Hospital Sterilization Prem Anand Nagaraja
INDEX
A
Accessories required for packaging 72
Acidity of water 33
Administrative area 238
Advanced sterilization products 155
Advantages and disadvantages of nonwoven sterilization 77
Aerobic bacteria 22
Age of microbes 107
Air
flow 235
leak tests 198
removal 114
Airtightness of sterilizer chamber 116
Alcohol 47, 213
Alkalies 36
Aluminium foil test 40
Amino acids 10
Amount of organic soil present 211
Anaerobic bacteria 22
Analysis of cell inactivation data 200
Antibacterial activity 138
Antifungal activity 138
Antimicrobial
effectiveness of chemical germicides 205
properties 138
Antisepsis 206
Antiviral activity 139
Application of UV rays for sterilization 154
Architectural aspects 236
Arithmetic scale 106
Arterial pressure transducers 217
Aseptic
opening and presentation 69
presentation 87
Assembly area 6
Association for advancement of medical instruments 11
Atmospheric pressure steam sterilization 116
Attire 13
Automatic cart wash area 238
Autotransport system 242
B
B.stearothermophilus 111
Bacillary dysentery 24
Bacillus subtilis 108, 111
Bacteria 21
Bacterial
barrier 77
capsules 22
reproduction 23
Basic
microbiology 21
principles of washing 17
Basin sets 66
Beneficial effects of UV rays 153
Benefits of reprocessing 176
Beta-lactamases 23
Beta-propiolactone 131
Binding system 75
Biocides 36
Biological indicators for sterilization by
ETO 185
steam 185
Blood
and blood products 24
pressure monitors 17
Bowie-Dick test 181, 193
Brushes 38
Builders 36
Bulk storage area 6, 237
C
Campylobacter jejuni 23
Capsule secretion 23
Carbohydrates 10, 108
Carbon dioxide 10
Carboxyphilic organism 23
Categories of
materials 203
surgical instruments 52
Cell wall structures 22
Central
sterile supply department 1
supply department 2
Chain of
infection 45
transmission 45
Chamber
air 190
water 117
Chemical
accessibility to targeted organisms 203
disinfectant
demand 203
of medical and surgical materials 203
indicators standards 182
properties 137
used in cleaning process 35
Chlorides 33
Chlorine 213
compounds 47
dioxide 131
Cholera 24
Classification of disinfectants 51
Clean receiving and breakout area 237
Clean-for-dirty exchange system 7
Cleaning 3, 17, 27, 58
action 29
circle 30
of goods is mandatory before sterilization 27
procedure in CSSD 29
tank 39
Clostridium tetani 23
Colony-forming units (CFU) 106
Commonly used instrument germicides 211
Communicable disease 24
Communication 235
Compatible with sterilization process 69
Components of ultrasonic cleaner 39
Composition of water 32
Conformability 77, 79
Containers for ethylene oxide sterilization 91
Corrosion inhibitors 36
Critical instruments or devices 204, 208
CSSD personnel safety 159
Cycle
development 135
verification indicators 182
Cytotoxicity 159
D
D value 111
Data loggers 42
Death phase 11
Decimal reduction time (DRT) 111
Decontamination 6, 9, 206
procedure 11
Desirable features of plastics 84
Determination of sterilization dose 145
Device-related risks of disease transmission 230
Diffusion phase 155
Dilution by
mass flow 115
pressure pulsing 115
Direct transfer 24
Dirty item receipt area 6
Disadvantages of nonwovens 79
Disinfection 45, 206
Dispatch area 238
Dispensing phase 81
Distillation 34
Distribution 4
systems 7
Dropped instruments 74
Dry heat sterilization 184
Drying 3, 40, 59
Drying of container load 90
Dust covers 73, 74
E
Education and training for CSSD technicians 3
Effect of
alkalination 140
microbial water content 109
oxygen and dose rate 148
radiation on pharmaceuticals 149
temperature 109
Efficacy of process 16
Efficiency of process 18
Electrical outlets 239
Emergency power 239
Emerging technologies 131
Employee
safety during decontamination 12
training and safety 179
Emulating indicators 182
Enabling sterilization 69
Endemic diseases 24
Endoscopic equipment 217
Endotoxin production 23
Engineering considerations 238
Entry through wounds 24
Environment and safety 137
Environmental
conditions 5
control 14
protection agency 137
requirements 236
surfaces 209
Enzymes 36
Epidemics 24
Equipment 132, 241
connection 171
testing and storage area 238
Escherichia coli 23, 25
Establishing reuse program 176
Ethylene oxide 105, 128, 130
sterilization of medical products 134
sterilizers 242
ETO sterilization 185
Eukaryotes 21
Evacuation phase 155
Evaluation of container in flash sterilization 91
Exotoxin production 23
External brushes 38
Extracellular enzymes 23
F
F value 111
F0 value 111
Facilitation of processing 77
Factors affecting
efficacy of disinfectants 50
affecting sterilization 120
considered in
sterilization process 98
storage 99
influencing
disinfectant activity 50
germicidal procedures 210
Facultative anaerobe 23
Filtration 34
Fimbriae 22, 23
Finishing treatment 75
First intermediate rinse 58
Flagella 22
Flat wrappers 95
Floor drains 239
Fluorescent powder and UV light 42
Food and drug administration (FDA) 75
Forceps 53
Formaldehyde 49, 130, 213
Formula of ETO 130
Functions of areas within CSSD 237
Fundamentals of pouch packaging 83
Fungi 21
G
Gas
concentration 131
plasma sterilization 131
Glass slide test 40
Gloves 41
Glutaraldehyde 49, 137, 214
Gonorrhea 24
Gram-negative bacteria 22
Gram-positive bacteria 22
Gravity displacement 114
Groceries system 7
Growth and death of microorganisms 9
Growth
phase 108
temperature 108
Guidelines for
packaging 80
ultrasonic cleaning 39
H
Haemophilus influenzae 23
Hand
cleaning 17
shower 38
Hard and soft water 32
Harmful effects of UV rays 153
Heat 30
Hemostats 52
Hepatitis
B 24
C 24
High level
disinfectants 51
disinfection 206
High vacuum sterilization 115
History of nonwovens 75
Hospital acquired infections 2, 25
Housekeeping surfaces 210
HVAC system 238
Hyaluronidase 23
Hydrogen peroxide 50, 131, 215
I
Importance of
steam quality 118
sterilization of medical supplies 1
Improving water quality 33
Indicators for use in specific tests 181
Infectious agent 45
Ingestion 24
Inhalation 24
Injection phase 155
Innate resistance of microbes 210
Inorganic growth nutrients 10
Inspection 62, 94, 216
Inspection and
assembly 3
testing 64
Installation qualification (IQ) 151
Instrument
flusher 38
marking 53
repair 64
sets 66
Integrating
indicators 181
PI/CI 190
Interaction with
bacterial cell constituents 140
bacterial spores 140
Intercom system 241
Interior doors and hardware 243
Intermediate level
disinfectants 51
level disinfection 207
rinse 40
Internal brushes 38
International Organization for Standardization 182
Interpretation of biological indicator 186
Intravenous fluid pumps 17
Introduction to central sterile supply department 1
Inventory 5
Iodine compounds 48
Irradiation of
powders for injection 149
water 149
K
Klebsiella pneumoniae 23
L
Laboratory functionality tests 159
Lag phase 10
Laminated film pouches 71
Laundry 93
Layout of central sterile supply department 235
Leak rate test 195
Leprosy 24
Levels of disinfectant activity 206
L-forms 22
Life expectancy of surgical instruments 54
Lighting 239
Linen processing area 6, 238
Load wetness 117
Location of CSSD 5
Lodophors 213
Low
density polyethylene 83
labor cost 77
level
disinfectants 51
disinfection 208
temperature sterilization 128
Lubricants 37
M
M. tuberculosis 51
Machine cleaning 30
Maintaining sterility 69, 227
Manpower 6
Manual
cleaning 30, 38
disinfection and cleaning 56
equipment wash area 238
Material selection 148
Measurement of efficiency of steam sterilization 188
Mechanics of steam sterilization 112
Mechanism of
ozone sterilization 161
radiation sterilization 144
Medical equipment surfaces 210
Meningitis 24
Microaerophilic organism 23
Microorganisms 132
Microscopic brush 39
Milk round system 7
Miscellaneous procedures and equipment 218
Mode of transmission 46
Moisture 122, 190
Monitoring of plasma sterilization 158
Monitoring sterilization process 181
Morphology of bacteria 23
Most probable number technique 109
Mouth mask 41
Multi-parameter indicators 181
Mycoplasma 21
N
Natural sources of UV rays 153
Needle holders 53
Neisseria
gonorrhoeae 23
meningitidis 23
Neutralizers 37
Non-critical instruments 204
Non-woven sheets 70
Normal bacterial flora of human body 25
Nosocomial infections 25
Novel formulations 141
Number of
bacteria invading body 23
microorganisms present 210
Nutrient conditions 108
Nylon 84
O
Obligatory aerobe 23
Occupational safety and health administration 137
Odor and color 148
Operating room instrument sets 66
Operational
qualification 151
supplies 168
Organic growth nutrients 10
Organization of CSSD 2
Overall functions of CSSD 3
Oxygen 10
Ozone 131
sterilization 161
P
Package
closure 86
types 83
Packaging 3
concept for sterile products 68
criteria 95
materials 69
of products for sterilization 68
using pouches 81
with rigid containers 89
with textiles 92
Paper
sheets 70
sterilization bags 70
Paratyphoid 24
Pasteurizers 19
Peracetic acid 50
Perfect pouch package 88
Performance
evaluation 5
qualification 151
tests for porous load sterilizers 192
Phenol compounds 212
Phenolics 48
Pili 22
Planning and layout 6
Plasma 128
phase 155
sterilization 155
Plastic apron 41
Plazlyte 129
Polyester 84
Polyethylene 85
Polypropylene 85
Polystyrene 85
Polyvinyl chloride 85
Possession of pili 23
Pouch packaging materials 84
Preparation of
biological indicator test for ETO 186
supplies for terminal sterilization 64
Preparing items for low temperature sterilization 128
Pressure 108
pulsing with gravity displacement 115
Prevention of
exposure to infection 14
musculoskeletal injury 15
thermal injury 16
Primary
packaging 68
stock 236
Principles of chemistry of cleaning 30
Problem
related to cleaning with water 31
resolution in chemical indicators 184
Prokaryotes 21
Properties of ETO 130
Propylene oxide 130
Proteins 10
Protoplast 22
Protozoa 21
Pseudomonas aeruginosa 23
Q
Quality
control for cleaning 42
system requirements 179
Quaternary ammonium compounds 49, 212
R
Radiation
sterilization 144
units 145
Radiofrequency emission 160
Rahn's heat-destruction model 107
Reaction with proteins 138
Record keeping 5, 129
Reduction of bioburden 27
Relative humidity 132
Removal of condensate 123
Reprocessing of flexible fiberoptic endoscopes 232
Requirements for primary packaging 69
Retractors 53
Reuse of disposable medical devices 170
Reuse testing protocols 170
Revaporization 119
Reverse osmosis 35
Rickettsiae 21
Rigid packaging systems 71
Room relationships and adjacencies 237
S
Safe work practices 14
Safety 13, 77
Salt 108
Sampled item portion 221
Sanitation equipment 241
Scissors 52
Second intermediate rinse 59
Secondary
packaging 68
stock 236
Secretion of kinases 23
Selection and use of packaging 95
Selection of
appropriate germicidal procedures 229
disinfection level 208
Sequential wrap method 80
Shigella dysenteriae 23
Silicates 33
Simultaneous method 80
Single
parameter indicators 181
transition point
indicators 189
integrating indicators 189
SMS combination technologies 76
Space planning criteria 236
Spheroplast 22
Sphygmomanometers 17
Splash screen 42
Spore formation 22
Sporulation 22
Spray gun 38
Spun-lace technologies 77
Staff flow 235
Staphylococcus aureus 25
Stationary phase 10
Steam
quality 117
sterilization 184
sterilizers 242
Sterilant mixtures 133
Sterile storage
area 6, 237
environment 164
Sterility
assurance level 4, 135
maintenance 91, 94
covers 97
test 224
Sterilization 4, 86, 94, 205
area 6
cycle development 187
dry heat 124
ethylene oxide gas 129
heat 110
indicator 69
process validation 224
quality assurance program 187
trays and cases 91
Sterilizer requalification 188
Sterilizing
containers 71
drums 71
Sterrad 129
Strains 23
Strength 69, 77, 79
Streptococcus
pneumoniae 23
pyogenes 23
Strict
aerobe 23
anaerobe 23
Superheated steam 116
Survivor curve 106
Susceptible host 46
Symbionts 25
Syphilis 24
T
Telecommunications 241
Temperature 131, 203
Tensides 32
Test for bacterial barrier 77
Test object for
flexible endoscopes 42
hollow instruments 42
Test object surgical instruments 42
Testing of container for a gravity displacement 89
Testing performance of ultrasonic cleaners 40
Textile
packs 73
sheets 70
Thermal death
point and thermal death time 111
time 111
Thermal
destruction of microbes 105
disinfection and final rinse 59
inactivation
kinetics 111
of viral particles 112
processing 11
resistance of spores 111
Total quality management 100
Toxicity 137
of hydrogen peroxide 159
Toxicology 141
Tracking medical supplies and inventory 100
Traffic control and dress codes 168
Transducers 39
Transmission
of bacterial diseases 24
route 23
Transport packaging 68
Trays and baskets 72
Trends in CSSD 236
Tuberculosis 24
Typhoid 24
U
Ultrasonic
cleaner 242
cleaning 38
cleaning equipment 39
generator 39
treatment 60
Ultraviolet
light 42, 152
radiation sterilization 152
United states pharmacopeia 144
Use of
boosters in plasma sterilization 160
sterile products 5
V
Vacuum phase 155
Validation 43, 136
Validation of
packaging system 69
radiation sterilization 151
washer/disinfectors 43
Various distributionsystems in CSSD 7
Verification of cleaning and drying 29
Verifying effective revaporization 120
Vertical transfer 24
Viruses 21
Visual inspection 42
Vitamins 10
W
Walkers 17
Washer-decontaminators/disinfectors 18
Washer-sterilizers 18
Water
cavitation 38
prevents wetting of surfaces 31
quality 32, 62, 217
structure and water properties 31
Web formation 75
Wet-laid technology 76
Wheelchairs 17
Work flow 235
Wrapping
phase 81
techniques for packaging using sheets 72
Z
Z value 111
×
Chapter Notes

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Introduction to Central Sterile Supply Department1

 
Importance of Sterilization of Medical Supplies
Today's medical technology and care of patients is being associated with infectious diseases, which pose a serious threat to people's health. Adequate sterile supply plays an essential role in the attempt to reduce the spreading of diseases within the health service. In a number of chapters, each step in the cycle of sterile supply as it is performed in most health facilities is explained. This chapter describes an overview of the sterile supply cycle.
People come to health facilities to be cured from diseases and injuries: Microorganisms cause many of these diseases. Therefore health facilities are places with a high incidence of disease-causing microorganisms, which are easily spread from patient to patient by the staff, equipment and other materials used for patient care. Moreover many people visiting hospitals are weak and therefore are extra susceptible for acquiring a disease. It is the task of the health facilities not only to cure diseases of its patients but also to prevent transmission of diseases from one patient to the other. An important measure against spreading of diseases is the requirement that all medical supplies, such as instruments, swabs, drapes, etc. which are used on open wounds or will be in touch with the inner fluids of the body, are free of any viable microorganisms. Some of these materials are sterilized at the factory and are designed for single use. However, many instruments and materials used for medical interventions are very expensive and are designed such that they can be re-used. A high-quality reprocessing cycle is necessary in which the used materials are treated such, that they can be used safely again. As the reprocessing of sterile goods has developed into a specialty on its own, reprocessing should be centralized in a single Central Sterile Supply Department (CSSD) serving the whole health facility. In most older health facilities, sterilization is still decentralized. The sterilization activities of these individual departments are best put under the responsibility of a single sterilization professional in charge of sterile supply for the whole facility.
The Central Sterile Supplies Department (CSSD) in the hospital receives, processes, sterilizes, stores, distributes and controls surgical supplies to all departments, wards, 2operating theatres and intensive care units. The CSSD is responsible for increasing the efficiency, economy and uniformity of supplies. CSSD (also called Central Supply Department (CSD) or Sterile Supply Department (SSD) in some hospitals) are responsible for washing and sterilizing certain patient care equipment and instruments and issuing patient care supplies as well as delivering equipment to patient care units.
The aim of the CSSD is to provide all the departments in a hospital with adequate supply of reliably sterilized materials and make them constantly available for both emergency and routine use (Table 1.1). The sterilization is achieved by conducting bacteriologically safe procedures under controlled conditions at a minimum cost. The ultimate aim would be to make patient treatment safe and effective, at the same time, reducing the chances of nosocomial infections (also known as Hospital Acquired Infections).
The whole concept of the CSSD is well understood and implemented by going through the various aspects in a systematic manner. It is essential that the CSSD technologist understands the scientific concepts and principles for effective implementation.
Table 1.1   The main objectives of the CSSD
  • To provide supplies of sterile instruments, linen packs, dressings and other sterile items used in patient care.
  • To maintain a record of the effectiveness of the procedures used in cleaning, disinfection and sterilization.
  • To monitor and enforce controls necessary to prevent nosocomial infection according to infection control policies.
  • To maintain an inventory of supplies and equipment, for a smooth functioning.
  • To be informed regarding newer developments in the field of sterilization practice in the interest of efficiency, economy, accuracy and to provide a better quality of patient care.
  • To provide a safe hospital environment for the patients and staff, in terms of handling patient care equipment.
 
Organization of the CSSD
CSSD should be under technical supervision of a responsible officer who is concerned with the day-to-day management of the unit. The CSSD manager will liaise with the infection control team, OT managers, ward in-charges and other clinical departments. The CSSD Manager is administratively responsible to the head of the health care facility. The CSSD manager also undertakes to provide regular re-orientation and teaching programs on a regular basis to all the CSSD staff and also training courses to new staff. The CSSD manager also undergoes periodic refresher and training courses in order to be updated in the newer aspects of sterilization.
 
Typical Duties and Responsibilities of a Central Sterile Technician (These may vary with the institution)
  1. Picks up and delivers equipment from all areas of the hospital.
  2. Disassembles, cleans and checks for proper function of equipment such as suction machines, feeding pumps, IV infusion pumps, etc.
  3. 3Performs minor repairs on equipment, replaces worn hoses and installs spare parts as needed.
  4. Installs equipment, such as siderails, trapeze assembly and Stryker frames, at bedside as needed.
  5. May provide some functional guidance to personnel operating equipment on units.
  6. Operates gas and steam sterilizers following authorized procedures.
  7. Stocks shelves with clean and sterile supplies.
  8. Washes and disinfects items such as bedpans, scissors, glass syringes and tubing with prepared antiseptic solutions and detergents.
  9. Dries, wraps, bags and seals item in preparation for sterilization.
  10. Cleans and disinfects work area.
 
Education and Training for CSSD Technicians (These may vary with the institution)
High school graduate and three to six months of on-the-job training. Alternately, a CSSD technician may have undergone a training course or ertification from a teaching institute.
Table 1.2   Overall functions of the CSSD
Rinsing, cleaning, drying, inspection, assembly, packing, sterilization, storage and issue of patient care items.
 
Overall Functions of the CSSD
Functions of the CSSD are broadly listed in the Table 1.2. Each of these topics is dealt in greater detail in the subsequent chapters.
  1. Rinsing: Rinsing of used articles is not permitted in patient care areas except in special circumstances.
  2. Cleaning: All reusable medical devices should be thoroughly cleaned prior to disinfection or sterilization. The instruments and materials are taken to the cleaning section of the sterilization department. In the cleaning section the dirty materials are handled; therefore this area is known as the ‘Dirty Area’ of the sterilization department. Cleaning implies the removal all (visible) debris and dirt. The large majority of microorganisms including any disease-causing agents are removed here. Adequate cleaning is considered the most essential step in the reprocessing cycle of sterile goods.
  3. Drying: All articles should be dried appropriately prior to assembly and sterilization.
  4. Inspection and assembly: Each item should be inspected for its correct functionality, defects, and breakage and then assembled using specific tools, if necessary. A missing or failing instrument while performing a surgical procedure is the annoyance of any surgeon. It can be the cause of great problems, for the patient as well as the staff performing an operation. It is therefore essential that instrument trays for all procedures are complete and that each instrument works correctly. That is why each individual instrument is subjected to a vigorous inspection, and that each tray should be double-checked for completeness.
  5. Packaging: Articles should preferably be packed in porous material and individual packs should not exceed 25 × 25 cm in size and not weigh more than 5 kilos. Dating of the package is essential. Details of packing materials and methods are dealt in a separate chapter. 4Before they are used, sterile goods are usually stored until they are needed. In order to prevent recontamination during storage, they have to be packed. This also implies that the load is to be sterilized inside its packaging. Therefore, the packaging should allow for the sterilizing agent to reach the actual load. Whereas after sterilization, it should prevent microorganisms from reaching the items inside; it should act as a microbial barrier. Packaging should guarantee sterility up to the moment a product is used. Poor or damaged packaging makes all the work of cleaning, packaging and sterilization useless.
  6. Labeling: Each pack should carry details of the name of the item, contents, name of person who inspected and packed it and date of sterilization. Each pack must also contain sterilization monitors, which are dealt in a separate chapter.
  7. Sterilization: The whole process of sterilization should be conducted and monitored by trained personnel. The machines used for this purpose should be constantly monitored for efficiency and reliability. After packaging the load is ready to be sterilized. In a sterilizer the microorganisms remaining after the cleaning process are killed. Their number is reduced to a probability, which is considered safe: the Sterility Assurance Level (SAL). A range of methods is in use, all with their specific field of application: Moist Heat, Dry Heat, Ethylene Oxide, Formaldehyde, Irradiation, and Gas Plasma. The most common and safe method used in health facilities is the sterilization by moist heat using pressurized high-temperature steam. The machines used for sterilization with steam are known as steam sterilizers or autoclaves. Sterilizers should meet the stringent technical standards for performance and safety (for example the European norm EN 285 for Large Steam Sterilizers). To ensure the safety of the staff and patients, for each sterilizer used for medical supplies, all processes in combination with each type of load in its packaging should be validated. Simply said: You have to prove that your sterilizer sterilizes.
  8. Storage : Sterilized materials should be stored in a separate area away from un-sterile supplies. Regular inventories are conducted and items staying in store beyond specified periods need to undergo re-sterilization. Upon completion of the sterilization cycle, the goods are taken out of the sterilizer. Based on the registered process data and indicators the cycle is checked and when the required conditions are met, the load is released for storage, transport and use. The sterile goods are stored in a dedicated storage area, where they are kept until they are taken away for the next use. In a sterile storage there are special requirements for environmental conditions and stock management. A regime of product shelf life or the concept of event related sterility is used to ensure the integrity of each sterile item until its use
  9. Distribution: The inflow of un-sterile items coming into the CSSD and the outflow of sterile supplies need to be controlled, logged and monitored.
 
Procedure Manuals
Standard procedure manuals are developed and implemented for all the activities of the CSSD. Operating procedures, monitoring procedures, material handling, re-useable material management, packaging, storage and transport 5of materials are all included in the manual. All staffs working in the CSSD need to be thoroughly familiar with the procedure manual. Regular updates are performed whenever newer techniques or machines are introduced in the CSSD.
 
Storage, Shelf Life and Distribution
Two separate stores are to be provided for storage of un-sterilized as well as sterilized items. Recommended practices for sterile storage environment are given in a separate chapter. The shelf life of a packaged sterile item depends upon various factors like quality of packaging material, storage condition, transport methods, handling procedures, etc. Written policies on shelf life determination are made available to all staff of CSSD. The stored stock is rotated on a principle of “First in, First out”. Upon completion of the sterilization cycle, the goods are taken out of the sterilizer. Based on the registered process data and indicators the cycle is checked and when the required conditions are met, the load is released for storage, transport and use.
 
Use of Sterile Products
Any sterile product needs to be used correctly to ensure its safe use on a patient. By simply opening the sterile package wrongly, the instruments can be contaminated, just before they are used. By considering the concept of aseptic procedures, the chances on recontamination at the moment of using sterile goods is to be reduced to a minimum. The aseptic opening of a sterile pack and the presentation of an instrument to the surgeon are examples of such procedures.
 
Inventory
An inventory control system needs to be designed for control, supplies and movement of items in the CSSD. Inventory of instruments should be maintained at both assembly level and user level. The worksheets needed for this purpose are detailed in a separate chapter. Color-coding of instruments may be implemented for easy identification and sorting of instruments.
 
Record Keeping
Proper records should be maintained with respect to inventory of instruments, functionality of sterilization equipment, maintenance, receipt and issue of supplies, sterilization monitors, damaged and condemned instruments or equipment, etc.
 
Performance Evaluation
A mechanism with requisite infrastructure facilities for evaluating the performance of CSSD should be available. The CSSD manager carries out performance evaluation and review on the basis of records and statistical indices regarding performance quality, productivity and material consumption, etc. once every month. Internal quality audit may be carried on a six monthly basis to assess the efficacy of the system. The feedback arising out of such evaluation should be recorded and made use of in improving the quality related activities in future. Appropriate records should consist of the data reflecting the qualitative and quantitative aspects of the various functional activities carried out in the CSSD. The statistical indices should be so formed that they facilitate quick assessment of the different aspects of the functional activities.
 
Process Validation
Validation of sterilizers shall be carried out as detailed in the following chapters.
 
Location of the CSSD
The CSSD should be located in close proximity to the areas that it serves and to the areas 6that serve it. This not only improves the efficiency of operations but also enhances the efficacy of the hospital infection control program and minimizing the transport of sterile medical and surgical items. Since the operating theatre is a major consumer of this service, the location and design of the CSSD should be designed so that services to the OT are delivered promptly without delay.
Small hospitals may not be able to afford a separate CSSD and in such cases, it may be logical to locate the sterile supplies department within the OT complex.
 
Environmental Conditions
The environment of the CSSD is important in maintaining the integrity of products and in promoting the health, safety and comfort of the CSSD staff. The specification for doors and window sizes, lighting, ventilation, heating, airflow, plumbing, etc. are detailed in subsequent chapters. These standards can also be referred to in the Indian Standard IS 10905 (Parts 1, 2 and 3).
 
Manpower
The number of employees and the space required for their needs (lockers, toilets, changing areas, etc.) shall also be considered while designing the CSSD. The number of employees in CSSD depends upon the bed capacity of the hospital. To prevent contamination and workplace hazard, a dress code shall be followed as set by hospital protocols. Training in handling contaminated supplies and equipment shall be periodically conducted to improve efficacy of the CSSD staff.
 
Systems and Equipment
The department design must accommodate present and planned operational systems; data processing systems, capital and patient care equipment. There must be sufficient space for installation, maintenance, use, transfer, and storage of equipments. The instruments and equipment required by CSSD may conform to the relevant Indian Standards. The number of beds in the hospital and also the required services shall govern the number of these equipments.
 
Planning and Layout
Planning of CSSD shall depend upon the budget allocation and needs. The budget requirements should be estimated according to need and resources.
Layout of a CSSD is dealt in a later chapter.
Upon assessing the data collected on the above factors and considering the following design factors, the CSSD in-charge should actively participate in intra- and inter-departmental planning meetings.
Space shall be provided for the efficient operation of all CSSD functions. The functional design and workflow patterns are designed to help separate soiled and contaminated supplies from those, which are clean and sterile, in order to prevent contamination. The department is broadly divided into six areas:
  1. Decontamination or dirty item receipt area: Here, soiled equipment and supplies are received, decontaminated and such cleaned supplies/items leave this area for clean assembly and storage.
  2. Assembly area: Here space is provided for the packaging of all supplies, non-sterile equipments and other supplies prior to sterilization. Closed shelves are advocated for storage of such non-sterile items until further processing is undertaken.
  3. Linen processing area: Here, clean linen is inspected, mended, folded, packaged and prepared for sterilization. 7Various types of dressings like gauze pieces, cotton swabs, and bandages are prepared in this area. The linen processing section must be ideally separated from instrument assembly area as a lot of cotton and linen fiber is generated in this section.
  4. Sterilization area: This area has the necessary equipment to carry out sterilization processes using Steam, ETO, dry heat, etc. This area is ideally situated between the assembly and sterile storage area.
  5. Sterile storage area: This area is meant for closed shelving of sterile supplies.
  6. Bulk storage area: Bulk supplies, bothsterile and non-sterile, are stored here.
 
Review
The hospital management should review the rough designs to ensure that departmental needs have been met, much before the CSSD is actually commissioned. Financial constraints may demand compromise in the final design and in scope of services. However, infection control principles must always be maintained and patient and employee safety protected. Periodic reviews regarding staff strengths, training and additional manpower/ equipment needs to be addressed in view of growing demands or expanding patient care.
 
Distribution Systems (Table 1.3)
These are methods used to rotate the patient care supplies between various departments and the CSSD. There are four methods in use. The most suitable one should be selected for that particular CSSD.
  1. One for one exchange system: All used articles are collected (in closed canvas bags or similar containers) and similar number of packs and trays in sterile state are returned to the ward. Two to three such rounds of collection and distribution are done in a day.
  2. The milk round system: This system involves the daily topping up of each ward's stock level to a required level. Maximum daily requirements for all the packs are kept in each department. Delivery and collection rounds are planned twice daily. If a single round is made, the stock provided needs to be 50% extra and when two rounds are made the stock provided should be 25% extra over and above the daily consumption.
  3. The groceries system: In this system the wards send their requisition to CSSD from where, deliveries are made in accordance with the demand. This system is not practicable as some wards take up the entire stock from the CSSD having nothing left for others. The efficiency of this system depends upon the seniority and judgment of the person making the indent.
  4. The clean-for-dirty exchange system: In this system, the user gets one clean/sterile article for each dirty article returned to CSSD under arrangement.
Table 1.3   Various distribution systems in the CSSD
  • One-for-one system
  • Groceries system
  • Milk round system
  • Clean-for-dirty exchange system
 
Quality Assurance
Each step in the sterile supply cycle is crucial to a effective and safe use of a sterile instrument or other item during a medical/ surgical 8intervention. A mistake or failure in any of the steps may cause recontamination and makes the whole procedure useless. It may result in huge costs and can cause serious suffering and even endanger the life of patients and staff. That is why each step shall be subjected to vigorous monitoring. This is realized through a Quality Assurance system, in which each step in the cycle is analyzed, documented and monitored. It thus is a tool, to deliver a product that meets predefined quality standards which implies the provision of sterile supplies that are safe to use for patients and staff and perform the function they are intended for against an acceptable price.