![ Cleaning: The physical removal of body materials, dust or foreign
material. Cleaning will reduce the number of microorganisms as well as
the soil, and reducing the risk of soil being fixed to the surface. Removal of
soil will reduce also the risk of inactivation of a chemical disinfectant and the
multiplication of microorganisms. The removal of contamination from
an item to the extent necessary for further processing or for
intended use. [ISO/TS 11139]](https://image.slidesharecdn.com/cssd-230317150821-b2370d17/85/CSSD-pdf-12-320.jpg)
CSSD.pdf
- 1. CSSD: DECONTAMINATION, PACKAGING, STERILIZATION AND MONITORING
- 3. The Central Sterile Supply Department (CSSD) is the service responsible for receiving, sorting, processing, distributing and controlling the professional supplies of sterile items for all users unit of hospital for the care and safety of patient under strict quality control
- 4. 10sft/bed There is no international guidelines regarding space requirements for CSSD. For 600 bedded hospitals 6 or 7 sft per bed around 4000sft space 100 bedded hospital, we may need 1000 sft space Number of operation theaters and number of surgical procedures to be done or being done also taken into consideration. A CSSD of 300 bedded hospital having 7 operation theaters may need lesser space than a CSSD of 250 bedded hospital having 10 operation theaters. ISHA- Indian Sterilization Healthcare Association 2017
- 5. Used Articles Rinsing Assembling Temporary storage in user dept Collection by CSSD Staff Transport to CSSD Transport to user dept Documentation Loading Place Indicators Packing & Labelling Trays Tray setting with checklist Decontamination Manual / Machine CSSD WORK FLOW Drying Unload & Storage in sterial area Sterilization Handover items into CSSD
- 6. Decontaminatio n Soiled Return Prep and Pack Sterilization Sterile Storage
- 7. LOCATION PRESSURE TOTAL ACH ALL ROOMS AIR EXHAUSTED OUTSIDE RELATIVE HUMIDITY TEMPERATURE Decontamination Negative 6 Yes No requirement 22 -26°C Pre pack/ packing Positive 4 No No requirement 22-26°C Sterile storage Positive 4 No Max 60% WHO 40-50% 22-26°C Sterilizer equipment Negative 10 Yes No requirement No requirement
- 8. 8 3M Health Care Academy SM Clotted Blood Open Trolleys for Instruments transportation Instruments transportation through common usage equipments
- 9. : 1) Instruments to be transported in dedicated Closed trolleys 2) Count the number of instruments per set and record in the Issue register in OT/wards also in Issue register 3) Sort sharp items/ micro-instruments 4) Inspect for any damage/ dried blood stains 5) If damaged-report to the Manager & remove from usage 6) Primary wash is to be done by the user department to prevent organic matter from drying on it 7) Possibly in a dedicated lift or by other means
- 12. Cleaning: The physical removal of body materials, dust or foreign material. Cleaning will reduce the number of microorganisms as well as the soil, and reducing the risk of soil being fixed to the surface. Removal of soil will reduce also the risk of inactivation of a chemical disinfectant and the multiplication of microorganisms. The removal of contamination from an item to the extent necessary for further processing or for intended use. [ISO/TS 11139]
- 13. The destruction or removal of microorganisms at a level that is not harmful to health and safe to handle. This process does not necessarily include the destruction of bacterial spores.
- 14. STERILIZATION The complete destruction or removal of microorganisms, including bacterial spores.
- 15. A. Cleaning & Decontamination Process Brushes for Cleaning Instrument Sorting & Disassembly Manual Drying & Drying Cabinet Compatible Cleaning Agent IFU Instrument Checklist Multiple Sinks for Cleaning
- 16. B. Methods of cleaning Ultra-sonic Cleaning • Use after gross soil is removed • Usually used for Micro-instruments to avoid their damage • Conduct Aluminum foil test to check the efficacy of the ultra-sonicator Manual Cleaning • Use brushes recommended for washing medical devices • Disinfect the brushes in the Multi-enzyme cleaner after every use or at least end of the day Washer Disinfector • Do not overload • Daily and preventive • Correct chemical & lubricants • Review and initial mechanical washer cycle printouts • Document results Final rinse by RO Water
- 17. FACTORS WHICH AFFECT CLEANING Effective cleaning and pre-cleaning of devices often requires chemicals, combined with mechanical action and heat. It can be performed manually and/or with machines. • Type and amount of soil • Quality of water • Type of detergent • Concentration of detergent • Type of instrument or device • Amount of time permitted for the detergent to act
- 18. P ASS T HROUGH W INDOW 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.
- 19. C. Instrumentation Inspection, Preparation & Packaging Internal Pack Control CI Cleaning Verification using ATP Instrument Checklist Double Wrapping Lubrication Magnifying Lens Verification
- 20. Test Method0 Soil Component Tested Limitations Length of test ATP Swab device, extract ATP from swab, and determine ATP ATP (present in eukaryotic cells and live bacteria) - Need instrumentation to read test 30 seconds Protein Swab device, immerse in reagent and assess for color development Protein Not applicable to lumens minutes
- 21. Equipment control -Bowie-Dick type(Autoclave)-class 2 Exposure control- external indicator class 1 Pack control- internal indicator class 4 or 5 or 6 Load control- internal indicator class 4 or 5 or 6 or BI
- 22. Equipment Monitoring is a way to find out whether or not your vacuum assisted steam sterilizer is doing its job properly. To monitor dynamic air- removal steam sterilizers, you begin each day with a Bowie-Dick type test to detect air leaks, inadequate air removal, inadequate steam penetration and the presence of non-condensable gases, any of which can compromise sterility.
- 25. Traceability can only be achieved if the trays are recorded(Batch label)
- 26. Sterilization Pre-vacuum Steam Sterilizer – High Speed ( Temperature 121 – 134 deg. C / Pressure 1.1 to 2.1 Bar) 16 Towel BI PCD Pack 16 Towel Challenge Pack using for Loaner and Implant load Biological Indicator(BI) Challenge Pack Steam sterilization loading techniques Following IFU
- 27. S.no Sterilization method Biological indicator Incubation 1. Steam Geobacillus stearothermophilus 60°C for 3hrs 2. EO B. Atrophaeus 37o C -4hrs 3. Plasma sterilisation Geobacillus stearothermophilus 58o C-24hrs
- 29. An internal indicator preferably class 5 (every pack) External class 1 indicator (every pack) Bowie dick-class 2 indicator-pre vacuum autoclave (every day empty load) Every load sterilized by EO Every load containing implantable devices in autoclave Every day for autoclave Every day for plasma sterilization
- 30. Autoclave: run 3 empty cycles with BI PCD and subsequently 3 empty cycles with Bowie-dick Other sterilizers: run 3 empty cycles with BI PCD
- 31. Advantages Cost and environment If chemically treated are resistant to moisture and dust Disadvantages More labor (laundry, inspect, delint between each use and may need to repair) Not lint free If chemically treated may require extended dry times IAHCSMM Central Service Technical Manual, 7th edition, Chapter 13 Sterile Processing University, LLC The Basics of Sterile Processing, 3rd edition, Chapter 7 Central Services Association of Ontario, The Manual for Reprocessing Medical Devices, 1st Edition, 2009
- 32. ) Best wrap barrier Water-repellent No linting Wrapped basin sets should not exceed 3 Kg Containerized instrument sets do not exceed 11kg Tears easier than woven textiles Has memory Advantages Disadvantages IAHCSMM Central Service Technical Manual, 7th edition, Chapter 13 Sterile Processing University, LLC The Basics of Sterile Processing, 3rd edition, Chapter 7 Central Services Association of Ontario, The Manual for Reprocessing Medical Devices, 1st Edition, 2009
- 33. Good to use for small, lightweight instruments or single items Contents easily visible Paper/Plastic Pouches: labeling is done on plastic side only Must select the correct size for contents so air can be expelled but not so large that the contents can move around and damage the seals Seal rupture possible Requires a heat seal Advantages Disadvantages IAHCSMM Central Service Technical Manual, 7th edition, Chapter 13 Sterile Processing University, LLC The Basics of Sterile Processing, 3rd edition, Chapter 7 Central Services Association of Ontario, The Manual for Reprocessing Medical Devices, 1st Edition, 2009
- 34. Excellent barrier to microorganisms Water repellent Easy-to-use Eliminates torn wrappers No linting Protects instruments from damage during processing, storage, and transport Ergonomics - adds weight to instruments May need additional dry time Additional space needed to store containers but may be able to stack for sterile storage Additional labor for cleaning in between use and inspection of gaskets, latches, valves, etc Advantages Disadvantages IAHCSMM Central Service Technical Manual, 7th edition, Chapter 13 Sterile Processing University, LLC The Basics of Sterile Processing, 3rd edition, Chapter 7 Central Services Association of Ontario, The Manual for Reprocessing Medical Devices, 1st Edition, 2009
- 36. LOADING OF ITEMS
- 40. Maintain items on sterilizer cart until adequately cooled Do not touch during the cooling process Could wick bacteria from hands into packaging Place sterilizer cart in a low traffic area, no air-conditioning or cold-air-vents Do not transfer warm items to a cool cart which could result in condensate forming and contamination May open door slightly at end of cycle to reduce the potential for condensation formation ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012, Section 8.8
- 41. Is event related and depends on • Quality of packaging material • Storage conditions • Conditions during transportation • Amount of handling Label each product • Expiration date or statement such as: “contents sterile unless package is open or damaged. Please check before using.” ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012, Section 8.9.3 and 10.3.3
- 45. WHO guidelines 2016 CSSD
- 46. Type of sterilizer Advantages Disadvantages Autoclave Inexpensive Fast Effective, with a wide margin of safety Penetrates medical packing, device lumens Non-toxic – low environmental impact Readily available Sterilizers are available in many sizes for many applications Cycle easy to control and monitor Unsuitable for anhydrous materials and for heat- and moisture-sensitive materials May leave instruments wet, causing them to rust Expertise Deleterious for heat-sensitive instruments Microsurgical instruments damaged by repeated exposure Potential for burns Hydrogen Peroxide (Plasma) Fast Safe for the environment Compatible with heat- and moisture-sensitive Absence of toxic waste Easy installation and operation No staff monitoring currently required No aeration required No chemical residues Cannot sterilize materials that absorb hydrogen peroxide (e.g. linen, gauze, cellulose/paper, wood) Low penetration power Medical devices must be dry before processing Cellulose (paper), linens and liquids cannot be processed Limitations to length of lumens of medical devices that can be effectively sterilized
- 47. Type of sterilizer Advantages Disadvantages ETO Non-corrosive Penetrates packaging materials, device lumens Has some ability to penetrate some synthetic materials Excellent material compatibility Simple to operate and monitor Toxic/carcinogenic to humans Lengthy cycle due to aeration requirements Requires monitoring of the work areas Requires control and monitoring of discharge into the environment Flammable and explosive. Expensive
- 48. Implantable devices till the BI testing is satisfactory Non implantable devices BI/ class 5or 6/specific cycle physical parameters in the load control
- 49. RAPID CYCLE OR FLASH STERILIZATION “Unwrapped” steam sterilization Should only be used when necessary Do not flash whole trays of instruments Items must be used immediately Avoid by keeping adequate supply of frequently dropped items Maintain records or “flash logs” Use to support need for additional instruments
- 50. Nurse from OT calls the CSSD to inform the Arthroplasty set is wet. What to perform next? 1. Receive the wet set process sterilize and return 2. Receive all the sets sterilized in the same load 3. CSSD technician observes the external indicator is working and tells to use the instrument 4. Its an issue between CSSD technician and the OT nurses, no need to inform others
- 51. Load contains positive BI- failed load and also all loads sterilized in that sterilizer till last successfully sterilized load Incorrect reprocessing of device Print out of reprocessing equipment failure to reach correct parameters CI has not changed colour Doubt about sterility of equipment(torn, wet) Notification to all concerned departments
- 53. Controlled temperature 24°C ≥ four air exchanges/hour Relative humidity not to exceed 60% Controlled traffic Positive air flow (out) Sterile items are stored at least 20-25cm (8-10”) above the floor, at least 45cm (18”) below the ceiling or sprinkler heads, and at least 5cm (2”) from outside walls. It should be located near a dock for the receiving of materials.
- 54. STERILE STORAGE Supplies are distributed on a First In First Out (FIFO) basis
- 56. AUDIT- APSIC CHECK LIST