Assignment on

Prepared By:

Dr Zulfiquer Ahmed Amin

M Phil (HHM), MPH (HM), PGD (Health Economics), MBBS

ARMED FORCES MEDICAL INSTITUTE (AFMI)

CENTRAL STERILE SUPPLY DEPARTMENT (CSSD)

Introduction

1. The Central Sterile Supply Department (CSSD) comprises that service within a hospital which receives stores, processes, distributes and controls professional supplies and equipment, both sterile and non-sterile to all departments of the hospital for the care and safety of patients1. By custom diets, medicines, and laundry are not included in the department, neither the supply of blood and crystalloid. However, type of supply varies from place to place, hospital to hospital, depending on the resources of the hospital and needs of the departments served.

2. The central sterile services department (CSSD), also called sterile processing department(SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization and other actions on medical devices, equipment and consumables; for subsequent use by health workers in the operating theatre of the hospital and also for other aseptic procedures, e.g. catheterization, wound stitching and bandaging in a medical, surgical, maternity or paediatric ward. Ideally, CSSD is an independent department with facilities to receive, clean, pack, disinfect, sterilizes, store and distribute instruments as per well-delineated protocols. The essentials of this department are correct design, appropriate equipments, skilful operators and proper work flow.

3. While CSSDs may not have the same label, responsibilities or reporting structure, there is one thing that never changes -- the fight against infection. The operations usually consist of cleaning of previously used devices, like stainless steel tools, with a sterilizing liquid. After drying the device on a stand (not by hand or cloth) it gets wrapped in a specialized paper bag (called an aseptor bag), tape-sealed and then sterilized by gas or in a steam autoclave, according to the prescripts in place at the facility.

Background

4. The history of CSSD starts in 1928 when American College Of Surgeons introduced theword CSSD. In1955 the Cambridge Military Hospital established Regular CSSD in United Kingdom. In India, Safdarjang Hospital New Delhi, established the first CSSD in 19652.

5. Until the 1940s, medical/surgical supplies were, for the most part, processed and maintained in the departments and patient care areas in which they were to be used. Under this system, there was considerable duplication of effort and equipment, and it was difficult to maintain consistently high standards for sterilization technique and product quality throughout the health care facility.

6. As the number and variety of surgical procedures grew and the types of medical devices, equipment, and supplies proliferated, it became apparent that a centralized processing was needed for efficiency, economy, and patient safety. The work of scientists W.B. Underwood and J.J. Perkins was instrumental in encouraging health care facilities to establish a separate and distinct department, the Sterile Processing Department, with specialized expertise and direct

responsibility for providing clean and sterile medical/surgical supplies and equipment to patient care areas.

Objective and functions

7. The Central Sterile Services Department (CSSD) is divided into five major areas: decontamination, assembly and processing, sterilizing, sterile storage, and distribution. The objectives of central service include the following:

a. To provide sterilized material from a central department where sterilizing practice

is conducted under conditions, which are controlled, thereby contributing to a reduction

in the incidence of hospital infection.

b. To take some of the work of the Nursing staff so that they can devote more time

to their patients.

c. To avoid duplication of costly equipment's, which may be infrequently used.

d. To maintain record of effectiveness of cleaning, disinfection and sterilization

process.

e. To monitor and enforce controls necessary to prevent cross infection according to

infection control policy.

f. To maintain an inventory of supplies and equipment.

g. To stay updated regarding developments in the field in the interest of efficiency,

economy, accuracy and provision of better patient care.

h. To provide a safe environment for the patients and staff.

Designing of a CSSD:

8. The workload in a CSSD varies from hospital to hospital. The size and location usually

depends on the number of the hospitals the CSSD will serve as well as the number of beds and

the future expansion of the hospital. However 6 to 10 square feet per bed is recommended as an

area of requirement for the CSSD3. It should be located as close as possible to the major user

areas such as Operation theatres, Accidents and Emergency department and wards. The CSSD

layout should be designed for a unidirectional flow. The CSSD should have four zones for a

smooth work flow.

a. The unclean and washing area

b. The assembly and packing area

c. The sterilization area

d. The sterile area

Planning

9. In planning a hospital CSSD, following essential points need to be kept in mind:

a. The materials/ items from contaminated and sterile areas should not get mixed.

b. There should be physical barrier between clean and dirty areas.

c. The floor should be smooth, impervious, non skid and robust.

d. Light fittings should be recessed

e. Relative humidity should be maintained at 45±5 per cent4.

f. The clean area should be provided with air locks and maintained at positive pressures relative to the adjoining spaces. The minimum ventilation rate should be six to 10 air changes per hour.

g. The work area should be made of marble / granite / stainless steel

h. The sterilisation must be planned for autoclaving by steam as well as by gas since certain items such as rubber, plastic or delicate instruments can not be autoclaved.

Location

10. The CSSD should be close to the casuality, operation theatre and wards which are the largest consumer of the sterilised material. In multistoried buildings CSSD may be planned in the lower floor right under the operation theatre where vertical movement will be the quickest possible movement of the material.

Floor Space

11. Ratios have been set up to show suggested relationship of floor of space to number of patients. The important consideration is that all functional areas should be provided consistent with the basic principle of keeping contaminated and sterile materials separate. The minimum area in square feet required per bed is as follows5:

Serial Beds available Floor space required for CSSD1 75-99 10 sq feet per bed2 100-149 9 sq feet per bed3 150-199 8.5 sq feet per bed4 200-249 8 sq feet per bed5 250-299 7.5 sq feet per bed6 300 or More 7 sq feet per bed

The Layout

12. A CSSD should have following layout:

a. Entrance lobby

b. Reception and Cleaning room

c. Glove room

d. Work room (Preparation and assembling of packs)

e. Sterilization room

f. Sterile store room

g. Nurses/Managers room

h. Staff changing room

Physical Facility and Equipment Availability

Sr. No.

Rooms in the CSSDNature of the work

Provision of the Space (%)

1. Wash Rooms Dirty 10

2.Work Room (Packing Room)

Clean 26

3.Syringe & Needle Processing

Clean 9

4. Unsterile Pack Store Clean 4

5. Bulk Store Clean 11

6. Sterile Store Sterile 16

7.

Miscellaneous (a)Gloves room (b)Office room (c)Rest room

Clean 19

8. Autoclaves Clean 5

Workflow in the CSSD

13. Following is the workflow pattern of CSSD7:

a. Receipt: The material that is to be sterilized coming from various

departments arrives in the reception area using stainless steel trolleys via a dedicated

elevator.

b. Cleaning: This function means cleaning of the used equipments/materials,

rubber and plastic goods either manually or by machines eg., washer-disinfector,

ultrasonic cleaner, jet glove washing machines and dryers.(Fig-1) This function may also

include cleaning ofthe delivery trolleys..The common items handled by the CSSD stores

are syringes and needles, Procedure sets which includes Lumbar puncture, Sternal

puncture, venesection, paracentesis. aspiration, catheterization, tracheotomy, suturing,

dressing, biopsy, incision & drainage, aortography cardiac resuscitation, gloves, I.V.

Fluids, treatment Trays, O.T Instruments, O.T. Linen, infusion Fluids for Renal Dialysis

and at times linen from wards etc.

c. Assembly and Packing: It includes checking of glass items for breakages,

needles and instruments for sharpness and breakages, assembling of the equipment after

washing and drying, making appropriate sets for use by various departments and

packaging along with sealing either manually or using a machine before sterilization.

Adequate documentation and labeling of each pack should be done and records should be

maintained.

d. Sterilisation: It renders materials sterile for quality patient care. It is achieved by

steam sterilizers working at specified cycles of temperature and duration to attain

adequate sterility assurance level (SAL). Advantage of steam sterilizers are rapid heating

& penetration of loads, destruction of all forms of microbial life and no residual

toxicity. Different types of Autoclaving machines that can be used are:

(1). Downward Displacement

(2). Vacuum Assisted.

(3). Pulsed Steam Dilution.

e. The capacity of the sterilizer is based on the load and the number of cycles per

day. The load is calculated by estimating litres to each procedure and converting it into a

standard unit i.e st.u(1 st.u = 54L). This value is then divided by the number of cycles

that will be run per day to obtain a value of st.u/cycle. The capacity of the sterilizer is

then selected based on the value obtained. It is better to have 2 sterilizers in case of

breakdowns. Additionally an ethylene oxide sterilizer can be included in a separate

compartment of this area in order to sterilizeheat sensitive instruments.

f. Storage: The function includes storage of sterilized materials where space is

also provided for storing distribution trolleys. Sterile store maintains inventory of all

types of sterile packs. At the end of the path of the treated material a computer terminal

should be provided in order to manage delivery of materials and transport documentation.

g. Issue and Distribution: The function entails issue of the sterilized packages, dressings, linen, instruments and disposables to various departments of the hospitals.

h. Methods of Distribution of Supplies: The aim is to avoid hoarding of supplies in order to minimize unproductive storage of expensive items, re-sterilization of packs kept for long periods and also to avoid stock outs during emergency needs. To satisfy above stated conditions there are following four systems in use:

(1) One for One Exchange System: All the used articles are collected in the locked canvas bags and similar number of packs and trays in sterile state are returned to the respective areas. 2 such rounds of collection and distribution are done in a day.

(2). The Milk Round System: Daily topping up of each department stock level to an agreed level. Maximum daily requirement for all the packs are kept in each department. Delivery and collection rounds are planned twice daily. If single round is made stock provided needs to be 50 per cent extra and when two rounds are made the stock provided should be 25 per cent extra of over and above the daily consumption.

(3). The Grocery System: The departments send their requisition to CSSD from where deliveries are made in accordance with the demand. This system is sometimes not practical as some departments demand the entire amount of stock from the CSSD having nothing left for the others. The efficiency of the system depends on the wisdom and experience of the person making the indent.

(4). The Clean for Dirty Exchange System: According to this system one clean article is issued for each dirty returned to the CSSD.

Process of sterilization:

14. The items to be sterilized at the Central Sterile Supply Department are washed (with

detergent or chemical as applicable), sorted in the washing area. linen from wards and OT are to

be sent directly to the laundry for cleaning. The laundry washed linen are to be received , packed

and forwarded to the CSSD for sterilization.

15. The CSSD technicians or trained nurses shall receive the unsterile packs, inspect them to

check the status of the item (torn, punctured, cracked etc) and place them at the unsterile packs

storing platform. Entry must be made in CSSD receipts register including date, time, type of

instruments in the pack, ward, its source, procedure used for, and case infected or not, name and

signature of person handing over, and name and signature of person receiving The autoclave

indicator is pasted in the packs by the CSSD technician and the packs are taken to the main

sterilizing area where the sterilizing units are placed.

16. The CSSD technician places the unsterile packs under appropriate temperature and

pressure specifications in the sterilizing units. The temperature, pressure specifications and

accordingly the temperature period are for Normal Sterilization, temperature of 1210 C at 15 lb

for 20 minutes, and for Rapid Sterilization, 1400 C at 20 lb for 15 minutes. At the end of the

sterilization the packs are removed from the sterilizing units, the autoclave indicators are

checked to confirm adequate sterilization of the packs, and incase the sterilization is not adequate

the process is to be repeated.

17. A material is pronounced sterile if it achieves 99.99% kill of bacterial spores. Packs

which are adequately sterilized are stored in the sterile storage area. If the sterile packs are torn,

if it has been opened, they are wet, etc, and then the whole process is to be repeated again. In

case the packs which are sterilized in the CSSD and issued to the departments remains un

utilized in the respective user departments for a period of 72 hours , the same are returned to the

CSSD department for re-sterilization.

18. Registers to be maintained in the CSSD are:

a. CSSD receipt register,

b. CSSD issue Register,

c. Equipment Maintenance Record register and Equipment Calibration Register.

19. Maintenance of the equipments are to be done as per the annual maintenance contract

(AMC) entered into with the vendor of the respective CSSD equipments. All details in these

regard are maintained by the Maintenance Department of the hospital. All equipments used in

the department are to be appropriately calibrated at periodic intervals to ascertain whether they

are performing at the expected level and a record of the same is documented in the department as

well as with the concerned case workers working in the administration.

Sterilization Methods

20. Reliable sterilization depends on contact of the sterilizing agent with all surfaces of the item to be sterilized. Selection of the agent to achieve sterility depends primarily upon the nature of the item to be sterilized. Time required to kill spores in the equipment available for the process then becomes critical. Following are the sterilization methods applied in CSSD8:

a. Steam: Heat destroys microorganisms, but this process is hastened by the addition of moisture. Steam in itself is inadequate for sterilization. Pressure, greater than atmospheric, is necessary to increase the temperature of steam for thermal destruction of microbial life. Death by moist heat in the form of steam under pressure is caused by the denaturation and coagulation of protein or the enzyme-protein system within the cells. These reactions are catalyzed by the presence of water. Steam is water vapor; it is saturated when it contains a maximum amount of water vapor. No living thing can survive direct exposure to saturated steam at 250 F (120 C) longer than 15 minutes. As temperature is increased, time may

be decreased. A minimum temperature-time relationship must be maintained throughout all portions of load to accomplish effective sterilization. Exposure time depends upon size andcontents of load, and temperature within the sterilizer. At the end of the cycle, re-evaporation of water condensate must effectively dry contents of the load to maintain sterility.

b. Ethylene Oxide: Ethylene oxide is used to sterilize items that are heat or moisture sensitive. Ethylene oxide (EO) is a chemical agent that kills microorganisms, including spores, by interfering with the normal metabolism of protein and reproductive, processes, (alkylation) resulting in death of cells. Used in the gaseous state, EO gas must have direct contact with microorganisms on or in items to be sterilized. Because EO is highly flammable and explosive in air, it must be used in an explosion-proof sterilizing chamber inn a controlled environment. When handled properly, EO is a reliable and safe agent for sterilization, but toxic emissions and residues of EO present hazards to personnel and patients. Also, it takes longer than steam sterilization, typically, 16-18 hrs. for a complete cycle.

c. Dry heat: Dry heat in the form of hot air is used primarily to sterilize anhydrous oils, petroleum products, and bulk powders that steam and ethylene oxide gas cannot penetrate. Death of microbial life by dry heat is a physical oxidation or slow burning process of coagulating the protein in cells. In the absence of moisture, higher temperatures are required than when moisture is present because microorganisms are destroyed through a very slow process of heat absorption by conduction.

d. Microwaves: The non-ionizing radiation of microwaves produces hyperthermic conditions that disrupt life processes. This heating action affects water molecules and interferes with cell membranes. Microwave sterilization uses low-pressure steam with the non-ionizing radiation to produce localized heat that kills microorganisms. The temperature is lower than conventional steam, and the cycle faster, as short as 30 seconds. Metal instruments can be sterilized if placed under a partial vacuum in a glass container. Small tabletop units may be useful for flash sterilizing a single or small number of instruments, when technology is developed for widespread use.

e. Formaldehyde gas: Formaldehyde kills microorganisms by coagulation of protein in cells. Used as a fumigant in gaseous form, formaldehyde sterilization is complex and less efficacious than other methods of sterilization. It should only be used if steam under pressure will damage the item to be sterilized and ethylene oxide and glutaraldehyde are not available. Its use for sterilization has been almost abandoned in the United States, Canada, and Australia. The method dates back to 1820, and it is still used in Europe and Asia.

f. Hydrogen peroxide plasma: Hydrogen peroxide is activated to create a reactive plasma or vapor. Plasma is a state of matter distinguishable from solid, liquid, or gas. It can be produced through the action of either a strong electric or magnetic field, somewhat like a neon light. The cloud of plasma created consists of ions, electrons, and neutral atomic particles that produce a visible glow. Free radicals of the hydrogen peroxide in the cloud interact with the cell membranes, enzymes, or nucleic acids to disrupt life functions of microorganisms. The plasma

and vapor phases of hydrogen peroxide are highly sporicidal even at low concentrations and temperature.

g. Ozone gas: Ozone, a form of oxygen, sterilizes by oxidation, a process that destroys organic and inorganic matter. It penetrates membrane of cells causing them to explode. Ozone is an unstable gas, but can be easily generated from oxygen. A generator converts oxygen, from a source within the hospital, to ozone. A 6 to 12 percent concentration of ozone continuously flows through the chamber. Penetration of ozone may be controlled by vacuum in the chamber, or enhanced by adding humidity. At completion of exposure time, oxygen is allowed to flow through chamber to purge the ozone. Cycle time may be up to 60 minutes depending on the size of the chamber or load.

h. Chemical solutions: Liquid chemical agents registered by the EPA as sterilants provide an alternative method for sterilizing heat sensitive items if a gas or plasma sterilizer is not available, or the aeration period makes ethylene oxide sterilization impractical. To sterilize items, they must be immersed in a solution for the required time specified by the manufacturer to be sporicidal. All chemical solutions have advantages and disadvantages; each sterilant has specific assets and limitations. These chemicals are: peracetic acid, glutaraldehyde, and formaldehyde.

i. Ionizing radiation: Some products commercially available are sterilized by irradiation. It is the most effective sterilization method but is limited for commercial use only. Ionizing radiation produces ions by knocking electrons out of atoms. These electrons are knocked out so violently that they strike an adjacent atom and either attach themselves to it, ordislodge an electron from the second atom. The ionic energy that results becomes converted to thermal and chemical energy. This energy causes the death of microorganisms by disruption of the DNA molecule, thus preventing cellular division and propagation of biologic life.

Quality Assurance

21. To ensure that instruments and supplies are sterile when used, monitoring of the sterilization process is essential.

Administrative Monitoring

22. Work practices must be supervised. Written policies and procedures must be strictly followed by all personnel responsible and accountable for sterilizing and disinfecting items, and for handling sterile supplies. Following methods to ensure efficient functioning of sterilization process must be routinely checked:

a. Mechanical Indicators: Sterilizers have gauges, thermometers, timers, recorders, and/or other devices that monitor their functions. Most sterilizers have automatic controls and locking devices. Some have alarm systems that are activated if the sterilizer fails to operate correctly. Records are maintained and review for each cycle. Test packs (Bowie-Dick test) are run at least daily to monitor functions of each sterilizer, as appropriate. These can identify process errors in packing or loading.

b. Chemical Indicators: A chemical indicator on a package verifies exposure

to a sterilization process. An indicator should be clearly visible on the outside of every on-site

sterilized package. This helps differentiate sterilized from unsterilized items. More importantly,

it helps monitor physical conditions within the sterilizer to alert personnel if the process has been

inadequate. An indicator may be placed inside a package in a position most likely to be difficult

for the sterilant to penetrate. A chemical indicator can detect sterilizer malfunction or human

error in packaging or loading the sterilizer. If a chemical reaction on the indicator does not show

expected results, the item should not be used.

c. Biological Indicators: Positive assurance that sterilization conditions have

been achieved can be obtained only through a biologic control test. The biologic indicator detects

nonsterilizing conditions in the sterilizer. A biologic indicator is a preparation of living spores

resistant to the sterilizing agent. These may be supplied in a self-contained system, in dry spore

strips or discs in envelopes, or sealed vials or ampoules of spores to be sterilized and a control

that is not sterilized. Some incorporate a chemical indicator also. The sterilized units and the

control are incubated for 24 hours for Bacillus stearothermophilis at 131 to 141°F (55 to 66°C) to

test steam under pressure, for 48 hours for Bacillus subtilis at 95 to 98.6°F (35 to 37°C) to test

ethylene oxide. A biologic indicator must conform with USP testing standards. A control test

must be performed at least weekly in each sterilizer. Many hospitals monitor on a daily basis;

others test each cycle. Very load of implantable devices must be monitored and the implant

should not be used until negative test results are known. Biological indicators also are used as a

challenge test before introducing new products or packaging materials, after major repairs on the

sterilizer, or after a sterilization failure. All test results are filled as a permanent record for each

sterilizer.

Conclusion

23. Each day, millions of medical procedures are performed in healthcare facilities worldwide, with caregivers and patients relying on the availability and use of a wide range of supplies, instruments and equipment. These devices must be properly cleaned, disinfected and/or sterilized, inspected for quality to ensure good working condition, and available at the point of care. In the absence of proper handling, processing and storage, these devices may become contaminated and compromise quality patient care. In most healthcare facilities, the central sterile supply department (CSSD) plays a key role in providing the items required to deliver quality patient care. A well planned, well managed and well staffed CSSD can ensure an infection free environment of hospital and save valuable life and money.

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