CDHO Infection Prevention and Control (IPAC) Guidelines PDF
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2022
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Summary
The document provides guidelines for infection prevention and control (IPAC) in dental hygiene practices. The guidelines cover infection prevention and control strategies, personal protective equipment (PPE), reprocessing procedures, and environmental cleaning.
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Infection Prevention and Control (IPAC) Guidelines Last Revision: August 3, 2022 First Published: December 2018 Revised: September 2019; August 2022 © 2022, College of Dental Hygienists of Ontario CDHO Infection Prevention and Control (IPA...
Infection Prevention and Control (IPAC) Guidelines Last Revision: August 3, 2022 First Published: December 2018 Revised: September 2019; August 2022 © 2022, College of Dental Hygienists of Ontario CDHO Infection Prevention and Control (IPAC) Guidelines Table of Contents Introduction................................................................................................................................ 4 Professional and Regulatory Considerations......................................................................... 5 Written Policies and Procedures.............................................................................................. 6 Occupational Health and Safety Requirements and Workplace Hazardous Information System (WHMIS)................................................................................................... 8 Human Rights.......................................................................................................................... 10 Transmission of Microorganisms.......................................................................................... 11 Oral Health Care Provider and Client Safety......................................................................... 13 Routine Practices........................................................................................................... 13 Risk Assessment................................................................................................ 13 Hand Hygiene.................................................................................................... 14 Alcohol-Based Hand Rub vs Soap and Water........................................ 15 Effective Hand Hygiene Techniques...................................................... 16 Barriers to Effective Hand Hygiene........................................................ 17 Personal Protective Equipment (PPE)............................................................... 18 General Considerations.......................................................................... 18 Protective Covering................................................................................ 18 Masks..................................................................................................... 19 Protective Eyewear................................................................................. 19 Gloves.................................................................................................... 20 Environmental Controls...................................................................................... 23 Handling of Sharps and Exposure Prevention........................................ 23 Exposure Management.......................................................................... 24 Administrative Controls...................................................................................... 25 Education and Training........................................................................... 25 Immunization.......................................................................................... 25 Illness and Work Restrictions................................................................. 25 Additional Precautions................................................................................................... 26 Reprocessing........................................................................................................................... 27 Classification of Client Care Equipment......................................................................... 28 Single-Use Items/Devices.............................................................................................. 28 Reprocessing Area........................................................................................................ 29 Cleaning Reusable Dental Instruments/Devices............................................................ 30 1 CDHO Infection Prevention and Control (IPAC) Guidelines Manual Cleaning................................................................................................ 30 Ultrasonic Cleaner.............................................................................................. 31 Washer-Disinfectors........................................................................................... 31 Disinfection.................................................................................................................... 31 Low to Intermediate Level.................................................................................. 31 High Level (Cold Soak)...................................................................................... 32 Preparing and Packaging of Reusable Dental Instruments/Devices.............................. 32 Sterilization of Reusable Dental Instruments/Devices................................................... 34 Steam Sterilization............................................................................................. 34 Unacceptable Methods of Sterilization............................................................... 35 Flash Sterilization............................................................................................... 35 Monitoring................................................................................................................................ 36 Determining the Effectiveness of the Steam Sterilization Process................................ 36 Process Challenge Devices (PCD).................................................................... 37 Air Removal/Bowie-Dick PCD Test Pack........................................................... 38 Biological Indicator PCD Test Pack.................................................................... 38 Biological Indicator PCD Failure......................................................................... 39 Chemical Indicator PCD Test Pack.................................................................... 40 CI, CI PCD and/or Physical Parameters Failures............................................... 40 Logging the Sterilization Process................................................................................... 43 Documenting a Recall Incident...................................................................................... 43 Qualifying and Requalifying Your Sterilizer.................................................................... 43 Storage of Reprocessed Dental Instruments / Single-Use Devices............................... 44 Environmental Cleaning.......................................................................................................... 45 Public Contact Surfaces................................................................................................. 45 Clinical Contact Surfaces............................................................................................... 45 Barriers............................................................................................................... 46 Waste Management....................................................................................................... 47 Biomedical Waste.............................................................................................. 47 General Office Waste......................................................................................... 48 Disposal of Teeth............................................................................................... 48 Mercury-Containing Waste Protocol................................................................... 48 2 CDHO Infection Prevention and Control (IPAC) Guidelines Special Considerations........................................................................................................... 49 Dental Unit Waterlines................................................................................................... 49 Devices with Lumens..................................................................................................... 50 Dental Handpieces and Other Devices.......................................................................... 50 Ventilation...................................................................................................................... 51 Boil-Water Advisory....................................................................................................... 51 Saliva Ejectors and Suction Lines.................................................................................. 51 Radiography Equipment................................................................................................ 51 Film.................................................................................................................... 51 Digital Radiography............................................................................................ 52 Intraoral Cameras.......................................................................................................... 52 Lasers............................................................................................................................ 52 Sharpening Stones........................................................................................................ 52 Injectable Medications, Vials and Solutions................................................................... 53 Dental Laboratory.......................................................................................................... 53 Sending Items to a Commercial Lab.................................................................. 53 Receiving Items from a Commercial Lab........................................................... 53 Sending Items Out for Repair and/or Maintenance........................................................ 53 Resources................................................................................................................................ 55 Glossary................................................................................................................................... 57 3 CDHO Infection Prevention and Control (IPAC) Guidelines Introduction Oral health care workers (OHCW) have an obligation to their clients to establish and maintain practice environments that have organizational structures, policies and resources in place that are consistent with legal, professional and ethical responsibilities that promote safety, respect, and support for all persons within the practice setting. An OHCW meets this practice standard by: ensuring that all legislative requirements are met ensuring written policies and protocols are in place for the practice environment, such as workplace health and safety, infection prevention and control, managing hazardous wastes, and respecting human rights maintaining facilities, equipment, supplies and technology sufficient to provide a full scope of practice safely and effectively securing and maintaining appropriate service schedules and service records ensuring that current scientifically accepted infection prevention and control practices are in place. 4 CDHO Infection Prevention and Control (IPAC) Guidelines Professional and Regulatory Considerations These guidelines contain infection prevention and control (IPAC) best practice recommendations which must be followed by all dental hygienists practising in Ontario while providing client care. The CDHO’s infection prevention and control guidelines are consistent with guidance documents from Public Health Ontario (PHO), the Public Health Agency of Canada (PHAC), the Provincial Infectious Disease Advisory Committee (PIDAC) and the Canadian Standards Association (CSA). This document will be used by the College of Dental Hygienists of Ontario and/or may be used by others in determining whether appropriate standards of practice and professional responsibilities have been implemented and maintained. The CDHO recognizes that this aspect of practice is constantly evolving, therefore, this document presents best practices at the time of publication and will be amended as new information becomes available. 5 CDHO Infection Prevention and Control (IPAC) Guidelines Written Policies and Procedures According to PIDAC, CSA and PHAC, all oral health care workers are required to establish and document practice-specific written policies and procedures that are based on current recognized standards and best practices. A policy and procedure manual for up-to-date IPAC protocols must be followed by all OHCWs, reviewed at least annually or more frequently as new information becomes available, and must address the following: requirements for education and training of all OHCWs, including a process for continual improvement, and documentation of quality improvement IPAC goals immunization and vaccination status of OHCWs routine practices such as o hand hygiene o risk assessment o appropriate selection of personal protective equipment all aspects of the reprocessing of dental hygiene instruments/devices including o the employment of single-use items when dental equipment/devices cannot be cleaned and reprocessed according to the recommended standards o the removal of faulty instruments/devices until repaired or replaced o the documentation of maintenance and repair of all cleaning and sterilization equipment kept for 10 years as indicated in the CDHO Records Regulation o quality monitoring and documentation of the reprocessing procedure including biological indicator tests, chemical indicator tests, and physical parameters. (All test results must be logged, evaluated after each cycle, signed by the person responsible, and kept for 10 years as per the CDHO Records Regulation.) o information to be recorded on instrument packages which must include a sterilizer number, load number and date of sterilization, load contents, and person who assembled the package o a recall of improperly reprocessed equipment that includes notification of the appropriate authorities, assessment of client risk, and determining if additional notification of client, other facilities, and/or regulatory bodies (e.g. public health unit, regulatory college) is required o a documented auditing process of competency of OHCWs involved in reprocessing and IPAC procedures, including corrective measures if needed o a regular schedule for environmental cleaning of the reprocessing area that includes clearly defined responsibilities managing hazardous waste (biohazardous, mercury, lead, sharps) 6 CDHO Infection Prevention and Control (IPAC) Guidelines water and water use within the dental setting o for maintaining dental unit waterline quality o during a Boil-Water Advisory (Safe Drinking Water Act, 2002, Ontario Regulation 169/03 regulatory standards for drinking water) suction and suction line maintenance procedure for immediate containment, cleaning and disinfection of spills of blood and body fluids facilities maintenance (environmental cleaning, even if contracted out), such as o a detailed schedule of cleaning of each area of the clinic o sufficient equipment, supplies and technology for all areas requiring environmental cleaning o the maintenance of appropriate service schedules and service records. 7 CDHO Infection Prevention and Control (IPAC) Guidelines Occupational Health and Safety Requirements and Workplace Hazardous Information System (WHMIS) In Ontario, employers have the responsibility to meet the requirements of the Occupational Health and Safety Act (OHSA) which includes the Ontario Regulation 860: Workplace Hazardous Materials Information System (WHMIS). Employers and employees must comply with provincial legislation and use any equipment, protective devices or clothing required. According to OHSA, it is a requirement that written policies and procedures are established to protect health care workers in their workplace. The policies and procedures must include the following: a specified health and safety representative or committee to audit the health and safety program within the practice a written workplace violence and harassment policy a clear expectation that OHCWs do not come to work when ill with symptoms of infection training for all new employees, new equipment, and/or new job procedures workplace inspections and hazard analysis investigations of any accidents that may occur in the workplace, including the management of needle stick injuries with specific post-exposure protocols o knowing the immunization status of OHCWs is important information for the physician to have in the event of an injury the prohibition of eating/drinking, storage of food, smoking, application of cosmetics and handling of contact lenses in non-designated areas a health and safety budget a formal means of communication to promptly address the concerns of workers material-handling practices and procedures (see Workplace Hazardous Materials Information System) emergency procedures, including medical emergencies first-aid and rescue procedures fire prevention and emergency procedures/evacuation plan. 8 CDHO Infection Prevention and Control (IPAC) Guidelines WHMIS is Canada’s national communication standard that deals with hazardous materials in the workplace. According to WHMIS, any workplace that uses materials classified as controlled products is required to: use cautionary labelling on hazardous materials o label must display the product identifier, safe handling precautions, and reference to the safety data sheets (SDS) maintain the most current SDS for all hazardous substances, which must be renewed every three years provide worker education programs on how to use, handle, store and dispose of hazardous material. A useful resource, Workplace Hazardous Materials Information System (WHMIS): A Guide to the Legislation is available at the Ontario Ministry of Labour website: https://www.ontario.ca/document/workplace-hazardous-materials-information-system-guide-legislation 9 CDHO Infection Prevention and Control (IPAC) Guidelines Human Rights The Ontario Human Rights Code (the Code) provides for equal rights and opportunities, and freedom from discrimination. The Code prohibits discrimination based on any of the following: Race Ancestry Place of origin Colour Ethnic origin Citizenship Creed Sex Sexual orientation Gender identity Gender expression Age Marital status Family status Disability The Code recognizes persons living with certain illnesses as disabled. As such, OHCWs must not discriminate against such clients. This includes using additional and/or unnecessary infection control practices or other measures that are not used for other clients. Modifications to routine practices may be required based on the risks associated with certain procedures, provided that they are used for all clients undergoing the same procedures. 10 CDHO Infection Prevention and Control (IPAC) Guidelines Transmission of Microorganisms There are six elements in the chain of infection. All six need to be present in order for infection to spread. Absence of any one of these elements will break the chain. Infectious Agent – the pathogen that causes the disease (bacteria, fungi, parasites, viruses, prions) Reservoir – where the pathogen lives (people, water, food) Portal of Exit – the way the infectious agents leave the reservoir (blood, secretions, excretions, skin) Mode of Transmission – the way the infectious agents are transferred (direct or indirect contact, droplet, airborne) Portal of Entry – the way the infectious agents enter the host (mucous membrane, respiratory, skin, gastrointestinal tract) Susceptible Host – any person at risk Infectious Agent Susceptible Reservoir Host CHAIN OF TRANSMISSION Portal of Entry Portal of Exit Mode of Transmission It is critical that OHCWs understand the modes of transmission for infection to occur in order to protect their clients, their colleagues and themselves. Visiting an oral health care setting presents the risk of exposure to pathogenic microorganisms. 11 CDHO Infection Prevention and Control (IPAC) Guidelines Understanding the modes of transmission is important in the development of appropriate IPAC principles. The three main modes of transmission of microorganisms in an oral health care setting are: Direct transmission (from hands) Indirect transmission (from object such as a dental scaler) Droplet transmission (from coughing or sneezing) 12 CDHO Infection Prevention and Control (IPAC) Guidelines Oral Health Care Provider and Client Safety Routine Practices The Public Health Agency of Canada uses the term “routine practices” to describe basic standards of infection prevention and control that are required for safe client care. Routine practices are based on the assumption that all clients are potentially infectious, even when symptoms are not clinically evident. The same safe standards of practice must routinely apply to everyone when dealing with blood, body fluids and secretions (e.g. saliva), mucous membranes and non-intact skin, in order to break the chain of transmission. There are five principles that are essential in routine practices: 1. Risk assessment 2. Hand hygiene 3. Use of personal protective equipment 4. Environmental controls 5. Administrative controls Risk Assessment The first step for an effective use of routine practices is the performance of an at point risk assessment by the OHCW, relevant to the task at hand. A point-of-care risk assessment is applied before and at every interaction with the client, including: When booking and/or confirming of appointments (if appropriate, e.g., same day or next day appointment). A good opportunity to screen clients in advance for illness is when confirming dental hygiene appointments. Upon arrival in the reception area. All clients must be prescreened for any symptoms of communicable disease or acute respiratory infections such as influenza, fever, cough, vomiting, diarrhea, or cold and must be rescheduled in order to prevent the spread of microorganisms. An appropriate sign to alert clients to report the above symptoms must be displayed prominently in the reception area. In the dental hygiene operatory. OHCWs must screen the client to determine whether the client has a communicable disease and to assess the risk of exposure to blood, body fluids, secretions, excretions and non-intact skin and thus identify the strategies that will decrease exposure risk throughout the dental hygiene appointment. For more information on specific conditions which may require rescheduling of clients, please refer to the CDHO Knowledge Network http://www.cdho.org/my-cdho/practice-advice/the-knowledge-network Click here to access the Point-of-Care Risk Assessment (PCRA) 13 CDHO Infection Prevention and Control (IPAC) Guidelines OHCWs should check regularly with their local Public Health Unit for any diseases which may require pre-screening. Hand Hygiene The term “hand hygiene” encompasses washing hands with soap and water or the use of alcohol- based hand rubs (ABHR). Hand washing with soap and water is required to remove visible soil, and remove/kill transient microorganisms from the hands. ABHR is the preferred method of hand hygiene if hands are not visibly soiled. A hand care program supports hand hygiene and includes actions taken to maintain healthy hands and fingernails. Maintaining good skin integrity is important in a thorough hand hygiene routine as intact skin is the first line of defense to protect one’s self from infection. For a quick reference please refer to the 4 Moments of Hand Hygiene by Public Health Ontario. Hand hygiene must be performed: BEFORE: initial contact with a client making contact with items in client environment entry into the treatment room, even if the client has not been touched putting on personal protective equipment eating or drinking. AFTER: care involving contact with blood, body fluids, and secretions of a client, even if gloves are worn removing personal protective equipment moving between extra oral and intra oral procedures contact with a client or items in their immediate surroundings hands are visibly soiled personal bodily functions. 14 CDHO Infection Prevention and Control (IPAC) Guidelines Alcohol-Based Hand Rub vs Soap and Water Alcohol-based hand rub (ABHR): Hand washing with soap and running water: preferred use when hands are not visibly preferred when hands are visibly soiled soiled because alcohol is inhibited by organic matter must contain 70%–90% alcohol requires mechanical action of washing, takes less time than hand washing rinsing and drying, which removes most transient bacteria more effective than hand washing with soap and water when hands are not lifts and washes away microorganisms visibly soiled must not include bar soaps. requires mechanical rubbing action to kill transient bacteria less drying to hands than soap and water kills the intended microorganisms. *** Best evidence suggests that antimicrobial soap is equivalent to ABHR in terms of microorganism reduction but is harsher on the hands and more time-consuming to use. Alcohol-based hand rub and liquid soap must be dispensed in disposable containers and must not be “topped up”. A good hand hygiene routine should include a moisturizer that is compatible with gloves and the product being used to clean your hands. 15 CDHO Infection Prevention and Control (IPAC) Guidelines Effective Hand Hygiene Techniques [Source: Just Clean Your Hands] 16 CDHO Infection Prevention and Control (IPAC) Guidelines Barriers to Effective Hand Hygiene Consider the following barriers when performing effective hand hygiene: Condition of the hands: the presence of dermatitis, cracks, cuts or abrasions can trap bacteria and compromise hand hygiene. Barrier creams are absorbed by the skin and may actually be harmful as they trap agents beneath them. Nails should be short enough (i.e. not more than 2 mm beyond fingertip) to allow thorough cleaning underneath and not cause glove tears. Acrylic nails harbour more microorganisms and are more difficult to clean than natural nails. Artificial nails and nail enhancements (i.e. Shellac) are also associated with poor hand hygiene practices and result in more tears to gloves. Studies have shown that chipped nail polish or nail polish worn longer than four days can harbour microorganisms that are not removed by hand washing. Gel polish has been shown to damage nails, resulting in nail weakness, brittleness and thinning, putting nails at increased risk for breaking. Nail art (adding decorative paint effects to nails) has been shown to be associated with outbreaks of infection.i Accessories such as rings and watches are highly discouraged as they have the potential to harbour microorganisms. If worn, rings must be limited to a single smooth band without projections or mounted stones and watches should be covered by a glove or sleeve. Long sleeves or jewelry should not interfere with, or become wet when performing hand hygiene. If watches and other wrist jewelry are present, remove or push up above the wrist before performing hand hygiene.ii Artificial nails and nail enhancements are not to be worn by those having direct contact with a client/patient. 17 CDHO Infection Prevention and Control (IPAC) Guidelines Personal Protective Equipment (PPE) General Considerations Personal Protective Equipment (PPE) is worn to protect the OHCW and clients from exposure to potentially infectious material. PPE serves as a barrier to protect from exposure to splashing, spraying or spatter of blood, saliva or other body fluids, and from introducing microorganisms into deeper tissues by traumatic injuries. The selection of PPE must be based on a thorough risk assessment and the potential for transmission of infectious agents. PPE includes gloves, gowns and/or lab coats and facial protection (i.e. protective glasses, masks, face shields) as well as any techniques or equipment (e.g. high-volume suction) used to protect against diseases spread by droplets, spatter and sprays. PPE not only protects the OHCW but also protects the clients against any cross-contamination from previous clients. PPE should be removed prior to leaving the operatory. Single-use barriers, such as gloves and masks, must be discarded immediately after use. Protective Covering Whenever spatter or spray is anticipated during dental hygiene procedures, the use of a water-resistant gown is required. Clinical and laboratory coats or jackets are not a substitute for gowns where a gown is indicated. Regular clinical attire (e.g. uniforms, scrubs) is not intended to function as protection against a hazard where spatter or spray is anticipated. If clinical attire becomes inadvertently contaminated it must be changed. Clinical attire must NOT be worn outside of the office or worn home. A gown must be worn if it is anticipated that arms and/or clothing will be in contact with blood, body fluids, secretions or excretions. Disposable gowns must be removed and discarded immediately after use and prior to leaving treatment and/or reprocessing room. Reusable gowns must be laundered between patients/clients. Gowns must be long-sleeved and cuffed and provide full frontal coverage from neck to mid-thigh or below. Footwear worn in the client treatment and reprocessing areas, needs to have enclosed toes and heels and be easily cleaned. Hair must be secured and worn away from the face or properly covered with hair or a beard covering. If hair coverings are worn, they must be changed at least daily or more frequently if soiled. Staff involved in reprocessing must confine all hair including facial and body hair. Staff must never share PPE. 18 CDHO Infection Prevention and Control (IPAC) Guidelines Contaminated PPE must never come in contact with clean surfaces; for example, a contaminated gown must be removed and discarded prior to removing sterilized items from the sterilizer. Clients’ clothing should be protected against spatter and debris with plastic-lined single-use bibs. Bib chains/holders require cleaning and low-level disinfection between clients or may be purchased in a single-use form. Masks Surgical masks that cover the nose and mouth must be worn during dental procedures to protect the respiratory mucosa from coming in contact with droplets and spatter. Masks also form the basis of protection for diseases spread by the droplet route (e.g. influenza). Masks lose efficiency over time and must be changed when they become contaminated (wet, visibly soiled and/or according to manufacturer’s directions) and between clients. Masks are: to be worn by OHCWs when performing aseptic or invasive procedures to be securely covering the nose and mouth and substantial enough to prevent droplet penetration to be put on immediately before the procedure for which it is required to be removed and discarded immediately after the intended use not to be re-used (must be changed after each client or more frequently as needed) not to be touched while being worn not to be hung around the neck or under chin not to be folded or stored in a pocket. Protective Eyewear Protective eyewear for the client and the OHCW shields the eyes from spatter and debris that may be created by the use of certain instruments (e.g. handpieces, ultrasonic instruments, air/water syringe) as well as protection from sharps or foreign objects. Protective eyewear: must always be worn throughout the appointment to shield the eyes and the conjunctival mucosa from spatter and debris generated during dental procedures should be comfortable, fit securely, and not interfere with vision is to be put on immediately before the procedure for which it is required is to be removed immediately after the intended use 19 CDHO Infection Prevention and Control (IPAC) Guidelines re-usable protective eyewear including loupes, must be cleaned and disinfected after use or according to manufacturer’s instructions for use (MIFU), between clients, and once they become visibly contaminated. Prescription eyeglasses for oral health care workers are not considered appropriate eye protection as they do not provide protection against splashes around the top and sides of the glasses. Gloves Gloves are worn to protect the hands of the OHCW from contamination. The following should be considered when using gloves as a PPE: selection of gloves should be appropriate to the task do not replace the need for hand hygiene appropriate hand hygiene protocols must be followed before donning and after removing must be worn when contact with mucous membranes, non-intact skin, or body fluids is anticipated must be put on immediately before the activity for which they are being used must be removed and discarded immediately after the activity for which they were used must not be worn outside any room or area where they are required for personal protection must not be washed and reused as soaps and alcohols can compromise the surface of the glove, leading to micro-perforations and loss of integrity must be changed between care for each client or more frequently as necessary if using lotion, check with the manufacturer’s recommendations regarding the compatibility of lotions with gloves; for example, petroleum-based lotions may weaken the glove material resulting in increased permeability. 20 CDHO Infection Prevention and Control (IPAC) Guidelines 21 CDHO Infection Prevention and Control (IPAC) Guidelines 22 CDHO Infection Prevention and Control (IPAC) Guidelines Latex Allergy/Sensitivity Many common dental products such as gloves, rubber dams and prophylaxis cups may contain latex and pose a severe risk for clients with latex allergies/sensitivities. Consider the following: As part of the medical history-taking process, questions should be asked relating to possible latex allergy/sensitivity. Treat in an environment where contact with latex proteins, either directly or airborne, is kept as low as reasonably achievable. Remove all latex-containing materials or devices from the operatory. Always check labels of dental products for latex content. The use of latex gloves is not recommended. Allergic reactions have been reported with the use of latex gloves, and consideration must be given to this when purchasing gloves. If the OHCW or the client has a latex allergy, latex-free gloves must be used. Environmental Controls Handling of Sharps and Exposure Prevention Sharps are devices that are capable of causing a cut or puncture wound. Sharps should be kept out of the reach of clients and safely collected in a clearly labelled puncture-resistant container at point of use and/or must be transported to the reprocessing area in a leak-proof covered container (i.e. plastic tray with a secured hard plastic cover) or cassette. Exposures to blood-borne pathogens can occur via percutaneous injuries, non-intact skin, or through the eyes, mouth and nose. Injury prevention strategies include: maintaining good skin condition; intact skin is the first line of defense as a barrier to disease transmission using occlusive dressings to protect non-intact skin; work duties may need to be adjusted to accommodate any large skin lesions ensuring needles are capped prior to use and immediately recapped using a one-handed scoop method or commercial recapping device removing disposable sharps from the tray and disposing inside an appropriate sharps container immediately after use transporting sharps by using a puncture-resistant secured container when disposal at point of use is not possible removing burs from handpieces immediately after use wearing heavy-duty utility gloves and appropriate PPE when cleaning instruments. 23 CDHO Infection Prevention and Control (IPAC) Guidelines In Ontario, all health care settings shall use safety-engineered needles, according to the Needle Safety Regulation (O. Reg. 474/07). The regulation is available at: http://www.ontario.ca/laws/regulation/070474 Exposure Management Pathogens that are blood borne such as Hepatitis B (HBV), Hepatitis C (HCV), and Human Immunodeficiency Virus (HIV) can be transmitted to OHCWs through the exposure to blood, saliva and other body fluids via a puncture/laceration or by splashing onto non-intact skin or mucosa of the eyes, nose or mouth. An exposure management protocol must be included in the IPAC manual and must include the following: First aid procedures for the management of exposure to blood-borne pathogens Treatment by the appropriate health care professional (personal physician or emergency department). This may include counselling, post-exposure screening, baseline and follow-up serology and/or post-exposure prophylaxis Documentation of the incident o Include the name and vaccination status of persons exposed o Record the date and time of the incident and what the OHCW was doing, including the dental hygiene procedure being performed o Identify what preventive measures were being implemented at the time of exposure (i.e. use of utility gloves while handling sharp instruments) o Document name (case number) and health status of source person if known, including any known blood-borne diseases (e.g. Hepatitis B, Hepatitis C or HIV indicated on their medical history). All oral health care workers should be aware of the exposure management protocol and should review it periodically. 24 CDHO Infection Prevention and Control (IPAC) Guidelines Administrative Controls Education and Training OHCWs receive education in IPAC in their professional programs. It is their responsibility to ensure that current scientifically accepted infection control practices are in place and followed. In addition to their formal training, OHCWs, including those who own their own clinic, need to ensure: formal IPAC education and training appropriate to their position and responsibilities is provided upon hire, at least annually, and whenever new equipment or processes are introduced regular continuing education is required and should be supported, as well as encouraged those assigned to reprocess dental equipment/devices/instruments receive device-specific reprocessing instructions from the manufacturer and seek clarification or education as required there are regular documented internal audits to assess the competency of staff involved in IPAC procedures IPAC Manuals are reviewed by all staff members and updated at least annually. Immunization Immunizations are an important component to infection prevention and control. They minimize the OHCWs potential risk for contracting an infectious disease from a client and from transferring an infectious disease to clients and other staff. All OHCWs should be aware of their personal immunization status and ensure their vaccines are up to date. It is highly recommended that health care professionals be immunized against: Hepatitis B (HBV) Measles Mumps Rubella Varicella Influenza Diphtheria Pertussis Tetanus Polio Refer to the Canadian Immunization Guide for a complete list of recommended immunizations for health care workers. Illness and Work Restrictions Hand hygiene is the single most important measure in protecting clients and clinicians from the transmission of microorganisms. However, even with the best of efforts, a clinician may fall victim to microorganisms and become ill. 25 CDHO Infection Prevention and Control (IPAC) Guidelines When should an OHCW not work on clients? If they have acute conjunctivitis If they have severe respiratory illness with fever If they have influenza or a common cold If they have acute viral gastroenteritis with vomiting and diarrhea If they have non-intact skin lesions, they may need to adjust their work duties until any skin lesions have been resolved If an OHCW is immunocompromised, they are at an increased risk of becoming infected, therefore, when possible, considerations for work duties and exposure risk should be taken into account. Additional Precautions In some cases, routine practices may not be sufficient for clients who are infected or colonized with certain microorganisms. The term “additional precautions” refers to measures that are taken in addition to routine practices to break the chain of transmission of such microorganisms. This is especially relevant for OHCWs treating clients in health care institutions, such as a long-term care home. Clients with weakened immune systems and chronic illnesses are more susceptible to methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococcus (VRE), or respiratory tract viruses like influenza. Clients who may be suspected of having infections transmitted by respiratory droplets must be rescheduled until the period of communicability is over. In emergency situations, persons who are known or suspected of having infections that can be transmitted by respiratory droplets should be offered a mask and hand hygiene upon arrival, and ideally, should maintain a distance of two metres from others in the office. The use of dental hygiene instruments such as ultrasonic scalers, handpieces, air polishers and the air/water syringes may create sprays, droplets or spatter. Every effort should be made to reduce the spread by using a high-volume suction or a rubber dam. Using these items will also reduce the possibility of your client ingesting or inhaling contaminated material and/or debris. According to the Ministry of Health and Long-Term Care document Occupational Health and Safety and Infection Prevention and Control in Health Care Settings, during a pandemic influenza warning, a N95 respirator is required for OHCWs. 26 CDHO Infection Prevention and Control (IPAC) Guidelines Reprocessing In order to prevent transmission of microorganisms, all reusable dental equipment and instruments being used on clients must be cleaned, disinfected and/or sterilized according to the current standards and guidelines from the Provincial Infectious Diseases Advisory Committee (PIDAC), Canadian Standards Association (CSA), and Public Health Agency of Canada (PHAC). General considerations include: Manufacturers must supply information for all dental equipment/instruments and decontamination equipment. Facilities must maintain manufacturers’ instructions in a format that allows for easy access by staff carrying out the reprocessing activities. Equipment that is used to clean, disinfect or sterilize must meet standards established by Health Canada and provincial best practices. Designated staff assigned to reprocessing must be trained to a level required for the volume and complexity of the equipment to be reprocessed. There must be a written protocol to deal with staff exposures that occur during reprocessing (chemical exposures, heat exposure, and sharps exposure). 27 CDHO Infection Prevention and Control (IPAC) Guidelines Classification of Client Care Equipment All dental equipment/instruments used in client care are categorized as critical, semi-critical, and non- critical. The classifications of these equipment/instruments determine the minimal type of reprocessing required and the potential risk of infection associated with their use. Category Use Minimum level of Examples reprocessing Critical Enters sterile body site Cleaned and sterilized Periodontal scalers, or vascular system ultrasonic scaler tips and surgical instruments Semi-critical Comes in contact with Cleaned and sterilized Handpieces including mucous membranes or motors and impression If items are heat non-intact skin trays sensitive, then they need to be replaced by single- use items Noncritical Comes in contact with Clean and low-level Stethoscope, blood only intact skin and not disinfection pressure cuff, shade mucous membranes guide, bib chain/holder Newly purchased, non-sterile critical and semi-critical dental/medical equipment/devices must be inspected and reprocessed prior to use, according to their intended use as per manufacturer's recommendations. Single-Use Items/Devices Single-use items are intended for one-time use only and are to be discarded after each client. Single-use instruments/items include: such items as syringes, needles, prophylaxis cups and brushes, saliva ejectors, gloves, and bibs some prophylaxis angles, high-volume suction tips and air/water syringe tips certain orthodontic brackets. 28 CDHO Infection Prevention and Control (IPAC) Guidelines Single-use devices are usually not heat-tolerant and cannot be reliably cleaned or disinfected. Therefore, they must be disposed of appropriately after use. Single-use items will be labelled with icons similar to the following: Reprocessing Area The reprocessing area is where all instruments, devices and equipment are cleaned, disinfected, dried, packaged, sterilized and prepared for reuse. The physical space used for reprocessing instruments must have the following: a clearly segregated area away from direct client care and from where clean, disinfected or sterile items are handled and/or stored a one-way work flow from dirty to clean to prevent cross-contamination that include separate areas for cleaning, rinsing/drying, packaging, and sterilization/cooling a sink sufficient in size and depth for cleaning client care equipment and instruments a dedicated handwashing sink or 70%–90% alcohol-based hand sanitizers available for use if a sink is not available surfaces (walls, cabinets) capable of being cleaned and disinfected a sufficient cleanable, non-porous counter space to handle the volume of work slip-proof flooring that can withstand wet mopping the ability to control the environment (e.g. temperature, ventilation, humidity) readily available PPE (gloves, gowns, mask, and/or eye protection) for staff a plumbed or self-contained eyewash station within a 10-second walk (16 to 17 metres [55 feet]) of the reprocessing area that has a flushing capacity of 15–20 minutes a puncture-resistant sharps container. Any instruments or sharps that are transported to the reprocessing area must be transported in a leak-proof, puncture-resistant and sealed container (e.g. plastic tray with hard plastic cover) or cassette. 29 CDHO Infection Prevention and Control (IPAC) Guidelines Cleaning Reusable Dental Instruments/Devices Cleaning is the removal of gross debris, organic and inorganic matter including blood and saliva. The following criteria must be incorporated into cleaning routines: Instruments must be pre-cleaned of gross debris immediately after use at chair side to ensure that organic material will not dry on them. If cleaning cannot be performed immediately, instruments must be kept moist and placed in a puncture-resistant holding container and soaked with a detergent or an enzymatic cleaner to prevent drying of organic material. If an instrument is not cleaned, remaining organic and inorganic matter may prevent effective disinfection and sterilization. All instruments and devices must be cleaned according to manufacturers’ direction. This may include disassembly of removable parts and opening of hinges. Manual Cleaning Cleaning is achieved by manually scrubbing the instruments with a surfactant, detergent, or an enzymatic cleaner and must be done while immersed in water to minimize splashing. The brush used for scrubbing instruments must be inspected frequently and rinsed throughout the day. All brushes must be disposed or sterilized at the end of each day. Instruments must be rinsed after cleaning to remove any disinfectant, or surfactant residue. Instruments must be dried with a lint-free cloth or designated automatic dryer. Instruments must be visually inspected to ensure all organic and inorganic materials have been removed and integrity of the instruments has not been altered. To prevent injury when handling contaminated and sharp instruments, the following precautions should be taken: Using puncture-resistant utility gloves Not reaching into trays or containers that are holding sharp instruments that cannot be seen (for example, soap-filled sinks) Using a long-handled brush if manually scrubbing instruments Wearing a mask, protective-eyewear, and gown to protect from sprays, splashes and spatter. 30 CDHO Infection Prevention and Control (IPAC) Guidelines Ultrasonic Cleaner Equipment must be tested for efficacy at least weekly and preventive maintenance should be performed according to the MIFUs. Basket must not be overloaded and lid must remain on especially when in use. Instruments must be rinsed after cleaning to remove any disinfectant, or surfactant residue. Instruments must be dried with a lint-free cloth or designated automatic dryer. Instruments must be visually inspected to ensure all organic and inorganic materials have been removed and integrity of the instrument has not been altered. Detergent or enzymatic cleaning solutions must be discarded at the end of each day, or more frequently, if they become soiled or cloudy and as per the MIFU. A log of all testing and maintenance procedures must be maintained. Washer-Disinfectors Washer-disinfectors are computer-controlled units used for cleaning, disinfecting, and drying solid and hollow surgical and dental equipment. Manufacturer’s instructions must be followed for the operation, maintenance and testing of the washer-disinfector to ensure that it works properly. The cleaning and disinfecting process must be monitored regularly according to the manufacturer’s instructions and fully documented. Instruments must not be stacked or overloaded in the washer-disinfectors and devices must be disassembled if required. Instruments must be dried with a lint-free cloth if required. Instruments must be visually inspected to ensure all organic and inorganic materials have been removed and integrity of the instrument has not been altered. Disinfection Low to Intermediate Level Appropriate Personal Protective Equipment (PPE) should be worn during disinfection. An appropriate disinfectant must be selected that: o has a Drug Identification Number (DIN) from Health Canada o has efficacy for the intended use o is compatible with the material to be disinfected (as per MIFUs) o is safe for use, with minimal toxic and irritating effects to/for staff. 31 CDHO Infection Prevention and Control (IPAC) Guidelines Manufacturer’s recommendations regarding the stability and integrity of material when selecting products for disinfection must be followed (e.g. amount, dilution, contact time, safe use and disposal). High Level (Cold Soak) The use of high-level disinfectant (HLD) is highly discouraged because of its toxic vapours, special ventilation requirements, and its inability to destroy some microorganisms. Preparing and Packaging of Reusable Dental Instruments/Devices All cleaned instruments must be prepared and packaged in a manner that will maintain sterility until use. Preparing and packaging must include the following: Instruments requiring sterilization must be packed and/or wrapped according to MIFUs. Instruments must be prepared for packaging in a manner that will allow adequate air flow and steam penetration (e.g. avoid over filling packages). Hinged instruments must be packaged and processed open and unlocked. Disassembled instruments/devices must remain disassembled until use. Suitable packaging materials could include peel pouches of plastic/paper, and woven or nonwoven sterilization wrap that is compatible with the sterilization process being used. Each package must be labelled before sterilization with: o Date processed o Sterilizer used o Cycle or load number o Initials of the OHCW who packaged the instruments. Labels must be placed on the transparent side of a plastic/paper pouch or directly on the closure tape of wrapped packages, taking care not to block the breathable area of the package. Permanent soft-tipped markers that have been validated for the sterilizer should be used ensuring they do not puncture or damage the packaging. The inside contents of the package need to be labelled if instruments are not visible (e.g. in a wrapped cassette). All packages must include both external and internal chemical indicators. 32 CDHO Infection Prevention and Control (IPAC) Guidelines Please see Monitoring – Determining the Effectiveness of the Steam Sterilization Process section for requirements for physical, chemical and biological indicators on page 36. If quarantine pending BI results is not possible, evaluation of a Type 5 or 6 chemical indicator and the specific cycle physical parameters may be used to justify the release of routine loads. There are contingency plans (i.e. recall policy and procedure) in the event of reprocessing failures. 33 CDHO Infection Prevention and Control (IPAC) Guidelines Sterilization of Reusable Dental Instruments/Devices Sterilization is the killing of disease-producing microorganisms, including spores. All critical and semi- critical instruments/devices must be sterilized before use on clients. When sterilizing, ensure that: written policies and procedures are in place for the sterilization of instruments following the MIFUs. MIFUs have been validated, meaning that the instruments/devices will be effectively sterilized when written manufacturer’s instructions for sterilization are followed. validated MIFUs shall be followed when sterilizing reusable instruments/devices. In the absence of validation, evidence-based IPAC standards and guidelines should be incorporated into the sterilization process. the MIFUs for the installation, operation, cleaning and preventive maintenance of the sterilizing equipment are followed. staff involved are trained to operate sterilizers, including ongoing audits and documentation of training. all sterilizers are tested for performance using physical, chemical and biological monitors and indicators. loading of packaged items into the sterilizer must follow both the MIFUs of the sterilizer and the individual instruments/items being sterilized. temperature at which items are sterilized must follow both the MIFUs of the sterilizer and the individual instruments/items being sterilized. all sterilized instruments/items must be fully dried in the sterilizer chambers prior to unloading. when unloading items from the sterilizer, heat-resistant mitts must be used and laundered at least weekly. a record is kept of all maintenance and repairs performed on all equipment used to sterilize instruments. a log is kept of all procedures and results used to confirm proper functioning of all sterilizers (physical, chemical and biological indicators). Steam Sterilization The most common method of sterilization in a dental hygiene setting is through the use of dynamic air removal sterilizers. Pre-vacuum table-top sterilizers are recommended, however, steam flush pressure- pulse sterilizers are also acceptable for clinical office settings. All sterilization equipment used must have a Health Canada medical device licence. The cycles available on the sterilizer must be compatible with the cycles required to sterilize your instruments as per the MIFUs. 34 CDHO Infection Prevention and Control (IPAC) Guidelines Unacceptable Methods of Sterilization The following methods are NOT acceptable methods of sterilization. Dishwasher Boiling (including those with sanitizing cycles) Ultraviolet irradiation Glass bead sterilizers Chemiclave sterilizers Microwave ovens Flash Sterilization Flash sterilization, also known as immediate-use steam sterilization (IUSS), is a modification of conventional steam sterilization in which an unwrapped item is placed in an open tray or is placed in a specially designed, covered, rigid container to allow for rapid penetration of steam. Flash sterilization should only be used in urgent emergency situations where the instrument will be used immediately and no other options are available. Client scheduling and/or lack of instruments do not qualify as reasons to use flash sterilization. The following must be considered regarding the use of flash sterilization: A log is kept of all particulars when this method is used (i.e. client name, procedure and instrument used). Instruments must be clean and dry prior to sterilization. Every cycle must be monitored using the appropriate indicators. Care is taken to prevent contamination of instruments prior to use. A log must be kept of immediate-use steam sterilization including contents of the load and confirming all physical parameters were met. Equipment/devices sterilized in this manner must be noted in the patient’s chart along with the rationale. 35 CDHO Infection Prevention and Control (IPAC) Guidelines Monitoring Determining the Effectiveness of the Steam Sterilization Process Monitoring of the sterilizer must be done routinely and involves the evaluation of physical, chemical and biological parameters. Physical – Physical indicators are the gauges or displays on the sterilizer for cycle time, temperature and pressure. Newer sterilizers have the capability to print results and/or record digitally. Physical indicators must be checked and recorded for each load. Readings that indicate the required time, temperature and pressure have been reached do not ensure sterilization was successful and for this reason chemical and biological testing must also be used. However, unacceptable readings must be investigated. Chemical – Chemical indicators (CI) (internal and external) use sensitive chemicals to access physical conditions such as time, temperature and presence of steam. Chemical indicators must be used on the inside and outside of each package to show that it has undergone a sterilization cycle. The colour change alone is not enough to prove that sterilization has been achieved. External indicators are intended to indicate that the unit has been directly exposed to steam for a minimum amount of time and is used to distinguish between a processed and unprocessed package. Each package must have an externally visible Type 1 indicator. Internal indicators are intended to respond to one or more chemical or physical change. An internal CI must be placed in each package that is undergoing sterilization in the area least accessible to steam penetration. At minimum an internal Type 4 indicator must be used in each package. Classes of Chemical Indicators Type Description Common Uses Type 1: Used to differentiate processed from Responds to one or more critical process Process non-processed items variables Indicators Usually applied to the outside of packages E.g. Peel back pouches usually have a chemical indicator manufactured on the paper side of the package and chemical indicator tape is also available Type 2: Indicator is used in specific tests or To be used with dynamic air removal (pre- Specific Test procedures to evaluate sterilizer vacuum) sterilizer and must be performed each Indicator performance day the sterilizer is used Its purpose is to evaluate proper air E.g. Bowie-Dick Test removal from the sterilizer 36 CDHO Infection Prevention and Control (IPAC) Guidelines Type 3: Reacts to a single critical process Exposure control monitoring in a specific location Single Variable variable (i.e. temperature or time) Indicator Rarely used in dental settings Type 4: Indicator reacts to two or more critical May be used for process control Multi-Variable variable in the sterilization cycle Indicator E.g. Indicator strips are manufactured inside on The manufacturer specifies the the paper side of the peel back pouches conditions under which the parameters are met Type 5: Responds to all critical variables in Used as an internal CI process control Integrating the sterilization process (i.e. time, Indicator temperature, presence of steam) Responds to all critical variables in the same way that a BI responds May be used as an additional monitoring tool to release loads that do not contain implants E.g. Indicator strips Type 6: Indicator reacts to all critical variables Used as an internal CI process control Emulating (time, temperature and presence of A different Type 6 emulating indicator is required Indicator steam) for a specified sterilization for each sterilization cycle time and temperature cycle (i.e. 10 min, 18 min, 40 min) used May be used as an additional monitoring tool to release loads that do not contain implants Ontario Agency for Health Protection and Promotion (Public Health Ontario). Provincial Infectious Diseases Advisory Committee. Best practices for cleaning, disinfection and sterilization of medical equipment/devices. 3rd ed. Toronto, ON: Queen’s Printer for Ontario; May 2013. Biological – Biological indicators (BI), also known as spore tests, use viable microorganisms (e.g. spore-laden strips or vials) to test sterilizer efficacy. Spore tests are the most accepted means for monitoring sterilization because spores are the most difficult microorganisms to kill. When choosing a BI spore test, the microorganism used to test must be compatible with the sterilization process being used. For example, Geobacillus stearothermophilus is the best microorganism to use to test efficacy of steam sterilization. A passed BI indicates that live spores have been killed, and therefore, indicates that all other microorganisms have also been killed. BI testing must be done each day a sterilizer is used and with each type of cycle. Best practice is not to release items of the processed load until the results of the BI test are available. Process Challenge Devices (PCD) A process challenge device is “a test device intended to provide a challenge to the sterilization process that is equal to or greater than the challenge posed by the most difficult item routinely processed.” (1, 2) A PCD is used to confirm that a sterilizer has effectively sterilized ALL items processed in that cycle. One example of a PCD is a set of instruments with a BI spore test and a Type 5 indicator strip inserted inside the package. This package is then placed in a routine load with other instrument pouches or wrapped cassette to challenge and test the sterilization process. If these two tests show that all spores have been killed in the BI test, all critical variables have met or exceeded the performance requirements according to the Type 5 indicator results, and that all physical parameters (time, 37 CDHO Infection Prevention and Control (IPAC) Guidelines temperature and pressure) have been verified, you can be confident that the sterilization process has been effective and that the sterilizer is working properly. It is important to note that a PCD must only be used for the sterilizer type and sterilization cycle for which it is intended (2). The three types of PCDs most commonly encountered in a dental hygiene practice are: 1. Air removal/Bowie-Dick PCD test pack 2. A biological indicator PCD test pack 3. A chemical indicator PCD test pack Air Removal/Bowie-Dick PCD Test Pack If using pre-vacuum sterilizer, a Bowie-Dick PCD test pack (Type 2 CI) must be performed in an empty sterilizer at the beginning of each day it is used. The MIFUs of both the sterilizer and PCD will indicate where the test pack should be placed in the sterilizer. It is critical to confirm the type of sterilizer being used as this test is only required for pre-vacuum sterilizers. An air removal/Bowie-Dick PCD test pack can be purchased commercially and is used to assess if air has been properly evacuated and whether any air leaks are present. Once the cycle containing the test pack has passed, record the results and dispose of the test pack. For all sterilizers, follow the manufacturer’s instructions for relevant sterilization monitoring tests. Biological Indicator PCD Test Pack A BI PCD test pack is used for daily monitoring of sterilizers and is placed in the chamber with a full load of items to be sterilized. This must be completed once a day at the same time for each type of cycle (i.e. wrapped, plastics, handpieces, etc.) A BI PCD test pack can be either prepared commercially or in office. To prepare your own, consider all packages routinely sterilized and choose the one that is most challenging to sterilize. For example this could be considered a package that has the most instruments. The package must be assembled as indicated by the MIFU, with a BI spore test and a Type 5 CI strip added in the area of the package where steam would have most difficulty penetrating. The package must be sealed and labelled “PCD”. A BI PCD test pack must be placed in the area of the load that will be coolest during the cycle. To determine the coolest areas, the MIFUs must be followed. Upon cycle completion, the BI is to be removed from the PCD test pack, prepared and incubated for the recommended time as indicated by the MIFU. A control BI, from the same lot as the test indicator not processed through the sterilizer, must be prepared and incubated with the test BI; effective sterilization is indicated when the control BI yields positive results for bacterial growth while the sterilized BI yields negative results. 38 CDHO Infection Prevention and Control (IPAC) Guidelines The Type 5 CI must also be checked. If the results indicate a pass and all physical parameters have been met (time, temperature, pressure), the instruments may be released for use. Once the PCD test pack has been opened, it is no longer sterile, and therefore, all items within the PCD test pack must be repackaged with new indicators and re-sterilized. Although instruments can be released based on the results of the chemical indicator (Type 5), best practice is to quarantine the load until results of the BI are available. A log must be kept documenting the date and time of sterilization, sterilizer number, sterilizer cycle, and location of the PCD within the cycle. Once the results are available and documented, the BI may be disposed of according to the MIFU. The results of all sterilization monitoring tests must be recorded and retained for 10 years as per the CDHO Records Regulation. Biological Indicator PCD Failure In the event a BI PCD yields positive results for bacterial growth (a failed test), the OHCW should follow the steps below to ensure the client’s safety: 1. Inform the supervisor/owner of the practice. o The supervisor/owner will want to know the time and date of failure, sterilizer and load/ cycle number in question, CI results, results of physical monitoring, BI results, and any other information that may be useful in determining the problem. 2. Investigate the problem. o Review cycle parameters (physical and CI) since the last negative BI (successful test) result Discuss the possibility of errors such as overloading, failing to provide acceptable package separation, and using incorrect and/or excessive packaging material with all equipment operators. 3. Temporarily take sterilizer out of service and quarantine all instruments back to previous negative BI (successful test). 4. Retest the sterilizer with a second BI PCD test. o While waiting for the test results, the sterilizer should remain out of service. 5. If the repeat BI PCD test is negative for growth (successful test) and chemical and physical indicators demonstrate adequate processing, the sterilizer may be put back into service. o All items from the failed load must be resterilized. 6. If the repeat BI PCD test is positive for growth (failed test) and all sterilization procedures have been performed accurately, the sterilizer must remain out of service and be inspected and repaired. Prior to returning the sterilizer to service, it must be qualified with three BI PCD tests in three consecutive empty chamber cycles. All three tests must yield negative results. o Initiate recall protocol, which means all items from suspect loads dating back to the last negative BI must be recalled, to the extent possible, and reprocessed. 39 CDHO Infection Prevention and Control (IPAC) Guidelines 7. Follow the recall protocol for client notification as per policy, including consulting with your local public health unit for risk assessment and to determine if client notification is necessary. 8. Keep a recall log of all maintenance associated with a positive BI PCD test. Chemical Indicator PCD Test Pack A CI PCD test pack measures two or more variables for the area in the sterilizer in which it is placed. If the sterilizer has a printer/USB, and instruments are not quarantined, a CI PCD test pack containing a Type 5 CI must be placed in every subsequent load after the BI PCD test pack load. The remainder of the packages in the load need to have a Type 1 CI on the outside and a Type 4 CI on the inside. If the sterilizer does not have a printer/USB, plan to replace it with one that does. In the meantime, all the physical parameters (time, temperature, pressure) need to be evaluated and documented manually, and a Type 5 CI must be used in every package. The easiest way to assemble a chemical indicator test pack in office is to choose the instrument pack that is most challenging to sterilize (i.e. the package with the most instruments) and insert a CI strip (Type 5) in the area of the package where steam would have the most difficulty penetrating. The package should be sealed and labelled as a “PCD”. The CI PCD test pack should be placed in the area of the load that will be coolest during the cycle. To determine the coolest areas, the MIFUs must be followed. Once the load containing a CI PCD test pack has been sterilized, the Type 5 CI within the PCD should be evaluated for a successful pass and all physical parameters should have been met (time, temperature, pressure). Once confirmed, the instruments may be released for use. As soon as the CI PCD test pack has been opened, it is no longer sterile and therefore all items within the CI PCD test pack must be repackaged with new indicators and re-sterilized. If Instruments are quarantined and the sterilizer has a recording device (i.e. USB/printer), every package must have an external Type 1 CI and an internal Type 4 CI. CI, CI PCD and/or Physical Parameters Failures 1. Inform the supervisor/owner of the practice. o The supervisor/owner will want to know the time and date of failure, sterilizer and load/ cycle number in question, CI results, results of physical monitoring, BI results if available and any other information that may be useful in determining the problem. 2. The sterilizer should be temporarily taken out of service. 3. The cause of the failure should be investigated. 4. If the failure is confined to one load and can be immediately corrected, simply correct the problem and reprocess the load. 40 CDHO Infection Prevention and Control (IPAC) Guidelines o If a failed CI is found in one package, the contents of the package must be reprocessed before use. o If a failed CI is found in multiple packages, or if any physical parameters are not met, the entire load must be reprocessed. 5. If the failure cannot be immediately corrected, recall and reprocess all items back to the last successful load (both CI and physical parameters met). 6. If a major repair is done, requalify the sterilizer (see section below for qualifying and requalifying sterilizers). 7. Keep a log of all maintenance associated with any failed tests. Do not use any reprocessed instrument if there are any doubts about the sterility of instruments. 41 CDHO Infection Prevention and Control (IPAC) Guidelines 42 CDHO Infection Prevention and Control (IPAC) Guidelines Logging the Sterilization Process A log book must be maintained for each load sterilized. This is a key component of the recall protocol as it allows for identification of clients who may have been exposed to non-sterile instruments or equipment. The log book needs to include: 1. Date 2. Load number 3. Time cycle started 4. Cycle parameters (total time of cycle, pressure and temperature reached) 5. Load contents 6. Internal and external chemical indicator results (pass or fail) 7. Biological and chemical indicator results via BI and CI PCDs (pass or fail) Documenting a Recall Incident A recall log must be kept of all failed tests outlining the procedures for the recall of improperly reprocessed items. The following should be included: 1. Circumstances (i.e. failed tests) that prompted a recall order 2. A list of medical devices, sterilizers, loads included in the recall 3. A list of supervisors, owners or public health units that were notified of the recall 4. A list of items that were ordered for recall but not collected (i.e. those that were already used on clients) 5. The corrective actions taken to resolve the issue and procedures implemented to prevent re-occurrence 6. The client notification procedures Qualifying and Requalifying Your Sterilizer Sterilizers must be rigorously qualified on installation and requalified following disruptions to their normal activity. They must be installed according to the manufacturer’s instructions by a qualified technician and must pass three consecutive cycles with the appropriate Bowie-Dick (if required), and three BI PCDs placed in three additional empty loads. Finally, the sterilizer must be qualified with at least one full BI PCD test load, before the sterilizer can be put into routine service. A sterilizer must not be approved for use if any indicator(s) yield a failed test on any of the tests conducted for the purposes of qualifying or requalifying the sterilizer. 43 CDHO Infection Prevention and Control (IPAC) Guidelines Sterilizers must be monitored with a test load and be fully requalified annually and under the following circumstances: 1. The purchase and installation of a new sterilizer or loaner sterilizer 2. After construction or other environmental changes in the area 3. The relocation of a sterilizer 4. After the sterilizer is repaired or modified 5. After unexplained sterility failure. Storage of Reprocessed Dental Instruments / Single-Use Devices All items must be carefully handled and stored to avoid contamination through small, often undetected holes: in a clean, dry, moisture- and dust-free area (e.g. closed shelves or containers) away from high areas of traffic not under sinks as this may cause contamination. If the integrity of the package has been maintained during storage, the sterilized items remain sterile. A plastic jacket may greatly extend the shelf life of the package and should be used on muslin- or crepe- wrapped packs. The expiry dates that some manufacturers put on their packaging products must also be followed. Prior to use, sterile packages/bags must be checked to ensure that the sterility has not been compromised by: visually inspecting for discoloration, dampness, dust, soil, and tears validating CI results checking for defects in the instruments. Extremes of temperature and humidity must be avoided. Instruments/devices must always be stored at a temperature of 18°C to 23°C and humidity level of 30% to 60%. It is a standard of practice for dental hygienists to ensure that current scientifically accepted IPAC guidelines are in place and followed. Other team members may be involved in the reprocessing, but ultimately, the dental hygienist as the end user is responsible for verifying whether the equipment used on his/her client is sterilized and treatment is provided In a clean and safe environment. 44 CDHO Infection Prevention and Control (IPAC) Guidelines Environmental Cleaning Dental hygiene services should only be provided in environments that are able to support safe, quality care. When evaluating the environment, OHCWs should consider ways in which to minimize the transfer of microorganisms from soiled hands, soiled instruments or soiled environmental surfaces. When choosing finishes and furnishings for the clinical practice setting, seamless, non-porous and easy to clean items should be considered. There are two categories of environmental cleaning for clinical office settings: Public contact surfaces (low-touch surfaces) Clinical contact surfaces (high-touch surfaces) Public Contact Surfaces Generally, there is minimal risk of microorganism transmission in these areas as they typically do not come into contact with blood and saliva. Some examples of public contact surfaces include the reception area (e.g. chairs, toys, countertops, etc.), consultation rooms and business office. To minimize the risk to clients and staff, any soiled clothing (lab coats/gowns worn during treatment) and PPE must be removed after leaving treatment rooms and before entering public spaces. These areas should be cleaned daily, or more frequently, if soiled. Floors should be HEPA-filter vacuumed and/or wet mopped daily. Mop heads and buckets must be cleaned thoroughly between uses and allowed to dry completely. Mops used in clinical contact areas should not be used in public contact areas. Carpeted areas and upholstered furnishings are discouraged, however, if used, must be cleaned on a regular schedule. In the event public contact surfaces become soiled with blood or body fluids (i.e. a client vomits in the reception area), using appropriate PPE, the surfaces must be cleaned first, and then disinfected for the appropriate contact time according to the product’s MIFUs. Clinical Contact Surfaces Carpeted areas, upholstered and wood furnishings are not acceptable in treatment rooms or instrument reprocessing areas as they are difficult to clean and disinfect. Clinical contact surfaces are very likely to be contaminated with blood and body fluids through direct spray, spatter, contaminated instruments, or from the clinician’s gloved hands. 45 CDHO Infection Prevention and Control (IPAC) Guidelines High-contact surfaces include: Dental chair/switches Overhead light handle and switches Chairside computer keyboards, Radiography equipment monitors and mouse Intraoral cameras Drawer and door handles Sink and faucet handles Countertops Telephones (if in operatory) and pens Clinical contact surfaces include those high-touch surfaces that are in the immediate area of client treatment and must be cleaned of gross debris and then disinfected with a low-level disinfectant between every client and at the end of each work day. Treatment areas must be free of clutter and unnecessary supplies and equipment on counter tops in order to minimize contamination with spatter, droplets or sprays and facilitate effective disinfection. Appropriate PPE must be worn while disinfecting surfaces to prevent occupational exposure to infectious microorganisms and chemicals. Barriers Barriers should be used on high-touch surfaces that are difficult to clean and disinfect. Suitable barriers should be moisture-proof such as plastic bags or plastic sheets. Consideration should be given to using barriers on: exposure button on radiography equipment switches of low- and high-volume suctions buttons of air/water syringe computer keyboards, mouse and monitor screen headrest overhead light handle and switches radiography equipment and digital sensors intraoral cameras Barriers must be changed between clients using appropriate PPE. Areas covered by barriers should be disinfected and allowed to dry completely prior to placing a new barrier as these areas may become contaminated during treatment. Any surfaces that come into contact with blood and saliva must be readily cleaned first, and then disinfected. 46 CDHO Infection Prevention and Control (IPAC) Guidelines Waste Management Waste must be separated into biomedical waste (hazardous waste) and general office waste then disposed of in an appropriate manner to prevent the transmission of possible infections from contaminated waste. Biomedical Waste Biomedical waste requires special storage, handling and disposal according to Ontario provincial and municipal regulations. Biomedical waste must be: stored in colour-coded containers that are marked with the universal biohazard symbol released to an approved biomedical waste carrier for disposal. Blood-soaked materials (release liquid or semi-liquid blood if compressed) Blood-soaked materials must be placed in a YELLOW liner bag labelled with the universal biohazard symbol. If blood-soaked materials are to remain on site for more than four days, they must be stored in a refrigerated storage area marked “Biomedical Waste Storage Area” displaying the universal biohazard symbol. Blood-soaked materials must be released to an approved biomedical waste carrier for disposal If gauze, cotton rolls, and examination gloves do not release liquid or semi-liquid when compressed, they are considered general office waste. For more information refer to Best Management Practices for Disposal of Biomedical/ Pathological Waste in Ontario Sharps (needles, syringes with needles, scalpel blades, clinical glass, scalers and cavitron tips, etching tips, etc.) Sharps must be disposed of in a YELLOW puncture-resistant, leak-proof container specifically designed for their management and labelled with the universal biohazard symbol o Containers must not be filled beyond their designated capacity o Must only be released to an approved biomedical waste carrier for disposal. 47 CDHO Infection Prevention and Control (IPAC) Guidelines General Office Waste General office waste includes items that are no more infectious than residential waste and therefore require only careful containment and removal. Plastic bags to line garbage containers should be removed and tied when ¾ full and replaced with a new bag (do not overfill). Use waterproof containers with tight-fitting lids for storage until disposal. Environment Canada provides a reliable resource on best practice options which are clinically effective and environmentally sound in the management and disposal of dental waste materials. Flowcharts are available and provide all members of the dental community with an easy access to best practice options for the management/disposal of heavy metals, biomedical/pathological and chemical wastes with minimum impact on the environment. Disposal of Teeth Teeth can be disposed of as general office waste if they do not contain amalgam restoration. If teeth contain amalgam restorations they should be discarded according to the guidelines for mercury- containing waste. Mercury-Containing Waste Protocol Best practices for the disposal of dental amalgam and mercury wastes in Ontario are subject to provincial regulations and municipal bylaws. For more information refer to Best Management Practice Flowchart. 48 CDHO Infection Prevention and Control (IPAC) Guidelines Special Considerations Dental Unit Waterlines Dental unit waterlines (DUW) are made of narrow-bore plastic tubing that carries water to handpieces, air/water syringes, ultrasonic scalers and prophy jets. They can become heavily colonized with waterborne microorganisms, including bacteria, fungi, and protozoa by forming a biofilm on the interior surface of the waterline. However, DUW are generally not considered to be conducive environments for the colonization of bacteria commonly found in the oral cavity. Generally, high numbers of these opportunistic microorganisms are not dangerous to the general population, unless the client or OHCW is an immunocompromised susceptible host. Examples of immunocompromised susceptible hosts include OHCW or clients with HIV, persons undergoing oncology treatment or organ transplantation procedures, those with cystic fibrosis, or those with chronic bronchitis. The potential risk of infection from DUW microorganisms can be effectively reduced to counts similar to those in potable water standards by following regular waterline maintenance procedures. For offices using city water supplies: Waterline heaters must not be used, as the heat can foster the growth of microorganisms. All waterlines must be purged at the beginning of each workday by flushing them thoroughly with water for a minimum of 2 minutes. Handpieces, air/water syringe tips and ultrasonic tips must be removed prior to purging the waterlines. Handpieces using water coolant are run for a minimum of 20 seconds after each client. The handpiece is then removed for reprocessing. For offices using closed or other special water delivery systems: The MIFUs must be followed for required maintenance. OHCW should be careful not to touch the tubing with fingers or soiled gloved hands when changing the water coolant bottle, as this can easily contaminate the entire system. Manufacturer’s instructions regarding testing, maintenance and preventative maintenance of lines, anti-retraction valves and other accessories must be followed. 49 CDHO Infection Prevention and Control (IPAC) Guidelines Devices with Lumens During the sterilization process, a sterilizing agent has more difficulty penetrating dental devices with a hollow centre or lumen, than it does penetrating one with a solid centre, such as a dental mirror. Air can become trapped in the lumen and can hinder the efficacy of the sterilizing agent’s contact with the internal surface of the instrument. To safeguard against putting patients/clients at risk, the following process must be followed for cleaning of dental devices that have lumens where applicable. Cleaned with a brush as per the MIFU. Manually or mechanically flushed with a detergent solution. Final rinse with commercially prepared sterile, pyrogen-free water. Checked for obstructions and leakage. Dried with compressed air that has been filtered and dried. For devices that have small lumens, such as air/water syringes that cannot be properly cleaned as stated above, single-use devices shall be used. Dental Handpieces and Other Devices There are many different devices used in the dental office that contact mucous membranes and are attached to the air and/or waterlines of the dental unit, including: high- and low-speed handpieces prophy