Chapter 6-9 Study Guide PDF

Chapter 6 Vocabulary: Regulation: rules issued by administrative agencies that have the force of law. Standard: a uniform method of defining basic parameters for processes, products, services, and measurements. Best practice: A method or technique that has consistently shown results superior to t...

Chapter 6 Vocabulary: Regulation: rules issued by administrative agencies that have the force of law. Standard: a uniform method of defining basic parameters for processes, products, services, and measurements. Best practice: A method or technique that has consistently shown results superior to those achieved by other means Premarket approval (PMA): The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices Serious injury: an injury or illness that is life-threatening, resulting in permanent impairment of a bodily function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body structure MedWatch: The US FDA’s safety information and adverse event reporting system that serves healthcare professionals and the public by reporting serious problems suspected to be associated with the drugs and medical devices they prescribe, dispense or use. Medicare: A federal medical insurance program that primarily services those older than 65 years (regardless of income), people under 65 with certain disabilities, and people of all ages with end-stage renal disease Medicaid: A federal and state assistance program that pays covered medical expenses for low-income individuals. It is run by state and local governments within federal guidelines Health Insurance and Portability and Accountability Act (HIPAA): HIPAA Privacy Rule provides federal protections for individually identifiable health information held by covered entities and their business associates and gives patients an array of rights with respect to that information Standards (AAMI): Voluntary guidelines representing a consensus of AAMI members that are intended for use by healthcare facilities and manufacturers to help ensure that medical instrumentation is safe for patient use Technical Information Reports (TIRs): Reports developed by experts in the field that contain valuable information needed by the healthcare industry Concept: FDA Medical Device Classification Class I devices: low-risk devices, such as most handheld surgical instruments, hospital beds and ultrasonic cleaners. These items are subject to “general controls” which include registration and device listing, medical device reporting, and quality system regulation and labeling Class II devices: devices considered to pose potential risks great enough to warrant a higher level or regulation. Sterilization equipment, Bis & Cis. Usually subjected to performance standards, post market surveillance studies, and specific guidelines or special labeling Class III devices: the most stringently regulated devices, including heart valves, pacemakers, and other life- sustaining devices. Manufacturers of new Class III devices must obtain a PMA from the FDA to demonstrate product safety and efficacy FDA Recalls Class I: High Risk- means there is a reasonable chance the product will cause serious health problems or death. The manufacturer must notify customers and direct them to notify the product recipients. The notification must include the name of the device being recalled, the lot or serial numbers, the reason for the recall, and instructions to correct, avoid or minimize the problem. The manufacturer must also issue a press release to notify the public. In addition, the FDA may issue its own press release or public health notice. Class II: Less Serious Risk- means there is a possibility that the product will cause a temporary or medically reversible adverse health problem, or there is a remote chance that the device will cause serious health problems. The manufacturer must notify customers and sometimes ask them to inform the product’s recipients. Generally, neither the FDA nor the manufacturer issues a press release Class III: Low Risk- means the use of a product is not likely to cause adverse health consequences. The manufacturer must notify customers, and neither the FDA nor the manufacturer will issue a press release Agencies: Centers for Disease Control and Prevention (CDC): Federal agency that works to promote health and quality of life by preventing and controlling disease, injury and disability and by responding to health emergencies Developed the first practical recommendations for isolation techniques and guidelines for infection control Guideline for Disinfection and Sterilization in Healthcare Facilities US Department of Transportation (DOT): Federal agency dedicated to ensuring a fast, safe, and efficient transportation system Regulatory agency US Environmental Protection Agency (EPA): Federal agency responsible for minimizing greenhouse fases and toxic emissions, regulating the reuse of solid wastes, controlling indoor air pollution, and developing and enforcing chemical regulations Every disinfectant and sanitizer manufacturer must obtain an EPA registration number for every covered product Regulated emission standards for EO sterilization Regulatory agency Occupational Safety and Health Administration (OSHA): Primary role and responsibility is to protect workers from occupationally caused illnesses and injuries Many of OSHA’s regulations and standards are represented by laws passed by US Congress The Occupational Exposure to Bloodborne Pathogens Standard General Duty Clause of the Occupational Safety and Health Act o OSHA may intervene in a matter of worker protection, even if there is no specific regulation that covers the situation OSHA representatives may enter a facility for a specific reason, however, once inside the facility, they have the right and obligation to investigate any violation they may find in any department Regulatory agency Centers for Medicare and Medicaid Services (CMS): Responsible for the operation of Medicare, Medicaid, and State Children’s Health Insurance Program Administers the standards of the Health Insurance and Portability and Accountability Act (HIPAA) Performs both announced and unannounced surveys of hospitals, long-term care facilities, ambulatory surgery centers, and laboratories Failure to follow CMS standards may result in the loss of all federal funding Association for the Adcancement of Medical Instrumentation (AAMI): Nonprofit voluntary consensus organization whose membership is comprised of healthcare technology professionals ANSI/AAMI ST70:2017: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities ANSI/AAMI ST58: Chemical sterilization and high-level disinfection in healthcare facilities ANSI/AAMI ST80: processing of healthcare products- quality management systems for processing ANSI/AAMI ST91: flexible and semi-rigid endoscope processing in healthcare facilities AAMI TIR34: water for the reprocessing of medical devices AAMI TIR63: Management of loaned critical and semi-critical medical devices that require sterilization or HLD AAMI TIR67: Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities AAMI TIR 68: Low and intermediate level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces Professional association American National Standards Institute (ANSI): Primary mission is to “enhance the global competitiveness of US business and American quality of life by promoting and facilitating voluntary consensus standards.” Professional association Association of perioperative Registered Nurses (AORN): Consists of perioperative nurses and others who are dedicated to providing optimal care to the surgical patient Comprised of AORN members and allied association members who develop nationally recognized guidelines Guidelines for Perioperative Practice Association for Professionals in Infection Control and Epidemiology (APIC): Voluntary organization who’s members work to prevent HAI International Organization for Standardization (ISO): Non-governmental, international organization that brings together experts to develop voluntary, consensus based standards International standards give state-of-the-art specifications for products, services, and good practice, helping to make the industry more efficient The Joint Commission (TJC): Private, independent, nonprofit organization that develops standards for healthcare facilities Evaluate healthcare organizations and programs in the US Conduct on-site surveys at least every three years Unannounced surveys last 2-5 days Voluntary organization, with significant weight (loss of accreditation) National Fire Protection Association (NFPA): International organization that works to reduce the burden of fire and other hazards around the world United States Pharmacopoeia-National Formulary (USP-NF): Creates and revises standards for the purity of medicines, drug substances, and dietary supplements World Health Organization (WHO): Agency that works to further international cooperation in improving health conditions Society of Gastroenterology Nurses and Associates (SGNA): Nonprofit organization dedicated to the safe and effective practice of gastroenterology and endoscopy nursing Establishes standards and guidelines related to thr processing of flexible endoscopes American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE): Responsible for ANSI/ASHREA/ASHE Standard 170: Ventilation of Health Care Facilities o Identifies the operating parameters for healthcare heating, ventilation and air conditioning (HVAC) systems Chapter 7 Vocabulary: Gross soil: tissue, body fat, blood and other body substances Biohazard signage: notices posted in easily seen locations that alert people in the area about the presence of harmful bacteria, viruses, or other dangerous biohazardous agents or organisms Biofilm: a collection of microorganisms that attach to surfaces and each other and form a colony. The colony produces a protective gel that is very difficult to penetrate with detergents and disinfectants Sharps: cutting instruments, including knives, scalpels, blades, needles, and scissors of all types. Could also include chisels, osteotomes, saws, etc. Turnover/turnaround: term used to describe instruments or equipment that must receive priority processing in order to be made available for another procedure Musculoskeletal disorders: injuries or disorders of the muscles, nerves, tendons, joints, cartilage, and spinal discs Concept: Goals of Point-of-Use Treatment & Transport Removal of gross soil Prevention of damage Prevention of cross-contamination Timeliness Keeping others safe Reasons for Point-of-Use Treatment Prolong instrument life Dry soil/debris are much more difficult to remove than moist soil/debris Soil and excess moisture promote the formation of biofilm colonies Dried soil require more aggressive cleaning methods and take longer to clean Point-of-Use Treatment Guidelines Have education, training, and completed competencies for the task being performed Wear PPE Remove gross soil Follow the manufacturer’s IFU Separate reusable sharps from other instruments Protect delicate instruments from damage during transport Separate reusable linen Remove disposable components Open hinged instruments/disassemble multi-part instruments Place instruments in the appropriate tray and in an orderly manner Keep items together Empty fluids from containers If reusable instruments were used during a case with suspected or known Creutzfeldt-Jakob Disease (CJD) notify SP & Infection Prevention & Control Notify SPD about items needing repair Off-site Transport Dirty and clean must remain separate Care should be taken to protect the instruments form damage and excessive movement The quickest and safest route must be taken Care should be taken to avoid extreme temperatures and humidity Establish cleaning procedures of the vehicle/clean after transporting soiled items All individuals involved in transporting activities must be educated and have competencies kept on file Chapter 8 Vocabulary: Decontamination area: the location within a healthcare facility designated for the collection, retention and cleaning of soiled and contaminated items Humidity: amount of water vapor in the atmosphere; expressed as a percentage of the total amount of water vapor the atmosphere could hold without condensation Negative pressure: air pressure inside the room that is lower than the air pressure outside the room, causing the air to flow into the room with the lower (negative) air pressure Biohazardous waste: waste containing infectious agents that present a risk or potential risk to human health Utility water: water as it comes from the tap that may need further treatment to achieve the required specification. This water is mainly used for flushing, washing, and rinsing Critical water: water that is extensively treated to ensure that microorganisms and organic and inorganic material are removed Biocide: a substance or microorganism that kills or controls the growth of living organisms Reverse osmosis (RO): a water purification process by which impurities are removed from water using a semipermeable membrane Deionized (DI) water: water that has had all ions removed through an ion exchange process Distilled water: water that is heated to steam, then allowed to cool and condense Instrument air: compressed air that has had dust, dirt, and other pollutants removed Automatic dosing units: dosing units are used to deliver a specific and consistent amount of detergent to water to produce the cleaning solution Cavitation: the process used by an ultrasonic cleaner in which low-pressure bubbles collapse (implode) and dislodge soil from instruments Electroplating: a process that uses electrical current in a solution to produce a metallic coating Impingement: the spray-force action of pressurized water against instruments being processed to physically remove bioburden Thermal disinfection: use of heat to reduce the amount of microorganisms (excluding spores) on a medical device Emulsifier: any ingredient used to bind together substances that typically do not combine such as oil and water Surfactant: a substance that lowers the surface tension of the water and increases the solubility of organic compounds Chelating agents: chemicals that hold hard water minerals in solution and prevent soap or detergent from reacting with the minerals Toxic anterior segment syndrome (TASS): acute postoperative inflammatory reaction in which a noninfectious substance enters the anterior segment of the eye and induces toxic damage to the intraocular tissues Concept: Wash sink: water (80-110˚F) and enzymatic detergent mixed in a ratio as provided by the manufacturer’s IFU Ultrasonic: solution temperatures should be 80-109 ˚F Enzymes used in SPDs Protease enzymes (protein) that break down blood, mucous, feces and albumin Lipase (fat) enzymes that break down fatty deposits, such as bone marrow Amylase enzymes that catalyze (change) starch into sugars Detergents Neutral detergent: most commonly used in the US (pH 6-8) o Advantages: effective on organic & inorganic soils and safe on aluminum o Disadvantages: not very effective in hard water & produce more foam which is harder to rinse Alkaline detergents: (pH 8-11) o Advantages: remove wider range of soil than any other type of detergent, highly effective on organic soils (blood, fat, oils) o Disadvantages: require thorough rinsing because they can leave a powdery residue, cannot be used on bronze, copper, or aluminum Acid detergents: (pH 1.6-3) o Advantages: excellent for removing mineral deposits and urine, they work well on inorganic soils, neutralize alkaline residues, and make stainless steel shine o Disadvantages: can damage surfaces of stainless steel, aluminum, bronze, and glass, disposal down drains might be restricted in some states Chemicals that should NOT be used to clean instruments (unless recommended by the device manufacturer IFU) Abrasive cleaning compounds Saline Buffered iodine Hydrogen peroxide Bleach Any chemical NOT specifically recommended by the device IFU Soiled receiving: Fluids should be disposed of or contained at the POU (If possible) disposable items and reusable textiles should be removed at the POU o If not, bagged and sent to decon Reusable sharps, including scissors and chisels, should be separated and safely contained at POU Disposable sharps should be removed and discarded at POU o Misplaced sharps should be reported to the immediate supervisor Items for third-party reprocessors should be placed into their specific container Remove all tray liners, indicators, filters, tip protectors and other disposable items left inside the trays Remove the filter retention plates from rigid containers If the container system has a valve-type closure, it should be cleaned and inspected Interior baskets should be removed from inside containers Ensure the transport container or the case cart is completely empty then clean it per IFU Chapter 9 Vocabulary: Bactericidal: a substance that kills bacteria Disinfectant: a chemical that kills moth pathogenic organisms but does not kill all spores Disinfection: the destruction of nearly all pathogenic microorganisms on an inanimate surface Spaulding Classification system: developed by Dr. E. H. Spaulding that divides medical devices into categories based on the risk of infection involved with their use Sterile/Sterilization: completely devoid of all living microorganisms High-level disinfection (HLD): the destruction of all vegetative microorganisms, but not bacterial spores Low-level disinfection: the destruction of some vegetative forms of bacteria Intermediate-level disinfection: the destruction of viruses, mycobacteria, fungi and vegetative bacteria (but not bacterial spores) Organic materials: compounds containing oxygen, carbon, and hydrogen; derived from living organisms Activated (activation): process by which a solution is combined with an activating chemical before use. Glutaraldehyde, for example, must be mixed with an activating solution before use Minimum effective concentration (MEC): the percentage concentration of the active ingredient in a disinfectant or chemical sterilant that s the minimum concentration at which the chemical meets all its label claims for activity against specific microorganisms Concept: Spaulding Classification System Critical: enters sterile tissue or the vascular system o Examples: implants, surgical instruments, needles o Requires: sterilization Semi-critical: touches mucous membranes, except dental o Examples: flexible endoscopes, laryngoscopes, endotracheal tubes o Requires: sterilization (if possible) or HLD Non-critical: touches intact skin o Examples: thermometers, stethoscopes o Requires: low-level disinfection Preparation of disinfectant solutions…check Expiration date Reuse-life date of chemical (if applicable) Appropriate concentration for use Dilution or mixing requirements Correct temperature required Water quality and pH requirements Requirements for Effective Disinfectant Right chemical Right contact (time and coverage) Right dilution  Low-Level Disinfectants Type of Advantages Disadvantages Uses Disinfectant Quats Bactericidal, fungicidal and Not sporicidal Environmental virucidal against lipophilic Not tuberculocidal or virucidal sanitation of non- MUST REMAIN viruses against hydrophilic viruses critical surfaces WET FOR 6-10 May be inactivated by cotton or (floors, walls, Wetting agents with built-in paper furniture) detergent properties Not compatible with soap Super quat may be Not effective against some gram- used on negative organisms instruments if Deactivated by organic material rinsed properly Alcohol: ethyl Bactericidal agent against No residual activity To disinfect non- or isopropyl vegetative microorganisms Volatile; flammable moblile equipment Relatively fast acting Inactivated by organic material after cleaning and MUST REMAIN No residue Can dissolve lens mountings on for patient care WET FOR AT Non-staining certain optical instruments items (stethoscope) LEAST 5 Tends to harden and swell plastic Can be used as a MINUTES tubing, including polyethylene drying agent if Non-sporicidal approved by the Can be a fixative for debris on device’s IFU stainless steel Phenolics Broad-spectrum of use; Not sporicidal Walls, floors, bactericidal for gram-negative Inactivated by organic material countertops, and gram-positive bacteria, Corrosive to some plastics furniture fungicidal and tuberculocidal; Copious rinsing is required to May be used in the active against lipophilic eliminate the potential for skin decon area for viruses burns disinfection of hard Residual activity (can also be surfaces disadvantage) Chlorine Effective against gram-positive Inactivated by organic matter 1:10 dilution of 5.25% and gram-negative Corrosive to metals sodium MUST REMAIN microorganisms, Non-sporicidal hypochloride WET FOR 1-2.5 tuberculocidal, fungicidal, and Stain fabrics, plastics and other recommended by MINUTES virucidal synthetic materials CDC for cleaning Fast acting Relatively unstable blood Iodophors Bactericidal, virucidal, and Corrosive to metals unless 1:10 dilution used in tuberculocidal combined with anti-corrosive skin preparation MUST REMAIN Rapid action against vegetative agents when formulated Disinfection of some WET FOR 2 bacteria Detrimental to some plastics equipment MINUTES Stains fabrics and other materials May require long contact time to kill some fungi  High-Level Disinfectants Type of Advantages Disadvantages Uses Disinfectant Glutaraldehyde Kills vegetative bacteria (within 2 Noxious odors; good ventilation Semi-critical items minutes) is required STERILIZATION: Bactericidal (gram-positive and Unstable (14-28 day product life) 6-10 HOURS gram-negative), Dilution of product reduces the tuberculocidal, fungicidal, activity necessary for HLD virucidal, and sporicidal OPA Solution is compatible with wide Does not have a sterilant label Semi-critical items range of endoscopes and claim other medical devices Requires no activation or mixing 14-day reuse life Can be discarded down facility drains Hydrogen Broad-spectrum HLD, kills Corrosive to some materials Disinfection of hard Peroxide bacteria and viruses, including and soft surfaces norovirus, rotacirus, RSV, MRSA and TB Can be used as a sterilant at the right concentration Peracetic Broad-spectrum HLD Corrosive to some materials HLD of laryngoscope Acid May be used as a sterilant in the blades, appropriate AER endoscopes Compatible with many materials Pasteurizers: equipment provides disinfection Water temperatures of 150-170˚F Temperature is maintained for 30 minutes Automated Endoscope Reprocessors (AER) Reduce personnel exposure to the HLD disinfectant and vapors May increase quality assurance by providing consistent processes and documenting cycle parameters Advantages: o Consistent exposure to the cleaning agent o Timed contact with the liquid chemical disinfectant o Continuous movement of the HLD o Use of an air flush cycle to remove excess moisture o Use of copious and consistent amounts of rinse water o Documentation of the cycle parameters HLD Documentation MEC MEC test strip results Lot number of HLD process (AER or soak basin number) o Items being disinfected (quantities & serial numbers) Patient ID Physician name & procedure HLD Solution information (activation/dilution date, last date the solution may be used) Exposure time and temperature Date and time of the process Technician ID