Cleaning, Disinfection and Sterilization

Cleaning, Disinfection and Sterilization
APIC Chapter 26 November 11, 2008 Rosie Fardo RN, BSN, CIC 1 1

This picture has been shown repeatedly to audiences to demonstrate high touch areas of contamination in the health care environment and why cleaning and disinfection is so essential. The green X’s are to illustrate areas of contamination. 2 2

1. Review the Chain of Infection
Program Objectives 1. Review the Chain of Infection 2. Define and discuss common cleaning, disinfection sterilization terminology 3. Discuss and review the “chemistry” of cleaning , disinfection, sterilization and Spaulding Classifications-medical devices 4. Discuss sterilization methods and monitoring 5. Describe components of instrument loaner protocol 3

Breaking the Chain of Infection by Effective Cleaning
Causative Agent Susceptible Host Reservoir Portal of Entry Portal of Exit The infection process can be described as a chain of infection. Understanding the (6) chain must precede breaking its links, which leads to prevention of infection. Each component, or link, in this chain is connected to another link in the chain and it is key to identify how these links can be broken or how they can be dealt with. Mode of Transmission 4 4

Causative Agent Pathogen
The right antibiotic can control the pathogen inside or on the body The right disinfectant, properly used, can control or destroy most pathogens almost everywhere else Causative agent can be biological, physical, or chemical.Biological agents can be bacteria, viruses, fungi, protozoa (Trichomanas vaginitis), helminthes (worms), or prions (CJD) Physical-heat, light, radiation, dangerous object Chemical- pesticides, pharmacologic, food additives, industrial Agents characteristics for success at causing infection: invasive enough to enter tissues Capable of multiplying Capable of causing damage Sufficient virulent to be pathogenic Low number need to cause disease i.e. (Norovirus only virus particles required to be pathogenic, not killed by 70% alcohol- bleach 1:50 dilution)Viable in free state, Virus was called Norwalk virus from an outbreak of gastroenteritis in a school in Norwalk, Ohio 1968—3 ounces of stool can have over 80 million viruses. NO AGENT NO INFECTION Practice failure NOT product failure. 5 5

Reservoir The medical staff cares for living reservoirs- the human body The environmental staff cares for the living reservoirs by managing and cleaning the inanimate environment The word reservoir-source are sometimes used interchangeably Reservoir is a place in which an infectious agent can survive but may or may not multiply Commons reservoirs: Humans Animals Environment It is important to prevent the healthcare environment from becoming a reservoir of unwanted and harmful (pathogenic) microorganisms to protect patients, staff, and visitors from potential exposure. ELIMINATE THE RESERVOIR FOR THE CAUSATIVE AGENT AND BREAK THE CHAIN AND ELIMINATE THE CHANCE FOR INFECTION 6 6

Reservoirs (humans) expel pathogens
Portal of Exit Reservoirs (humans) expel pathogens Keeping the inanimate environment clean is essential for this reason Path by which the agent for an infection leaves the reservoir Examples of portals of exit: Respiratory tract Gastrointestinal tract Skin/mucous membranes transplacental (mother to fetus) Blood In most scenarios the portal of exit is the most difficult link to break Every one (reservoirs) excretes 7 7

Mode of Transmission The chain of transmission is broken when:
Appropriate PPE is used Public surfaces that are contaminated by direct or indirect contact are cleaned with hospital grade EPA approved products Waste is properly handled and discarded Hand hygiene Method by which the causative agent for infection reaches the susceptible host Contact with the agent: Direct contact Indirect contact Droplet contact Airborne Vectors Common vehicles such as food, water INTERRUPT THE MODE OF TRANSMISSION- BREAK THE CHAIN Donning and removing PPE should be a direct observation competency 8 8

Portal of Entry Appropriate PPE is used
Covering injured skin, not touching mucous membranes Hand hygiene Means by which the causative agent enters the susceptible host Example of portal of entry: Respiratory tract Gastrointestinal tract Skin/mucous membrane Transplacental (mother to fetus) Parenteral (percutaneous via blood) N-95 respirator or powered air purifying respirator (PAPR) for airborne diseases such as TB PREVENT THE CAUSATIVE AGENT FEROM ENTERING THE SUSCIPTLE HOST AND THE CHAIN OF INFECTION IS BROKEN 9 9

Susceptible Host Maintain personnel health Immunizations
Antibiotic stewardship Proper use of PPE Hand hygiene Susceptible host is a person or animal lacking effective resistance to a particular pathogen or lacking sufficient barrier protection Some host characteristics that influence susceptibility status: Immunity status Health status Use/nonuse of personal protective equipment Flu shot every year- pneumococcal for high risk or age 65 and older Antibiotics only treat bacterial infections. Most every day illnesses are viral. If antibiotics are ordered by your physician take them as prescribed. Don’t just take a couple of doses and when you start feeling better stop taking the meds. NO “SUSCEPTIBLE HOST’” THEN CHAIN IS BROKEN AND NO INFECTION 10 10

Cleaning/Disinfection Terminology
Antiseptic - substance that tends to inhibit the growth and reproduction of microorganisms in or on humans or animals Clean - removal of all visible dust, soil and any other foreign material Decontaminate - remove disease producing microbes rendering safe for handling Disinfectant - kills or destroys nearly all disease-producing organisms, except spores (used on inanimate objects) Terminology in alphabetical order not necessarily in the order in which they are used Antiseptics- because of its association with living tissue, antiseptics are considered drugs and are regulated by the Food and Drug Administration (FDA). Antiseptics are used on skin. An antiseptic is a germicide except in the case of a drug represented as an antiseptic. Geek word “against putrefaction” to prevent the spoilage of eggs and meat Clean- “Elbow grease” is a necessary ingredient to successful cleaning Decontaminate- To remove pathogenic and undesirable microorganisms or soil from surfaces by chemical or physical means. Decontamination renders medical instruments, devices or environmental surfaces safe for handling, but not necessarily safe for patient use. Freeing a person or an object from potentially harmful material. Disinfectant- Chemical intended to destroy or inactivate microorganisms on inanimate objects. A disinfectant is a product that will kill 100% of most vegetative bacteria, but is not capable of killing endospores 11 11

Cleaning/Disinfection Terminology
Germicide - an agent capable of killing microorganisms (germs). Applies to compounds used both on living tissue and inanimate objects Sanitize - reduce microbes on surfaces to a safe or relatively safe level Sterilize - all organic and inorganic soils, microorganisms and spores are destroyed Vegetative- the stage of a cell that is not replicating or forming spores Specific medications can also be called germicides. A germicide is a chemical that destroys microorganisms but not spores. Sanitizers reduce the microbe population and are safe enough for contact with food utensils and surfaces where food is prepared. Sanitizing- Foodservice areas are typically cleaned and then rinsed with sanitizers. Sanitizers are defined as formulas that reduce % of microbes under test conditions Vegetative- C. difficile is in the vegetative state when initially excreted from humans. Soon after the C. difficile is excreted it dries and forms a spore. Vegetative cells can survive for at least 24 hours on surfaces and spores can survive at least 5 months. 1:10 or 1:50 bleach. Vegetative state is defined as an active growth phase of an organism. EPA issued a product labeling statement September 22, 2008 that requires manufacturers of disinfectants to remove the statement of being effective against C. difficile in its vegetative state since this is considered misleading. The vegetative form is not the organism of concern for infection control processes. C. difficile spores have the ability to remain viable for months on contaminated surfaces. Currently no registered antimicrobial products have demonstrated sporicidal kill. Label claims must be changed within 18 months of September 22, 2008 which is March 2010. 12 12

The Chemistry of Cleaning
The first and most important step in infection prevention and control is cleaning Microbes hide in soil Often simple cleaning will remove soil and the microbes along with it Cleaning ensures that your disinfectant cleaner will be able to reach the microscopic contamination underneath and destroy microbes You can’t kill microbes if you don’t clean first! Definition of cleaning is The physical removal of all visible soil and other foreign material Dust bunnies (I don’t mean pets) contain not only dust and debris but microbes as well. 13 13

A detergent is a liquid or solid chemical that can do one or more of the following: Wet or penetrate soil Break apart the soil Surround and emulsify greasy soils Suspend the soil in the scrubbing water 14

The surface-active agent or surfactant is the active ingredient in a detergent The surfactant increases the wetting power of scrub water by reducing its surface tension, helping water spread out and better penetrate the soil A detergent molecule has two distinct ends, each with a special job- hydrophobic and hydrophilic Hydrophobic (water –repelling) end wraps itself around the soil particle while the hydrophilic (water-attracting) end is attracted to the wash water The mechanical action of scrubbing or friction helps the hydrophobic end pull soil apart and into the wash water. Then, a thin wall is formed around the soil particles, keeping them suspended and separated until they are rinsed away with water 15 15

Selecting the Right Detergent
Types of detergents fall into three categories: Anionic detergents Cationic detergents Nonionic detergents Anionic have a simple composition, similar to bar soaps. They are effective in cleaning but have limited ability to kill bacteria. Changes in water PH can reduce the detergent effectiveness and can produce foams which can leave residue on the surfaces cleaned or result in re-soiling problems Cationic detergents have many of the same properties of anionic detergents, but they can be excellent germicides and fungicides. These detergents are often combined with nonionic detergent agents or with other disinfectants to form one-step cleaners/disinfectants Nonionic detergents have superior detergent properties and are very stable in hard water. They are not GEGERMICIDAL. They have low foaming ability. They do not tend to leave any buildup on surfaces, so in many cases, no rinsing is required. Nonionic products are commonly used with cationic detergents for use in industrial formulations. 16 16

Three Basic Elements in Determining and Managing Cleaning Operations
Detergents, solutions and/or chemicals needed to clean and/or disinfect the surface The tools and/or equipment needed Labor resources needed to properly execute the process 1. Always follow manufacturer instructions for proper cleaning 2. Pour bottles are preferred over sprays (less aerosol, more directed solution quantity) 3. Adequate staff and appropriate training of the staff 17 17

The Factors of Cleaning Success- T.A.C.T.
Time or labor involved Agitation Concentration of the chemical Temperature of the cleaning solution It takes TACT for cleaning success. An increase in any one factor usually increases the results achieved or compensates for the reduction in one of the other factors. IMPORTANT to remember that cleaners must be used at the concentration and for the contact time specified on the product label. Sometimes people become unofficial chemists when mixing chemicals. 18 18

Chemical Cleaning There are five basic elements involved in cleaning with chemicals: Contact time Temperature Concentration Mechanical action pH (potential hydrogen) Contact time refers to how long the chemical is in contact with the surface area to be cleaned. Temperature refers to the recommended cleaning solution temperature range. In the past it was commonly believed that a hot solution would perform better. Presently chemicals are formulated to enable use with warm or cold water. Therefore it is vitally important to follow manufacturers instructions Concentration refers to the strength of the chemical when diluted with water. More is not always better and mixing with other chemicals is dangerous. Mechanical action is the process that agitates or displaces unwanted matter from an area being cleaned. “Elbow crease.” The pH scale measures the level of acidity or alkalinity in a solution. Chemicals with a low pH (acidic 0-<7) or a high pH (alkaline>7-14) may be damaging to surfaces and should be employed on surfaces or finishes able to tolerate solutions within a specific pH range. Neutral cleaning solutions have a pH of 7 and are generally safer to use both for the user and for the finish or surface being cleaned. 19 19

Tools and Equipment for Cleaning
Using the proper tool or equipment with the proper chemical products is the most effective and productive method of cleaning Factors to consider: Initial price (acquisition cost) Useful life Suitable for the task Labor cost to use the item 20

Introduction of New Tools and Equipment Microfiber System
Microfibers are densely constructed polyester and nylon fibers that are approximately 1/16 the thickness of human hair The density holds 6 times its weight in water, making it more absorbent than conventional cotton mops The Microfiber System demonstrated superior microbial removal compared to cotton-string mops with detergent When making the business case for the introduction of new cleaning tools or equipment provide research data or information (conducted by well respected and quoted professionals i.e. Dr. Rutala, and guidelines such as ASHES, CDC etc. to verify the need to make changes. Cotton mops cause degradation of ammonium chlorides (Quats) Microfiber mops can withstand over 300 launderings Positively charged microfibers attract negatively charged dust particles and are able to penetrate microscopic pores on surfaces Dr. Rutala et. al. (University of North Carolina) conducted the study of cotton versus microfiber fiber mops Rutala et. al. Microbiologic evaluation of microfiber. Mops for surface disinfection. AM J Infect Control 2007 21 21

Clock or counter clockwise Working from top to bottom
The Cleaning Process Environmental Services should approach cleaning in a methodical fashion Clock or counter clockwise Working from top to bottom Cleanest to the dirtiest 22 22

The “Chemistry” of Cleaning
One can clean without disinfecting, but one can not disinfect without cleaning It may not be a failure of the cleaning and disinfecting agents but rather a failure to completely follow the cleaning and disinfecting process A couple of statements to keep in mind and reinforce with Environmental Services. 23 23

Foundation and Principles of Environmental Services
Maintaining the built environment of a healthcare facility or an environment where healthcare services are delivered is driven largely by regulations set forth by: OSHA JCAHO CDC EPA APIC AORN ASHES OSHA Bloodborne Pathogen 1992 released instructions on Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens Standard 29 CFR Better known as the BBP, this document specifies how to clean surfaces in any facility or site where the potential for contamination from blood and other potentially infectious material exposure may occur. PPE requirement is under the BBP. ASHES uses the Bloodborne Pathogen Guidelines from OSHA has revised their guidelines for how to clean up blood spills. Either a tuberculocidal disinfectant should be used or a disinfectant that has a label claim against HBV and HIV. Some products are tested against duck hepatitis B as a surrogate for HBV. The EPA has a list of antimicrobials that are registered as antimicrobials effective against bloodborne pathogens. JCAHO- SAFE, QUALITY HEALTHCARE- Infection Control and Environment of Care- CDC Environmental Guidelines 2003 EPA Environmental Protection Agency requires that animal test are to be used to assess the safety of disinfectants. All products used should have an EPA registration Number and an EPA Establishment number. Shows that the FDA has approved the product and its label and show where the product is being manufactured. Also EPA has requirement for protecting the environment from disposal of chemicals, wastes, emissions, air pollution etc.APIC guidelines based on regulatory and advising guidelines AORN Association for Perioperative Nursing has guidelines for cleaning in the operating room setting as well as other recommendations for practices in the Perioperative setting ASHES is the American Society for Healthcare Environmental Services (affiliated with the American Hospitals Association that recommends cleaning protocols for professional practice The new Practice Guidance for Healthcare Environmental Cleaning has been published this year Information in this PowerPoint includes the new guidance recommendations 24 24

Decreasing Order of Resistance of Microorganisms to Disinfectants/Sterilants
Prions Spores Mycobacterium Non-Enveloped Viruses Fungi Bacteria Enveloped Viruses The hierarchy of microorganisms and the order in which they are the most difficult to kill (starting from the top down) Prions Little-understood, virus-like infectious agents that differ from viruses by containing neither DNA or RNA, ONLY protein. They are extremely resistant to inactivation by heat and disinfecting agents. Spores- The dormant state of an organism, typically a bacterium or fungus. It has resistance to heat, radiation, desiccation (drying) and various chemicals. Viruses require living host cells to grow and reproduce. Viruses do not themselves possess a cell. Thus they replicate upon entering another cell. The capsid (protein shell) defines the acellular stage of the virus. Viruses without an envelope or non-enveloped are referred to as hydrophilic (attract water) or NakedExamples of Non-Lipid –Non-enveloped viruses are: HAV, rotavirus, poliovirus, adenovirus, rhinovirus Fungi- 100,000 identified species of fungi; 100 are common in humans and only 10 are pathogenic to humans and cause infectious diseases which are called mycoses (i.e. athlete’s foot, candidiasis etc.) Fungi can live on nonliving organic matter, either natural or synthetic or as parasites on or in living cells or plants, animals or humans. Molds, Yeasts Examples: Candida, Cryptococcus, Aspergillus, Histoplasmosis Bacteria- microbes that reproduces by splitting Examples: Pseudomonas, E. Coli, Proteus mirabilis, Staphylococcus aureus, epidermidis, Streptococcus, Enveloped viruses possess envelopes, which are lipid bilayers surrounding the virus capsid. Enveloped viruses are common among animal viruses. Enveloped Lipid viruses are referred to hydrophobic or lipophilic. Examples of Lipid Enveloped viruses: HIV, HCV, HBV, CMV, Epstein-Barr (Mononucleosis), Influenza, RSV, Varicella 25 25

Spaulding Classification for Medical Devices
Dr. Earle H. Spaulding devised a rational approach to disinfection and sterilization of patient-care items or equipment He believed that the nature of disinfection could be understood more readily if instruments and items for patient care were divided into three categories based on the degree of risk of infection involved in the use of the item The Spaulding classification is a strategy for reprocessing contaminated medical devices. The system classifies medical devices as critical, semi-critical, or non-critical based on the risk from contamination on a device to patient safety. The CDC adopted the classification scheme that was first proposed by Spaulding Spaulding classified disinfection by three levels; high, intermediate, low. The level of disinfection is dependent on the item to be disinfected and the intended use of the item. 26 26

Disinfection and Sterilization Levels
STERILE HIGH - LEVEL We will discuss each one starting at the bottom of the pyramid. We will also discuss which devices require which level of disinfection and or sterilization. INTERMEDIATE- LEVEL LOW- LEVEL 27 27

Processing Non-Critical Items
NON-CRITICAL - objects will not come in contact with mucous membranes or skin that is not intact. Objects that touch only intact skin can be expected to be contaminated with some microorganisms and only require low-level disinfection. Examples: Bedpans; crutches; bed rails; EKG leads; bedside tables; walls, floors and furniture. Method: Low-level disinfection (or detergent for housekeeping surfaces) 28 28

Low-Level Disinfection
Effective against: Vegetative bacteria Fungi Lipid viruses Not Effective against: Spores Non-lipid viruses Less active against Pseudomonas and Mycobacterium Quaternary compounds (Quats) are low level disinfectants and equivalent to an EPA hospital disinfectant (hospital grade), not registered effective against Mycobacterium Low-Level Non-critical devices Environ. surfaces Lipid virus consist of a core of nucleic acid surrounded by a coat of protein Non-lipid- (naked) generally viewed as more resistant to inactivation than lipid Quat disinfectants (ammonium chloride) are usually a mixture of two or more quaternary ammonium chloride compounds. These complex molecules work by wrapping themselves around the protein of a virus or bacteria May be used house wide but not recommended for blood spills or areas contaminated by body fluids (Surgery). Need to use either tuberculocidal disinfectant or one that is registered effective against HBV and HIV for these (per OSHA Bloodborne Pathogens Standard). LOW level hospital disinfectants have passed the potency tests against 3 representative microorganisms; Pseudomonas aeruginosa, Staphylococcus aureus and Salmonella choleraesuis Quats are generally less harsh on surfaces and safer for worker to use 29 29

Intermediate-Level Disinfection
Effective against: Vegetative bacteria, Fungi Lipid and non-lipid viruses Mycobacterium Not effective against: Spores Phenolics, alcohols, and iodophors are examples of intermediate-level disinfectants Intermediate-Level Non-critical devices Environ. surfaces Association between Phenolics and hyperbilirubinemia in newborns. If Phenolics are used in unoccupied bassinets, etc. you should have the cleaning staff rinse off the disinfectant with clear water after it has dried (per CDC Environmental Infection Control Guidelines 2003). 30 30

Processing Semi-Critical Items
SEMI-CRITICAL - objects that touch mucous membranes or skin that is not intact require a disinfection process that kills microorganisms except high numbers of bacterial spores requires high-level disinfection. Examples: Respiratory therapy Anesthesia equipment GI endoscopes Endocavitary probes Tonometers Tonometers- measure intraocular eye pressure 31 31

High-Level Disinfection
Effective against: Vegetative bacteria Fungi Lipid and non-lipid viruses Mycobacterium Some spores Not effective against: Large numbers or all bacterial spores Compounds include aldehydes, hydrogen peroxide, peracetic acid High-Level Semi-Critical Devices Instrumentation Typically, Environmental Services will not be involved in activities related to high level disinfection as it is employed for reusable instrumentation or devices that come into contact with mucous membranes. Aldehydes (formaldehyde, gluteraldehyde) 32 32

Terminology Sterilize - is the highest level of clean in the health care facility in which all organic and inorganic soils, microorganisms and spores are destroyed Sterilization is required for surgical procedures Sterilization requires heat or extended contact with the strongest chemicals to control both microbes and spores Sterilization is not practical or required for environmental services housekeeping procedures Because of the misuse of the term of sterilization, the Council on Pharmacy and Chemistry of the American Medical Association (1936) officially went on record stating that the term sterilization was intended to convey an absolute meaning, not a relative one. A substance cannot be partially sterile. 33 33

Processing Critical Items
CRITICAL - objects which enter normally sterile tissue or the vascular system or through which blood flows should be free from ALL microorganisms, including bacterial spores and must be STERILE. Examples Surgical instruments Cardiac catheters Urinary catheters Implants Probes used in sterile body sites 34 34

Chemical Sterilants Chemicals used to destroy all forms of:
Microbiological life Fungal and bacterial spores Prolonged exposure times (6-10 hours) High-level disinfectants when used as a sterilant may not convey the same level of sterility assurance as other methods (sterilizers) Sterile 35 35

Minimum Effective Concentration (MEC) Test Strips
Dilution of chemical occurs during routine use Test strips depends on frequency use of chemical e.g. use daily, then test daily Do not use test strips beyond expiration date. Test & document when opening a new bottle; refer to manufacturer’s protocol Most test strips will expire in days. JCAHO watches to see that strips for any testing are dated and that your facility is following policy. MEC- % concentration of the active ingredient in a disinfectant or chemical sterilant that is the minimum concentration at which the chemical meets all label claims for activity against specific organisms. AAMI ST58 states the MEC of liquid chemicals should be monitored before each use. This is for both manual and automated procedures. 36 36

Types of Sterilizers The term sterilizer is an agent that destroys or eliminates all forms of microbilial life in the inanimate environment, , including all forms of vegetative bacteria, bacterial spores, fungi, fungal spores, and viruses. WASHER/STERILIZER SHOULD BE CALLED WASHER/SANITIZER- This is used in decontamination 37 37

Types of Sterilizers Thermal (Heat)
Moist (Tabletop, Gravity, & High Speed Vacuum) Dry Chemical ETO HLD Chemicals Ozone Radiation Ozone sterilizer (TSO3) was approved by FDA in not utilized much, competitor to ETO. Uses medical grade oxygen and result is oxygen and water. Company claims cost is $0.06 per cycle compared with $7.35 for EtO and $8 for gas plasma. Chamber is small and cost must include purchase of new machine. Radiation has been used in the food industry for many years. These two methods will not be discussed since at this point the use of these two methods is very limited. 38 38

Dry Heat Sterilization
Gravity Convection- heated air rises and displaces cooler air- temperatures within the chamber tend to be inconsistent Mechanical Convection – blower actively forces heated air through-out the chambers so it is more efficient than gravity and the temperature is more uniform Dry heat should only be used for those items that cannot be sterilized by steam, when the moisture would either damage the materials or they would be impermeable to it. Petroleum, oils, powders, and glassware. Advantages: No corrosion or rust. Disadvantages – penetrates slowly and unevenly. Long exposure times necessary. High temps damage rubber and some fabrics. Dry Heat Sterilization Hot air is the sterilant for dry heat sterilization. The principle behind dry heat sterilization is conduction. Heat is absorbed at the exterior surface 39 39

Steam Pre-vacuum Sterilization or High Speed Vacuum
Low cost, quick turnover, no toxic chemicals, accommodates large loads Air is removed by a pump then steam is rapidly introduced Advantage: much quicker than Gravity Steam sterilization. For example, a wrapped item sterilized at 133° C or 272° F is sterilized: Gravity Steam - 15 minutes High Speed Vacuum – 4 minutes Also, ETO will take 3-6 hours Disadvantages – same as the Gravity Steam sterilizers except cost of purchasing the sterilizer may be higher. PREVACUUM STEAM STERILIZER.—The prevacuum steam sterilizer was designed to help overcome the trapping of air in the chamber. Trapping of air is one of the greatest dangers encountered when using saturated steam under gravity cycles. When errors are made by improperly packaging items or overloading the sterilizer chamber, cool air pockets may form resulting in items not being sterilized. The speed and efficiency of the steam sterilizer may be improved by removing air from the chamber with a powerful pump, creating a nearly perfect vacuum before steam is introduced into the chamber. This procedure allows fast and more positive heat to penetrate the entire sterilizer load. The improved sterilizer is referred to as the prevacuum steam sterilizer. Full heating of the loads is faster in the prevacuum sterilizer than in the gravity displacement sterilizer. For example, wrapped instruments can be sterilized at 270°F (131°C) after 4 minutes exposure in a prevacuum steam sterilizer. Consult the manufacturer’s instructions for specific details on operation and user maintenance information. The Bowie-Dick type test was developed for pre-vacuum sterilizers to determine if the air has been removed from the chamber during the pre-vacuum stage. Air must be removed so that steam can penetrate the load instantaneously. It must be understood that this is not a test for adequate exposure to heat in terms of time-at-temperature. A commercially prepared Bowie-Dick type test can be used by carefully reading and following the manufacturer’s instructions. Example of an Electronic High Speed pre-and post-vacuum autoclave. 40 40

Steam Gravity Sterilization
Low cost, quick turnover, no toxic chemicals, accommodates large loads Steam enters the chamber by gravity & displaces air (so steam can penetrate load) Takes longer for steam to reach required temperature 4 key parameters; steam, pressure, temperature, time Advantages – rapid heating and rapid penetration of textiles. Non-toxic, inexpensive, can be used for some liquids. Disadvantages – items must be heat and moisture resistant. Cannot be used to sterilize powders or oils. Types of Steam Sterilizers A steam sterilizer, also know as an “autoclave,” is a pressure-type vessel with a door or cover, valves to control the entry and exit of steam and air, and monitoring devices to allow the operator to observe conditions inside. It is designed to hold items and allow steam under pressure to penetrate these items. Steam sterilizers are available in many sizes, ranging from portable countertop to the fixed room-size sterilizer. Effective steam sterilization and exposure time are measured from the moment the thermometer in the discharge line indicates the desired preset temperature. The pressure inside the sterilizer is not an indication of positive sterilization because other factors determine the pressure inside the sterilizer. Pressure merely maintains temperature. 41 41

Flash Sterilization Acceptable only for items: Urgently needed
Cleaned well Used close to point of sterilization Adequately covered or protected from contamination AAMI guidelines for implants (do not approve) AORN guidelines for implants (do not approve) Single instruments only (not trays) AORN defines Flash sterilization is the process designed for the steam sterilization of patient care items for immediate use.Flash sterilization is a process by which unwrapped instruments are sterilized for immediate use when an emergency situation arises; process of sterilizing an item that is not packaged. Flashed item is placed in an open tray to allow rapid steam penetration Flash sterilization is considered acceptable for processing cleaned patient-care items that cannot be packaged, sterilized, and stored before use. It also is used when there is insufficient time to sterilize an item by the preferred package method. Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time Take item apart, flush lumens. Will staff do this in the surgical area? Possibly not as well as the CPS staff. How far away is the sterilizer from the OR suite? AAMI-must have a biological indicator and quarantine till results known. AORN says only flash implants in emergency, do a BI and CI with each load and quarantine till RI results known. AAMI specifies if an implant is flashed and then place into a patient before the biological indicator results are known, documentation must be completed for premature release. Exception Form for Premature Release of Implantable Devices Releasing implants before the BI results is unknown is unacceptble and exception not rule Question: What is flash sterilization? Flash Sterilization usually means steam sterilization of an unwrapped instrument or device for 3 to 10 minutes in 270° F saturated steam. Flash sterilization is usually accomplished with a gravity displacement cycle, although certain newer sterilizers may employ a vacuum at the beginning or end of the cycle to remove air, steam, or aid in drying.Question: Why use flash sterilization? Flash sterilization is used when rapid sterilization of instrument or devices is required. This need may be the result of a limited number of instrument sets, a need for unanticipated instruments, or a contaminated instrument. Question: What is the main problem with flash sterilization? The problem is not with the sterilization process, but with the difficulty in maintaining sterility at the end of sterilization. It has been common practice to sterilize items in an open mesh basket. Upon removal from the sterilizer, the basket containing the items is covered or wrapped. The basket is then transported through non sterile areas to the operating site.Once the sterilizer is opened at the end, of the cycle, the basket and its contents may be exposed to recontamination. Even with subsequent wrapping or covering, it is difficult to ensure the items have remained sterile. Question: What can be done to prevent recontamination? The only way to prevent recontamination of flash sterilized items is to enclose the items within a biological barrier prior to opening the sterilizer at the end of the cycle. Question: Why not use muslin on non-woven wrap in the flash sterilizer? Muslin and non-woven wraps provide an effective barrier for steam or gas sterilized items. These wraps are used in hi-vac and certain gravity displacement steam cycles. In order for items wrapped in these materials to sterilize properly, air entrapped within the package must be eliminated. The hi-vac sterilizer accomplishes this with the use of a vacuum. The gravity displacement cycle relies on time (30 minutes or more) for elimination of air. When employing flash sterilization proper pre-vacuum or adequate time may not be available for proper removal of air. Failure to remove the air may result in inadequate sterilization. Question: Are there any containers for flash sterilization which prevent recontamination? Yes. One such product brand is: FlashPak which is a rigid container system which is designed specifically for flash sterilization and the prevention of recontamination. “Flash-Guard” is another brand on the market. 42 42

Flash Sterilization Considerations:
Risk of pt. burns from hot instruments Recontamination of instruments during transport Keep logs of all flashing Monitor times used, procedures, who, and why – use as Performance Improvement Monitor staff performance What are some of the other issues of flash sterilization? Surveyors will review these logs and expect PI projects focusing on why it is done and how improvements were made. Education for Surgery dept. should monitor the staff’s ability to describe the procedure and precautions. Surveyors will ask staff persons if implants are done. You need to know what the staff are going to say to the surveyors. 43 43

Low Temperature Sterilization
Ethylene oxide (EtO); Used for heat & moisture sensitive devices Lengthy aeration time must follow each cycle to allow removal of harmful residuals before opening chamber doors EtO is a carcinogen Alarms, ventilation, and training of staff promote safe use of this agent Destroys microorganisms by alkylation ( replacement of hydrogen atom in a molecule with an alkyl group) prevents the cell from metabolizing or reproducing. Disadvantages: Cycle time 3-6 hours Requires ETO permeable pkg Cost Toxic to patient & personnel - Must aerate items well before use Must exhaust to the outside Room must have 10 Air Changes (AC) per hour, Temp 70°F with 50% Humidity 44 44

Sterilization is Complex!
Human Factor Variables Sterilizer Equipment Performance Variables = Inconsistent Processes This is why we need to be familiar with all of the tools and technology we have available to monitor the effectiveness of the sterilization process. Cycle phases of a steam sterilizer: Conditioning Exposure Exhaust Drying 45 © 3M All Rights Reserved.

Reasons for Testing the Sterilization Process
Ensure probability of sterility of processed medical devices Detect sterilization failure ASAP: quarantine medical devices until final BI result known Verify a corrected failure ASAP…… get sterilizer back into service Remove medical devices involved in failures before patient use Control costs The objectives of monitoring the sterilization process with physical monitors and chemical and biological indicators is to ensure the probability of the absence of all living organisms on medical devices being processed. That is the ultimate goal of sterilization. Monitoring is also done to detect failures in the process as soon as possible and to verify that the failures have been corrected so that equipment can be put back into use. We use sterilization monitoring tools to detect sterilization failures. By quarantining medical devices until the final BI result is known, we can help prevent potentially unsterile devices from being distributed for patient care. YOU CAN’T SEE STERILITY! 47 © 3M All Rights Reserved.

Reasons for Testing the Sterilization Process: Quality Control
Helps determine if events during sterilization process met parameters Provides verification of adherence to policies/procedures CS Departments go to a lot of work cleaning, decontaminating, inspecting, assembling, packaging, and loading items into the sterilizer. Each step in those processes can be checked or visually monitored. However, once the sterilizer door is closed, CS technicians can’t “see” the process. They must rely on sterilization quality control to determine if the process was effective. 48 © 3M All Rights Reserved.

Variables Affecting the Outcome of Steam Sterilization Process
Low temperature Inadequate air removal Poor quality steam Utilities 5% Equipment malfunction 10% Human error 85% There are three main variables that can cause a steam sterilization process failure. The numbers associated with these failures are from Charles Hancock an engineer who developed steam sterilizers for Castle for more than 25 years before it was purchased by Getinge. The numbers are based on his personnel experience. Human error accounts for 85% of the sterilization process failures. Human error includes incorrect packaging and loading. And choosing the incorrect BI PCD for the and incorrect cycle parameters for the load. A process challenge device (PCD) is defined as an item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process. Sterilizer malfunctions account for 10% of the sterilization process failures. Equipment malfunctions include low temperature and inadequate air removal. The physical monitors may say temperature was reached but it was not. The temperature at sterilization can be too low for the entire time or the sterilizer starts timing the sterilization part of the cycle to soon. Utility problems account for 5% of the sterilization process failures. And of course poor quality steam which is the most difficult variable for those of you in central processing to measure and control. Incorrect packaging, loading Incorrect Biological Indicator (BI) Process Challenge Device (PCD) for load Incorrect BI PCD placement in load Incorrect cycle parameters for load 49 © 3M All Rights Reserved.

Steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST42 Steam sterilization and sterility assurance using table-top sterilizers in office & amb facilities ANSI/AAMI ST46 ANSI/AAMI ST37 Steam sterilization and sterility assurance in health care facilities Flash sterilization: Steam sterilization of patient care items for immediate use The Comprehensive guides to steam sterilization and sterility assurance in health care facilities are listed in this slide. ANSI/AAMI ST46 - Steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST42 - Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgical, and dental facilities ANSI/AAMI ST37 - Flash sterilization: Steam sterilization of patient care items for immediate use ANSI/AAMI ST35- Safe handling and biological decontamination of medical devices in health care facilities and in nonclinical settings ANSI/AAMI ST33 - Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities The other recommended practice we will discuss is ST79 which is the Comprehensive guide to steam sterilization and sterility assurance in health care facilities that is a replacement for the 5 previous AAMI documents listed on the slide. ANSI/AAMI ST35 ANSI/AAMI ST33 Safe handling and biological decontamination of devices in facilities & nonclinical settings Guidelines for reusable rigid sterilization containers for EO and steam sterilization in facilities 50 © 3M All Rights Reserved.

Association of PeriOperative Registered Nurses
Recommended Practices for Sterilization in Perioperative Practice Setting Recommended Practices for Selection and Use of Packaging Systems for Sterilization 51 © 3M All Rights Reserved.

Sterilization Monitoring Systems
Mechanical Indicators- Charts for time, temperature, pressure Chemical Indicators- Internal and External; Bowie Dick Biological Indicators Physical/Mechanical Chemical Biological 52 51

Sterilization Monitoring: Mechanical Indicators
Cycle time, temperature, & pressure is displayed on the sterilizer gauges with each instrument load Printout or graph also measures these indicators Mechanical/physical monitors verify that the parameters of the sterilization cycle have been met, or simply finding out whether or not your sterilizer is doing its job properly. Can be in the form of Charts, gauges, or printouts (tapes or digital displays) on the equipment. These indicate the machine functioned properly. Surveyors may ask for copies of the past autoclave readout tapes. Limitations are: most temperature sensors indicate the temperature at the drain or exhaust line of the sterilizer, but not the center of the packs. Improper load configuration or package composition can interfere with air evacuation and steam penetration, conditions that will not e revealed in the temperature recording. Therefore, physical monitoring and other indicators of sterilizer performance should never be considered a substitute for careful adherence to prescribed packaging and loading procedures. 53 52

Sterilization Monitoring: Chemical Indicators (CI)
The CI is a temperature indicator that signals the item has been exposed to sterilization process A CI is affixed to outside of package and used with every load An indicator is also placed inside the pack to verify steam penetration Chemical indicators are defined as systems that reveal a change in one or more predefined process parameters based on a chemical or physical change that resulting from exposure to a process. 2 types of process indicators are Internal and External Examples: Tape, load cards, or labels. Color change on tape is what is often used . Chemical indicators can help identify the reason for potential sterilization failures. CIs are an integral part of the sterilization quality assurance and are used in conjunction with physical and biological indicators to demonstrate the efficacy of the sterilization process. Class no hierarchical significance 54 53

Chemical Indicator (CI) placed in the tray prior to sterilization
Be sure you are aware of type used in your facility and the color changes. This should also be part of routine education for all staff nurses. 55 54

Examples of Bowie Dick Tests
The Bowie Dick (Steam Sterilizers) is an example of a chemical indicator- Class 2 Uniform color change means OK, monitors efficacy of air removal and steam penetration, run daily before 1st load and 1 pk. Per load, also initial instillation, relocation and sterilizer repair. This is not a sterility check . This is done to determine the efficacy of air removal in steam sterilizers. If there is insufficient air removal, steam will not drive the available air back into the load, air pockets will be created and sterilization will not occur. 56 55

Integrators (Class 5) Emulators (Class 6)
Integrating indicator- chemical indicator designed to react to all critical parameters over a specified range of sterilization cycles Emulating indicators- cycle verification indicators which shall be designed to react to all critical variables for specified sterilization cycles And whose performance has been correlated to the performance of the relevant biological indicator under the labeled conditions of use. Emulators are often called cycle specific indicators. Class 5 react to all the critical variables (time , temperature and steam) Class 6 indicators of cycle verification which shall be designed to react to ALL critical variables for specified sterilization cycles. AAMI ST79 does not have recommendations for Class 6 emulators but refers users to use the instructions provided by the manufacturers of Class 6 emulators. Dr. Rutala---Class 6 do not mimic Bis. Class 5 integrators have not replaced the usuage of b iological indicators 57 56

Sterilization Monitoring: Biological Indicators (BI)
Challenges the sterilization process against a Bacillus spore Use BI daily if sterilizer is used frequently Use a BI for every implant and EtO Placement Procedures: notification, instruments, used, documentation & report Biological indicators (BIs) are the only sterilization process monitoring devices that provide a direct measure of lethality. They are intended to demonstrate whether all required conditions including air removal and steam presentation were adequate to exceed the bioburden on items being sterilized and sterilization achieved. Sterilizer manufacturers validate their sterilization cycles using BIs; therefore, routine sterilizer efficacy monitoring in healthcare facilities should also be conducted using BIs. BIs are spores in or on a carrier, usually (as in the case of self contained Bis) accompanied by incubation media . Spores are used since they are the most resistant to the sterilization process. Steam: Geobacillus stearothermophilus formally called Bacillus stearothermophilus ETO: Bacillus atrophaeus formally known as Bacillus subtilus Process Challenge Devices (PCD) Many CSP depts perform this with the Microbiology dept monitoring the procedure, performance, results, and QI monitoring. New AAMI: If a sterilizer is designed for multiple types of cycles (gravity, prevac, steam flush pressure pulse, or flash) then each mode must be tested. Each type of tray configuration for flash sterilization should be tested separately. Test each type of steam sterilizer cycle and tray configuration. AORN and AAMI both state a biological should be done at least weekly and with every implant Biological indicators contain > 100,000 spores 58 57

Biological Indicators (BI)
Following the autoclave cycle, the BI is placed in an incubator Rapid readout 1-3 hours, or 24 hours Control positive Positive test = sterilization process has failed Pull instruments If rapid testing is used, you can pull instruments before they are used and surgeons don’t have to be notified of failed sterilization of instruments. A major concern if instrument was used: was it an implantable? What type of surgery? Surgeon may feel that patient should be given antibiotics or just be aware and watched for signs of infection. Positive test means the load was probably not processed or inadequately processed, exposure time not appropriate for load, cycle or equipment failure, BI test pack not properly prepared, BI contaminated in activating. 59 58

3M™ Attest™ Rapid Readout Biological Monitoring Products for Steam Sterilization
1291 270°F/121°C, gravity 1296/1296F PCD/test pack 270°F/131°C, dynamic-air-removal, ≥4 min 250°F/121°C, gravity, ≥40 min 1292 270°F/131°C, dynamic-air-removal 250°F/121°C, gravity 41382/41382F PCD/test pack 270°F/131°C, dynamic-air-removal, ≥4 min 250°F/121°C, gravity, ≥30 min Technology detects the activity of a naturally occurring enzyme located in the spore. The reaction results in the production of fluorescence and requires both incubation and a growth media. 60 © 3M All Rights Reserved. 59

BI Monitoring Frequency
Some facilities are moving to a higher standard of patient care by monitoring every sterilization load with a biological indicator. The disruption to patients, surgeons, ORs and SPD staff caused by a recall brings us to our next Continuous Quality Improvement topic: BI Monitoring Frequency. One trend seen across the country is facilities electing to practice the highest standard of care by monitoring every sterilization load with a biological indicator process challenge device. 61 © 3M All Rights Reserved.

BI Monitoring Frequency
Why monitor every load? Universal standard of patient care Cost and impact of a recall To be certain all implants, including those in loaners, are appropriately monitored Ensure every type of sterilization cycle used is monitored Ensure every type of packaging used in flash sterilization is monitored Reduce risk and cost of healthcare-associated infections (HAIs) Different facilities have different motivations for making the switch but reasons we hear repeatedly include: … Remember that earlier in today’s session we learned that in October 2008, hospitals will no longer be reimbursed by Medicaid for costs related to certain healthcare associated infections (HAIs) that could have reasonably been prevented through the use of evidence-based guidelines. So prevention and control of infections becomes more critical. It’s really all about patient safety. Using a biological indicator PCD in every load, along with thorough decontamination of all devices and proper equipment maintenance, provides you with the highest probability of assurance that you’re killing the bioburden on all items in the load. 62 © 3M All Rights Reserved.

Time Related vs. Event Related Sterilization
Time related- expiration date Event related sterilization –package must be intact, dry, clean Time-related package is labeled with expiration date (e.g., 2 months) Advantage is: Easy for the staff to police items. Items are repackaged and reprocessed after expiration (if items are reusable). Disadvantage – easy to miss items and these show up during JCAHO and State surveys. Also, staff may rely on date to determine good/bad – fail to check package integrity. Event related should include rotating items on the shelf to ensure that older items are used first. 63 62

Storage of Clean/Sterile supplies
Store at least 8-10 inches from the floor & 18 inches from the ceiling Solid bottom shelf The floor clearance allows for mopping of area without contamination of supplies. The ceiling clearance allows for fire sprinkler coverage. You can use solid bottom containers/bins on the shelf/cart instead of the solid plastic sheet 64 63

Continuous Quality Improvement (CQI)
AAMI ST79 CQI programs are used to assess and improve all components of the sterilization process Desired outcome of improving patient care by consistently delivering sterile product to the user No single “right way” to implement CQI Team approach Chapter 11 of AAMI ST79 discusses continuous quality improvement. ST79 reminds us that CQI programs are used to assess and improve all components of the sterilization process. All components include the entire process from decontamination, prep and pack, sterilization, quality control, sterile storage and product distribution. Another message in ST79 that’s good to remember is that there is no single “right way” to implement CQI. As you know, there are a variety of tools and methodologies available. Today we’ll discuss a few methods, such as Lean and Six Sigma. Some of you may be using one of these tools, others may find the concepts new to them. The important thing is that you use a systematic program to continually improve. While there is no “right way”, it is generally agreed that a team approach works best for CQI programs. The advantages to assembling a team to tackle a CQI project is that you can collect input from people actually doing the job and that employee involvement encourages both ownership and commitment to the solution. 65

Managing Loaner Instrumentation
Use of loaners has become common practice across U.S. Increasing need to borrow instruments, implants and other devices from vendors and/or neighboring facilities 66 © 3M All Rights Reserved.

Why Do Hospitals “Borrow” So Much?
Ever-changing technology Multiple cases in the same day: block scheduling Procedures done infrequently Specialty procedures (e.g., pediatrics) Cannot afford to purchase everything Space/storage issues 67 © 3M All Rights Reserved.

Loaner Instrumentation Issues
Patient Safety Timelines (flashing is not recommended) Communication (OR, SPD, Vendor) Quality MDM Reprocessing Guidelines Adequate time Implants Potential for lost items Issues Patient Safety Timelines (flashing is not recommended) Communication (OR, SPD, Vendor) Quality Medical Device manufacturer (MDM) written re-processing guidelines Adequate time to clean, inspect, inventory, wrap, sterilize, cool, document, and track large volume of loaner trays Implants: BI results before releasing Potential for lost items Frequently inadequate information provided by Medical Device manufacturer (e.g. reprocessing instructions, inventory of trays) Often complex instruments with which staff is unfamiliar. Heavy instruments: does loaner comply with AORN & AAMI 25 pound limit (including packaging) or container manufacturer’s pound restriction? Plastic trays – dry times 68 © 3M All Rights Reserved.

Managing Loaner Instrumentation – AORN
“A formalized program between health care organizations and health care industry representatives should be established for the receipt and use of loaner instruments” AORN, 2008 AORN’s newly revised recommended practices for sterilization in the PeriOperative practice setting includes a new recommendation around the use of loaner instrumentation. 69 © 3M All Rights Reserved.

Loaner Process should include Request to vendor Receiving items, with inventory list Obtaining MDM’s written instructions for cleaning & sterilization of loaner instrumen-tation Decontamination and sterilization of borrowed instruments Following procedure, returning loaner instrumentation to sterile processing dep’t for decontamination, inventory and return to MDM Keeping records of transactions Slide is animated on click. Loaner Process should include: Request to vendor Receiving items, with inventory list Obtaining MDM’s written instructions for cleaning and sterilization of loaner instrumentation Decontamination and sterilization of borrowed instruments Following procedure, returning loaner instrumentation to sterile processing dep’t for decontamination, inventory and return to MDM Keeping records of transactions 70 © 3M All Rights Reserved.

Allow sufficient time for conventional sterilization methods: “…circumvent the need for flash sterilization” Have loaner instruments delivered to decontamination Sterilize implantable devices with a BI and a Class 5 integrating indicator The recommended practice stresses the importance of planning to allow sufficient time to conduct in-house disassembly, decontamination, packaging and sterilization by conventional methods. “Flash sterilization should not be used as a substitute for sufficient instrument inventory resulting from the late delivery of loaner instrumentation.” Facilities should develop and follow a Policy and Procedure to manage loaners 71 © 3M All Rights Reserved.

Resources for Loaner Instrumentation
Joint position paper created and adopted by ASHCSP and IAHCSMM AORN Recommended Practice Managing Infection Control Journal in-service “Loaner Instrumentation: Keeping Patient Safety First” by Rose Seavey, April, 2007 72 © 3M All Rights Reserved.

Summary 1. Defined and discussed common cleaning, disinfection sterilization terminology 2. Reviewed the Chain of Infection 3. Discussed and reviewed the “chemistry” of cleaning , disinfection, sterilization and Spaulding Classifications-medical devices 4. Discussed sterilization methods and monitoring 5. Described components of instrument loaner protocol 73

References Guidelines:
Association for the Advancement of Medical Instrumentation (AAMI) Association of periOperative Registered Nurses (AORN) American Society for Healthcare Environmental Services (ASHES) 74 73

References CDC Guidelines for Environmental Infection Control in Health-Care Facilities International Association of Healthcare Central Service Materials Management (IAHCSMM) (Rutala, William A.) Disinfection, Sterilization and Antisepsis 75 74

Thank You 76 75

Cleaning, Disinfection and Sterilization

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