instruments should be wiped, not to soak
  in solution directly.
• After proper handover ,followed by signing for
  authorization.

22
Decontamination(ST79, section 7.2.1, 7.4.1)

• Decontamination is a physical or chemical process
  to remove, inactivate , kill or destroy of
  pathogenic microorganism in an object, where they
  are unable to transmitting infection and the
  object will be safe for use or disposal.
• It breaks the chain of cross infection between
  patient to patient or patient to co-worker.
• Decontamination process always starts at the
  point of use (From user area)

23
Purpose of cleaning(ST79, section 7.5.3.1 and
7.5.3.3)

• In healthcare facilities, cleaning consists of
  the removal from any kind of soil (ex blood,
  protein or other debris) from the surfaces,
  crevices, serrations, joints, and lumens of
  instruments by a manual or mechanical process
  that prepares the items for safe handling or
  further decontamination.
• 
  1)Manual Cleaning
• 2)
  Mechanical Cleaning
• Ultrasonic Cleaning
  Washer Disinfector
• Proper cleaning can reduce 90 of the total
  bio-burden on an object
• Ideal Disinfection or Sterilization process
  cannot be possible without proper cleaning.

24
Manual cleaning(ST79, section 7.5.3.1 and
7.5.3.3)

• Keeping instruments wet after use (by mineral
  free sterile water) because body fluids
  polymerize on surface when getting dry.
• Manual cleaning is required before mechanical
  cleaning.
• Open the all lock/joints s of surgical
  instruments first before cleaning.
• Soaking in enzymatic solution (pH 7-8) at-least
  for 5-10 minutes.
• Water temperature for manual cleaning not more
  than 30c.
• Soft bristle nylon brush is required to clean
  instrument jaws, ratchet, grooves or hollow
  devices.
• Washer and Air jet gun is required for hollow
  instruments cleaning and drying purposes.

25
Mechanical cleaning by Sonic cleaner(ST79,
section 7.5.3.1 and 7.5.3.3)

• Vibration with frequency greater than sound
• Gas bubbles develop, large and implode
• All debris comes out from microsurgical items
  through vibration.
• Loading with wire mesh basket for better
  vibrating effect. Max weight 3kgs.
• Temperature required 50c
• Time required 10-15 minutes
• Detergent pH value Neutral or Slightly Alkaline

Mechanical Testing
26
TMC-CSSD Cleaning and Disinfecting agents(ST79,
section 7.5.2)
Sl. No Name of the Agent Usage Picture
1 Neodisher LM2 Cleaning (For Ultrasonic)
2 Neodisher IR Rust Cleaner
3 Neodisher FA Alkaline (For W/D)
4 Neodisher N Acidic (For W/D)
Sl. No Name of the Agent Usage Picture
5 Enzymatic Enzymatic Cleaner (For manual cleaning)
6 Perasafe (DuPont) High Level Disinfectant
7 Bacillol-25 (Raman Weil) Disinfectant
27
Disinfection(ST79, section 7.6.2 and 7.6.3)

• Destruction of pathogenic, and other
  microorganisms by thermal or chemical processes
• Disinfection destroys most recognized pathogenic
  microorganisms but not necessarily all bacterial
  spore
• Disinfection as described in this topic relates
  to its use for decontamination purposes only
  not terminal processing that is performed just
  prior to patient use

28
Washer Disinfector(ST79, section 7.5.4)

• At least 3 stages are required for disinfection
• (Pre rinse- Intermediate rinse- Final
  rinse) followed by drying.
• A good water pressure is required for cleaning
  processes. Maximum weight 10 kgs as per IFU.
• Minimum two dosimeter required
• 1)Alkaline detergent
• 2)Acidic detergent(Neutralizer)
• Temperature rise up to 90c and hold for 2-3
  minutes for disinfection
• Cleaning indicator should be used daily for
  checking effectiveness of Washer Disinfector

29
Cleaning Parameters(EN ISO 15883-5)

• 1) Time
• 2) Mechanical action
• 3)Chemical concentration
• 4)Temperature

30
Typical Washer-Disinfector system (ST79, section
7.5.4)
31
Hand wash and eye wash station in Soil
zone(ST79, section 3.3.6.8)
32
Cleaning and Disinfection monitoring

• Central Sterile Supply Department
• (Tata Medical Center)

33
Washer Disinfector Printout(ST79, section 10.2)

• Printout is required for documentation purpose
• Each steps has been clearly mentioned
• Overlapping (Step jump) can be avoided.

Washer Disinfector Print out
34
Quality monitoring system for mechanical
cleaning(ISO 15883-5) and (ST79, section 10.2)
Foil test for Ultrasonic cleaner
Soil test for Washer Disinfector
35
ATP test for monitoring cleaning efficacy (ISO
15883-5) and (ST79, section D)

• Dedicated swab used on the tested sample.
• Then keep the swab into the test tube containing
  luciferase enzyme.
• Shake well for 30 seconds
• Use luminometer for result
• 150 RLU is pass and gt150 RLU is fail
• Use computer and dedicated software for
  preserving the documents.

36
Monitoring water quality

• Central Sterile Supply Department
• (Tata Medical Center)

37
Tools for water quality monitoring
Water TDS- total dissolved salt- Conductivity
meter CSSD targetlt10 mg/L Source Aesculap
Water chlorine level- Colorimeter O-toluidine/
Electronic Target 0.2-0.5 ppm Ref WHO
Water microbiology Membrane filtration Target Col
iforms- 0/100 ml Pseudomonas- 0/100 mL Ref WHO,
HPA (UK)
38
CSSD water quality monitoring

• Water pressure 4Kg/cm2
• Residual chlorine 0.05 PPM
• TDS 5-10 PPM
• pH test 7-8
• Microbiology test Every month
• Appearance Colorless, clean, without sediment
• Periodically cleaning or changing the filters for
  better purification.

39
Water pH label test (weekly)
40
Chemical and Microbiological test of CSSD
water(According to WHO)
Sr. No. Location TDS of water Chlorine content in water (ppm) Test result Day 1 Test result Day 2 Test result Day 3 Staining result Gram stain
1 CSSD wash sink (R-O water) - left 50ppm 0.26ppm 2 CFU 2 CFU 2 CFU Gram-positive cocci in pairs and short chains
2 CSSD wash sink (Electro de-ionized water) - right 5ppm 0.07ppm NG NG NG NA
41
PACKAGING AREA
Equipments Accessories

• Key Functions
• Drying
• Assembling, Lubricating
• Checking
• Packaging
• Loading
• Sterilization
• Quality Control

• Accessories
• Packaging Materials (SMMS, Flat Reels, Pouch
  Pack)
• Quality monitoring kit (Physical, Chemical
  Biological)
• Instrument Lubricant
• Stainless Steel Furniture
• Sterilizer Loading Trolleys
• Loading Baskets
• Instrument Baskets

• Equipments
• Drying Cabinets
• Rotary Sealers
• Magnifying Lamp
• Steam Sterilizer
• Gas Sterilizer
• Plasma Sterilizer
• Computer system
• Barcode scaner/printer

42
Thermal Drying Cabinet(ST79, section 8.4.3)

• A type of hot air oven.
• Depending on a heater and a blower system
• A HEPA type filter system is there for air
  purification
• Temperature rise up-to 90c
• This is also a thermal disinfection system.

43
Surgical Instrument Sorting Inspection(ST79,
section 8.4.3)

• After thermal drying instruments should be
  cooled down before thorough checking. This
  include sharpness, cracks, blood stain and
  breakage or tilted
• Open the instruments as much as possible for
  lubrication.
• A computerized check list is required for every
  set for surgical instrumentation.
• One chemical indicator should be placed inside
  the every surgical set for sterility assurance.

44
Instrument Lubrication(ST79, section 7.5.6) (EN
ISO 17665)

• Characteristics
• Water soluble
• Anti corrosion
• Sterilant permeable
• Silicon free
• Contain Paraffinic oil 2 and Propane and Butane
  70 (Used as propellant gas)

45
Instrument checking with printed check
list(ST79, section 8.4.3)
46
Rotary sealer

• Temperature for polypropylene pouches- 180c
• Temperature for polyethylene pouches-120c
• All instrument locks should be open while sealing
• Seal thickness should be min 10 mm
• Not too tight packing that can affect seal
  integrity.
• Not too loose packing because more air can trap
  inside and problem during vacuuming.
• Labeling should be on plastic side only.
• Seal check indicator or methylene blue test
  should be performed for checking effectiveness of
  sealer.

47
TYPES OF INSTRUMENT BASKETS USED IN TMC-CSSD
WAGNER THERMOLOCK RIGID CONTAINER AND STORZ
STEEL SHOCK PROOF BOX

48
PACKAGING MATERIALS (ST79, section 8.3.1 and
8.3.2)
Sl. No Packaging Materials Picture
1 SMMS Wrappers
2 Flat Reels / Peel Pouch
3 Tyvek Rolls for Sterrad
49
Characteristics of medical grade
wrappers(ST79, section 8.3.1 and 8.3.2)

• Excellent microbial barrier quality (98
  assurance)
• Lint free
• Tensile strength
• Water repellent
• Neutral PH value
• Chloride and Phosphate free
• Antistatic
• Light weight
• Free from toxic and heavy materials
• Superior durability
• Excellent porosity
• Chemical resistance
• Withstand physical condition(Temp, Moisture,
  Pressure, Vacuum)

50
Ready Pack For Sterilization(ST79, section 8.3.6)

• Packaging system as per international guideline
• Instrument set maximum weight 12.5 kgs
• Basin pack weight 3 kgs
• Use locking indicator as a external chemical
  indicator
• Affix batch label for sterility assurance.
• Affix barcode label for set tracking purposes.

51
Re-usable linen packing system

• Inspect linen for holes, any tears, stains and
  adhesive
• Linen should be laundered prior to sterilize
• All linens should be packed aseptically
• Crisscross pack is required to avoid dense mass
• Weight should not be more than 5.5kgs
• Pack size should not be more than 12x12x20)
• Composition 70 cotton and 30 polyester
• Daily documentation for laundered linen, packed
  linen and returned linen.

52
Weight of a reusable linen drape in TMC-CSSD
53
Scanning before sterilization(ST79, section
10.5.1)

• Benefits
• Physical monitoring system
• Stored data up-to 200 cycle
• If cycle abort then all data of this cycle has
  been cancelled
• Long time data preservation
• Result No false documentation

These boxes are now ready for Sterilization
54
Sterilizer loading(ST79, section 8.5)

• Loading technique
• Avoid overloading, items never touch with chamber
  wall.
• Basin separate items should be placed on edge.
• In case of mix load linen on top and sets are
  bottom to avoid condensation.
• Maximum weight of sterilizer cart should not
  exceed 100 kgs for 8 STU sterilizer.

55
Sterilizer unloading(ST79, section 8.8.1)

• Unloading technique
• Always wear PPEs at the time of unloading
• After complete sterilization, keep items
  at-least 10 minutes inside the chamber to
  acclimatize with room temperature.
• Trolleys should be clean and dry.
• Check the integrity of the packing materials
  before keeping on the shelf.
• Labeling should be checked while unloading.

56
Sterilization (EN 556)

• Process to kill all types of vegetative or
  pathogenic microorganism including bacterial
  spore.
• In-capsulated spore never kill at 100c and
  required more pressure or temperature to destroy
  the microorganisms.
• Modern definitions of goods declared sterile do
  not indicate the absolute absence of biological
  activity, but determine aseptic conditions with a
  certain probability, called Sterility Assurance
  Level (SAL), which is lt 10-6 according to EN 554

57
Types of healthcare sterilization

• Thermal sterilization
• a) Moist Heat sterilization (100 dry
  saturated steam)
• b) Dry heat sterilization (Dry steam)
• Low Temperature Gas Sterilization
• a)EO Sterilization (100 EO gas)
• b)H2O2 gas (Plasma) Sterilization (60
  concentration)

58
Basic Steam Sterilizer

• 
  

Steam to Jacket
Steam to Chamber
JACKET
Front side
CHAMBER
Rear side
Drain Strainer
Thermostatic Trap
16
59
Steam sterilizers (EN 285)

• Parameters (ST79, section 8.6.1)
• Staved Value for Autoclave
• Temperature 121c and 134c
• Pressure 1.1bar and 2.2bar
• Time 20mins and 4mins
• Steam quality 97 dry and 3 moisture
• Phase
• Pre-vacuum (Vacuum Pulsing
  Heating)
• Sterilization (Heat up time
  Kill time Safety factor as per BI)
• Post-vacuum (Exhaust Final
  drying)
• Destroyed microorganisms by Oxidation,
  coagulation and
  denaturalization of protein

60
Gravity and Pre-vacuum Steam Sterilization cycle

• Gravity Cycle white, Pre-vacuum Cycle black

38
61
ETO Sterilizer (EN ISO 11135)

• No stated value for EO
• (ST79, section 8.6.1)
• Exposure time - 1hr to 3hrs
• Sterilization temparature
• (37C and 55C)
• Relative humidity60
• Gas concentration 100 EO
• Aeration -- 10 HRS
• Total cycle time -12 to 14 hours
• Destroyed microorganisms by Alkilation method

62
EO sterilizer cycle
63
Gas Plasma Sterilizer

• No stated value for H2O2
• (ST79, section 8.6.1)
• Sterilization temperature (50C)
• Relative humidity60
• Gas concentration 58
• Total cycle time -1 hr
• Destroyed microorganisms by Oxidation process

64
(No Transcript)
65
Types of materials sterilized in C.S.S.D
Steam Sterilizer ETO Sterilizer Plasma Sterilizer
Stainless Steel Instruments All types of plastic, rubber items All types of plastic, rubber items
Utensils made of Stainless steel Stainless Steel Instruments All stainless steel Instruments
All kinds of dressing materials Long luminal devices based on steel, rubber, plastics Lumen device bigger than 2mm diameter smaller than 1mt length
All types of heat resistance luminal instruments Any types of papers
Silicon or Rubber based materials
Re- usable Linen
Liquid (Water)
66
Sterilization monitoring

• Central Sterile Supply Department
• (Tata Medical Center)

67
Physical monitoring system (ST79, section 10.5.1)

• Print out system
• Inbuilt gauze glass
• Program linked control
• Software programming
• (Graphical presentation)
• Data can be transferred through USB port

68
Chemical indicators for sterilizers(EN 11140-1)

• Class 1 Expose control tape and batch monitoring
  label
• Class 2
• a) Bowie-Dick test pack
• b) Hollow PCD (Bowie-Dick simulation system,
  Batch monitoring system)
• Class 3 Single parameter indicator
• Class 4 Multi variable Indicator
• Class 5 Integrating indicator
• Class 6 Emulating indicator

69
Biological indicators for sterilizers(EN 11138
series)

• Non-pathogenic bacterial spore strips
• Most resistance in specific sterilization
  processes
• Used in hollow PCD for hollow penetration
  challenges

70
Daily equipment monitoring system (ST79, section
10.5.1)
PHYSICAL (Frequency) CHEMICAL (Frequency) BIOLOGICAL (Frequency) PCD/ OTHERS (Frequency)
Decontamination With Ultrasonic Cleaner Frequency tester N/A Aluminum Foil Testing
Decontamination With Washer Disinfector Manual System (Each Cycle) One indicator in every cycle N/A N/A
Steam Sterilization Automatic Printouts (Every Cycle) Leak test Every week Class I Every Pack Class II Once a day Class IV Each pack Class V Each Pack Geo bacillus stearothermophilus Once in a day. (For implant every cycle) Every Cycle
EO Sterilization Automatic Printouts (Every Cycle) Class I Every Pack Class IV Each Pack Bacillus atrophaeus Every Cycle Every Cycle
Plasma Sterilization Automatic Printouts (Every Cycle) Class I Every Pack Class III Each Pack Geo bacillus stearothermophilus Once in a day. N/A
Sealing Automatic Printouts (Every Packs) Seal Check Methylene Blue test (at-least weekly) N/A N/A
Monitors
Process
71
Validation of a sterilizer

• Check physical parameter(Printer, Gauge
  glass, P.L.C,)
• (ST79, section 10.5.1)
• Leak testing (every fortnight) (EN 285)
• Chemical ( B.D. Tests) (Everyday 1st cycle)
• (ST79, Section 10.7.6.1 and 6.4)
• Biological indicator (at-least everyday 1st
  cycle)
• (ST79, section 10.7.2.3)
• Chemical indicator (Every pack
  internal/external)
• (ST79, section 10.5.2.2.1 and 2.2)
• HPCD test for chemical and biological test
• (ST79, section 10.7.5.1 and 10.8.1)
• Yearly external calibration
• (https//youtu.be/xKG60o-C4hs)

72
Air holding room (ST79, section 8.9.2)

• Pass through method should be maintained
  properly.
• PPEs should be followed up strictly.
• Maintain hand hygiene before touching any sterile
  products.
• Separate ducting system required for incoming and
  outgoing air in this room.

73
STERILE STORE
74
CSSD sterile storage area(ST79, section 8.9.2)

• Post sterilized items should be close to room
  temperature while unloading from sterilizer and
  dry before handling.
• Check wrappers and labels during unloading
  issue
• Keep store away from Dirt, Dust, Fluid Moisture
• Inflow and outflow duct should be cleaned at
  frequent basis.
• Sterile shelf should be
  4 (6) inch high from the floor
• 48 (18) inch lower from the ceiling
• 2 inch gap from the wall

75
Distribution of sterilize items (ST79, section
8.10.1)

• Before handling, items should be cool and dry.
• Trolley should be clean and dry.
• Maintain FIFO method to avoid expiry.
• Touch the sterile items not more than 3 to 5
  times.
• Mishandling should be avoided.
• Avoid hanging the sterile items and hold in a
  horizontal way.
• Transport sterile items in a close dedicated
  trolley.

76
Monitoring Air Quality

• Central Sterile Supply Department
• (Tata Medical Center)

77
Tools for monitoring air quality
Air Particle Counter
Anemometer
Agar plates- settle plates
Agar Strips for MAS
Microbiological Air Sampler (MAS)
78
Airborne Particulate Count from CSSD Sterile Store (Filter size 5 um and 10um) Volume 1 ft3 and every sample collection time 1 minute (Airflow is about 3000 cfm Air changes per hour is more than 20 times Air pressure is 0.1mmHg)
0.3 um 0.5 um 1 um 3 um CSSD5 um CSSD 10 um
73891 8976 951 145 43 13
74400 8771 736 76 13 2
74111 8676 664 78 11 1
72890 8739 728 92 17 6
72730 8318 649 59 16 3
79
Air microbiology in CSSD sterile store (ISO
14644-2 2000)
Location examples At rest (cfu) Operational (cfu)
Clean support room (ISO STANDARD) 5 50
LOCATION MEDIUM CFU Morphology Gram's staining Interpretation
Shelf next to unloading bay of T-max autoclave Nutrient Agar 36 Small and large whitish and creamish colonies GPCs and GPBs Acceptable colony counts lt 50 cfu under operational settings. No fungal colonies.
Shelf next to unloading bay of T-max autoclave Sabouraud's Agar 10 Small whitish and creamish colonies GPCs and GPBs Acceptable colony counts lt 50 cfu under operational settings. No fungal colonies.
Shelf near entrance door of CSSD sterile store Nutrient Agar 3 Small whitish, creamish, and couple of grayish colonies GPCs and GPBs Acceptable colony counts lt 50 cfu under operational settings. No fungal colonies.
Shelf near entrance door of CSSD sterile store Sabouraud's Agar 2 Yellowish colonies GPBs Acceptable colony counts lt 50 cfu under operational settings. No fungal colonies.
80
IBMS assisted temperature and humidity monitoring
in TMC-CSSD (ST79, section 8.9.2)

• STD recommendation

• CSSD maintained

• Temperature maintain 20c to 24c as per
  international standard
• Maintaining relative humidity 30 to 60 as per
  international standard

81
CSSD sample sterility testing in Microbiology
Lab no CSSD/19/1490
Sample received on 03/07/19
Specimen type STEEL BAR
Department CSSD
Media used Blood Agar plate
Date of collection NA
Date of expiry NA
Incubation type an temperature Aerobic and 37C
Result after 5 days of incubation No growth
Report No growth after 72 hrs.of aerobic incubation.
Status Final
Reporting Date 06/07/19
82
Time related sterility assurance (from Dutch
study)

• Quality of decontamination process from Soil
  items receiving to sterile items issue
• Time, Temperature, Result of leak test, Loading
  technique, number of wet pack incident etc
• Quality of packaging materials and total
  monitoring indicators
• Environmental condition in CSSD especially in
  sterile store
• Result of sterility testing in microbiology

• Method of sterilization
• Steam sterilization
• Ethylene oxide
• Plasma sterilization
• Liquid sterilization
• (Water)

• Shelf life
• Three months
• Six months
• Six months
• One day

83
Documentation System

• Central Sterile Supply Department
• (Tata Medical Center)

84
CSSD records to MRD (Hard copy only)(ST79,
section 10.2, 9.7, 10.3.2)
CSSD different important records Preservation period in MRD
Bowie-Dick test file with Batch label system 6 months in CSSD and 3 years in MRD
Biological Indicator file (Steam/EO/Plasma) 6 months in CSSD and 3 years in MRD
Sterilizer Cycle Print out (Steam/EO/Plasma) 6 months in CSSD and 3 years in MRD
Washer disinfector cycle record 6 months in CSSD and 3 years in MRD
Sterilizer Register (Stem/EO/Plasma) (Including implantable materials) 6 months in CSSD and 3 years in MRD
Sterile product dispatch register 6 months in CSSD and 3 years in MRD
Equipment preventive maintenance by 3rd party and calibration report 6 months in CSSD and 3 years in MRD
CSSD Manual (SOP) , Product material safety data sheet (MSDS) and product quality certificates Permanent
85
CSSD records (Soft copy)
Sl. No CSSD Records (Soft copy)
1. Number of sterilizers run per day
2. Numbers of materials sterilized per day
3. Numbers of dressing materials issued per day
4. Numbers of wet pack occurrences in every month
5. Numbers of surgical instrument damage in every month
6. Water TDS and chlorine test monitoring
7. Temperature Humidity monitoring in sterile store
8. List of patients with documented infections (HIV, Hep B)
9. Surgical set tracking system
10. ATP test for cleaning monitoring
86
Affix batch label in CSSD records and Patient
file for legal issues

87
Batch label is used for Re-call processesST79,
section 10.11.1)
88
Daily CSSD audit report
89
Types of CSSD waste and colored disposal bins
Types of waste materials Colored bin Area of waste generate
ETO gas cartridge BLACK Packing zone
Plasma cassettes BLACK Packing zone
Biological Indicator N/A Not disposed from CSSD
Plastic wrapper RED Packing / Soil zone
Non woven wrapper RED Packing zone
Chemical indicator (if any) BLACK Packing zone
Any sharp items, Broken glass SHARP CONTAINER (WHITE) Soil zone
Any bloody cotton items YELLOW Soil zone
Food particles BLACK Soil zone
Rubber tube, catheters RED Soil zone
Cartons BLACK Packing zone
Human tissues (if any) YELLOW Soil zone
Solution container RED Soil zone
Oil spray container BLACK Packing zone
Cap/ Mask RED Soil zone
Gloves/ Apron RED Soil zone
Tissue paper BLACK Soil zone
90
Other CSSD quality indicators- at a glance
Sl. No QUALITY INDICATORS EVIDENCE
1. Audit for broken or damage surgical instruments Soft copy
2. Documented all relevant quality certificates and MSDS Hard/Soft copy
3. Audit for wet packs Hard copy
4. All equipments are under the CMC for better services In Biomedical
5. Surgical set tracking system TCS Software
6. Audit for expired re-call items TCS Software
7. Audit for so-called single used devices (SUDs) Performed in O.T
91
For occupational health safety

• Central Sterile Supply Department
• (Tata Medical Center)

92
CSSD equipments for occupational safety purposes
EO DETECTOR LIGHT FITTED LINEN TABLE

TROLLEY WASH SYSTEM EYE WASH STATION

93
Yearly CSSD running cost

• Central Sterile Supply Department
• (Tata Medical Center)

94
Cost of Equipment and Environmental quality
indicators
Test parameters Name of the monitors Frequency of use Cost per test/piece INR (US) Cost per year INR (US)
Cleaning monitoring Soil indicator test Every cycle 86 (1.26) 516000 (7588.2)
Cleaning monitoring Adenosine Tri Phosphate (ATP test) Every day 130 (1.91) 39000 (573.5)
Sterilization monitoring (Internally) Bowie-Dick test Every day  140 (2.05) 100800 (1482.3)
Sterilization monitoring (Internally) External Steam CI Every set 548 (8.05) 157824 (2320.9)
Sterilization monitoring (Internally) Internal Steam CI Every set 15.5 (0.22) 669600 (9847)
Sterilization monitoring (Internally) External EO CI Every set 1180 (17.35) 14160 (208.2)
Sterilization monitoring (Internally) Internal EO CI Every set 7.5 (0.11) 216000 (3176.4)
Sterilization monitoring (Internally) External Plasma CI Every set 1439 (21.16) 34536 (507.8)
Sterilization monitoring (Internally) Internal Plasma CI Every set 6 (0.08) 14400 (211.7)
Sterilization monitoring (Internally) Steam BI Every day 162 (2.38) 120400 (1770)
Sterilization monitoring (Internally) EO BI Every day 158 (2.38) 45504 (669)
Sterilization monitoring (Internally) Plasma BI Every day 320 (4.70) 92160 (1355.2)
Sterilization monitoring (Externally) Wireless data logger system Every year 30000 (441.17) 150000 (2205.8)
Environmental quality monitoring Water quality monitoring Every month 55 (0.80) 660 (9.70)
Environmental quality monitoring Air quality monitoring Every month 100 (1.47) 1200 (17.64)
Environmental quality monitoring Sterility testing Every month 200 (2.94) 2400 (35.29)
Total cost per year (annum) Total cost per year (annum) Total cost per year (annum) Total cost per year (annum) 2174644 (31980.05)
95
Total operation cost of TMC-CSSD per annum (For
250 hospital beds)
Sl. No Heads Description Cost (INR)
1 CONSUMABLES Cleaning Disinfection Rs. 14,81,280.00
1 CONSUMABLES Packaging Rs. 26,07,076.00
1 CONSUMABLES Quality Control Rs. 21,74644.00
1 CONSUMABLES Dressing Materials Rs. 72,00,000.00
2 ENERGY Electricity Rs. 20, 239.20
2 ENERGY Air-conditioning Rs. 70,464.00
2 ENERGY Water Rs. 7,20,000.00
3 MANPOWER Staff Salary Rs. ?????
Total Total Total Rs. 1,42,73,703.2 (APPX)
In figures One crore forty two lacks seventy three thousand seven hundred and three In figures One crore forty two lacks seventy three thousand seven hundred and three In figures One crore forty two lacks seventy three thousand seven hundred and three In figures One crore forty two lacks seventy three thousand seven hundred and three
96
Academic activities (CSSD seminars)

• Monitoring of Cleaning and Sterilization
  Processes in Healthcare Facilities
• 
  Year 2013
• Session on Infection Prevention and  Global Best
  Practices in  OT CSSD
• 
  Year 2014
• Eastern Indias first innovative CSSD live
  workshop program.
• 
  Year 2015
• Care and maintenance of open surgery instruments
  and their associated problems.
  Year 2016
• Awareness program on proper CSSD processes .
  
• Year 2017
• Cleaning and Disinfection of surgical
  instruments.
• 
  Year 2018
• HISICON Pre-Conference Workshop on Infection
  Control in OT (including CSSD)

97
Academic activities (Online publications)

• CSSD in Tata Medical Center web page
• https//tmckolkata.com/tmc/vision-tmc/infection-co
  ntrol/
• http//www.web.tmckolkata.com/page.php?pid4page_
  id96
• Live CSSD workshop, Year-2015
• https//www.youtube.com/watch?vutCzhZdVitE
• Sterilizer validation by data logger system at
  Tata Medical Center, Kolkata.
• https//youtu.be/xKG60o-C4hs
• Cleaning and Disinfection of surgical
  instruments, Year-2018
• http//www.medivue.in/gallery.php
• ATP monitoring system in Tata Medical Center-CSSD
• https//youtu.be/xXmV6VxDzYw

98
Academic activities (Publications in
international journals)

• An overview of central sterile supply department
  of the Tata Medical Center, Kolkata. In
  Scientific Operating Procedures for Sterilization
  Practices in India.
• The importance of the central sterile supply
  department in infection prevention and control.
  Source Infection Control and Hospital
  Epidemiology, Vol. 35, No. 10 (October 2014), pp.
  1312-1314
• Sterilization Indicators in Central Sterile
  Supply Department Quality Assurance and Cost
  Implications. Infection Control Hospital
  Epidemiology, Available on CJO 2014
  doi10.1017/ice.2014.40
• The Importance of Chemical Solutions Used for
  Cleaning Stainless Steel Surgical Instruments in
  the Central Sterile Supply Department. Infection
  Control Hospital Epidemiology, 36, pp 868-869
  doi10.1017/ice.2015.106
• The Economics of Autoclave-Based Sterilization
  Experience from Central Sterile Supply Department
  of a Cancer Center in Eastern India. Infection
  Control Hospital Epidemiology, Available on CJO
  2016 doi10.1017/ice.2016.94
• Reason behind wet pack after steam sterilization
  and its consequences An overview from Central
  Sterile Supply Department of a cancer center in
  eastern India. J Infect Public Health (2016),
  http//dx.doi.org/10.1016/j.jiph.2016.06.009  

99
Academic activities (Publications in
international journals)

• The importance of paper records and their
  preservation period in a Central Sterile Supply
  Department An experience from a oncology center
  in eastern India. J Infect Public Health (2017),
  http//dx.doi.org/10.1016/j.jiph.2016.10.004  
• Comparing sterilization efficacy and cost
  implications of various gas-based sterilization
  methods used in a Central Sterile Supply
  Department A short review J Acad Clin Microbiol
  201820108-10
•  
• A comparative study on non-woven fabric and rigid
  container-based packaging system used in Central
  Sterile Supply Department Experience from a
  cancer research centre in Eastern India. J Acad
  Clin Microbiol serial online 2018 cited 2019
  Jan 72046-8.
• Requirement of clinical waste autoclave in a
  healthcare institution A mini-review J Acad
  Clin Microbiol 20182074-6
• Appropriate use of chemical indicators in the
  steam sterilization process Assured sterility
  and economy. Infection Control Hospital
  Epidemiology, 40 831832, https//doi.org/10.1017
  /ice.2019.126
• Requirement of hollow process challenge device
  for monitoring hollow and complex instruments
  sterilization a simulator for proper sterility
  assurance. Infection ControlHospital
  Epidemiology, https//doi.org/10.1017/ice.2019.138
  

100
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