Medical Device Reprocessing Manual (Decontamination Specialist) PDF

MEDICAL DEVICE REPROCESSING (DECONTAMINATION SPECIALIST) Cover & Contents.indd 1 02/05/2017 17:12 Cover & Contents.indd 2 02/05/2017 17:12  Acknowledgements Iheed would like to thank...

MEDICAL DEVICE REPROCESSING (DECONTAMINATION SPECIALIST) Cover & Contents.indd 1 02/05/2017 17:12 Cover & Contents.indd 2 02/05/2017 17:12  Acknowledgements Iheed would like to thank a number of organisations that provided some of the images used in this Student Workbook. CDC Centers for Disease Control and Prevention Public Health Image Library (PHIL) - https://phil.cdc.gov/ M2 CDC/Janice Haney Carr; Jeff Hageman M2-6 CDC/ Dr. Mae Melvin M2-7 CDC/ Dr. Mae Melvin M2-8 CDC M2-10 CDC/Cladosporium mansonii Dr. Lucille K. Georg; Curvularia - CDC/Dr. William Kaplan; Fusarium - CDC/ Dr. Hardin; Trichophyton tonsurans – CDC/Trichophyton tonsurans; M2-14 Mycobacterium tuberculosis - National Institute of Allergy and Infectious Diseases (NIAID); Streptococcus - CDC/ Bette Jensen M2-24 CDC/ Teresa Hammett M2-26 CDC/ Cleopatra Adedeji, RRT, BSRT Getinge AB Lindholmspiren 7, SE-417 56 Gothenburg, Sweden - www.getinge.com Getinge kindly provided the following images: M1-11, M1-21, M1-25, M1-27, M2-35, M5- 12, M5-16, M5-21, M6-6, M6-12, M6-26, M7, M7-1. Steelco S.p.A. Via Balegante, 27 31039, Riese Pio X (TV), Italy - www.steelcospa.com Steelco kindly provided the following images: M1-7, M1-10, M1-14, M1-19, M1-22, M1-23, M1-26, M1-27, M1-30, M1-31, M5-5, M5-6, M5-7, M5-9, M5-10, M5-11, M5-15, M5-20, M6-1, M6-7, M6-8, M6-21, M6-25, M7-3, M8, M8-6, M8-7, M8-8, M8-13, M9-10, M9-11. Steris 5960 Heisley Road, Mentor, OH 44060, USA - www.steris.com Steris kindly provided the following images: M1-9, M1-12, M1-15, M1-25, M3-20, M3-21, M3-22, M3-23, M3-24, M3-25, M3-26, M5, M5-8 M2-20 Holder BP, Simon P, Liao LE, Abed Y, Bouhy X, Beauchemin CAA, et al. (2011) As- sessing the In Vitro Fitness of an Oseltamivir-Resistant Seasonal A/H1N1 Influenza Strain Using a Mathematical Model. PLoS ONE 6(3): e14767. https://doi.org/10.1371/journal. pone.0014767 Medical Device Reprocessing (Decontamination Specialist) Cover & Contents.indd 3 02/05/2017 17:12  Contents Module 0 Introduction 2. Learning Outcomes 3. Introduction 4. Pre-Module Quiz 4. Adult Learning 9. Multicultural Workplace 11. Confidentiality 13. Introducing Khaled and Maryam 14. Exercises and Checklists Module1 Introduction to Decontamination 16. Learning Outcomes 17. Introduction 17. Pre-Module Quiz 20. Decontamination Life Cycle 22. Decontamination Design 30. General CSSD Requirements 33. Exercises and Checklists Module 2 Microbiology and Infection Control 35. Learning Outcomes 36. Introduction 36. Pre-Module Quiz 37. Microbiology and Decontamination 40. Microorganisms 50. Microbes and CSSD 52. CSSD Workwear and Personal Protective Equipment (PPE) 57. Standard Precautions and Infectious Agent Transmission 58. Chain of Infection and Routes of Transmission 63. Housekeeping and Infection Control 64. Exercises and Checklists Contents Cover & Contents.indd 4 02/05/2017 17:12  Module 3 Surgical Instrument Types 66. Learning Outcomes 67. Introduction 67. Pre-Module Quiz 67. Standard Device Manufacturing 71. Classification and Overview of Surgical Devices 83. Care of Instruments 88. Vendor Repairs 88. Powered Surgical Devices 91. Rigid, Semi-Rigid and Flexible Endoscopes 92. Endoscope Reprocessing Procedures 94. Exercises and Checklists Module 4 Contaminated Medical Device Transportation 96. Learning Outcomes 97. Introduction 97. Pre-Module Quiz 98. Pre-cleaning 100. Transport containers 102. Spill Kit 103. Transport carts 104. Handling 106. Exercises and Checklists Module 5 Cleaning and Disinfection 108. Learning Outcomes: 109. Pre-Module Quiz 109. Introduction 110. Choice of Decontamination Process 112. Sorting and Disassembly of Contaminated RIMD 119. Manual Cleaning 122. Disinfection 123. Process Chemicals 125. Routine Testing of Decontamination Equipment 130. Exercises and Checklists Medical Device Reprocessing (Decontamination Specialist) Cover & Contents.indd 5 02/05/2017 17:12  Module 6 Inspection, Assembly & Packaging (IAP) 132. Learning Outcomes 133. Introduction 133. Pre-Module Quiz 134. The IAP Room 137. Washer-Disinfector to Sterilizer 139. Inspection and Function Testing 141. Assembly and Checking 144. Packaging 148. Exercises and Checklists Module 7 Sterilization 150. Learning Outcomes 151. Introduction 152. Pre-Module quiz 152. When is Sterilization Required? 153. Device Compatibility 153. Steam Sterilization 159. Dry Heat Sterilization 162. Sterilization Validation 166. Exercises and Checklists Module 8 Sterile Storage, Handling & Transportation 168. Learning Outcomes 169. Introduction 169. Pre-Module Quiz 170. Product Release 171. Product Rejection 171. Product Recall 172. Sterile Storage Room 174. Sterile Supply Expiration 176. Quality Assurance Checks 177. Time Versus Event Related Sterility 178. Consumable Inventory Management 179. Sterile Transportation 181. Exercises and Checklists Contents Cover & Contents.indd 6 02/05/2017 17:12  Module 9 Endoscope Decontamination 183. Learning Outcomes 184. Introduction 184. Pre-Module Quiz 184. What Is an Endoscope? 186. Endoscopic Procedure and Decontamination 187. Transmission of Infection 188. Decontamination of Duodenoscopes 189. Decontamination Failure Investigation 190. Staff Education and Training 191. Staff Health 191. Record Keeping 192. Flexible Endoscope Decontamination 198. Automated Endoscope Reprocessor (AER) 199. Accessories 200. Facilities for Decontamination 203. Exercises and Checklists Module 10 Dental Instrument Processing 205. Learning Outcomes 206. Introduction 207. Pre-Module Quiz 207. Dental Clinics and the Dental Chair Unit 214. Handpiece Decontamination and Maintenance 216. Characteristics of an LDU 219. The Dental Decontamination Cycle 219. Single-Use Devices 221. Reusable Devices (RD) 223. Dental Device Decontamination Process 228. Exercises and Checklists Module 11 Introduction to Quality Control and Assurance in the CSSD 232. Learning Outcomes 233. Introduction 234. Pre-Module Quiz 234. What is Quality? Medical Device Reprocessing (Decontamination Specialist) Cover & Contents.indd 7 02/05/2017 17:12  236. Quality Management Systems (QMS) 240. Staff Performance and Training 242. Key Performance Indicators (KPI) 244. CSSD Electronic Tracking Systems 246. CSSD Auditing Appendices 248. Appendices Contents Cover & Contents.indd 8 02/05/2017 17:12  Module 0 INTRODUCTION Key Terms Central sterile service department (CSSD) | autonomous competence | confidentiality | diversity Module 0 KSA Manual A4.indd 1 02/05/2017 17:13  Learning Outcomes By the end of this module you will be able to:  Describe learning approaches and characteristics for adult students  Describe common challenges faced by returning adult students  Discuss challenges in a multicultural workplace and methods to succeed  Explain the importance of workplace confidentiality 2 Introduction Module 0 KSA Manual A4.indd 2 02/05/2017 17:13  Introduction Welcome to the Medical Device Reprocessing (Decontamination Specialist) program. This introductory module helps you, the returning student, prepare to come back to an educational environment. This module highlights basic concepts of adult learning as well as key requirements to be successful in a clinic or hospital working environment. The aim of this module is to help you study and learn with confidence. We will look at some of the unique issues you may face as adults re-entering the education system. Becoming familiar with the material in this module will help you achieve success The measure of with this program. We strongly advise that intelligence is the you take the time to study the content, as ability to change. it will help you understand how to retain —Albert Einstein and apply what you learn. We wish you an interesting and productive program. Medical Device Reprocessing (Decontamination Specialist) 3 Module 0 KSA Manual A4.indd 3 02/05/2017 17:13  The illiterate of the 21st century will not be those who cannot read and write, but those who cannot learn, unlearn, and relearn. —Alvin Toffler Pre-Module Quiz Keep these questions in mind as you go through the content and don’t worry if you don’t know the answers yet—that’s what you’re here to learn. Q:Can you list five different learning approaches you used in your previous studies? Q: What are the characteristics of an adult learner? Q:W  hat are some of the challenges you may face as a returning student? Q: Do you know what conscious incompetence means? Q: In what ways could a colleague from another country be different from you? Q: What are good traits to ensure effective communication in work? Q: What does confidentiality mean to you and how might that be different in a hospital? Adult Learning Students participating in this program must have a bachelor’s degree in science, which requires strong skills for studying and learning. Some of you completed this degree recently, while others completed it years ago. This gap in learning may present challenges, as you may have forgotten previous study practices or they may not be as strong due to lack of practice. To help reduce the frustration of returning to the learning environment we will look at ways to achieve successful learning and many of the common challenges that returning students may face. 4 Introduction Module 0 KSA Manual A4.indd 4 02/05/2017 17:13  Approaches to Learning The table below illustrates different approaches to learning and how they impact learners and their ability to retain and apply knowledge. On-the-job training has the highest impact on learning while reading has the lowest. High On-the-job training Case studies and teaching others Mentoring and coaching Impact on learner Simulations and virtual learning retention and application Problem solving group activities Interactive discussions Lectures Low Reading Table M0–1 Approaches to learning Which of these approaches to learning do you think works best for you? These approaches help guide us to effective techniques for learning, but for education to truly be successful, we must also consider the characteristics of you, 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 Medical Device Reprocessing (Decontamination Specialist) 5 Module 0 KSA Manual A4.indd 5 02/05/2017 17:13  Autonomous Adult learners resist learning when they feel others are pushing information, ideas or actions. The foundation of this program is based on reading materials to encourage self-directed learning and we use interactive exercises such as questionnaires and checklists for students to complete on their own. Experienced Adults like the opportunity to use their existing foundation of knowledge and apply their life experiences to their professional development. This program is designed to recognize the knowledge from your bachelor’s degree and build additional learning through your interaction with your instructors. Goal Oriented Adult learners are more effective when they feel a need to learn in order to cope more satisfyingly with real life tasks or problems. We will ask questions that motivate reflections, inquiry and further research to increase the motivation to learn. Relevancy Oriented Adult learners want to know the relevance of what they are learning to what they want to achieve. Through the instructors, we will check meaning, understanding and relevance to the context of the work throughout the learning experience. Practical Classroom and textbook learning create a foundation but hands on exercises and practice provide the highest impact of learning and retention. We will use competency documents with clear content and rationale explaining how it is applicable to the specialist’s work. The strongest focus for this program will be to provide opportunities for repetition to promote skill development, confidence and competence. 6 Introduction Module 0 KSA Manual A4.indd 6 02/05/2017 17:13  Respectful Adult learners like to be respected. We will demonstrate this by acknowledging the wealth of knowledge and experience each student brings and encouraging the expression of new ideas, reasoning and feedback throughout the program. Challenges for Returning Students We may understand approaches to learning and the importance of adult student characteristics but additional challenges can also impact students returning to study after time away. Responsibilities Social fears Learning curve Diversity Responsibilities Family and work responsibilities are among the greatest challenges to returning students as many will now have spouses and children. This program will require a commitment from students to apply themselves and focus on learning the content and participating in assigned tasks. It is also structured to allow for self-study through reading, tutorials and on-the-job training to ensure your success. Social Fears Age doesn’t stop the impact of social pressure and personal fears so this program is structured with the expectation that it may take some practice to return to learning. This program allows for mentoring to help discuss challenges. Diversity As the world becomes more globalized so does the classroom, with students from different age groups, experiences and backgrounds. In the workplace it is also common to work with people of different nationalities. Medical Device Reprocessing (Decontamination Specialist) 7 Module 0 KSA Manual A4.indd 7 02/05/2017 17:13  Learning Curve Returning students often learn how things have changed since their first classroom experience. This program will include team work, group discussions and mentoring to help new learners through these four stages of competence. The Four Stages of Competence You don’t understand or know how to Unconscious do something. You must recognize Incompetence your incompetence before moving on to the next stage. Though you do not understand or Conscious know how to do something, you Incompetence recognize the deficit and see the value in learning a new skill. You know how to do something, Conscious but must use strong concentration Competence to execute the new skill. You have had so much practice with the new skill that it has become Unconscious second nature and can be performed Competence easily. At this level the skill can be performed while doing another task and you may be able to teach it to others. Table M0–2 The four stages of Competence Acquire new knowledge whilst thinking over the old, and you may become a teacher of others.—Confucius 8 Introduction Module 0 KSA Manual A4.indd 8 02/05/2017 17:13  Multicultural Workplace In a multicultural team people come from many different countries and backgrounds and may have different perspectives and perceptions based on influences like: Age Class Race Ethnicity Gender Language Education Religion Disability These items are the foundation of a person’s identity and can lead to an increased chance of disagreements and conflicts if they feel their view is challenged. At the least this would only negatively affect individuals but could also negatively impact the performance of the whole team. To help reduce the chance of conflict in a diverse internal environment there needs to be a clear system for communication that allows sharing of ideas while respecting each other’s diversity. Multiculturalism can be defined as acknowledging, understanding, accepting and valuing differences among people with respect to things like age, class, race, ethnicity, gender, language, education, religion and disabilities. Treating people differently can constitute harassment or a hostile work environment. Medical Device Reprocessing (Decontamination Specialist) 9 Module 0 KSA Manual A4.indd 9 02/05/2017 17:13  Basic Tools for Communication Do Don’t Show respect and Insult, name call or put down positive regard for the people or their ideas other person through courtesy, politeness and kindness Actively listen to try to Never speak over or cut off understand the other another person perspective and allow them to finish expressing their viewpoint Focus on sharing praise Share negative criticism more frequently than criticism and encourage all members of the team to do the same Initiate discussion that Make decisions in isolation encourages idea sharing that may impact your to solve problems as a colleagues team Be aware of your body Shout and negatively gesture language, tone of voice and demeanor as they can negatively impact the perception of your communication Treat people the same no Treat others in a way you matter their race, religion, would not want to be treated gender, size, age or country of origin so they feel they are treated fairly and equally Table M0–3 Basic rules for communication Treat others as you wish to be treated. 10 Introduction Module 0 KSA Manual A4.indd 10 02/05/2017 17:13  We may have all come on different ships, but we’re in the same boat now —Martin Luther King, Jr Confidentiality Data regarding recruitment, compensation, and management of employees is naturally sensitive in organizations and workplaces. In the wrong hands, this information could be used to commit fraud, discrimination, and other possible violations. Professionalism, safety, and security for all members of an organization are dependent on confidentiality. In a health care environment, confidentiality is given an even higher priority as there are legal and ethical obligations to protect a patient’s health information and ensure it is only accessed by authorized users. Confidentiality in the workplace is important—to maintain it you will: Capture documentation accurately Share information only if you are authorized Document and store information as per local legislation requirements Disclose information only to those who have the right and need to know Handle confidential records securely and store them in the correct place Take appropriate precautions when communicating confidential or sensitive information to those who have the right and need to know In order to meet this higher obligation of confidentiality it is important to know your local policies and who to contact if you have questions. Medical Device Reprocessing (Decontamination Specialist) 11 Module 0 KSA Manual A4.indd 11 02/05/2017 17:13  Ethical Guidance A good guideline for ethical behavior is to ask yourself the following questions when considering your actions: Is the action legal? Does the action hurt anyone? Is the action fair to others? Am I being honest as I carry out the action? Would I publicize my actions? What if everyone did it? Equal Opportunity All people should be treated similarly, unhampered by artificial barriers, prejudices or preferences, except when particular distinctions can be explicitly justified. Principle of non-discrimination emphasizes that opportunities in education, employment, advancement, benefits and resource distribution, and other areas should be freely available to all citizens irrespective of their age, race, sex, religion, political association, ethnic origin, or any other individual or group characteristic unrelated to ability, performance, and qualification. We all should know that diversity makes for a rich tapestry, and we must understand that all the threads of the tapestry are equal in value no matter what their color. —Maya Angelou 12 Introduction Module 0 KSA Manual A4.indd 12 02/05/2017 17:13  Introducing Khaled and Maryam Meet our fictional characters, Khaled, a manager, and Maryam, a newly arriving Decontamination Specialist student. Throughout this program, Maryam asks common questions that new students may have, and Khaled provides answers that are typical for most CSSDs. Khaled Khaled is the CSSD Manager, originally from Tabuk and has been working in CSSD for 20 years. After high school, he completed a two-year diploma and started working at a local hospital as a pharmacy technician. He really enjoyed this role as he worked closely with pharmacists, doctors and nurses and felt he was doing important work. The pharmacy was located next to CSSD so he frequently had lunch with their team and found it exciting to hear their stories of assisting surgery with complex surgical instruments sets and all the equipment required to sterilize surgical instruments. The manager in CSSD noticed Khaled’s interest and recommended he complete one of the distance learning programs from the United States. After completing the IAHCSMM technician course Khaled was hooked, and after 5 years working in pharmacy decided to apply and switch to CSSD. Khaled worked diligently to learn about surgical instruments and processes and after a year felt knowledgeable, but was interested in learning more. He asked for additional training from the equipment manufacturers and also took a course on surgical instruments. Within two years of working in CSSD, because of his initiative, the manager promoted him to a lead technician role so he could share his learning with others and mentor new employees. This new role was fulfilling for Khaled as he really loved to share his experience, so he decided to take additional training in education, and a distance program for leadership. After a couple of years of practice and education Khaled was one of the favorite mentors for new employees, respected by his CSSD team, and recognized throughout the hospital as a CSSD expert. Medical Device Reprocessing (Decontamination Specialist) 13 Module 0 KSA Manual A4.indd 13 02/05/2017 17:13  Khaled completed a bachelor of science degree in healthcare management, and became the CSSD manager after his manager retired. Maryam Is from Riyadh, and after high school completed a bachelor’s degree in science as she had an interest in chemistry and research. At the end of her studies she got married and as she began her search for work, found out she was blessed with her first child. Being a mother became her priority and within the next few years she had two more children, a girl and another boy. When her children went to school she had more spare time and was interested in looking for work but was nervous as she had completed her degree almost 10 years ago and had not worked before raising her family. That’s when she found out about the new Decontamination Specialist program being offered for graduates returning to work. Maryam I’m concerned about my ability to study, it’s been over 10 years since I was in school! Khaled We’ve designed this program with you in mind Maryam. Each module introduces new material and builds on the previous module. We do require a commitment from you to apply yourself and focus on learning the content and participating in assigned tasks. There is a mixture of reading, self-directed learning, practical exercises and checklists to help you get used to learning again. Exercises and Checklists Introductory Exercise: Meet and Greet Go to your log book and complete the exercise. 14 Introduction Module 0 KSA Manual A4.indd 14 02/05/2017 17:13  Module 1 INTRODUCTION TO DECONTAMINATION Key Terms central sterile service department (CSSD) | sterile processing department (SPD) central supply department (CSD) | central decontamination unit (CDU) decontamination | decontamination life cycle | sterilization manufacturing | single use | reusable medical devices (RMD) inspection assembly and packaging (IAP) | sterile storage | air pressure Module 1 KSA Manual A4 Template.indd 15 02/05/2017 17:43  Learning Outcomes By the end of this module you will be able to:  Describe the function of a decontamination unit and key requirements for unit design  Describe international standards available for decontamination units  Describe why policies and procedures are required for an effective decontamination unit 16 Introduction to Decontamination Module 1 KSA Manual A4 Template.indd 16 02/05/2017 17:43  Introduction Decontamination is an entry-level program for new entrants to the field of decontamination and sterilization in a hospital, dental or ambulatory clinic setting. In this module, Introduction to Decontamination, we will talk about reusable medical device reprocessing, the facilities required to carry out this function, and how the life cycle of a reusable medical device fits in. Pre-Module Quiz What is CSSD? Keep these questions in mind as you go Central Sterile Service Department (CSSD) through the content and don’t worry if you is a place in hospitals or healthcare facilities don’t know the answers yet—that’s what that performs reprocessing of reusable you’re here to learn. medical devices used by health workers in the operating room for surgical and other patient Q: C  an you describe what procedures. This department is sometimes manufacturing means? called the sterile processing department (SPD), central supply department (CSD) and Q: C  an you list five items that you use central decontamination unit (CDU). Any of daily that are manufactured? these or other variations will be referred to as Q:Can you describe the CSSD in this program. decontamination life cycle? Manufacturing Q: D  econtamination facilities are separated into key zones to maintain Manufacturing is the term most safety, how many do you think there commonly applied to industrial production, are? where raw materials are transformed into finished goods on a large scale. Cars, Q: C  an you list five items used to electronics, appliances, and furniture are assist in cleaning reusable medical examples of items we buy that are devices? manufactured with standards to ensure Q: D  o you know what the acronym PPE they are reliable and safe for use. Most means? consumables we purchase in supermarkets Q: W  hat should the air pressure be are also manufactured, and need to be in the sterile storage room of a produced in a consistent safe process to decontamination unit? ensure no harm to consumers. With RMD, producing quality results is especially Q: W  hat should the temperature be in a important as they will be used on patients decontamination unit? with compromised health. Medical Device Reprocessing (Decontamination Specialist) 17 Module 1 KSA Manual A4 Template.indd 17 02/05/2017 17:43  Medical Device Manufacturing Medical devices are defined by international regulatory bodies, such as the US Food and Drug Administration (FDA) and the European Medical Devices Directive, as any object or component used in the diagnosis, treatment, prevention, or cure of medical conditions or diseases, or affects body structure or function through means other than chemical or metabolic reaction to humans or animals. This includes all medical tools, excluding drugs, ranging from tongue depressors, to surgical instruments and radiology treatments. Most medical procedures require the use of medical supplies, surgical instruments and equipment. Some of these items are single use and used once then discarded, while many are designed for reuse. RMD must be thoroughly cleaned, disinfected, inspected, packaged and sterilized before they can be safely reused on another patient. In healthcare, CSSD is where the critical function of reprocessing reusable medical devices occurs. In a hospital setting, reusable medical devices and surgical instruments are more commonly used than disposable ones, as it is more cost effective and creates less environmental waste. This is especially true for surgical procedures in operating rooms where 50 or more surgical instruments are commonly used. 18 Introduction to Decontamination Module 1 KSA Manual A4 Template.indd 18 02/05/2017 17:43  Some of these groups are: AAMI Association for the Advancement of Medical Instrumentation ST79 - Comprehensive guide to steam sterilization and sterility assurance WHO World Health Organization Decontamination and Reprocessing of Medical Devices for Health-care Facilities IAHCSMM International Association of Healthcare Central Service Material Management Technical Manual CBSPD Certification Board for Sterile Processing and Distribution The Basics of Sterile Processing AORN Association of perioperative Registered Nurses Recommended Practices for Cleaning and Care of Surgical Instruments UK DH Decontamination of Surgical Instruments (HTM 01-01) IE HSE Ireland Health Service Executive Standards and recommended practices for Central Decontamination Units Table M1– 1 Standard practices and procedures for reusable medical device reprocessing There is such a wide variety of equipment classified as reusable medical devices, that regulatory agencies have no single standard, but they do have an international standard, ISO 17664, that specifies what all manufacturers must do to create procedures or instructions for use (IFU) when processing their specific RMDs. Professional groups and associations use research and evidence-based practice to define minimum standards used to help set guidelines for standard practices and procedures for reusable medical device reprocessing. These and other similar professional bodies are used to ensure policies and procedures will produce safe, high quality and reliable RMD. Medical Device Reprocessing (Decontamination Specialist) 19 Module 1 KSA Manual A4 Template.indd 19 02/05/2017 17:43  Maryam: Do all hospitals have the same setup for processing reusable medical devices? Khaled: All hospitals follow specific guidelines for optimum health and safety. Older hospitals may have special areas adapted to comply with these rules, while newer facilities have departments with rooms built specifically for decontamination. Decontamination Life Cycle The decontamination life cycle model shows the critical steps required for reprocessing reusable medical devices, and the pathway through the whole organization. This model will be referenced throughout this program, to detail how to safely meet standards and keep patients safe. ACQUISITION  1. Purchase 2. Loan CLEANING DISINFECTION TRANSPORT INSPECTION At all stages Location Facilities USE Equipment PACKAGING Management Policies/Procedures  DISPOSAL 1. Scrap 2. Return to lender STORAGE STERILIZATION TRANSPORT Table M1–1 Decontamination life cycle ACQUISITION - Purchase - Loan 1 CLEANING & DISINFECTION TRANSPORT 2 INSPECTION USE DISPOSAL - Scrap - Return to lender 3 PACKAGING STORAGE STERILIZATION TRANSPORT Table M1–2 Cleaning and disinfection life-cycle 20 Introduction to Decontamination Module 1 KSA Manual A4 Template.indd 20 02/05/2017 17:43  Stage Frequency Cleaning involves removing all visible soil such as body fluids and tissues from reusable medical Cleaning devices. This may involve wiping or pre-cleaning, ultrasonication, manual or automated cleaning. At completion of this stage, 95% of microorganisms are removed from the device. Disinfection follows cleaning and kills the majority of remaining microbes, usually by chemical or heat treatment. Spores, some mycobacteria, and prions may not be inactivated by this. For flexible Disinfection endoscopes and other delicate reusable medical devices, this may be the final hygiene stage and must be as rigorous as possible. The reusable medical device is then inspected for functionality, visible soil, and damage. Remaining Inspection soil or damaged areas on reusable medical device may harbor clusters of microorganisms that are difficult to remove. Such reusable medical device are rejected or returned to the cleaning stage again. Reusable medical device which have been cleaned and disinfected are wrapped in special barrier Packaging packaging, ready for sterilization of the contents. This packaging will prevent microorganisms from entering the pack until time of use. Sterilization kills any remaining microorganisms in the reusable medical device pack. There is no such Sterilization thing as a device being more or less sterile—sterile means zero live microorganisms. Sterile reusable medical devices are transported to the storage zone or to the point of use in a careful Transport way to prevent damage or rupture to the packaging and prevent recontamination. Packed sterile reusable medical devices must be stored in a zone having cleanroom conditions in a Storage way that does not damage or rupture the packaging during handling or storage. Sterile reusable medical devices are used on patients in surgeries, theatres and wards. Once used, Use the reusable medical device is contaminated by microorganisms on or in the patient. Used reusable medical devices are contaminated by microorganisms and must carefully be Transport transported back to the decontamination facility. Loss, spillage or carelessness could result in the spread of infection. Standard Precautions are implemented. Table M1–3 Reprocessing life cycle Medical Device Reprocessing (Decontamination Specialist) 21 Module 1 KSA Manual A4 Template.indd 21 02/05/2017 17:43  Decontamination Design Before the CSSD, the critical role of design, construction and equipping of the zone areas were often neglected, but are now recognized as significant factors in ensuring safe practices in the reprocessing of RMD. Some building design resources are: HBN 13 Health Building Note: Sterile Services Department—Department of Health UK AAMI Building for the Future AIA  Guidelines for Design and Construction in Health Care Facilities Ensuring a proper one-way flow is a key part of safe reprocessing of reusable medical devices. Separating dirty, clean, and sterile items avoids routes and workflows that could re-contaminate processed reusable medical devices. In CSSD this is achieved by using walls to separate the work areas into three primary functional zones. ZONE 1 ZONE 2 ZONE 3 DECONTAMINATION INSPECTION, ASSEMBLY STERILE STORAGE & PACKAGING (IAP) Dirty Items Receiving 1  Clean Items Inspection 2  3 Sterile Items Storage Cleaning Assembly Dispatch Disinfection Packaging Sterilization Figure M1–1 Functional Zones in the CSSD 22 Introduction to Decontamination Module 1 KSA Manual A4 Template.indd 22 02/05/2017 17:43  Zone 1 DECONTAMINATION ZO Figure M1–2 Decontamination zone 1. Decontamination Zone Decontamination is the combination of processes (including cleaning, disinfection and sterilization) used to render reusable medical devices safe for 1 ‣ Gowning room—provides controlled entry and exit to the wash area, space for changing into PPE, a hand wash sink for hand hygiene, and an eye wash station in case of eye splash ‣ Wash room—space to carry out preparation, handling by staff and for use on patients. All reusable medical devices returned to cleaning and disinfection of contaminated the decontamination zone are considered reusable medical devices contaminated and potentially infected. You, as a decontamination specialist, must have ‣ Environmental cleaner room— dedicated an in-depth knowledge of microbiology, to cleaning only the decontamination room infection control and safe cleaning practices To ensure safety and prevent exposure to ensure safety for yourself and for to pathogens and other contaminants, patients. Ideally this zone is defined by decontamination specialists must wear personal specific rooms or at minimum segregated protective equipment such as: areas to ensure safety to staff and a Cover gown with sleeves unidirectional flow of reusable Face mask medical devices. Eye protection Gloves ‣ Contaminated returns room—provides  Shoe covers or alternative shoes outside staff with secure and controlled or boots access into the zone, allowing delivery of Head covering contaminated containers and trolleys Medical Device Reprocessing (Decontamination Specialist) 23 Module 1 KSA Manual A4 Template.indd 23 02/05/2017 17:43  With the wide variety of surgical specialties and procedures, there is an extensive range of complex reusable medical devices being used. In order to clean these specialized reusable medical devices, processes and appropriate tools are required such as: Hand wash sink– with liquid soap and paper towels Instrument cleaning sink— with two or three basins Brushes Figure M1–3 Personal Protective equipment in CSSD Air guns Water guns Magnifiers Additional lighting Detergents Disinfectants Lubricants Ultrasonic washers Automated washer disinfectors Cart washer Figure M1–4 Hand wash sink and instrument cleaning sinks Automated endoscope re-processer Environmental monitors— temperature, humidity  and pressure Spill kits Figure M1–5 Brushes Figure M1–6 Air/Water Gun Figure M1–7 Magnifying Lamp In the decontamination zone: PPE is worn to ensure specialist safety Reusable medical devices received are checked for Figure M1–8 Enzymatic Detergents Figure M1–9 Disinfectants Figure M1–10 Environmental Monitoring missing parts, manually pre-cleaned and prepared for automated washing Reusable medical devices not compatible with automated washers are manually cleaned and disinfected Figure M1–11 Automated washer disinfectors Figure M1–12 Ultrasonic washers 24 Introduction to Decontamination Module 1 KSA Manual A4 Template.indd 24 02/05/2017 17:43  Zone 2 Inspection, Assembly and Packaging (IAP) Zone Figure M1–13 Inspection, Assembly and Packaging (IAP) Zone 2. Inspection, Assembly and Packaging (IAP) Zone After cleaning and disinfection, reusable medical devices are received in the Inspection, Assembly and Packaging 2 Gowning room—provides controlled entry and exit to the IAP zone, allows for changing into personal protective zone to prepare for sterilization. Reusable equipment, and a hand wash sink for hand medical devices are now safe for handling hygiene to protect clean instrumentation and extra care must be taken to ensure that from the risk of contamination they are not re-contaminated. Strict hand hygiene must be maintained and personal Materials transfer room—maintains an protective equipment must be used at air-lock to bring raw materials in and out of all times. Ideally this zone is defined by the IAP zone specific rooms or at minimum segregated areas to ensure safety to staff and ensure a Environmental cleaner room—dedicated unidirectional flow. to cleaning materials and equipment for use only in the IAP zone Inspection, assembly and packing (IAP) room—this room is restricted only Sterilization room—in newer CSSD to specialists who inspect, assemble designs sterilization equipment is located and package cleaned RMD to prepare in a room separate from IAP and Storage for sterilization. Sterilizers are frequently to further reduce contamination risks to located in this room. unwrapped RMD Medical Device Reprocessing (Decontamination Specialist) 25 Module 1 KSA Manual A4 Template.indd 25 02/05/2017 17:43  The extensive range of complex instrumentation requires specialized processes and appropriate tools for inspection and packing such as: Packing tables Chairs Figure M1–14 View Pack Pouches Figure M1–15 Tip Protectors Magnifiers Additional task lighting Wrappers and containers View pack pouches Heat sealers Surgical instrument tip protectors Tray liners Air guns Figure M1–16 Heat Sealers Figure M1–17 Packing tables Pass through hatchs Drying cabinets Sterilizers—high temperature Sterilizers—low temperature Biological incubators Environmental monitors temperature, humidity and pressure In the Inspection, Assembly Figure M1–18 Surgical Instrument Wrappers and Packaging zone, surgical instruments are unloaded from automated washers or pass through hatches (if manually cleaned) and: Visually checked to ensure cleanliness Manually inspected against a checklist to ensure items are correct and functional Packaged in appropriate materials and labelled Sterilized with the correct process or passed to a sterilization room if separate Figure M1–19 Pass-through hatch from IAP 26 Introduction to Decontamination Module 1 KSA Manual A4 Template.indd 26 02/05/2017 17:43  Figure M1–20 Steam Sterilizers Figure M1–21 Low Temp Sterilizers Medical Device Reprocessing (Decontamination Specialist) 27 Module 1 KSA Manual A4 Template.indd 27 02/05/2017 17:43  Figure M1–22 Low Temperature Formaldehyde sterilizers Figure M1–23 Drying Cabinets 28 Introduction to Decontamination Module 1 KSA Manual A4 Template.indd 28 02/05/2017 17:43  Zone 3 STERILE STORAGE ZONE Figure M1–24 Inspection, Assembly and Packaging (IAP) Zone 3. Sterile Storage Zone CSSD requires a safe storage zone for sterile and clean supplies used in production. Sterile reusable medical devices are packaged, and stored safely in an 3 environmentally monitored (temperature, humidity and pressure) room using: Figure M1–25 Sterile Storage Shelving Washable, round-edged shelving designed to avoid damage to packaging Additional CSSD Support Transport carts Areas Workstations The CSSD is segregated into three primary zones and additional areas are required In the Sterile Storage zone processed to support the safety of specialists and reusable medical devices are: surgical instruments. Transferred from the sterilizer to this Staff Facilities—Changing, Toilets, room where they will either be kept until and Showers required or staged for end-user delivery Male and female toilets and areas to Removed from shipping boxes and change from outdoor to working clothing containers before being transferred here Lockers to accommodate storage of for storage or staged for end-user delivery specialist belongings Medical Device Reprocessing (Decontamination Specialist) 29 Module 1 KSA Manual A4 Template.indd 29 02/05/2017 17:43  Showers located close to the decontamination area to ensure quick access in case of a workplace spill or contamination incident Hand hygiene station Mirrors to check PPE Staff Rest Room Facilities to prepare hot and cold drinks for staff breaks Area for eating and drinking (restricted to this area) Materials Storage Separate segregated area for bulk storing of production materials Sufficient stock levels of materials to ensure smooth operations Not used to store sterile processed items Education, Training and Meeting Rooms Separate from the work area and provides space for teaching materials and work samples Support for important regular Figure M1–26 Transport carts training and education for all grades of staff Central Detergent Dosing Room Adjacent room for detergent replacement without entering the contaminated area, reducing the opportunity for automated washer contamination General CSSD Requirements The unit is used exclusively for reprocessing reusable medical devices, must be physically separated Figure M1–27 Workstations from other work areas and never used as a thoroughfare to other units. 30 Introduction to Decontamination Module 1 KSA Manual A4 Template.indd 30 02/05/2017 17:43  Unit Access Air Pressure Due to the critical nature of this unit, access Air pressure is regulated to prevent cross is restricted to authorized personnel and contamination of airborne pathogens trained specialists. between each zone. A ventilation system is used to either exhaust air out of a room, Lighting creating negative air pressure, or vent air The light is kept at a brightness and into the room, creating positive air pressure. color balance for good working practices and visual examination of reusable Work Surfaces medical devices. Additional task lighting Walls are smooth, non-shedding, and magnification are available in water resistant and withstand frequent decontamination and IAP areas. cleaning. Floors are a washable non-slip material Temperature and have no exposed seams or Room temperature is controlled between openings. 18–25°C (64–77°F) and kept at a relative All tables, workstations and shelving humidity of 30–60% depending on the are made of easily cleanable materials activities carried out in the area. with non-glare surfaces. Adequate spacing allows for staff and equipment movement. Decontamination Negative (-) prevents air from exiting the room IAP Positive (+) prevents air from entering the room Sterile Storage Positive (+) prevents air from entering the room Figure M1–32 Sterile storage zone Positively Negatively Pressured Room Pressured Room Clean Dirty         Figure M1–28 Air pressure regulation Medical Device Reprocessing (Decontamination Specialist) 31 Module 1 KSA Manual A4 Template.indd 31 02/05/2017 17:43  ∞ ∞ General Changing Room General Domestic Contaminated (Male & Female Offices Waste Services Returns Lobby + WCs) Disposal/ Room § Laundry Returns One-way * Contaminated transfer Staff Returns Holding Area § hatch entrance Domestic Test Equip Gowning Trolley Services and Data Wash Room WC Reception Room Room * Materials Store * Training Wash Room Transfer * Chemical Transfer Hatch Hatches * * Staff Materials Room Transfer Room * * Washer- Washer- disinfectors IAP disinfectors IAP Gowning Goods Packed Product Room Transfer Facility entrance Domestic Services Room Sterilizer loading area Despatch Cooling Area Processed Products Store * Waste Interlocking doors Work flow Raw materials ∞ Controlled exterior access Departmental personnel § Controlled interior access (within wash room) Note: this diagram does not provide for specialist plant Non-departmental personnel areas, ie ventilation plant, reverse osmosis, clean steam and compressors Figure M1–29 SSD layout (source: DH Estates and Facilities and HBN 13 https://www.gov.uk/government/publications/the-planning-and-design-of-sterile-services-departments) 32 Introduction to Decontamination Module 1 KSA Manual A4 Template.indd 32 02/05/2017 17:43  Exercises and Checklists You have been introduced to a central sterile service department and what an important function it provides to safe patient care. The following exercises will help you compare what you have learned to real-world examples in your current training environment. Assignment Compare what you have learned to real-world examples in your training environment. Explore your current department by completing the exercise in your log book. Medical Device Reprocessing (Decontamination Specialist) 33 Module 1 KSA Manual A4 Template.indd 33 02/05/2017 17:43  34 Introduction to Decontamination Module 1 KSA Manual A4 Template.indd 34 02/05/2017 17:43  Module 2 MICROBIOLOGY AND INFECTION CONTROL Key Terms CSSD | microbiology | infection | PPE | microbiome | efficacy autoclave | instructions for use (IFU) | pathogens standard precautions | pathogenic | commensals | biosphere cavitation | healthcare acquired infections (HAI) | biofilm reservoir | nosocomial infection Module 2 KSA Manual.indd 35 02/05/2017 17:50  Learning Outcomes By the end of this module you will be able to:  Understand the basic principles of microbiology and infection control practices  Demonstrate the use of appropriate (PPE)  Compare detergents, disinfectants and sterilants  Minimize risks to self, patients, staff and visitors  Wash your hands using proper hand hygiene technique  Demonstrate knowledge of basic housekeeping materials and cleaning procedures  Follow the dress code and entry and exit rules for each zone  Respond to infection risks  Handle and dispose of waste using the proper method for each waste-stream 36 Microbiology and Infection Control Module 2 KSA Manual.indd 36 02/05/2017 17:50  Introduction The CSSD has an extremely important role to play in preventing the spread of infection to and between patients, and staff who work with or around reusable medical devices. Maryam: What exactly needs to be cleaned off a reusable medical device? Khaled: Well, the visible tissue, proteins and body fluids, need to be removed, as well as the invisible or tiny microorganisms that are almost always on reusable medical devices. These may have come from a patient, people handling or transporting the reusable medical devices, or just from exposure to the environment. Since some of these microorganisms have the potential to cause disease, the decontamination facility makes sure that reusable medical devices are thoroughly cleaned, disinfected and/or sterilized before reuse. This module will help you understand just how critical the role of decontamination is in reducing the risks of microbial infection to patients and to the staff working in the CSSD. Pre-Module Quiz Keep these questions in mind as you go through the content, and don’t worry if you don’t know the answers—that is what