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.
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)
- Picks up and delivers equipment from all areas of the hospital.
- Disassembles, cleans and checks for proper function of equipment such as suction machines, feeding pumps, IV infusion pumps, etc.
- Installs equipment, such as siderails, trapeze assembly and Stryker frames, at bedside as needed.
- May provide some functional guidance to personnel operating equipment on units.
- Operates gas and steam sterilizers following authorized procedures.
- Stocks shelves with clean and sterile supplies.
- Washes and disinfects items such as bedpans, scissors, glass syringes and tubing with prepared antiseptic solutions and detergents.
- Dries, wraps, bags and seals item in preparation for sterilization.
- 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.
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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.
- Rinsing: Rinsing of used articles is not permitted in patient care areas except in special circumstances.
- 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.
- Drying: All articles should be dried appropriately prior to assembly and sterilization.
- 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.
- 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.
- 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.
- 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.
- 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
- 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:
- 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.
- 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.
- 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.
- 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.
- Sterile storage area: This area is meant for closed shelving of sterile supplies.
- 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.
- 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.
- 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.
- 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.
- 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.
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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.