Title/Description: Central Sterile Services Department: Central Sterile Services Personnel: Central Sterile Services Personnel Effective Date: 1/97 REVISED: 1/97, 11/07, 2/12 I. PURPOSE Central Sterile Services Department will receive, decontaminate, process, store and/or dispense sterile and non-sterile to departments requesting. II. POLICY A. Personnel Wear gloves if you have: Clean cuts. Traumatized areas (burns, etc.). Handled any contaminated item. Rotate through decontamination area to reduce exposure to contaminants and biohazardous material. B. Attire-General Appropriate clean scrub clothes. Employees may launder their own scrub clothes only if there is no blood/body fluid contamination. Personalized warm-up jackets over scrub attire when leaving the department. Clean, comfortable, closed toe shoes will be worn. C. Jewelry Jewelry should be kept to a minimum. Earrings - small studs or circles, no dangling type (all must be covered by cap). Rings - wedding band and simple types.
D. Attire-Decontamination Area Scrub clothes covered by a full length gown with long sleeves. Hair covered by lint free cap. Disposable gloves. Goggles (safety type) or eye shields. Disposable mask. E. Work Flow Patterns Design and space provides for separation of soiled and contaminated items from those that are clean and sterile. All soiled reusable items shall be brought to the soiled receiving area for appropriate decontamination and cleaning. The decontamination area is provided with a negative air flow pressure and in a limited enclosed access area. Sterile supplies and clean equipment are dispensed from the clean area of the department. The area for dispensing and storage of clean and sterile items is supplied with a positive airflow. The general processing room for all equipment and supplies is furnished with a positive airflow. Sterile items should be stored in a well-ventilated area. Sterile items must be clear of sprinklers and air vents within the storage area. Sterile items must be stored in a limited access area. Open shelving is used for the storage of clean equipment. The bottom shelf must be solid or covered. Sterile storage is accomplished by utilizing a covered space. All equipment that leaves the department is covered. Shipping cartons are to be unloaded in the waiting area and not allowed in the storage area. Fans are not allowed in the area due to positive and negative air.
F. Transporting Sterile Items Items should be transported so as to maintain clean lines and sterility and to prevent physical damage. Supplies should be handled carefully to avoid crushing, bending, compressing or puncturing the packages, or otherwise compromising the sterility of the contents. Packaging should be given thorough visual inspection. Covered or enclosed carts are recommended to protect sterile items from inadvertent contact with personnel and other environmental contamination. G. Decontamination Area All equipment and items designated for patient usage must be subjected to a "decontamination" process by the Central Sterile Services prior to its reuse. All contaminated equipment will be received in the "dirty area" of Central Sterile Department for cleaning. All contaminated items and equipment must be covered and labeled with the biohazard symbol. All disposable equipment is to be used one time, single patient use only. All returned equipment and instrument trays must be checked by floor personnel prior to sending it to Central Sterile for the removal of: 1. All sharps, which must be placed in a puncture proof sharps container that is leakproof on the sides and bottom labeled with the biohazard symbol. 2. All disposable items. 3. All equipment which cannot be processed by Central Sterile. H. Isolation Equipment or any Equipment Exposed to Blood or Body Fluid: 1. Red bagged. 2. The biohazard symbol prominently displayed. I. Cleaning Manually washed in a neutral ph detergent.
Never put hands in sink with sharps, use open weave stainless steel mesh baskets to lift the sharps out of the water before handling. Any visible blood must be cleaned with an approved hospital disinfectant. Any equipment that can not be washed must be cleaned with an approved hospital disinfectant. Inspected for mechanical and electrical defects. Dried and transported to the processing area for labeling and wrapping in appropriate packaging. Instrumentation will be washed in the ultrasonic washer and the automatic washer disinfectant. Rinse instrumentation under running water to remove gross contaminants and reduce bioburden. Water in ultrasonic is changed 2-3 times per shift or more frequently as needed. Open all hinged instruments and load in open weave stainless steel mesh baskets, separate all cannulated instruments. Remove washed instruments from ultrasonic washer and process through the washer sterilizer. Load automatic washer and activate. When cycle is complete, the personnel in the clean area will remove and process the washed instruments. All equipment and/or instruments having been released from this department and in patient contact will be regarded as contaminated. Therefore, no matter what the bioburden or contaminant, all equipment and instrumentation will receive terminal disinfection and/or sterilization before it is released for another patient s usage. In the rare event that any unsterile item leaves Central Sterile before sterilization the container must be opened, peeled partly opened or the tray unwrapped. J. Sterilization/ High Level Disinfection Patient care equipment that enters normally sterile tissue or the vascular system should be sterilized. Laparoscope and other scopes that enter the peritoneal cavity should be subjected to a sterilization procedure. If this is not feasible, then high level disinfection. Endoscopes and Respiratory Therapy equipment that touches the mucous membranes must be at least high level disinfected.
High level disinfection takes place at the point of service of usage that is possible. Methods of Sterilization In Central Sterile Steam - Gravity or pre-vacuum. Sterrad - Hydrogen Peroxide Plasma Material For Processing K. Non-Woven Synthetics, Paper/Plastic Combination Paper product in use must meet the standards set for medical grade paper. Bacteria barrier design. Hypoallergenic bio-degradable. Check for defects, holes, sealing lines continuity. Utilize appropriate size for item to be contained. L. Stericloth Stericloth blend offers far greater durability than previous all cotton versions. Stericloth is the most tightly woven fabric available, which helps cut down on airborne bacterial migration. When any fabric is woven, there are open spaces between the warp yarns and the filler yarns. These open spaces are called "INTERSTICES", and bacteria can migrate through the interstices of any woven fabric. However, in Stericloth, the interstices are extremely small, so it is difficult for bacteria to penetrate (as bacteria are moving through the air, they meet the Stericloth fabric, most bacteria would be stopped by hitting the yarns themselves, and an extremely small percentage would actually penetrate through the fabric itself). In addition to curtailing airborne bacterial migration, Stericloth has a Fluid Repellent finish to retard the passage of fluid-borne bacterial migration. Proper precautions must be observed to assure that Stericloth is removed from service once the finish has lost its effect.
For this reason, there is a "Grid" on all wrappers to make it easier to know when an item should be removed from service. M. Stericloth Wraps Packs shall be wrapped utilizing the oblong design. Wrap as loose as practical to allow steam penetration. Place last item to be used first in the pack. All packs double wrapped with outer wrapper serving as dust cover/barrier. Linen is to be packed separately. Place chemical indicator in center of linen pack. Tape, label and process. N. Non-Woven Material 1. Paper Instrument trays wrapped utilizing the envelope method. Utilize paper size and weight appropriate to item. Double wrap all trays, outside wrapper is dust cover. Include a chemical indicator in center of tray. Tape, label and process. 2. Paper/Plastic - Pouches Self seal/heat seal. Utilize size to fit item. Double wrap those items with sharp points, edges or if a quantity or more than two (to facilitate ease in handling). Include chemical indicator in packaging - seal. Label and process.
O. Instrument-Lock-Box Container System Place filters in container sections - lock Arrange instrument tray lined with paper pouches to protect instrument points. Include chemical indicator in center of instruments. Lock box with self-containing handles and insert arrow. Insert breakable "arrows" as tamper proof seals. Visually and mechanically check internal gaskets. Process tray. Labeling and Identification P. Muslin / Steri Cloth Wraps Packs Autoclave tape - proof of heat process. Type of pack. Julian Calendar date, load number, and autoclave number. Initials of technician preparing pack. Q. Linen Towels, gowns, sheets etc. Contents named on front. Secured with autoclave tape to show proof of heating. Julian Calendar date, load number, and autoclave number. Initials of technician preparing linen items. R. Paper Products Tray's contents listed or name of tray. Peel packages not necessary to list name of item (opaque).
Autoclave tape if necessary to securing package or tray. Julian Calendar date, load number, and autoclave number. Initials of technician preparing the items. Make sure that chemical indicator is visible. S. Instrument Sets Preparing and wrapping: Inspect instruments for cleanliness, dryness and function. Open, unlock or disassemble to permit steam contact of all surfaces. Use mesh bottom trays or equivalent. Distribute instruments equally and avoid concentration of metal mass. Place chemical indicator ink side up on instrument. Wrap box, secure and identify. Total weight not to exceed 17# (tray, instruments, wrappers) Process accordingly. T. Unusual Occurrences Instrument set weighing more than 17#. Prepare in standard fashion. Process by itself and increase dry time. Use larger tray than ordinary to distribute metal mass. Separate instrument layers. U. Loading Steam Sterilizers (Gravity and Pre-Vacuum) Place wrapped instrument trays flat on loading car shelf. Wrap packs on edge for steam penetration. Combined loads: Fabrics and hard goods. Place fabric on top shelf.
Hard goods on bottom shelf. Middle shelf can be mixed with fabric under fabric on top shelf. Must be in that order. Space items to allow circulation and steam penetration. Paper wrapped items placed in a tray lying on long side with air space between packages or flat with paper side down. Allow air space between items and sterilizer chamber wall on both sides of loading cart. No item should touch wall. Provide at least 3 inches between sterilizer chamber ceiling and topmost package of the load. Unloading Sterilizers V. Steam Sterilizers Remove cart from sterilizer and place where there is no air conditioning or other cold vents in proximity. Visually inspect outside wrapper for dryness. If there are any water droplets or visible moisture on the exterior of the package, it is considered unacceptable. Remove textile packs from loading cart when they have reached ambient temperature. Transfer to a well padded fabric surface to prevent condensation. W. Steam Sterilization Load Cards/ Recordkeeping Load record card to be filled out completely with every cycle of steam sterilization: 1. Contents of load processed. 2. Sterilizer number used. 3. Initials of the Technician operating sterilizer. 4. Number of items for sterilization. 5. Place completed load record in center of contents and run cycle. 6. Compare indicator line with color standard. 7. Release load for usage if indicator is as dark or darker than standard.
8. If indicator is not satisfactory, notify supervisor and do not release load. 9. If indicator is not satisfactory, rework and reprocess entire load in another autoclave and close unsatisfactory autoclave for maintenance check and culturing. 10. File documentation. X. Documentation of Sterilizer Performance Steris PRINTCON RECORDER Automatically records all set parameters for sterilization process: Cycle Started: Date Printed Type of Sterilization: Prevacuum Temperature Setting: 270 degree F Temperature Control: 273.8 degree F Time, Temperature and Pressure is recorded. Conditioning cycle (repeated until parameters achieved) Sterilization cycle (time period designated). Exhaust - Vacuum pulled until pressure down and "dry" time set. Cycle completed - Safe to open door and remove contents. Sterilize: 4 minutes Dry: 15 minutes Total Cycle: 39 minutes Load ex. Sterilizer Operator CYCLE COMPLETE Time Temperature Pressure
10:45p.m. 198.0 0. 2V Door Open "PRINTCON" strip removed from sterilizer. Technician fills in operator initials and sterilizer number. Technician files document in record log book. Technician must not sign PRINTCON strip for another person. Y. Biological and Chemical Controls All prevacuum checked daily with "Bowie Dick", residual air test denotes accuracy of pump action. Biological Tests live spores Geobacillus stearothermophilus are performed daily and every implant load. Any time maintenance is done three biologicals must be done. Random loads after repair or maintenance. Processed spore vial incubated in the Central Sterile Department incubator. Culture logged in by technician performing the test and results are read at 24 and 48 hours. A monthly report of the cultures is sent to the Infection Prevention and Control Department for review. Any positive results are sent to the Infection Prevention and Control Department immediately. Records are kept in storage for seven years for the steamed sterilization. Random samples of sterile items purchased or processed by Central Sterile are subjected to sterility testing only as indicated by the Infection Prevention and Control Committee for evaluation of specific problems. Z. Sterility Dates All sterilized items will be supplied with a Julian Calendar date, load number, and autoclave number. 1. Package intact and not subjected to undue stress or handling.
2. Sterility is considered event related not time related. 3. Sterility of packages governed by the method of packaging: 4. Fabric/cloth wrapped - Sterility is considered event related not time related. 5. Peel pouch (paper/plastic) - Sterility is considered event related not time related. 6. Plastic dust covers - 3 ml plastic dust covers must be used if turn around time on tray is not rapid. 7. Container systems - Sterility is considered event related, not time related. 8. Initials of person preparing the item for sterilization must appear on the outer package next to the date. 9. All sterile packages must be checked for integrity or damage before use. AA. Maintenance Preventative maintenance agreement with manufacturer Johnson & Johnson. (Engineer specially trained by Steris for PM and repair.) Availability of Steris Company maintenance representative. Preventative maintenance of all autoclaves in the hospital performed monthly. Manufacturer s representative makes most repairs. Hospital engineering personnel are available for emergency measures and minor occurrences. Central Sterile Technicians maintain cleanliness of autoclaves at least weekly and as needed. Cleaning of chambers should be done with a dilute solution of approved cleaner and water. Drains and filters checked daily by the technicians and recorded on documentation charts that are posted by each machine. All maintenance and company representatives when performing maintenance must abide by the listed dress codes for this Department. BB. Linen Processing The airflow should be of a downdraft type, and the number of air exchanges per hour should be sufficient to minimize lint particles in the air. There should be sufficient space for clean linen storage
Lint and airborne particles can carry microorganisms. A relatively lint-free environment is also important to the comfort and safety of employees. CC. Bulk Supplies Uncased bulk supplies for processing trays, sets and single items are maintained in a separate, enclosed area. Because these supplies will be used to prepare items for sterilization, they should be stored in an environment that limits potential contamination. DD. Central Service Technicians Wash counters and table tops daily with hospital approved disinfectant. Maintenance of autoclave chambers. Weekly and as needed, clean external surfaces of autoclaves and washers with manufacturers recommended agents (dry clean, and spray). Wipe carts daily and clean wheels weekly, also as needed. Change linen and trash bags as needed. Call for pickup. Weekly - scrub sterilizer carts with approved cleaner. Replace Genesis Filters for sterilized equipment with every container. EE. Waste Management If employees must handle and/or transport infectious waste, the red bags must be tied securely at the top and handled by the knot and held away from the body. Gloves must be worn as a minimum PPE. FF. Supplies After Hours Nursing supervisor has the authority to requisition supplies after regular operational hours. The Technician on call or Central Sterile Director for the night shift is available every night if their assistance is needed. The technician on call can be reached through the switchboard operator.
GG. Traffic Control Only authorized personnel are allowed within the Central Sterile Department. Central Sterile is a restricted area. The only unrestricted areas are the office and front foyer. In restricted areas, employees must be in proper attire. Persons in decontamination area must only drop off equipment and promptly leave. Contaminated equipment must be labeled with the biohazard symbol.