كتاب الهيئة مع النقاط المهمة والمفيدة PDF

Summary of The CSSD Book- 2023. Made by: Talal Albudayri i Module1: Introduction to Central Services The Four Stages of Competence: The adult learner. Characteristics of adult learners—adults are: Autonomous and self-directed Experienced and knowledgeable Goal oriented Relevancy oriented...

Summary of The CSSD Book- 2023. Made by: Talal Albudayri i Module1: Introduction to Central Services The Four Stages of Competence: The adult learner. Characteristics of adult learners—adults are: Autonomous and self-directed Experienced and knowledgeable Goal oriented Relevancy oriented Practical and learn by doing Respectful and want to be respected ❖ Hot Lines: ✓ It is a place in hospital or healthcare activities that performs reprocessing of reusable devices used by health workers in the operating room for surgical and other patient procedures: Central sterile service. ✓ most likely applied to industrial production, where raw materials are transformed into finished goods on a large scale: Manufacturing. ✓ it specifies what all manufacturers must do to create procedures or instructions for use (IFU) when processing their specific RMDs: ISO 17664. ✓ n zone 2 (IAP/PrepPack, Sterilization): it maintains an air-lock to bring raw material in and out ✓ of the IAP zone: Material Transfer Room. Summary of The CSSD Book- 2023. Made by: Talal Albudayri Module2- MEDICAL TERMINOLOGY, ANATOMY AND PHYSIOLOGY Prefix: a short word part added before a root to modify its meaning. A prefix usually, but not always, indicates location, time, number, or status. Root: Is the fundamental unit of each medical word. It establishes the basic meaning of the word and is the part to which modifying word parts are added. Suffix: is a short word part or series of parts added at the end of a root to modify its meaning. Suffixes Meaning “Pertaining To” compound word: contains more than one root. like: bedpan, and wheelchair, cardiovascular. Combining Forms: A combination of the root word(s) and the combining vowel. Combining vowel: A vowel that links the root word to the suffix or to another root words. Like: neurology. Body systems: 1- Nervous System: consisting of the brain, spinal cord, and nerves, and including the sensory system and special senses, with emphasis on the ear and the eye. This system receives and processes stimuli and directs responses. 2- Integumentary System: which includes the skin and its associated structures, such as hair, sweat glands, and oil glands. This system functions in protection and also helps to regulate body temperature. 3- Skeletal System: which includes the bones and joints. 4- Muscular System: moves the skeleton and makes up the walls of internal organs. The muscular system and skeleton protect vital body parts. 5- Circulatory System: 6- Endocrine System: consisting of individual glands that produce hormones. 7- Cardiovascular system: consisting of the blood, heart, and blood vessels. 8- Lymphatic system: organs, and vessels that aid circulation and help protect the body from foreign materials. 9- Respiratory system: which obtains the oxygen needed for metabolism and eliminates carbon dioxide, a byproduct of metabolism. 10- Digestive system: which takes in, breaks down, and absorbs nutrients and eliminates undigested waste. 11- Urinary system: which eliminates soluble waste and balances the volume and composition of body fluidsThe male and female reproductive systems concerned with production of offspring. Summary of The CSSD Book- 2023. Made by: Talal Albudayri Body planes: - Frontal ( Coronal ) plane. - Transverse plane. - Sagittal plane. Cells make up tissues, which are composed of similar cells working together to perform similar tasks. 4 Main Types of Tissues: 1. Epithelial Tissue : cells pack tightly together and cover and protect underlying tissue; Lines our organs; Ex: stomach lining & skin. 2. Connective Tissue: joins, supports, protects, and nourishes organs; Ex: ligaments, tendons, cartilage, bone, blood. 3. Muscle Tissue: contracts and relaxes for movement Skeletal muscle moves bone; voluntary (works when you want it to) Cardiac Muscle-Only found in the heart. Involuntary (works all the time) Smooth Muscle involuntary (works all the time) 4. Nervous Tissue: sends electrical signals throughout the body. Ex: Brain, Spinal Cord, Nerves. Body Cavities: Dorsal cavity protects the nervous system, and is divided into two subdivisions: - Cranial cavity is within the skull and encases the brain - Vertebral cavity runs within the vertebral column and encases the spinal cord Ventral cavity houses the internal organs (viscera), and is divided into two subdivisions: - Thoracic and Abdominopelvic cavities. - Thoracic cavity is subdivided into pleural cavities, the mediastinum, and the pericardial cavity Pleural cavities – each houses a lung Mediastinum – contains the pericardial cavity, and surrounds the remaining thoracic organs Pericardial cavity – encloses the heart - The abdominopelvic cavity is separated from the superior thoracic cavity by the dome- shaped diaphragm It is composed of two subdivisions Abdominal cavity – contains the stomach, intestines, spleen, liver, and other organs Pelvic cavity – lies within the pelvis and contains the bladder, reproductive organs, and rectum Vital Signs: 1. Temperature. 2. Pulse 3. Respiration. 4. Blood Pressure 5. O2 Saturation. 6. Pain Summary of The CSSD Book- 2023. Made by: Talal Albudayri The human adult skeleton is composed of 206 bones, which are organised for study into two divisions: I. AXIAL SKELETON: forms the central core or “axis” of the body’s bony framework, It consists of: 1. the skull 2. the thorax (chest) 3. the vertebral column II. APPENDICULAR SKELETON 1. Shoulder girdle. 2. Upper limbs. 3. Pelvic girdle. 4. Lower limbs. ❖ Hot Lines: ✓ The joints, or articulations, are classified according to the degree of movement they allow. ✓ The vertebral column consisting of 33 vertebrae. ✓ Between the vertebrae are disks of cartilage that add strength and flexibility to the spine. ✓ The thorax consisting of 12 pairs of ribs joined by cartilage to the sternum (breastbone). ✓ The rib cage encloses and protects the thoracic organs. ✓ Cartilage Covers and protects the ends of long bones. ✓ Ligament a strong band of connective tissue that joins one bone to another bone. ✓ Tendon a fibrous band of connective tissue that attaches a muscle to a bone. ✓ The musculoskeletal system protects , supports, and aids in the movement of body parts. ✓ the musculoskeletal system, particularly the bones, are essential in hematopoiesis or blood production. ✓ A cell membrane that allows certain substances in and out. ✓ A nucleus that directs activities within the cell. ✓ Mitochondria that generate energy for the cell. ✓ Cytoplasm that is a watery fluid that fills the spaces outside the nucleus. ✓ Cells make up tissues, which are composed of similar cells working together to perform similar tasks. ✓ Tissues with common functions come together to form the body’s organs, which perform specialized functions. ✓ A group of organs forms an organ (body) system, and each system has its own special purpose. ▪ Don’t forget to check the movement of the body parts and the types of Fractures and the conditions of the spine affects. Page number (60,61,62,63,64). Summary of The CSSD Book- 2023. Made by: Talal Albudayri Module 3: MICROBILIOGY FOR CENTRAL SERVICE TECHNICIAN 1. Protozoa. 2. Bacteria 3. Viruses 4. Fungi 5. Yeasts 6. Prions Protozoa: are large complex one-called parasites that may spend part of their lifecycle in our bodies. they cause diseases as they multiply whithin our body. Bacteria: Bacteria are small microorganisms that come in many shapes and types. They lack a nucleus and multiply by cell division. Viruses: Small non-living infectious objects containing genetic information enabling them to hijack living cells in the body. Fungi: are large to medium- sized microorganisms that grow filamentous root-like structures called hyphae. Some fungi live on our skin and in our gut naturally. Yeasts: are single-celled organisms with a nucleus and are a type of fungus. Yeasts are larger than bacteria, and multiply mainly by budding. Prions: Very small proteinaceous units that cause Transmissible Spongiform Encephalopathies (TSEs) when folded in an abnormal way. Abnormally folded prions can cause disease (particularly in the brain) ❖ Identification: ❖ Protozoa: clinical specimens, or serological immune reactions of the host. ❖ Bacteria: culturing ❖ Viruses: cytopathic effect ❖ Fungi: growing them in the laboratory ❖ Yeasts: culturing ❖ Prions: histopathology Summary of The CSSD Book- 2023. Made by: Talal Albudayri ❖ Cleaning : ❖ Protozoa: some have life-cycle stages which are encysted (within a tough protective capsule). These stages are more difficult to kill as they resist disinfectants but heat will kill them. ❖ Bacteria: Bacteria are quite small and can be difficult to remove from uneven surfaces during cleaning. Most can be killed by disinfectants and heat although spores often resist disinfectants. ❖ Viruses: they are not alive, disinfection or heat does not kill them. Instead it dismantles or disrupts their chemical structure—most are susceptible to this but there are some which can be resistant. ❖ Fungi: Fungi are relatively easy to clean from reusable medical devices, however, their thick cell walls and spores are often resistant to disinfectants but heat will kill them. ❖ Yeasts: They are relatively easy to remove from reusable medical devices when cleaning and are susceptible to disinfectants and heat. ❖ Prions: They are very difficult to inactivate using heat or disinfectants. Reusable medical devices used on prion-infected patient tissues are not used on other patients due to difficulty in decontaminating them. It is important to have a traceability system for medical devices in place to ensure these reusable medical devices are not used again. ✓ PPE on: 1- Shoe 2- Gown 3- Mask 4- Goggles/Face Shield 5- Gloves ✓ PPE off: 1- Gloves 2- Goggles/ Face Shield 3- Gown 4- Mask 5- Wash hands Hand washing: Duration of the entire procedure: 20-30 seconds Summary of The CSSD Book- 2023. Made by: Talal Albudayri Module 4: INFECTION PREVENTION Summary of The CSSD Book- 2023. Made by: Talal Albudayri Module5: Regulation and Standards Introduction Regulatory standards: Defined as standard mandated by the government > legal penalties Voluntary standards: Defined as a benchmark that is highly recommended by a governing agency or professional organisation that provides a recommendation and guidelines > no legal penalties Saudi, food and drug administration SFDA Started: 2003 Reports : directly reports to the President of clinical of ministers Job: The main aims for the SFDA is to regulate the following: 1. The safety of food and drugs for human and animal.2 2. The safety of biological and chemical substance.3 3. The safety of electronic devices that related to human health. 4. The accuracy and safety of medical and diagnostic devices. 5. The control and supervise licenses procedures for food, drugs and medical devices factories. 6. The disseminate and exchange information with local and international scientific and legal agencies and setting up a database for food and drug. Medical device classification The regulations placed on the Medical Devices depends on their classification as per the FDA which are: Summary of The CSSD Book- 2023. Made by: Talal Albudayri FDA classifies product recall into three categories: Organisations related to CSSD: Centers for Disease Control (CDC): “not a regulatory body” It is a federal agency within the department of Health and Human Services in USA. The aim of the agency is to promote the wellbeing and prevent injuries, diseases and disabilities. CSSD professionals are in charge of developing infection control and prevention guidelines and isolation techniques. Environmental Protection Agency (EPA):”a regulatory body” The USA congress developed the EPA department in 1970 as a regulating agency that: 1- protects human health and the environment. 2- to reduce the greenhouse gases and toxic emissions. 3- control indoor air pollution. 4- create, and reinforce pesticide regulations. Greenhouse gasses: are defined as gasses that absorb solar radiation such as carbon dioxide, methane, ozone and fluorocarbons. Occupational Safety and Health Administration (OSHA): ”a regulatory body” was developed in 1971 under the U.S. Department of Labor. Its main objective is to protect all kind of workers from occupation associated injuries and illnesses. Many of the OSHA regulations and guidelines are incorporated into the Saudi Labor Law. Guidelines and standards of OSHA related to the CSSD are: 1. The Occupational Exposure to Blood-borne Pathogens standards 2. Guidelines for the use of Ethylene Oxide Sterilization 3. The General Duty Clause of the Occupational Safety and Health Act Summary of The CSSD Book- 2023. Made by: Talal Albudayri Association for the Advancement of Medical Instrumentation (AAMI): “a voluntarily body” was established in 1967, its nonprofit organisation that comprised of multidisciplinary healthcare professional from technicians, engineers, scientists and members of other organisations such as FDA. The aims is to develop a Technical Information Reports (TIR) that are address the following: 1. To develop, manage and the utilization of safe and effected reusable medical devices 2. To address the proper care and reprocessing of reusable medical devices. 3. To develop standards related to medical products labelling and performance requirement American National Standards Institute (ANSI): “not a regulatory body” The ANSI institution was established in 1918 with a mission “To enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems and safeguarding their integrity”. ANSI is the only U.S representative to the International Standards Organisation (ISO). International Standards Organisation (ISO): “not a regulatory body” non-governmental organisation with national standards representing more than 163 countries. The standards from the ISO give specifications related to products, service or practice. the ISO The ISO standers in regard to the CSSD are submitted by the AAMI organisation therefore it’s a trend by the healthcare organisations internationally to become ISO- Certified in the field of CSSD. Association of Operating Room Nurses (AORN): “to protect and guide” is a professional organisation that consists of Registered Nurses in the specialty of the Preoperative Care and other professionals with an aim to enhance patient care related to surgery. The AORN standards are reprinted annually and reviewed every five years. Association for Professionals in Infection Central and Epidemiology (APIC): “a voluntarily body” provides guidelines related to infection prevention and control in order to prevent Hospital Acquired Infection (HAI) in the healthcare organisations. The Infection Prevention and Control Department can conduct CSSD departmental surveys annually depending on the organisations policy. Examples of the APIC guidelines are: Bioterrorist Readiness Plan. Guidelines for Infection Prevention. Control in Flexible Endoscope Society of Gastroenterology Nurses and Associates (SGNA): “a voluntarily body” non-profit organisation that develops voluntarily guidelines to assure safe and effective practice of the gastroenterology and the endoscopy nursing services. Moreover, the organisation develops and reviews guidelines related to reprocessing flexible endoscopes. Examples of the SGNA guidelines are: 1. Guidelines for the Use of High Level Disinfectants and Sterilization for Reprocessing of Flexible Gastrointestinal Endoscope. 2. Standard of infection Control in Reprocessing of Flexible Gastrointestinal Endoscope. The Joint Commission (TJC): “not a regulatory body” is an accreditation organization that ensures quality standards are set, monitored and maintained by member healthcare facilities. Summary of The CSSD Book- 2023. Made by: Talal Albudayri Module6: Surgical Instrumentation the five major surgical instrument lines are: OR Grade: highest quality > U.S and German Mid-Grade: High quality > Pakistani stainless steel Physician’s Grade: Forged from surgical grade Pakistani stainless steel > exists in clinic for routine check Sterile Disposable Floor Grade: Ready to use, sterile disposables, > Pakistani steel. Floor Grade: reliable function at an affordable cost; ideal for non-critical applications. > Pakistani steel Single-use instruments: 1- Provide a solution to reprocessing instruments day to day. 2- Reduce cross contamination. 3- Eliminate the need for comprehensive reprocessing instructions and follow-through. 4- Reduce human error in cleaning and sterilizing. 5- Improve patient safety. 6- Reduce tangible and intangible instrument reprocessing costs. ❖ Hot Lines: ✓ The first surgical instruments were teeth and hands. ✓ After advancement, using instruments of bronze and iron. ✓ In the Middle Ages, using iron, steel and wood. ✓ Stainless steel is not actually “stainless” or fully stain-proof. It is stain resistant. ✓ stainless steel is the softer, more malleable type within the 300 Series; Martensitic is the hardened steel within the 400 Series. ✓ The 300 Series is used for probes, dilators, retractors and basins. It has the following characteristic: 1- Extreme corrosion resistance. 2- Non-magnetic. 3- Contains high chromium content and nickel. 4- Workable and malleable. 5- Cannot be heat treated to differing degrees of hardness. ✓ The 400 series is used for Hemostats, needle holders, scissors, clamps, forceps, etc. it has the following characteristics: 1- Good to corrosion resistance 2- Heat treated to varying degrees of hardness and sharpness. 3- High Carbon content. ✓ The highest quality, 410 grades stainless is used for gripping instruments like forceps, tweezers, retractors, dressing forceps, etc. ✓ The highest quality, 420 grades stainless is used for cutting instruments such as bone rongeurs, chisels, gouges, and scissors. Summary of The CSSD Book- 2023. Made by: Talal Albudayri ✓ Scissors are used to cut tissue or other materials. ✓ Forceps have interlocking teeth or serrated jaws used to grasp tissue. ✓ Sponge and towel clamps hold gauze or wall-off surgical areas. ✓ Needle holders drive suture needles through tissue. ✓ Retractors access and expose wounds. ✓ Hooks grasp bone, tissue, and suture strands during procedures. ✓ Curettes cut or scrape bones or sockets. ✓ Bone files and rasps smooth bone and cartilage. ✓ Bone chisels and osteotomies cut or mark a bone. ✓ All instruments are categorised by function. The nine categories are: 1- Accessory: mallets, harmonic scalpels and guide pins. 2- Clamping and Occluding: Crile hemostatic forceps and tube occluding clamps. 3- Cutting and Dissecting: scalpels, Iris scissors and curettes. 4- Grasping and Holding: Allis tissue forceps, and Backhaus towel clamps. 5- Dilating and Probing: uterine dilator, mini-dilators/OS finders and probes with eyes. 6- Exposing and Retracting: bone hooks, Volkman retractors and Zalkind retractors. 7- Aspirating and Suctioning: cannulas, aspiration suction tubes. 8- Stapling and Suturing: needle holders, suture needles and terminal end staplers. 9- Viewing: endoscopes, nasal specula, and lighted vaginal specula. ✓ the curved Crile is the most widely used clamp in all specialty areas. ✓ Examples of Basic Surgery Sets are: 1- Minor Surgery Tray 2- Minor Basic Surgery Set Summary of The CSSD Book- 2023. Made by: Talal Albudayri Module7: QUALITY ASSURANCE Standards: Standards can be defined as “a level of quality or attainment, something that can be used as a measure” or similarly “a level of quality or achievement, especially a level that is thought to be acceptable”. Quality Management Systems (QMS): is a formalised system that documents processes, procedures and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organisations activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. Quality policy: provides a short declaration of how an organisation will ensure the quality of its product or service by detailing what processes are in place to ensure that an organisation delivers what it says it can. Quality manual: contains procedures to outline activities in each area of the CSSD supplemented by work instructions that provide step-by-step instructions to specialists who will carry out the work. Quality Improvement (QI): is a formal system of performance analysis and systematic improvement. It involves measuring current performance, and identifying ways to make things better. QI specifically attempts to avoid attributing blame, and instead creates systems to prevent errors from happening. Quality assurance: focuses on preventing defects. Quality assurance ensures that the approaches, techniques, methods and processes used to manage and create procedures were followed correctly and are operative. It is a proactive process and preventative in nature. It recognises flaws in the process. Quality assurance precedes quality control, although one cannot exist without the other. Quality control: focuses on identifying defects. It ensures that the approaches, techniques, methods and processes are followed correctly. It monitors and verifies that defined quality standards have been met. It is a reactive, detection based process. Quality control must be completed after quality assurance has been completed. However, quality assurance and quality control are often used interchangeably as they are inextricably linked, referring to the actions performed to ensure the quality of a product, service or process. root cause analysis (RCA): reactive process that uses historical analysis of an adverse outcome to help prevent its recurrence. Failure mode and effects analysis (FMEA): has its origins in the military and industrial fields, and is a method of identifying and preventing problems with products and processes before they occur. Empowerment: is the action of driving the process of decision-making and implementation down the facility's chain of command. Process Management: Studying processes is critical because process problems cause errors. If errors are identified and resolved, patients and customers will experience fewer problems. Summary of The CSSD Book- 2023. Made by: Talal Albudayri Six Sigma: is to deliver high performance, reliability and value to the end customer. This process strives to eliminate variations in a product (a tray will look the same each and every time it is assembled, and will look like the same product produced before it), eliminating variations to prevent defects. Lean: is a production practice with the key tenet of preserving value with less work (eliminating waste). Eliminating wasteful processes reduces production time and costs. Staff orientation: is the first point at which basic training is provided. The quality of all future work is based on how well staff are trained in every aspect of reusable medical device processing. This training is reinforced by reference to the QMS documentation, policies and procedures and the step-by-step instruction provided by work instructions. Training: is key and all staff must receive instruction, not only on the technical requirements of carrying out their jobs, but also in other areas, for example, in customer service when answering the phone, giving their name and asking how they can help. Staff must be empowered to take any necessary action to deal with phone calls themselves and not pass them to someone else. Documentation: is critical to the operation of the CSSD. We have talked about having a QMS containing clear policies, procedures and work instructions. Key Performance Indicators (KPI): Key performance indicators are critical elements of performance that provide an indicator of how well or badly an organisation is performing. Continuous Improvement Cycle: it is important to routinely monitor standards within the CSSD. Plan-Do-Ceck-Act ISO 9000: Is quality management and quality assurance standards. ❖ Hot Lines: ✓ An activity designed to identify and resolve work task related problems is called: Process improvement. ✓ Biological indicators, Chemical indicators, and integrators as well as pressure gauges, graphs are charts are all examples of: Quality control indicators. ✓ A process that looks backwards at an event to help prevent it from reoccurring is called: Root cause analysis(RCA). ✓ is an international standard used by participating organisations to help ensure that they consistently deliver quality services and products: ISO 9000. ✓ Is a technical, statistical sampling method that measures the quality of production: Quality assurance. ✓ The quality process that uses the DMADV/DMAIC to improve processes is called: six sigma. ✓ The main objective of quality assurance is: proof of fitness of the products. Summary of The CSSD Book- 2023. Made by: Talal Albudayri Module8: DECONTAMINATION POINT ZONE Summary of The CSSD Book- 2023. Made by: Talal Albudayri The minimum levels of reprocessing for different types of sites are: Critical site: devices must be sterile at the time of use. This means devices are either single use, steam sterilized (for devices that are capable of withstanding heat), or have undergone low temperature sterilization (for “thermo-labile” devices that are not capable of withstanding heat). Semi-critical site : devices are either single use or sterilized after each use. If this is not possible, high level disinfection is the minimum acceptable level of reprocessing. Non-critical site: cleaning alone is generally sufficient for all noncritical items after every individual use, although either intermediate or low-level disinfection may be appropriate in specific circumstances. ❖ Hot Lines: ✓ Disinfection There are two types of disinfection, thermal and chemical. ✓ Stylets are used to unblock devices during use. ✓ Arrange medical devices in an orderly fashion in mesh trays so that all surfaces are exposed. ✓ Separate all sharp devices from general devices. This is to ensure ease of identification for personnel assembling the devices after cleaning, in order to prevent sharps injury. ✓ Cleaning and disinfection the brushes at least daily. ✓ The manufacturer should provide information regarding the appropriate brush size. ✓ Always use brushes under water to avoid splashing and aerosols. ✓ use detergents specifically designed to clean RMD. Household soap must never be used! ✓ Drying minimizes rusting, and staining and reduces the risk of recontamination during inspection and assembly of RMD. following key considerations: 1- Use a clean disposable lint-free, absorbent wipe when a drying cabinet is not available. 2- Take care not to exceed the temperature tolerances advised by the manufacturer. 3- Dry the RMD in a sloping position to facilitate drainage. 4- Do not use alcohol or other flammable liquids as drying agents ✓ Store chemicals below shoulder height. ✓ Make sure Safety Data Sheets (SDS) and labels are available to all staff in designated areas at all times, so that appropriate action can be taken in case of exposure to a hazardous substance. ✓ Read and follow the precautions and instructions given on the SDS and on the label prior to handling and use. ✓ Train all personnel who handle chemicals e.g. detergents, rinse aids, disinfectants, etc. Summary of The CSSD Book- 2023. Made by: Talal Albudayri Routine Testing of Decontamination Equipment Washer Disinfector: - Daily: Spray arm rotation Spray nozzles Removes and clean strainers and filters - Weekly: Automatic control test Safety checks Water hardness Water conductivity Cleaning efficacy test (residual soil detection) - Quarterly: Automatic control test Calibration verification of RMD Thermometric test for thermal disinfection Cleaning efficacy test by assessment of soil removal - Annually: Automatic control test Calibration verification of RMD Water system Drainage Doors Door interlocks Fault interlocks Water vapor discharge Aerosol discharge Chemical additive dosing Load carriers Air quality Cleaning efficacy Over-temperature cut-out Thermometric tests for thermal disinfection Load dryness test Process residues Summary of The CSSD Book- 2023. Made by: Talal Albudayri Routine Testing of Decontamination Equipment Ultrasonic Cleaners: - Daily: Remove and clean strainers and filters. Visual inspection of device post-cycle, i.e., look for visible soils or lack of cleaning when you remove items from the washer. If items are soiled then the load is rejected. - Weekly: Automatic control test (if using an automated ultrasonic cleaner) Safety checks. Cleaning efficacy test (residual soil detection) - Quarterly: Automatic control test Verification of calibration of RMD Ultrasonic activity test Cleaning efficacy test - Annually: Weekly safety checks Automatic control test Verification of calibration of RMD Water system Drainage, doors and door interlocks Fault interlock Aerosol discharge Chemical additive dosing Cleaning Efficacy Tests: TOSI—protein detection test Hemo-check—protein detection test Brownes soil test—visual test Ninhydrin test—protein detection test Foil test—ultrasonic cleaner Decontamination - Negative (-) - prevents air from exiting the room Temperature:18C-20C Humidity: 30% - 60% Air pressure -5 pascal Air changes 10 times per hour. Summary of The CSSD Book- 2023. Made by: Talal Albudayri Module9: ASSEMBLY AND PACKAGING ZONE Dress Code Requirement: 1- freshly laundered scrub suit 2- Head/Hair Cover 3- Shoes ❖ Hot Lines: ✓ all furniture in this area must be made of smooth non-porous easy to clean materials. ✓ A dedicated cleaning room is located within the IAP room to clean this area—no outside areas should be cleaned from this location. ✓ Microbiological monitoring is carried out in this room according to hospital infection control Policies: This monitoring is used as an early warning system to alert staff when environmental quality is drifting out of control. ✓ Testing results of Microbiological monitoring should be the same or better than this baseline. ✓ To determine how well the IAP room is being cleaned and give you a good idea of contamination during traffic flows and peak periods. ✓ chamber of WD can reach over 90c. ✓ When unloading, quality checks are carried out before any further processing. Quality checks consist of: 1- Correct cycle. 2- Spray arms not blocked. 3- Soil or stain. 4- Excessive wetness. 5- Damage due to configuration. 6- Devices correctly disassembled. 7- Completed documentation. ✓ Most often items are arranged from left to right in accordance to when they will be required in a procedure, for example, the scalpel handle used to make the initial incision is the first device on the left and the needle holders used to close the wound are on the far right. ✓ recommend that the maximum weight of surgical instrument sets trays is 25 pounds, this includes the weight of the instruments and the instruments containers. ✓ spunbond polyolefin- plastic (Tyvek pouch). ✓ Paper pouches are used for Steam and Ethylene Oxide sterilization methods. ✓ Tyvek pouches are used when sterilizing instruments by hydrogen peroxide. ✓ Avoid folding the inner pouch as it affects air removal and sterilant penetration. Summary of The CSSD Book- 2023. Made by: Talal Albudayri Local Policy Checks After Unloading (MUST BE DELETED DUE TO REPETETION): 1- Check that the chart record for the cycle conforms to the information established. 2- Check that the operating cycle selected is in accordance with the specification for the load. 3- Make a visual inspection of the load in order to ensure that there is no obvious damage, staining or residue. 4- Make a visual inspection of the load for dryness. 5- Unless there is clear indication why a small percentage of RMD in a load were not cleaned and/or dried effectively, the entire load should be returned for re-processing. packaging materials that are used “the most common”: 1- Rigid containers 2- Peel Pouches of plastic and/or paper 3- Sterilization Wraps Sterilization Flat Wrap: is made of nonwoven Spunbond-meltblown-spunbond (SMS) fabrics and designed as single use product. They are available in a variety of sizes and weights. Flat Wrapping Technique: 1/ Sequential Wrapping: Sequential wrapping refers to when two layers of wrap material are wrapped individually using a fold technique. A single layer is folded completely and then sequentially followed with a second sheet of wrap material and repeating. 2/ Simultaneous Wrapping: Simultaneous wrapping refers to when both layers of wrap material are wrapped together simultaneously. Square Fold Technique: The items to be wrapped are placed on the table parallel to the wrapper. This method is generally preferred with heavier items. Envelope Fold Technique: The items to be wrapped are placed on the table in a diamond shape to the wrapper. This method is frequently used for smaller items. Both square and envelope fold techniques are used with the sequential and simultaneous wrap method. Summary of The CSSD Book- 2023. Made by: Talal Albudayri Containers: Rigid reusable containers are making a comeback recently. Very popular in the 70’s and 80’s they can be seen in many CSSDs today. Easily disassembled for cleaning, drying and storage. Suitable for the method of sterilization being used. Compatible with the cleaning method and cleaning agent being used. Suitable for the storage configuration. Lockable, tamperproof and non-resealable. Packed in a manner which allows for penetration of the sterilizing agent. Able to remove contents without the risk of contamination of the contents. Disadvantage of using containers: 1/ Creates ergonomics challenge to those who will lift them due to heaviness. 2/ Requires additional space to store them as they are larger than wrapped trays. 3/ longer cycle time may be required to avoid issues associated with excessively wet packs. 4/ entails extra effort since the containers must be cleaned between uses. 5/potential risk of filter dislodge leading to instruments contamination. Package labelling: It is necessary that all packages be labeled before sterilization. Complete and accurate labeling helps the end user to select the correct pack. Label should include the following information: Package contents. Lot number. Sterilization date. Pack complete name. Assembler / packager name. The requesting department. Sterilizer number and used cycle. Labelling information should be written on sterilization tape, commercially available adhesive labels or in the plastic side of peel pouches. Summary of The CSSD Book- 2023. Made by: Talal Albudayri Module10: SERILIZATION ZONE Sterilization is most commonly achieved by using either thermal energy (heat) or low temperature chemical processes with the following methods: Steam (moist heat) at high pressure—cycle time approximately 40–60 minutes Dry Heat, similar to an oven, using normal pressure—cycle time up to 2 hours Gas plasma at ambient temperature—cycle time 45–75 minutes Ethylene Oxide (EO) at sub- atmospheric or high pressure1 Low temperature steam and formaldehyde vapor—cycle time Adson Tissue forceps > Adson > Allis DeBakey Atraumatic tissue forceps Grasping & holding Disposable Iris forceps Mayo Hegar needle holder Backhaus towel clamp Vaginal speculum Retracting & exposing D= disposable :‫الخطوات‬ S= straight 14 ‫) وعددهم‬Cutting dissecting ‫القسم األول من األدوات (قطع وتشريح‬ C= curved , TC= ‫ ومنه‬. tungsten carbide ‫ أدوات فقط‬6 ‫ولكن اختصرتهم الى‬ S&C ‫نوعين‬ ‫كيف؟‬ operating scissor ‫ فوق الصفحة كل حرف وايش يدل ثانيا مثال عندك‬Keys ‫اول شيء شف الـ‬ ‫ ولكن بنوع اخر‬،‫حطيت الحروف التالية اللي تعبر على نفس المقص‬ ‫ أنواع‬5 ‫وبالتالي من نفس االسم طلعنا‬  Quality Assurance Sigma divided by two types: DMAIC (define,measure,analyze,improve,control) Procedure monitor &improve existing process DMADV (define,measure,analyze,design,verify) Used to develop new processes Staff orientation: 1st point at which basic is provided QA: a way of preventing mistakes and defects in manufactured product & services QC: a process through which a business seeks to ensure that product quality is maintained or improved Total quality improvement focuses current output Continuous quality improvement focuses satisfaction method Total quality management focuses long term success Sigma: focus eliminate ‘variation’ Lean: focus eliminate ‘waste’  Decontamination area 1/ To prevent infection, all RMDs that come into contact with the patientor surgical field should be systematically decontaminated after each surgical procedure 2/ Decontamination process must be validated and RMD reprocessed to alevel appropriate for intended use 3/ The level is depends on body sites where device will be use and riskassociated with particular procedure 4/ The minimum levels of processing is called Spaulding classification,and based on 3 risk categories 5/ Critical must be sterile at the time of use – either single use or steam –devices are capable of withstanding heat – example: Travers retractor 6/ Semi critical must be single use or sterilized after each use – the minimum level acceptable is high level disinfection – Parkes retractor 7/ Non critical must be sufficient for all non-critical items after every individual use – cleaning alone – intermediate or low-level – stethoscope 8/ Reprocessing method must provide minimum decontamination &safety standards 9/ Be effective , RMD decontamination must be carried out a timelymanner 10/ Sorting, disassembly, and cleaning facilitates timely cleaning and minimize risk to you 11/ RMD are sorted usually according to need a manual or automatedcleaning 12/ Policies and procedure should be developed for the handling, sorting& disassembly of all device used within facility and for handling specialized items if required 13/ The manufactures instruction for cleaning are followed device is notdamaged and cleaned adequately 14/ Open all RMD box locks, hinges 15/ Place the RMD in a mesh basket >> effective cleaning of the device 16/ Don’t place RMD on top of one another >> overloaded baskets resultineffective cleaning 17/ Arrange RMD in an orderly fashion in mesh trays 18/ Place each jointed medical device in open position in mesh basket - if extra mesh basket required for cleaning , a device set a marker is placedin the extra basket to identify , set name , and number 19/ Place heavy retractors and other heavy medical device on bottom or aseparate tray 20/ Secure small and light items with a hold-down screen, not free tomove around during cleaning process 21/ Place scissors, light-weight medical devices, and microsurgicaldevices next 22/ Receivers & gallipots (bowl shaped items) mustn’t be placed overloaded baskets result in ineffective cleaning, may cause shadowingand interfere with cleaning process 23/Separate all sharp devices from general devices, ease of identificationfor personnel assembling the devices after cleaning 24/ For medical devices with one or more lumens (tubes), connect eachlumen to appropriate flushing system 25/ The tips of devices align and tips, not hooked or snagged items,misaligned, damaged, worn >> sent for repair 26/ Open ratcheted device for cleaning, box joints and jaws are cleaned,all debris removed 27/ Dismantle any device with valves, ports, multiple parts for cleaningand follow Manufacturer instruction 28/ Open, flush& brush tape, don’t come a part before mechanical cleaning 29/ Stylets used to unblock device, remove them an flush and brush device to mechanical cleaning, checked for correct fit and function 30/ Automated cleaning method maybe contraindicated for washing delicate or complex device 31/ Medical devices cannot be immersed in water, such as power tools 32/ Medical devices have an operating temperature lower than in Automated washing 33/ Mechanical damage may result from impact of water jet or other items in the load, wash and rinse devices according to IFU  Detergent Only orgnic soil ‫ متعادل‬- neurtal (ph: 6-8) ‫ قاعدي‬- alkali (ph: 8-11) acid - ‫(حمض‬ph: 1,6 - 3) need through rinsing mineral depost ( hard water) ‫ايجابيات‬ Leave powdary remove wider - urine for orgnic - non orgnic soil , safe cannot use soil more than any detergent - minerals with alminum bronze, copper, alumnum - scale ‫سلبيات‬ inorgnic soil hard water low foaming make stainsteel , shine more foaming ,diffrerent to rinse can damge : stainsteel , alumnum, bronze glass 34/ Non-immersion manual cleaning methods appropriate for certain device such as electrical tools, maybe compromised by soaking in wet solution 35/ Not a hand hygiene sink , a receptacle which hold enough water anddetergent to fully immerse item to be cleaned 36/ Validated method of dispensing a measured quantity is calleddetergent 37/ The wash and rinse sinks (usually < 40c) thermostatic mixer tap 38/ Nondamaging brushes in range of diameter and lengths for cleaningboth external and internal surfaces 39/ If not using single use , must be a protocol in place to decontaminate40/ Cleaning and disinfection the brushes at least daily 41/ The manufacturer should provide information regarding appropriatebrush size 42/ Always use brushes under water. why? To avoid splashing andaerosols after cleaning 43/ dry the manual washed devices that are not to be further processedthrough the WD 44/ Place device in drying cabinet, If drying cabinet is not available, use aclean disposable lint-free 45/ To effective manual cleaning follow written procedures (includingwearing personal protective equipment at all times while handling contaminated devices) 46/ Fill sink with water to predetermined level, specified temperature andamount of detergent (per manufacturers instruction) 47/ Use sink solely for cleaning of device not for any other purpose 48/ Types of sinks (washing, potable – tap water rinse – purified watersink) 49/ Use detergent specifically designed to clean RMD50/ Attention Household soap must never be used 51/ A mild detergent is preferred for manual cleaning (PH range 8.0- 11.5) 52/ Follow manufacturers instruction & local policies & procedures fordetergent & water temperature 53/ Consider use of an enzymatic detergent to cleaning of device with channel or complex parts 54/ immerse the item in the solution in order to displace trapped airimportant to ensure the cleaning solution reaches all surface 55/ Remove all visible soiling, including lumens & valves 56/ Remove stubborn staining by using inside non-abrasive, scouring pad,soaking 57/ Flush all lumened devices with a jet-gun (discharge under water toavoid splashing and aerosols) 58/ Rinse item in warm to hot water 59/ Dry mechanically in a drying cabinet or hand dry with lint free cloth60/ Note: items shouldn’t be left to dry in ambient air 61/ Inspect devices and equipment to establish that they are clean beforefurther processing or storage 62/ Ideally use single use brushes or identify cleaning brushes forcleaning only and wash, thermally disinfect and store them dry 63/ Keep a record of each device and device set has been manually cleaned 64/ Record should contain at a minimum (name of device or device set –name of processor – type of cleaning – type of detergent and detergent dilution – date) 65/ Ultrasonic cleaner used to remove soil from surgical devices aftermanual cleaned and before are sterilized 66/ Ultrasonic works by converting high-frequency sound wave intomechanical vibrations free soil from surface of device 67/ High frequency energy cause microscopic bubbles to form on surface of device and bubbles implode minute vacuum area, created drawing out tiniest particles of debris from crevices of UC, this process called cavitation 68/ Plastics and other similar materials cannot be successfully processedby method 69/ Cemented glass syringes and lenses will be damaged 70/ Consult the manufacturer IFU see if ultrasonic cleaning suitable fordevice 71/ De-gas time between (5-15mins) , are define removal of air from thewater to allow ultrasonic waves to pass more freely 72/ Cycle time for Ultrasonic depends on (machine - cycle program –how much soil on medical device) 73/ Water temperature is < 35C 74/ Thermal disinfection option (temperature between 80 – 93 C withholding time > 20s – 10 mins) 75/ Document scan and record all cycle and processes using track andtrace H2O2 + STEAM = geobacillus sterothemphilus ETO= bacillus atrophaeus TOSI (Protein detection test) HEMO-CHECK (Protein detection test) NINHYDRIN TEST(Protein detection test) FOIL TEST – ultrasonic cleaner BRONWES SOIL TEST – Visual test  Inspection and Assembly zone 1/ Assembly area is clean area. 2/ Inspected for (cleanliness, intactness, and functionality) 3/ The job in this preparation is critical as the surgical instrument 4/ handled for the last time before being dispensed to (OR room or clinics) 5/ The job must be carried by (trained decontamination specialists, technicians with manufacture IFU) 6/ The IAP takes place is (The effect of the sterilization process, minimize/reduce risk of contamination of RMD sets) 7/ Ventilation for IAP is (clean room standards according to ISO 14664-1:1999 Class 8 or other internationally) 8/ The room must be (Positive pressure) 9/Air flows outward instead of into the work area and the doors of IAP place are open 10/ Reduce the risk of airborne bacteria introduction of IAP 11/ All rooms in the department are ventilated and controlled comfortable working environment of 18-23C and humidity 30- 60% 12/ All furniture must be made smooth, non-porous easy to clean 13/ Fine fibers that lint carried by air current and settle on the clean surgical instrument 14/ lint introduced to sterile field, can cause infection to patient’s wounds 15/environmental cleaning must be daily accordance to hospital infection control policies and procedures 16/ A dedicated cleaning room located within the IAP room no outside areas should be cleaned from this location 17/ Microbiological monitoring carried out in room according to hospital infection control policies 18/ Monitoring used for an early waning system to alert staff 19/ Environmental quality drifting out of control 20/ One method of monitoring contact or settle plates in pre- planned location and send to lab for culturing and analysis 21/ Results of the analysis are compared to baseline of microorganisms (accepted level of contamination) 22/ Determined by microbiologist or contracted specialist 23/ Testing results same or better than this baseline 24/ Contamination during traffic flows and peak periods 25/ part of the sampling carried out facility unoccupied to achieve a baseline contamination level prior to sampling when occupied 26/ Staff movement, between dirty and clean not possible without passing through clothing change and hand wash 27/ Protective clothing worn by personal enter the IAP room 28/ Reduce the risk of possible contamination of clean RMD and environment 29/ Managers ensure that protective clothing is available 30/ All personnel responsible for correct use and disposal 31/ Low-linting is minimize bacterial shedding and provide comfort and professional appearance 32/ Freshly laundered is changed daily, it becomes visibly soiled or wet 33/ Appropriate clothing used by anyone entering this area such as staff maintenance and visitors 34/ A clean, single use, low lint, surgical hat/hood confines all hair is always worn in IAP 35/ Hat or hood must be > microbial dispersal minimized with head 36/ Head gear & beard mask discarded in waste stream 37/ Within the head & maybe worn “stud earrings” 38/ Make-up jewelry and wedding band not worn in IAP 39/ Sturdy shoes worn inside the IAP and never be used outside 40/ Shoes able to be protect the feet from item may in an undeliberate manner fall from work 41/ Shoes cover should be worn even if shoes are dedicated to department use only to protect shoes from contamination 42/ Automated process can use by conveyor belt-type 43/ If not automated, manually removed from chamber by heat resistance gloves 44/ Maximum temperature of the chamber over 90C 45/ Galipots or kidney dishes may have turned up-side down during washing process and hot water 46/ When unloading, quality check carried out before any futher processing 47/ If container cycle was inadvertently used for instrument, load rejected and sent back for reprocessing 48/ If arms blocked by RMD during cycle, load rejected as correct cleaning and disinfection 49/ Any soil or staining seen on visual inspection rejected and items sent back for repressing 50/ Excessive wetness caused by (blocked arm-incorrect loading- problems with WD settings) investigated 51/ If items impacted by spray arms or RMD was not compatible for WD processing 52/ If items not disassembled, adequate cleaning would not have concurred full set returned for reprocessing 53/ Load contents and any non-conformances and rejected load must be documented and reported to line manager 54/ Check the chart record for the cycle conforms to information during validation and all recorded variables within parameters permitted 55/ Check the operating cycle selected accordance with specification for the load such as surgical instrument or anesthetic, need different cycle type 56/ Visual inspection for the load, no obvious, damage, staining or residue 57/ If staining/residue are present maybe due to configuration of load, overloaded cart, malfunction in washing cycle 58/ Visual inspection for the load for dryness 59/ Unless there is clear indication, small percentage of RMD, load was not cleaned and / dried effectively, the entire load returned for repressing 60/ Quality checks must carried out accepting items were not processed in WD 61/ Any visible soil or staining rejected, and items must be back for reprocessing 62/ Items have manually cleaned and disinfected must be dry before moving to IAP 63/ If items was handled incorrectly or immersed in fluid when it should not have, reported immediately to manager 64/ If items not disassembled, adequate cleaning not have occurred, so item returned for reprocessing 65/ Manually cleaned items and non-conformances and rejected items must be documented and reported to manager 66/ Washer disinfector must be inspected for cleanliness, stains, corrosion, cracks, breakage, and stiffness of movable parts. 67/ Devices should be checked under magnification, because small pieces of bioburden or debris can be difficult to see 68/ Inspect each RMD from a set separately 69/ Inspect all areas of the device (box locks-serration-crevices) for cleanliness 70/ Check hinges (artery forceps, clamps) for ease of movement 71/ Check jaws and teeth (kocker – mosquito) for alignment 72/ Check ratchets for easy closure and firm hold 73/ Report any damaged, in complete or malfunction device to supervisor 74/ Check cannulated device to channel is patent(clear) 75/ Check telescopes and light cable per manufacture instruction 76/ Check each device set for completeness 77/ Check cutting edges (scissors rongeurs chisel curettes) for sharpness 78/ Check insulated device using a diathermy pinpoint tester, damage surface allow dirt and bacteria to collect and lead to a potential burn risk for patient and/ or user 79/ Check device for free movement of all parts & non sticking joints a water-based lubricant used if required 80/ Check edges of clamping RMD meet with no overlap and teeth mesh together properly 81/ Check all screws on jointed RMD for tightness, may become loose during cleaning process 82/ Devices have an outer insulation coating (diathermy forceps) close inspection to insulation remains intact Paper/plastic = steam and ethylene oxide Paper/Tyvek = hydrogen peroxide Sequential wrapping: 2 layers of wrap , material are wrapped individual using technique , a single layer is folded completely and sequentially followed with a 2nd sheet of wrap materials Simultaneous wrapping: both layer of wrap materials are wrapped together ‫تابع الكتاب‬ Square fold = heavier items Envelope fold = smaller item SMS meaning = spun bond melt blown spun bond  Regulation and standards Key words C-O-F-E-D Regulatory Agencies – governmental included: (CDC – OSHA – FDA – EPA – DOT) Professional Association agencies and there in CSSD (usually nonprofit) included: (AAMI – ANSI – AORN – APIC – ISO – TJC – NFPA – WHO – SGNA – CSA – USPNF – CEN)  Microbiology & infection control NAP (non-enveloped viruses) = ‫مكشر عن انيابه " كاشفها" غير محاط بالدهون‬ N= Norovirus, A= adenovirus , P= poliovirus "‫ غير الثالثة ذول اذا جت أسماء فيروسات نحط النوع األول اللي هو " االنفيلوب‬:‫مالحظة‬ ‫المحاط بالغشاء الدهني‬ Putting on PPE: 1/ shoe cover. 2/ gown 3/ mask Remember 4/ goggles or face shield Donning ‫دونــــأت‬ 5/ gloves ‫تناولها أي ترتدي‬ ‫ يعني‬Doffing ‫تــــدف الشيء‬ Removing on PPE: removing ‫تزيله‬ 1/ gloves 2/ goggles or face shield 3/ gown 4/ mask Hand washing 40-60 sec Hand rub 20-30 sec 5/ hand wash Medical asepsis: clean technique perform to reduce the number of microorganism to minimize spread example : hand hygiene , decontamination Surgical asepsis: Sterile technique procedure to eliminate presence of all microorganisms and or prevent the introduction of microorganisms to an area  Module 8 - Decontamination : 1- Automated Washer or Washer-Disinfector ( WD ) : Phases of a Typical Cycle : 1- Cold flushing pre-rinsing 1- Water: Cold Water 2- Temperature: < 40 °C ( Less than 40 °C ) 2- Warm washing : 1- Water: Warm fresh Water 2- Temperature: 60 °C 3- Rinsing: 1- Water : RO water or filtered water. 4- Disinfection : 1- Water : RO water or filtered water. 2- Temperature: 80 °C - 93 °C Usually : - Temperature 90 °C - Time : 5 min 5- Drying 2- Ultrasonic cleaners : De-gass time : 5 - 15 mins. Water Temperature is usually :