Sterilization Center Structure (RUMED) - PDF

# ESTRUCTURA DE LA RUMED O CENTRAL D'ESTERILITZACIÓ The centralization of sterilization activities is considered the most effective way to ensure that all stages of the process are carried out correctly and that the cost/benefit ratio is adequate. With it, all stages of the process, including the p...

# ESTRUCTURA DE LA RUMED O CENTRAL D'ESTERILITZACIÓ The centralization of sterilization activities is considered the most effective way to ensure that all stages of the process are carried out correctly and that the cost/benefit ratio is adequate. With it, all stages of the process, including the preparation of the material and its storage, are carried out in a specific physical location, with regular supervision and under the responsibility of qualified professionals in this area of health. Sterilization centers (CE) have as their general objective to make available to hospital services or health centers the appropriate and necessary material to diagnose, treat or care for patients when required by the established asepsis conditions. This is the one that receives, conditions, processes, controls and distributes the material. Centralized sterilization is the best option because it achieves the following objectives: - Unification of criteria for action. - Optimization of existing material and human resources. - Easy control of its operation. - Less need for staff (staff savings). - Lower economic cost by reducing equipment. - Greater service efficiency, by utilizing it 100%. - Better staff training, being specialized in material hygiene. ## Characteristics Of A Sterilization Center Or RUMED ### Location:  * Must be accessible to the services it attends. In large hospitals, it is recommended that it has autonomous transport facilities (dirty and clean lifts, elevator, etc.). In small hospitals, the center should be close to the services with the highest requirements, such as the operating room and the Obstetrics Service. ### Localization: * It should be a dust-free area, well-ventilated and lit, and physically separated from contaminated areas. ### Lighting: * It is recommended that it has natural light and that the possible characteristics of the floor, walls, ceiling and modifications for the installation of new equipment are taken into account. ### Size: * It should be planned according to the complexity and dimensions of the hospital. There is no rule as to the size of the departments, but they must be large enough for the tasks to be carried out in an orderly and comfortable manner. ### Construction Materials: * All departments must incorporate smooth, rentable and rounded edge coatings to facilitate cleaning. ### Environmental Conditions: * The following factors must be taken into account: - **Temperature and humidity:** - They must be within the ranges of 8 to 25°C and 35 to 50%, respectively. - **Ventilation:** - That allows the elimination of vapors and residual gases, as well as preventing the accumulation of dust and lint. A ventilation system with an approximate 10 air changes per hour is recommended, with a minimum of two air changes per hour, and the air going from the clean area to the dirty area and from there to the outside or to the recirculation circuit with filter. - **Lighting:** - The center must have natural light in all its sections. If this is not possible, the lighting system must be sufficient so that there is good visibility of the procedures and does not cause fatigue for staff. - **Washing:** - Each area must be equipped with a sink for washing the instrument. ## Structure Of The RUMED Or Sterilization Center If a hospital is planning the construction or renovation of a sterilization center, it must have a committee that sets out the objectives of the service and its functions, so that it can be designed to meet the identified needs. ## Structure Of The RUMED Or Sterilization Center The physical distribution is organized depending on the main activity that takes place in it and following a unidirectional circuit that always goes from the dirtier area to the cleanest area, never the other way around. Work circuit in a sterilization center: - Reception area (clean area) - washing and decontamination area (dirty) - Preparation and inspection of the material area (clean). - Packaging and storage of non-sterile net material area (clean). - Area where the different sterilization media are located (autoclaves, air chambers, Poupinel ovens...) (clean). - Storage and distribution of sterile material area (restricted or sterile area). Generally, there is also a lounge area, an administrative area, changing rooms and an office area. ## Organization Of A RUMED Or Sterilization Center To achieve the optimal objectives and supply materials and equipment in a timely manner with quality criteria, the center must have a series of human and material resources. As regards human resources, the sterilization center is within the scope of activities coordinated by the Preventive Medicine department. The management and internal organization depend, in general, on a nursing supervisor. There is a staff, structured in shifts, composed almost entirely of TCAI. The items and accessories that are necessary for the optimum functioning of the center are considered material resources. The quantity or number of these is conditioned by the type of hospital, which determines the volume of sterilization. Depending on the area, the following are the material resources needed: - Dirty and clean lifts. - Washing and disinfecting machines. - Ultrasonic cleaning tanks. - Dryers and their accessories. -Steam oven or Poupinel oven. - Deionizer. - Ethylene oxide sterilizers. - Sterilizers for alternative methods to ethylene oxide. - Ventilation chambers. - Heat sealing machines. - Instrument for packaging and labelling it. - Gas monitoring equipment. - Sterilization controls. - Spore incubators. - Clean and dirty transport carts. - Shelves and cabinets. - Information management systems ## Organigram Of The Staff Of A Sterilization Center * Nursing management. * Deputy director of the area. * Area supervisor * Sterilization center supervisor. * Nursing staff. -TCAE ## Main Tasks Of The TCAI In The RUMED or Sterilization Center The task of the TCAI is fundamental in this process. Its main objective is to obtain material free of contamination and safe for the patient This section will describe the main tasks of the TCAI, classified according to the area of the RUMED or sterilization center where they are to be performed. ## General Sterilization Cycle  * Users  - Collection point. - Reception and classification process. - Inspection and packaging process. - Sterilization process. - Verification process. - Storage (clean and sterile) process. - Distribution process. ## General Sterilization Process | Area | Task | | :---------- | :-------------------------------------------------------------------- | | Dirty area | Reception, washing, disinfection. | | Clean area | Revision, selection, packaging, sterilization. | | Storage area | Unloading (handling), Storage, Distribution, Transportation and delivery (handling). | ## 2.1. Dirty Area In this area (which may be divided into a decontamination zone and a cleaning zone), the TCAI will have to receive, review, clean, dry, lubricate, classify and check the material received. The material received in this area may be textile, metallic (surgical instruments), general material or specific to the different healthcare specialties. It arrives from the different services, through lifts (vertical communication), especially when it comes to metal material coming from the operating room or emergencies (accompanied by inventory) or transported in carts (horizontal communication). This area is physically separated from the rest. The final result is clean and decontaminated material with a minimal bacterial load, ready to be sterilized. ## Cleaning-Decontamination Process In A Sterilization Center. Unidirectional Flow * Reception of dry material or with pre-treatment in the dirty area of the CE through vertical communication lifts or carts transported by staff. * Registration of the material, reception, review and disassembly of the instrument to prepare it for cleaning. * Manual or automated cleaning in a thermodesinfector or an ultrasonic bath. * Physical separation of the space. The material is collected in the clean area. * Unloading of the clean and dry material in the clean area. * Inspection and conditioning of the material if lubrication is required. * Classification for packaging and preparation of the packages for sterilization (already in the clean area). ## 2.2. Clean Area The clean area includes two zones: the clean (for preparation and packaging of materials and sterilization) and the sterilized or aseptic (storage and distribution). ## Revision, Selection, Packaging and Sterilization In The Clean Area It is the second stage of the sterilization process. * **Revision of the material (from washing and textiles).** * **Selection of the sterilization system and the type of packaging.** * **Sterilization control (physical, chemical, biological).** * **Sterile material, transport to the storage area.** ## A. Preparation And Packaging Area It is part of the clean area. The material to be sterilized arrives at this area through a lock ("lock") that is located inside the "barrier" formed by the cleaning area equipment, the disinfection area and the drying area (this favors a minimal exposure of the materials, already clean and dry, to the dirty area environmental conditions). In this preparation and packaging area, the TCAI must: * Prepare the material packages for sterilization, following the center's protocol. * Place the necessary chemical and biological controls on the packages. * Put the dates of packaging and identify the packages, if necessary. * Seal the material envelopes with a heat sealing machine or with its own adhesive seal. * Wrapping technique with sheets for wrapping or packaging (with tissue paper or non-woven fabric). * After finishing, it will be sealed with adhesive tape, with an external chemical indicator and identified on the adhesive tape. ## B. Sterilization Area It is part of the clean area. This area is equipped with equipment and devices in the number appropriate to the workload of the sterilization center. They will include: steam sterilizers or autoclaves, ethylene oxide sterilizers, formaldehyde sterilizers, plasma gas sterilizers, etc. In the sterilization area, the TCAI will be responsible for carrying out the following tasks: * Classify the material according to the sterilization method to be used. * Check the correct packaging. * Introduce the packages according to the characteristics and the protocol of the sterilization equipment. * Collaborate in the startup of the equipment and in its subsequent control. * Complete the specific records. ## 2.3. Storage And Distribution Area It is part of the cleaning circuit. In this area, circulation is restricted to reduce the possibility of contamination of the sterilized packages. It is separated from the sterilization area by a wall of equipment with a double door (which opens, once finished, for this area). It also has a staff entry or lock, equipped with a hand washing area and protective clothing. Inside, there will be a sterile area and a delivery area, which is where the distribution to the different hospital services is carried out. ## Unloading, storage and distribution of the storage area It is the last stage of the sterilization process. - **Unloading of sterilizers:** - Steam autoclave. - Ethylene oxide sterilizer. - **Storage:** - Shelves. - Textiles, surgical materials and common sets. - Operating room or distribution carts. - Material and equipment needed for the next day's work. - **Distribution:** - Scheduled operating room. - Other units. - Delivery and collection circuit. ## Unloading, storage and distribution of the storage area It is the last stage of the sterilization process. **Sterilizer Unloading**  * Steam autoclave. * Ethylene oxide sterilizer. **Storage**  * Shelves  * Textiles, surgical material, and common sets. * Operating room or distribution carts. * Materials, and instruments needed for the next day's work. * Distribution: - Scheduled operating room. - Other units - Delivery and pick-up circuit ## A. Sterile Area  It forms part of the storage and distribution area. The TCAI must perform the following tasks: * Classify the material according to the criteria established (for services and hospitalization units) and according to the type of material it is (gloves, gauzes...) * Place the materials in the warehouse according to the protocol. * Prepare the orders for the operating rooms and the hospitalization wards. * Register the supplies that are delivered. The warehouse is a restricted area (to avoid environmental controls; 18-24°C and 45-60% humidity), with open shelving (to avoid the concentration of dust) and wheels to facilitate removal and cleaning. Sterile packages are arranged in homogeneous groups and vertically. Another recommendation that must be followed is the storage of packages at a height of at least 25 cm from the floor and 40 cm from the ceiling. Distribution is carried out in the identified area for collection (horizontal communication) or through a clean lift (vertical communication). ## 2.4. Quality Control and Assessment. Records Establishing a quality control system in a RUMED or sterilization center improves, in the long run, patient safety. Generally, managing the quality of all the processes that can guarantee the final quality, implies having (within a total sterilization control program) a guide or a protocol manual to be applied in the sterilization center, control of the stages of the process (through records or documents that allow the tracking of an item until the time of use), adequate equipment maintenance, replacement of defective equipment and ongoing training of staff. Records must be kept that document the tasks and processes carried out in various aspects, among which we highlight: - Daily work (number of packages prepared and sterilized) - Equipment evaluations. - Physical controls. - Daily sterilization cycles and load codes. - Accidents and work-related exposures. - Equipment maintenance. - Measurements of hazardous materials. There must also be programs to guarantee the quality and continuous improvement. They are applied through supervision, continuous education and control of the environmental conditions; for this purpose, they carry out tracking and traceability programs. ==End of OCR for page 17==