CSSD CENTRAL STERILE SUPPLY DEPARTMENT.pptx

Central sterile supply department

1. CENTRAL STERILE SUPPLY DEPARTMENT DR.P.B.PRAVEENKUMAR SECOND YEAR POST GRADUATE DEPARTMENT OF MICROBIOLOGY THANJAVUR MEDICAL COLLEGE

2. INTRODUCTION Integrated place in hospital that performs sterilization of devices, equipment and consumables which are used in OT and other areas. Primary aim – To provide safe, reprocessed, reusable, Invasive medical devices for clinical procedures.

3. MAIN OBJECTIVES To ensure sterilized articles available in the hospital at required time and place To ensure that all items receive the highest level of cleaning To prevent cross contamination and infection from devices patients To minimize damage to medical devices due to inappropriate handling To reduce HAIs To provide safe transportation of reprocessed devices To maintain records of effectiveness regarding cleaning, disinfection and sterilization process

4. TYPES OF CSSD Central Sterile Services/Supply Department (CSSD) Theatre Sterile Service Unit (TSSU) – Located near Ots (Remotely located OT)

5. SIZE OF CSSD More than 7 square feet/bed (For HCF with >300 beds) About 8-9 square feet/bed (For HCF with 100-300 beds) More than 10 square feet/bed (For HCF with <100 beds)

6. FACTORS INFLUENCING SIZE OF CSSD Average no. and type of surgeries per day Single use device (SUD) policy Whether Endoscope reprocessing area in same space or not Whether plasma sterilization or ETO used or not – Faster TAT Use of containers – More space requirement Manual cleaning method – Longer TAT Number of shifts per day and the number of employees per shift Front loading single-door type – Occupies more space than pass-through type with double doors

7. LOCATION OF CSSD Ideally located in close proximity to casualty, ward, OT and Labour ward Should have: Adequate supply of both hot and cold water Steam Compressed air

8. LAYOUT OF THE CSSD Unidirectional workflow starting from dirty(Unsterile) area to clean(sterile) area. Accessory area Decontamination area Inspection, assembly and packing (IAP) area Sterilization area Sterile storage area

9. LAYOUT AND CSSD WORKFLOW

10. ENVIRONMENTAL PARAMETERS OF THE CSSD Air quality – ISO 8573 (Must of medical air quality free of organisms, chemicals or dirt) Air filters – ISO 12500 (1micrometre pore size for solid particulate removal) Water quality – Soft water with very low minerals and salts Demineralized water (ISO 17665) is ideal for steam sterilizers Surfaces – Smooth, straight, easy to clean, waterproof without cracks and pores; Stainless steel preferred over wood Ceilings- Smooth, straight and without cracks and should be moisture proof Walls – Should be continuous, smooth (No peeling of paint), straight and coated with washable paint; Corners should be protected with metal ridges

11. ENVIRONMENTAL PARAMETERS OF THE CSSD (cont.) Floors – Straight, smooth, continuous and nonslippery ; without cracks; No sharp corners; Floor drains with appropriate slope Relative humidity – 40 to 50% Ambient temperature Decontamination area – 18 to 20 degrees Celsius Clean areas – 18 to 23 degrees Celsius Sterile storage area – 15 to 25 degrees celsius

12. ENVIRONMENTAL PARAMETERS OF THE CSSD (cont.) Ventilation Mechanical or controlled ventilation is preferred – 20 ACH In absence of MV outdoor air is preferred Outdoor air 10 to 20 ACH for dirty area (Negative air pressure) 12 to 20 ACH for clean area (Positive air pressure)

13. TRANSPORTATION Sterile and unsterile items should be transported separately via two dedicated lift (or) two separate closed vehicles Used and sterile items should always be kept in separate closed container Reception counter of used items and issue counter of sterile items should be located far away from each other.

14. ACCESSORY AREAS Entrance and corridors Separate entrance and corridor for used dirty devices and staff It should be connected to staff changing areas The corridors should be wide enough to take trolleys without human traffic Staff changing rooms Wear CSSD uniform, perform hand hygiene and wear appropriate PPE before entering into CSSD

15. DIRTY OR DECONTAMINATION AREA Dirty area must be physically separated from package and sterile storage area Reception zone and wash zone Easy access to hand hygiene facilities Delivery of dirty items by manually or dumb waiter (Connection between OT and CSSD) Cart or trolley cleaning area Sorting out items by method of cleaning (Manual/Ultrasonic/disinfection) Instruments (Having more than one part) disassembled and then proceed for CSSD.

16. DUMB WAITER (LIFT)

17. CLEANING (REPROCESSING) EQUIPMENTS Decontamination sinks for manual cleaning Cold water jet guns Medical quality air (For drying lumens) Tables or surfaces for registering and sorting the devices Hand hygiene station

18. DECONTAMINATION SINKS To facilitate devices with minimal movement without delay without overflow Triple sink (Soaking, Washing, Rinsing) method Size – Large and deep enough to avoid aerosols with comfortable height for personnel without bending Equipped with water ports for cleaning lumen And also with a section of air drying medical devices

19. USE OF PPE PPE INDICATION GLOVES FACE COVER OR VISOR HEAD GEAR APRONS OR GOWNS CLOSED SHOES Decontamination area Heavy duty gloves Face mask with goggles Yes Yes Yes Packaging area Not indicated Not indicated Yes Optional Yes Sterilization Heavy duty gloves (Heat resistant) Not indicated Yes No Yes Sterile stores Not indicated Not indicated Optional No Yes Transportation Not indicated Not indicated Optional No Yes Returning used medical devices Heavy duty gloves Only when handling open wet trays No Yes Yes

20. PRE-CLEANING Should be done at point of use Removing gross soil from instruments using clean dry cloth Involves soaking or spraying instruments using enzymatic solution NO CHLORINE…… Instruments should be covered with moist towel with water or foam or gel ANYWAY… PRE-CLEANING WON’T REPLACE CLEANING PROCEDURE…

21. CLEANING Removal of visible soil, organic and inorganic material from objects and surfaces Can be done manually or mechanically Thorough cleaning is needed before sterilization Medical devices should be disassembled to allow effective cleaning

22. CLEANING PRODUCTS Easily emulsifiable, saponifiable, water softening, free rinsing, nontoxic and have surfactant like action. Enzymatic (Proteolytic) cleaners – Removes only protein from instruments. Use rubber or nitrile gloves instead of latex gloves (Enzyme will degrade latex gloves) Cleaning chemicals (Detergents) – Reducing surface tension and dissolving fat and organic matter; It should have mild alkaline property with optimal dilution according to manufacturer’s recommendation

23. CLEANING METHODS Manual cleaning Mechanical or automatic cleaning (Ultrasonic washers, washer/disinfector and automated cart washers)

24. MANUAL CLEANING INDICATIONS: Resource limited setting Electrical or battery operated devices Narrow bore lumen devices Devices which needed pre-cleaning METHODS: Immersion method Non immersion method

25. IMMERSION METHOD Cleaning is performed under the surface of water not in running tap water to avoid aerosols Soft nylon bristle brushes with same diameter as instrument and also be long enough to reach it’s distal end Brushes should be thermally disinfected and dried at the end of the day Rinsing the instrument to remove loosened soil and residual detergent Use another sink for rinsing with commercially prepared, sterile, pyrogen free water / RO water ( NO DISTILLED WATER ) Drying prevents microbial growth which can be done mechanically or air dried or hand dried using clean cloth Lumens can be dried with medical grade or HEPA filtered air Stainless steel are dried immediately after rinsing to prevent spotting

26. NON IMMERSION METHOD Cleaned by wiping surfaces with a disposable, clean, non-linting cloth and detergent till visible soil is removed Rinsing by wiping surfaces with damp, disposable, clean, non-linting cloth till all detergent residue is removed Drying is same as immersion method Cleaning solution and water should be changed at each session and when visibly soiled

27. MECHANICAL OR AUTOMATIC CLEANING Faster throughput of devices, greater consistency of results and higher standards of cleaning If devices are heavily soiled (Manual cleaning first  Mechanical cleaning) TYPES : Ultrasonic cleaners Automated washers or Washer disinfectors Automated cart washers or trolley washer

28. ULTRASONIC CLEANERS Used to clean hard to reach parts of instruments Principle : Ultrasonic vibrations------->Pass through cleaning solution  Create bubbles---->Bubbles implode---->Cavitation------> Vaccum formation Draws the debris from the instruments into surrounding fluid. PREREQUISITES : Precleaning is must Water temperature should be 27-43 degrees Celsius not more than 60 degrees Water should be changed daily and when it is visibly soiled Ultrasonic unit should be degassed each time Lid must be closed prior usage to avoid aerosols and thoroughly cleaned and dried at the end of the day. Validation test is done once a year ( FOIL TEST )

29. ULTRASONIC CLEANER

30. FOIL TEST – ULTRASONIC CLEANER VALIDATION

31. AUTOMATED WASHERS OR WASHER/ DISINFECTORS Precleaning not needed here. Safe for staff since they won’t handle the instruments Front operated double door washer is ideal one PRINCIPLE : Use of pressurized water to physically remove the bioburden Pre-rinse Enzymatic washDetergent washLubricationFinal rinse PREREQUISITES : Washer racks should never be overloaded Spray arms should be inspected daily.

32. AUTOMATED WASHERS

33. AUTOMATED CART WASHERS OR TROLLEY WASHER To clean rigid containers, surgical basins and other medical devices Only surgical instruments validated by manufacturer were allowed to take part in this method.

34. CLEANING VERIFICATION AND QUALITY CONTROL By visual inspection (M/C) For automated washer – With commercially manufactured product like dried blood

35. INSPECTION, ASSEMBLY AND PACKAGING AREA (IAP) AREA These areas are adjacent zones and are physically separated. Items are thoroughly inspected, assembled and wrapped in appropriate packaging material --> Sent for sterilization.

36. INSPECTION AND FUNCTION TESTING Each instrument should be inspected for Serrations Movement Patency Functionality Sharpness

37. ASSEMBLY Uniform exposure Jointed instruments in unlocked position Heavy items should not damage  Lighter items Similar devices should be kept together Devices should be spread evenly by weight NO PAPERS…… DURING STERILIZATION PAPER LINT CAN BE TRANSFERRED TO INSTRUMENTS AND WILL HARM THE PATIENT.

38. PACKAGING Allows the penetration and removal of the sterilant during sterilization Protects the devices from contamination Permits aseptic removal of items at the point of use Labelling about content, lot number & expiry date Hollow devices should not be placed in textile packs Heavy items must be placed at the bottom Perforated trays used to allow for penetration of sterilant Sequential wrapping using two barrier type wrappers –tortuous pathway for microorganisms.

39. STORAGE OF PACKING MATERIAL Temperature – Room temperature (18-22 degrees Celsius) Relative humidity – 35-70% Packaging materials should be stored on shelves away from external wall (10 inch/28cm) above floor level Packaging material – First in, First out policy

40. TYPES OF PACKAGING MATERIAL Reusable woven fabrics (Linens) Natural fibers of cotton (linen) or Blends of cotton (Polyester) Used for steam, LTSF Prior to use laundering and inspection is must Double wrap is recommended Linen thread count is 140 Disadvantages: Poor bacterial barrier, Impede air penetration, Not for primary packaging.

41. TYPES OF PACKAGING MATERIAL Nonwoven disposable fabrics Made by methods other than weaving Suitable for steam, LTSF, ETO and gas plasma Single use products Excellent barrier, flexible and stretchable, virtually lint free Resist liquid penetration Non-absorbent

42. TYPES OF PACKAGING MATERIAL Flat wrappers Most versatile Available in various sizes 8*8 to 54*54 Two types : Envelope (Diagonal) fold or Square fold

43. TYPES OF PACKAGING MATERIAL Papers Types : Craft, Crepe, Glassine Used for steam, ETO, LTSF, and dry heat sterilization 60 GSM thickness is recommended

44. TYPES OF PACKAGING MATERIAL Peel Pouches Used for light weight items and minimum thickness is 2mm Types Plastic-Plastic pouches – Used in all sterilizers Paper-Plastic pouches – Not used for ETO One medical device per pouch Peel pouches should never kept in containers to avoid interference with air removal Only products with FDA 510 K clearance should be used

45. PEEL POUCHES

46. RIGID REUSABLE INSTRUMENT CONTAINERS Used for moist heat sterilization Having perforations in top lid, covered internally by HEPA filters After use, containers disassembled and cleaned with detergents and water Requires routine inspection and maintenance Keep the devices safe after sterilization and during transportation

47. OTHER PACKAGING MATERIALS Aluminium foil (75M) Glass bottles, vials and ampoules Non perforated containers of glass or metal

48. PACKAGING TECHNIQUES TYPES Parcel fold wrapping method Envelope technique / wrapping method

49. PARCEL FOLD WRAPPING METHOD

50. ENVELOPE WRAPPING METHOD

51. SEALING Sealing is essential for packages that use pouch system for device. Methods: Heat sealing (Best method) Tape sealing Air must be removed as much as possible from the pouches before sealing Follow appropriate sequential size of pouches while sealing Sealing has to be continuous, end-to-end and tightly secured

52. HEAT SEALER

53. LABELLING Commercially prepared, self-adhering preprinted or computer-generated labels are used. Done by either manual or label gun. SALIENT POINTS IN LABELLING Date of sterilization and expiry date Name of the product, wrapper and sterilizer Load number and operator name Package contents Initials of employee who prepared package

54. LOADING TO THE STERILIZER Packs with solid bottom must be placed on their sides Plastic side facing the paper side of next package No package should come into contact with chamber wall Place surgical instruments trays flat on the sterilizer Lighter items placed on the top; Heavier items at bottom Overloading should be avoided Use dry items only Instruments should not be held together using rubber bands Devices with lumen flushed with distilled water just before loading Instruments with rachets should be in unlocked position

55. LOADING TO THE STERILIZER

56. STERILIZATION AREA Double door sterilizers should be used (One door facing packing area and one door facing sterilization area) STERILIZERS USED IN CSSD: Steam sterilizer (Autoclaves) Immediate use system sterilization (IUSS) or flash sterilization Table top sterilizer Chemical (Low-temperature) sterilizers: Ethylene oxide Plasma sterilization Ozone sterilizer Low-temperature steam formaldehyde (LTSF)

57. STEAM STERILIZER (AUTOCLAVES) Similar to pressure cooker Mechanism: Moist heat destroys microorganisms by the irreversible coagulation and denaturation of enzymes and structural proteins Components of autoclave Large cylinder (Vertical or horizontal) made up of gun metal or stainless steel Steam jacket Lid fastened by screw clamps and by an asbestos washer (Discharge tap, Pressure gauge & safety valve) Electrical heater 121 degrees Celsius for 15 minutes at pressure 15 pounds (lbs)

58. STEAM STERILIZER

59. TYPES OF STEAM STERILIZER Gravity displacement type (M/C)= Vertical (Small volume) / Horizontal (Large volume) Positive pressure displacement type Negative pressure (Vacuum) displacement type

60. STERILIZATION CONTROL FOR AUTOCLAVE Biological indicator : Spores of Geobacillus stearothermophilus Chemical indicators Class I (External pack control / autoclave tape) Class II (Bowie-Dick test / Equipment control) Class IV or V (Internal pack control) Physical indicators – Digital displays on the equipment regarding temperature..

61. IUSS OR FLASH STERILIZATION For extremely urgent use in Ots. At 134 degrees Celsius for 3-10 minutes Never used for implants Never used for suction cannula

62. TABLE TOP STERILIZERS Sterilizer with chamber volume not more than 2 cubic feet Mostly used in OPD, rural and dental clinics Designated for small instruments

63. ETHYLENE OXIDE (ETO) Colourless gas and flammable along with explosive Both microbicidal and sporicidal activity Acts by combining with cell proteins, DNA and RNA causing alkylation

64. ETO STERILIZATION CYCLE Pre-conditioning – Air is removed and leakage test is done Sterilization Four essential parameters Gas concentration (450-1200 mg/L) Temperature (37-63 degrees Celsius) Relative humidity (40-80%) Exposure time (1-6h) Aeration (Degassing) – ETO residues in instruments may be toxic, So extensive aeration of 8-12 hours is must. Sterilization control – Bacillus atrophaeus

65. ETO STERILIZER

66. PLASMA STERILIZATION PRINCIPLE Gaseous state consists of ions, photons and free electrons and free radicals Gas plasma Excite the gas molecules (RF & MVE) Gas Charged particles / Free radicals like O and OH Disrupt the metabolism of microorganisms including spores by interact with cell components like nucleic acid and enzymes

67. STEPS OF PLASMA STERILIZATION Sterilization chamber evacuated to create vaccum Injection of chemical sterilant (H2O2 / H2O2 with peracetic acid) It will work based on the principle mentioned in previous slide Excess gas is removed and returned to atmospheric pressure by introduction of high-efficiency filtered air Low temperature is maintained (37-44 degrees Celsius) Cycle time = 75 minutes

68. PLASMA STERILIZER (STERRAD/PLAZLYTE)

69. NEWER AND NEWEST VERSION OF PLASMA STERILIZERS Newer version Two cycles per sterilization cycle One with H2O2 diffusion stage and Second with H2O2 plasma stage Reduces total processing time from 75 to 52 minutes Newest version New vaporization system Cycle time 28 to 38 minutes

70. PLASMA STERILIZER Biological indicator: Geobacillus sterothermophilus H2O2 may be toxic at the levels more than 1 ppm TWA (Time-weighted average) It has small chamber, therefore cannot be used for bulk items

71. OZONE STERILIZER Ozone is a potent antimicrobial chemical and requires high levels of humidity Principle: It creates O 3 internally from oxygen, steam-quality water, and electricity Sterilant(O 3 ) is reverted back to oxygen and water vapour at the end of the cycle Duration: 4 hours 15 minutes Not able to sterilize liquids, textiles and cellulose based materials

72. LOW TEMPERATURE STEAM FORMALDEHYDE (LTSF) Indicated for all materials used for hemodialysis Toxic, irritating and allergenic chemical Suspected carcinogen

73. STORAGE AREA Once packs removed from sterilizer, moved to an area where they allowed to cool Should be restricted and away from windows or traffic Positive air flow from sterile to other areas Entry – strictly restricted First in first out policy

74. MONITORING THE EFFICACY OF STERILIZATION Physical or mechanical indicator Chemical indicator (Type I to VI) Biological indicator (BI) Process challenge device (PCD)

75. CHEMICAL INDICATORS Type I Process indicator/Exposure indicator/External pack control Pack has directly exposed to sterilant Not assure sterility WE ARE USING IT IN OUR CENTRAL LABORATORY, WE ARE DOING IT WEEKLY ONCE

76. CHEMICAL INDICATORS Type 2 Bowie-Dick test Used only for pre-vacuum steam sterilizer Must be used daily in empty cycle before the first load Type 3 – Obsolete now

77. CHEMICAL INDICATORS Type 4 Internal pack control indicator Used inside each pack Measures any two variables (Time, Steam quality and temperature) Type 5 Internal pack control indicator Used inside each pack Measures all three variables Used for critical items Equivalent to BI

78. CHEMICAL INDICATORS Type 6 Cycle specific or emulating indicator

79. BIOLOGICAL INDICATOR (BI) The best indicator (Once a day (or) At-least weekly once) Types Next generation BI (Vials containing spore coated paper strip and growth media Run along with loadIncubated for 48 hours See for growth) Spore –strip BI (Used in past, 7 days incubation needed, Now obsolete, But we are still using this in our college) Rapid read-out BI Detects the presence of enzymes (B-glucosidase) and acid metabolites within 24 minutes – 4 hours by fluorometric method

80. BIOLOGICAL INDICATOR (BI) Next generation BI Spore strip BI Rapid read-out BI

81. SPORE STRIP BI (HOW IT WORKS…..)

82. PROCESS CHALLENGE DEVICE Preassembled challenge test pack Comprising a BI and One chemical indicator Class 4 or 5 Made up of 16 layers of surgical towels (Indicators kept in between eightfold above and eightfold below) Then PCD is placed near drain (EXPECT THE WORST…..) Which is difficult area to get sterilized If this test is passed – Sterilization confirms its effectiveness.

83. CONCEPT OF PCD (Just for fun…..)

84. THANK YOU