Introduction

In spite of all the remarkable advancements in medical science, hospital-acquired infection remains a serious problem in health care today. To make every effort to overcome this, hospitals must have a scientific and effective method of disinfection and sterilization called central sterile supply department (CSSD).

The central sterile supply department is responsible for providing sterile supplies of surgical Instruments, equipment, linen, and clothing. It serves the nursing units, operating rooms, intensive care units, delivery suites, nursery, outpatient department, accident and emergency, radiology, and clinical laboratories. The primary activities of the department are sterilizing, storing and distributing the dressings, needles and syringes, rubber goods (gloves, catheters, tubing), instruments, treatment trays and sets, linen packs, etc. There is one exception to the range of materials that should be sterilized centrally: the surgeon’s instruments used in major operating theatres. Because so many surgeons like to have their own individual sets of adjoining instruments, it is generally more convenient to arrange for these to be sterilized in a room the operating room. All other requirements for operations, including dressings, bowels, syringe, and so forth, can be supplied to the operating room from the CSSD.

 

Definition

CSSD is a service unit in a hospital that processes, issues, and controls the sterile stores supply to all departments of the hospital.

 

Historical Development

 

Now, CSSD in an integral part of every hospital

Aim

To provide the safe and sterile supplies to all the user units of the hospital.

 

Function Of Cssd

1. Receiving unsterile stores, instruments, equipment and linen from medical stores and various consumer departments of the hospital.
2. Sorting out the items.
3. Washing, disinfection (where required) and drying.
4. Gloves processing and testing, powdering (if disposables are not being used).
5. Washing, cleaning, drying of syringes and instruments.
6. Checking and packing of sets/trays/instruments.
7. Sterilization of all the items received, by using the appropriate techniques as applicable to the items.
8. Storage and issue of the sterilized items to the consumer departments.
9. Maintaining records of the stores received, processed and issued.
10. Validation of the effectiveness of sterilization techniques.
11. Training of the staff in the techniques of sterilization.
12. Advice to the consumer departments on sterilization of items of different nature.

 

Advantages of CSSD

1. Assured sterility by specialized technicians to release nurses for direct patient care.
2. Duplication of ward processing equipment is eliminated.
3. Storage and sterilizer space in wards is reduced.
4. Treatment equipment in circulation, and its control by nurses, is reduced.
5. Replacement of worn and purchase of new treatment equipment is better controlled.
6. More service is derived from equipment before it becomes redundant, obsolete, or deteriorated.
7. Standardization of items is assisted.

 

Objectives

To sterilize and supply

1. Reusable medical, surgical/nursing equipment, instruments, materials, clothes and solutions for wards and specialty areas.
2. Sterile disposable medical, surgical, and nursing materials and solutions, materials for dressings and procedures carried out in wards and outpatient departments.
3. Medical equipment, diagnostic, therapeutic/ surgical instruments, trays, furniture, and linen used in operating rooms.
4. Medical, surgical, and nursing equipment such
5. As ventilators, baby incubators, oxygen tents, etc. To effect economy by operating from one central area
6. To achieve greater uniformity by standardizing techniques of operation
7. To train personnel in processing procedures.

 

Policies

1. To maintain minimum inventory, capable of meeting normal and emergency needs, and to reduce reinvestments in specified supplies.
2. To prepare, store and supply sterile items as and when required by the hospital service units. To receive the items to be sterilized from all the departments of the hospitals only if it is packed properly.
3. To follow the technical and administrative procedures and infection control protocols of sterilization to keep required standards.
4. To carry out safe maintenance, operating sterilization machines as per the instructions manuals
5. To follow aseptic techniques while repacking and storing sterilized items
6. To use the right types of containers for holding steel drums and muslin wrappers
7. To meticulously follow fire-safety precautions and procedures
8. To schedule daily/weekly/monthly supply pattern of the sterile items to all consumer service units.

 

Procedures

1. Receiving and sorting soiled material.
2. To decide whether to reuse or discard
3. Processing of decontamination or disinfections prior to sterilizing
4. Carrying out specialized cleaning of equipment and supplies
5. Inspecting instruments, equipment and linen Assembling treatment trays, instrument sets, linen packs, etc.
6. Sterilizing
7. Packing, labelling and dating sterile items
8. Storing and controlling inventory Distribution of sterile items.

 

 

Rules

1. Only authorized staff to enter department Users’ supplies requisitions signed by authorized person except in emergencies
2. Length of storage time after which sterile items are re-sterilized
3. Information on wrapper or other container labels such as identification of contents and date processed
4. Frequency of changing water-still filters.

 

Environment

All storage areas should be clean and protected from condensation and vermin. Store cupboards should be warm and adequately ventilated. Work involves the possibility of workers sustaining cuts from instruments and burns from sterilizing equipment. Much of the work is repetitious.

 

Organization of CSSD Departments in the Hospitals

1. In all most all the hospital, the CSSD is attached to the nursing department; rarely does it function independently with the qualified CSSD staff because of non-availability of qualified staff
2. The qualified staff job responsibilities are supervised and coordinate inter and intra departmental staff and their flow of work, establishes methods and work performance standards for preparing and handling sterile items, demonstrate to personnel procedure such as proper use of sterilizing equipment, setting up treatment trays and maintenance of equipment’s, ensure aseptic techniques, ensures that work and storage area are clean and orderly, takes microbiological sample of air, equipment, air, and surfaces and sends to the laboratory for sterility check, maintains adequate stock on inventory records, follow the effective supplying procedure, prepare periodical reports on activities of the department, maintain necessary records and impart the in-service training for new staff

Usually, attached to the nursing department, a senior nursing staff, dedicated and hard working is sent for training for sterilization of hospital equipment’s and later the same person will be posted as the in charge of the department under the supervision of the nursing matron

Apart from the in charge two or three in-service trained CSSD technicians will be posted. Whereas in the big hospitals, a separate CSSD department with qualified personnel with modern equipment’s will be maintained.

 

Quality Management Of Services In CSSD

Quality management of services in CSSD is extremely important in view of its role in the hospital infection control and the catastrophic effects the poor-quality services may have on the patients. However, quality of services can best be judged from level of satisfaction of the clientele. The clients in case of CSSD are all internal (consumer departments/clinicians) and high quality CSSD services to them means:

1. Hundred percent reliability of sterility of the stores supplied by CSSD.
2. Timely supplies in the right quantities.
3. Contents of the trays/sets are as per the standard lists provided by users and all the contents are in full operational order.
4. The trays/sets are labelled correctly.
5. The sterile items supplied remain sterile up to their pre-determined shelf life.
6. Quality of the items does not deteriorate by the sterilization techniques used.
7. The quality of outcome, however, depends upon the quality of infrastructure and processes used in the CSSD.

Supplies

The following departments and its items to be supplied properly on time without any hindrance

1. Surgical Suite
2. Dressings
3. IV solutions
4. IV Administration sets,
5. Linen
6. Basin sets
7. Surgical instruments and accessories
8. Airway tubes
9. Succession catheters
10. Gloves
11. Disinfectants
12. Special trays
13. Neddles.

 

Delivery Suite

Diagnostic equipment

1. Dressings
2. IV solutions
3. IV Administration sets,
4. Linen
5. Linen packs
6. Basins
7. Delivery instrument sets
8. Gloves
9. Disinfectants
10. Special trays
11. Needles.

 

Nursery

1. Bathing sets
2. Sterile linen
3. Thermometers
4. Diagnostic equipment
5. Trays
6. Nursery incubators and resuscitators.

 

Outpatient Department

1. Diagnostic Equipment
2. Rubber goods, such as gloves and catheters
3. Trays
4. Dressings
5. gloves.

 

Radiology

1. Diagnostic sundries
2. Needles and syringes
3. Inhalation equipment
4. Gloves and rectal tubes
5. Miscellaneous supplies.

Work flow of CSSD

 

 

 Physical Facilities

Location

It should be ideally located in close proximity to the user units, i.e., OT, ICU, Wards, Emergency and Labour room for effectiveness and efficiency. It should have adequate facility of cold and hot water, steam and compressed air and electricity.

Space Requirement

The minimum area in square feet required per bed as recommended (Giford, DL-1963).

No of Beds	Space Requirement
75-99 beds	10sq. feet/bed
100-149 beds	9sq. feet/bed
150-200 beds	8.5sq. feet/bed
200-249 beds	8sq. feet/bed
250-299 beds	7.5sq. feet/bed
More than 300 beds	7sq. feet/bed

 

As a rule of thumb, the following requirement of CSSD in hospital

S. No	No of Hospital beds	Type of facility
1	Hospital up to 100 beds	TSSU
2	More than 100 beds	CSSD in service area
3	More than 500 beds	CSSD in service area and TSSU in OT

 

The total space is functionally divided into the following areas:

1. Sterile storage area.
2. Equipment storage area.
3. Clean work area including area for sterilization.
4. Syringes, needles and fluids storage
5. Receiving and clean up area
6. Glove processing area.

The flow of work should be unidirectional and without back tracking to prevent mixing of sterile goods with the unsterile goods.

 

Staffing

The CSSD staff will include:

1. Supervisor of CSSD
2. CSSD Technicians
3. Clerks
4. Assistants or helpers
5. Messengers.

The staff strength varies from hospital to hospital depending upon the bed strength and work load as a rough guide hospital management (1961) has recommended one employee per 30 beds.

 

Equipment’s

The types of equipment’s required in the CSSD are:

1. Hot air ovens
2. Cleaning and decontamination devices
3. Glove processing unit chemical
4. Dry heat, steam, gas, autoclaves
5. Instrument sharpeners
6. Needle sharpeners
7. Testing apparatus to measure efficiency of sterilization
8. Trolleys, work surfaces, repairing tools.

 

 

Sterilizer

Ethylene Oxide Sterilizer (ETO)

“Ethylene oxide sterilizer” is defined as equipment which uses ethylene oxide as a biocide to destroy bacteria, viruses, fungus and other unwanted organisms. Ethylene oxide is used in sterilization of items that are heat and moisture sensitive. Ethylene Oxide (ETO) is a chemical agent that kills micro organisms by stopping the normal metabolisms of protein and reproductive process resulting in death of microorganisms. This is a commonly used sterilizer in various industries including Medical-Disposable equipment suppliers, pharmaceuticals, museums, and hospitals.

 

 

Steam Sterilizer (Autoclave)

Steam sterilization is most commonly used sterilization because it is safe, inexpensive, and time saving. The outer layer of some microorganisms is softened by the steam which coagulates the internal portion of the organism. In this way, steam sterilization is effective against microorganisms. The steam sterilizer is operated either by supply of steam passed through a pressure reducing value from the boiler or by in built electrical steam generators. Steam sterilizers are used for sterilization of glass wares / containers, vessels, linen, rubber articles, operation theatre instruments, etc.

Dry Heat Sterilizer

Dry Heat Sterilizer is effective mode of sterilization. It is an equipment with electric resistors distributed inside the cabinet that is isolated with a panel for temperature control. Dry heat will penetrate all kinds of materials, such as oils, and closed containers.

Dry Heat Sterilizer is used to do dry sterilization of surgical instruments, medical, dental, aesthetic, laboratories, industries and other glassware’s.

Multi-column Distilled Water Plant and Pure Steam Generators

Sterilization process needs high quality pure steam with accurate pressure control. The steam generator removes non-condensable gases.

Medical. Washer Disinfector

An efficient aid for the cleaning and the thermal disinfection of all Medical, Dental and Laboratory instruments. A washer of a modern concept, designed and constructed in compliance with the guidelines indicated in the new European Norm concerning safety and hygiene. The washer can be placed on any work surface and is simple to install, the built-in detergent compartment and dispenser are standard features.

Sterilization

Sterilization is a process of freeing an article from all living organisms including bacteria, viruses, fungi and spores. The sterilization process prevalent in hospitals can be classified as:

1. Heat Sterilization

a. Dry heat sterilization

b. Sterilization by steam

 

2. Ethylene Oxide Gas (ETO) Sterilization

3. Chemical sterilization

4. Radiation sterilization- Gamma radiation

a. Heat sterilization by dry heat: In the conventional hot air oven, the sterilization is carried out at about 160°C for 1 hour. The most suitable article for dry heat sterilization is glass wares, particularly glass syringes, but now the use of glass syringes has become almost obsolete. Another article is cutting edge instrument.

b. Heat Sterilization by Steam: The item are first of all prepared for steam sterilization in the following manner:

 

Each type of the item is subjected to temperature of 134°C for 3 minutes on 121°C for 15 minutes. Flash sterilization or quick sterilization technique is usually preferred in TSSU, because flash sterilizer achieves a temperature and pressure for sterilization in minutes.

1. Ethylene oxide gas (ETO) sterilization: Ethylene Oxide kills microorganism altering the DNA by a process of alkylation. ETO may be diluted with carbon dioxide or Nitrogen. ETO is supplied in small cartridge of 100%. ETO and large cylinders of 12% ETO and 88% other halogenated hydro carbons. Delicate surgical instruments, such as cystoscopes, heart lung machine, electrical equipment’s, endoscopes, implants are sterilized by this method.
2. Chemical sterilization: It is an absolute process, where in the spores are also eliminated in addition to the above. Certain terms need clarification on the context of infection control practices:

a. Disinfectant: Applied to inanimate objects. Ii. Antiseptic: Applied to living tissue (anti sepsis).

b. Degerming: Mechanical removal of most microbes in a limited area, e.g. Alcohol swab on skin.

c. Sanitization: Use of chemical agent on food handling equipment to meet public health standards and minimize chances of disease transmission, e.g. Hot soap and water.

 

 

Factors affecting disinfection:

1. Types of organism present
2. Temperature and pH
3. Microbial load
4. Concentration of disinfectant.
5. Amount of organic matter present.
6. Nature of the surface.
7. Length of contact time.
8. Type of water used (hard or soft).

 

 

New methods of disinfection practices in the hospitals:

Process	Agent Used	Status
Disinfection Sterilization	Orthophtaldehyde (Cidex)	FDA cleared 1999
	Antimicrobial coating (Surfacing )	Not cleared by FDA
	Superoxide water (sterilox)	Not cleared by FDA
	Liquid sterilisation	Not cleared by FDA
	Rapid read out ethylene
	Oxide biological indicator (Attest)	Not cleared by FDA
	New Plasma sterilizer (sterrad)

 

New Disinfectant (Superoxide water): Concept of electrolyzing to create a disinfectant (saline +electricity) Sterilex (mixture of oxidizing species). Main products Hypocholorous acid (144mg/1) and chlorine radicals. Passing saline soln. over titanium coated electrode. Super oxidized water is rapidly effective (<2 min) reduce 5-log 10. Effective against Mycobacteria, viruses, fungi and spores. But organic material may reduce its effectiveness.

Chemical Sterilization System (Endocleans): Chemical use in endoscope-reprocessing system/machine controlled by computer. Chemical Sterilant that uses Performic acid generated by Hydrogen peroxide and formic acid. Effective against wide range of Bacteria and spore (less than 30 min). In whole process, two endoscope simultaneously can be cleaned. Washing, rinse detergent, cleaning, enzymatic detergent, leak detection everything can be performed.

Chemical methods of microbial control: Halogens: Effective alone or in compounds.

 

 

 

When mixed in water forms Hypocholorous acid:

Cl₂ + H₂O → H⁺   + Cl^–  + HOCI

(Hypocholorous acid)

 

Used to disinfect drinking water, pools, and sewage.

Chlorine is easily inactivated by organic materials.

1. Sodium hypochlorite (NaOCI): It is active ingredient of bleach.
2. Chloramines: Consist of chlorine and ammonia. Less effective as germicides.
3. Non-Carcinogenic Terminal Disinfectant: H₂O₂ + Ag + (11% v/v Stabilised H₂O₂ + 0.1% Ag).
4. Terminal cleaning: Make 5% soln. with water. Mop liberally all surfaces, walls and floor of OT. As aerial disinfectant: make 20% soln. with water then thorough cleaning.
5. Radiation Sterilization: Gamma rays are used for sterilization of articles. This method is useful for sterilization of the disposables. The advantages are that: reliability, high degree of penetration, large and diverse shaped article can also be sterilized and there is no residual radioactivity.

 

 

Reassembling and Packing Area

This area receives all the sterilized items from the sterilization-processing unit. Items are classified and separated again department wise to reassembling the set to ready for reuse. As a set it is ready for packing to supply the sterilized items to the concern departmental use.

1. Receives all the sterilized items, department wise. items are classified for packing
2. Inspects the items before repackaging and ensure that it is 100 percent sterile.
3. Inspects instruments and needle for their sharpness, impairment of performance, etc.
4. All items properly packed with 2 layers of linen or draft (thick brown wrapper paper), if craft paper is used, it may be finally wrapped with linen. The craft paper is efficient bacterial barrier between the atmosphere and sterilized item it encloses.
5. Ensure proper packing methods and techniques, thereby the constant control is effective all the packed items should forwarded to the storage and supply section.

 

Storage and Supply of Sterilized Items

1. Receives and keeps the all the packed items according to the department in respective earmarked area.
2. Maintain optimum stock to provide smooth supply, at least 5 sets should be available for each departmental purposes as they are 2 sets in the concerned departmental use, 1 set for ready for supply, I set for standby and 1 set under the sterilization processing.
3. As cost control maintain proper inventory accounts, avoid over stock, good control on pilferage, theft, and avoid rough handling of items. The same time never allow the under stock level, this hampers work as well as patient care
4. Sterilization of surgical instruments and linen for use in the operation theatre.
5. Supply of sterilized instruments and materials for dressing to the accident and emergency department, outpatient dressing room, orthopaedic dressing room, wards and other hospital department.
6. Packed Items were properly distributed on time.
7. Maintain an accurate inventory of supplies and equipment in the supplying sections. Maintain adequate stock on hand by visual inspection and counselling inventory records. There should be proper record system such as receiving register, separate file for all the requisition for sterilization processing from all the department, proper account for processing items, bin card for each item, bin card for each department, alphabetical index for all the items for cross reference, proper stock register, issuing register, request and register ordering new items, register for receiving new items. Receiving proper central inventory register for all the hospital items related to CSSD, register for condemned items
8. Process, maintain and dispense supplies and equipment required by operation theatre, intensive care unit, wards, accident and emergency department, outpatient and orthopaedic dressing room for care, diagnosis or treatment of patients. Surgical instruments and medical supplies do not normally offer a target for massive diversion. Even petty pilferage is rarely significant in this area in terms of total quantities, and most of it is not preventable. Disappearing thermometers can amount to a substantial loss over a long period, but stolen bandages, adhesive tapes, gauze bandages; pins and needles will never amount to more than a negligible fraction of the total expenditure for surgical supplies. The notorious loss of stethoscopes and ophthalmoscope at the end of the residents’ term usually a substantial, but it occurs once a year and again is not completely preventable. In central surgical supply itself scissors may be the one major target. Most staff that work in these departments has little use for other surgical instruments. There have been occasions where a connection was established between an employee in the central supply room and a privately owned surgical supply house, but those incidents are infrequent.

 

Periodical Monitoring, Reporting and Actions

Periodic and regular monitoring of infections occurrence or presence of patient, operation theatre, intensive care unit, accident and emergency service, wards, etc. within the hospital by patient blood sample investigation and report on swab culture of the section or equipment or instruments with the help of microbiologist. If any infectious case is found and it should be reported immediately hospital administration, infection control committee, and alert the concerned those who are involving particular patient or section. Also, the proper policies and procedures of infection control should be

 

Operation

1. Rinsing: It should preferably be carried out in CSSD.
2. Cleaning: It is done either manually or by ultrasound washers.
3. Drying: All items should be dried, as drying itself helps in sterilization.
4. Inspection and Assembly: Every item must be inspected from the point of view of functionality, defects and breakage or damages. Those damaged should be condemned or those repairable, should be repaired then assembled.
5. Packaging: It is done with the help of porous material like linen or paper.

6.Labelling: Labelling is done for identification and for knowing shelf life of item. Following details must be noted while labelling:

 

a. Identification number.

b. Barcode: If bar code facility is existing

c. Contents of pack

d. Date of sterilization

e. Shelf life

f. Quality check certificate “OK”

g. Initials of person who carried out sterilization

h. Initial of quality control person

i. Initial of packer

 

7. Sterilization: As per requirement, type of the article and as per the standard procedures.

8. Storage: There should be a separate storage area for sterile and unsterile goods.

9. Distribution: To provide quality medical care, there should be an effective distribution system. There are following types of distribution system in practice:

 a. Topping up: The predetermined levels of each item are fixed for each user unit. Maintaining these items at fixed levels. Topping up round are taken from CSSD.

b. Clean for dirty exchange: One clean article for each dirty returned to the CSSD by user unit.

c. Ordinary order system: The materials which are required by the user department are ordered directly to the CSSD as and when required basis.

d. Regular Complete stock Issue: Complete requirements of the user units are determined and full box, trolley or basket containing all such items. Are issued to the user units. At a regular interval, the full quota is replaced by the CSSD, whether the part or full quantity has been utilized by the user unit or not. Meaning thereby full quota is exchanged between user unit and CSSD.

 

Policies and Procedures

There should be a well documented policy of the CSSD and procedure manuals for all the procedures to be carried out in the CSSD, should be in place and be followed correctly:

Managerial Issues

1. Preventive maintenance of the equipment
2. Inventory control
3. Standard operating procedures (SOP) for all the procedures
4. Quality management and application of 5’S’ techniques and six sigma techniques for quality management
5. Monitoring and evaluation of the sterilization procedures, techniques and 1 effectiveness
6. Training of staff of CSSD
7. Evaluation system of sterilization process

 

The Infection Control Committee

1. Decides policies and procedures, on general cleanliness, termite and pest-control, aseptic techniques, disinfectant procedures including use of chemical disinfectants, antibiotics, immunization, communicable diseases, etc.
2. Conducts periodical review of statistics on nosocomial infections. Promotes comprehensive and concurrent screening systems to promptly detect all deviations from defined levels of care, carries out evaluation of routine surveillance activities including reports on microbiological swab counts of critical areas surveyed, supervises epidemiological investigations and convey execute infection control policies and procedures.
3. A response mechanism that concurrently corrects the errors by analysis and provides feedback for the growth and development of the system.
4. The Infection control committee has the responsibility of monitoring CSSD to:

a. Ensure proper sterilization procedures carried out in the CSSD.

b. Ensure safe storage, adequate in proper packing and labelling of sterilized items for the respective departments.

 

Common Problems

1. Unsterile supplies room becoming a dump for medical equipment discarded or waiting collection by manufacturers.
2. The ready availability of sterile items from CSSD may encourage waste in their use and consequent waste of resources.

 

Biological Indicator System

The biological indicators have been used worldwide by medical and industrial facilities to monitor steam, d low temperature steam, formaldehyde, ethylene oxide gas, propylene oxide gas, dry heat, hydrogen r peroxide, and radiation sterilization processes. The Smart-Read system includes the Smart-Read EZTest self-contained biological indicator for steam which is specially designed for rapid evaluation in the advanced Smart-Well® incubator.

 

 

Smart-Read™ EZTest Biological Indicator Monitoring System

The Smart-Read TM EZTest® Biological Monitoring System allows an organization to release sterile product with true biological confirmation faster and easier than ever before. This unique system uses a real biological indicator (BI)-with no added enzyme or chemical integrator-which is incubated, evaluated, and documented in one simple, automated operation. Relying only upon bacterial spore growth, the Smart-Read system can detect sterilization failure in as few as 3 to 5 hours, and confirm sterilization in only 10 hours. The Smart-Read system includes the Smart-Read EZTest self contained biological indicator which is specially designed for rapid evaluation in advanced Smart Well incubator. Based on familiar, proven technology, the Smart-Read system can be implemented by any organization with minimal training and validation.

Though a highly sophisticated tool, the Smart-Well incubator is easy to configure and monitor with its simple touch-screen interface. The incubator can evaluate up to ten Smart-Read EZ Test biological indicators independently, and contains an additional cell for a positive control unit. Each BI test result is automatically documented with a user-customizable printed report, and an alarm is sounded the moment that sterilization failure is detected. The incubator also contains an NIST-traceable thermometer marked at the appropriate incubation temperature to allow the operator to quickly verify proper operation.

The Smart-Well incubator is offered in a kit including the incubator itself, stylus, report printer, record book for storing reports, thermometer, and all necessary cabling.

 

Summary

CSSD is a very important department from the quality point of view because quality and efficiency of this department can affect the quality of services of all other departments that use sterile supplies from CSSD. Therefore, the department should have adequate infrastructure of the right quality, including well trained manpower, facilities and equipment conducive to high level of asepsis. There should be documented policies and working protocols that are strictly implemented to ensure that sterilization procedures are carried out as per acceptable norms and standards. Not only that, there should also be a system of monitoring the quality of process as well as outcome so that deficiencies can be detected and timely corrective actions taken to prevent disquality.