Reprocessing Reusable Medical and Dental Equipment: Policy and Protocols First Nations and Inuit Health Alberta Region

Transcription

1 Reprocessing Reusable Medical and Dental Equipment: Policy and Protocols First Nations and Inuit Health Alberta Region

2 This document was prepared for First Nations and Inuit Health, Alberta Region in consultation with the Alberta Regional Infection Control Committee, Alberta First Nations and Inuit Health Nursing, and Alberta First Nations and Inuit Health Dental. The following references were used in the preparation of this document: Alberta Dental Association and College (2010). Infection prevention and control standards and risk management for dentistry. Alberta: Author. Canadian Standards Association (2004). Infection prevention and control in office-based health care and allied services (PLUS 1112). Mississauga, ON: Author. Canadian Standards Association (2006). Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results (CAN/CSA-A ). Missisauga, ON: Author. Canadian Standards Association (2008). Decontamination of reusable medical devices: A national standard of Canada (approved December 2009) (CAN/CSA-Z ). Mississauga, ON: Author. Canadian Standards Association (2009). Effective sterilization in health care facilities by the steam process (Z ). Mississauga, ON: Author. Health Canada (1998). Infection control guidelines: Hand washing, cleaning, disinfection and sterilization in health care. Retrieved from Midmark (1999). M7 Speedclave steam sterilizer: Installation and operation manual. Versailles, OH: Author. Ontario. Ministry of Health and Long-Term Care and the Provincial Infectious Diseases Advisory Committee (2010). Best practices for cleaning, disinfection and sterilization in all health care settings: February Retrieved from program/infectious/diseases/best_prac/bp_cds_2.pdf Ontario. Ministry of Health and Long-Term Care and the Provincial Infectious Diseases Advisory Committee (2010). Routine practices and additional precautions: In all health care settings. Retrieved from best_prac/bp_routine.pdf SciCan Ltd. (2008). STATIM 2000/5000 Operator s manual. Toronto, ON: Author. 3M Health Care (2003). 3M Attest 290 auto-reader: Operator s manual. St. Paul, MN: Author. Page i

3 Contents Page Section 1: Abbreviations Section 2: Definitions Section 3: Policy Section 4: Purpose Section 5: Responsibilities of Management and Health Care Personnel Section 6: Qualifications, Education, and Training Section 7: Worker Health and Safety Section 8: Single-use/Disposable Equipment Section 9: Purchasing Reusable Equipment Section 10: Required Level of Reprocessing Section 11: Reprocessing Environment Section 12: Transporting and Handling Contaminated Equipment Section 13: Cleaning Equipment Prior to Disinfection or Sterilization Section 14: Low Level Disinfection Section 15: High Level Disinfection Section 16: Steam Sterilization Section 17: Liquid Chemical Sterilization Section 18: Storage of Reprocessed Equipment Section 19: Appendices Tables: Table 10.1 Classification of Equipment and Required Level of Reprocessing Table 13.1 Cleaning Immersible Reusable Equipment using Accel WASH Cleaner Table 13.2 Cleaning Immersible Reusable Equipment using an Ultrasonic Cleaner Table 13.3 Cleaning Large and/or Non-immersible Reusable Equipment using Accel WASH or Accel TB Wipes Table 14.1 Low Level Disinfection of Reusable Equipment using Accel TB Wipes Table 15.1 High Level Disinfection of Reusable Equipment using Accel CS Table 16.1 Steam Sterilization of Reusable Equipment Table 16.2 Wrapping Reusable Equipment for Steam Sterilization Table 16.3 Loading Sterilizer Racks Table 16.4 Sterilizing Loads using Midmark 7 SpeedClave Page ii

4 Table 16.5 Sterilizing Loads using Statim 2000 Steam Sterilizer Table 16.6 Incubating Attest 1261P Biological Indicator Table 16.7 Incubating 1291 Rapid Readout Biological Indicator Table 16.8 Failed Biological Indicator Protocol Table 17.1 Liquid Chemical Sterilization of Reusable Equipment using Accel CS Page iii

5 Section 1: Abbreviations CSA Canadian Standards Association FNIH First Nations and Inuit Health MSDS Material safety data sheet PPE Personal protective equipment Page 1-1

6 Section 2: Definitions Bioburden a population of viable micro-organisms on a raw material, component, finished product, and/or package. Biological indicator a test system containing viable micro-organisms providing a defined resistance to a specified sterilization process. Chemical indicator a system that reveals a change in one or more predefined process variables based on a chemical or physical change resulting from exposure to a process. Cleaning the physical removal of foreign material and organic material. Cleaning physically removes rather than kills microorganisms. It is accomplished with water, detergents and mechanical action. Contact time the specified amount of time a chemical must remain in contact with equipment for the chemical to be effective. Critical equipment Equipment that enters sterile tissues, including the vascular system (biopsy forceps, foot care equipment, dental hand pieces, etc.). Critical equipment presents a high risk of infection if the equipment is contaminated with any microorganisms, including bacterial spores. Reprocessing critical equipment involves meticulous cleaning followed by sterilization. Decontamination the process of cleaning, followed by the inactivation of pathogenic micro-organisms, in order to render an object safe for handling. Degassing the removal of unwanted gas from the cleaning solution in an ultrasonic cleaner. Detergent a synthetic cleansing agent that can emulsify oil and suspend soil. Disinfection a process that kills most disease-producing micro-organisms, but rarely kills all spores. Levels of disinfection include: high, intermediate, and low. Exposure time the time for which the sterilizer chamber is maintained within the specified range for temperature, sterilant concentration, pressure, and relative humidity. Equipment any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, intended by the manufacturer to be used for human beings for the purpose of client care. Immersible able to be dipped or lowered into a liquid until covered by it without damage Liquid-resistant the characteristic of fabrics that offer limited protection against the spraying of fluids. Liquid under pressure will pass through such garments. Low-level disinfection level of disinfection required when processing non-invasive equipment (noncritical equipment) and some environmental surfaces. Equipment and surfaces must be thoroughly cleaned prior to low-level disinfection. Lumen the cavity within a tubular structure. Management may include FNIH managers, health directors, and/or nurses-in-charge. Manufacturer s instructions the written directions provided by the manufacturer or distributor of a product that contain the necessary information for the safe and effective use of the product. Micro-organisms living organisms of microscopic size (bacteria, fungi, viruses, and bacterial spores). Page 2-1

7 Minimum effective concentration the minimum concentration of a chemical required for the chemical to be effective. Non-critical equipment equipment that either touches only intact skins (but not mucous membranes) or does not directly touch the client. Reprocessing of non-critical equipment involves cleaning and may also require low-level disinfection (blood pressure cuffs, stethoscopes, etc.). Non-immersible not able to be dipped or lowered into a liquid until covered by it without damage One-way workflow the practice of ensuring that reprocessing work flows in one direction, from the dirtiest to cleanest. One-way workflow ensures that each level of reprocessing including cleaning, disinfection, and sterilization, incrementally reduces the microbial load on equipment being reprocessed and reduces the likelihood of recontamination. Packaging a step in the sterilization process in which equipment is enclosed in materials or a container designed to allow the penetration and removal of the sterilant during sterilization and protect the device from contamination and other damage following sterilization and until the time of use. Personal protective equipment specialized clothing or equipment worn by personnel for protection against hazards. Reprocessing the steps performed to prepare used equipment for reuse. Reusable equipment equipment that has been designed by the manufacturer, through the selection of materials and/or components, to be reused. Reusable equipment in this document refers both to reusable medical equipment and reusable dental equipment. Routine infection prevention and control practices the approach to infection control in which all human blood and body fluids are treated as if infectious. All equipment received for reprocessing are considered potentially infectious. Semi-critical equipment medical equipment that comes in contact with non-intact skin or mucous membranes but ordinarily does not penetrate them (specula, CPR masks etc.). Reprocessing semicritical equipment involves meticulous cleaning followed by, at a minimum, high level disinfection. Single-use/disposable equipment designated by the manufacturer for one time use. Steam sterilizer a sterilizing apparatus that uses saturated steam under pressure as the sterilant. Sterilant a chemical used on equipment which results in sterilization of the equipment. Sterile free from viable micro-organisms. Sterilization a validated process used to render a product free from viable micro-organisms. (Note: the presence of micro-organisms on equipment can be expressed in terms of probability, while this probability can be reduced to a very low number, it can never be reduced to zero.) Ultrasonic cleaner a machine that cleans equipment by the formation of gas bubbles produced by ultrasound waves. Page 2-2

8 Section 3: Policy A signed copy of the Reprocessing Reusable Medical and Dental Equipment policy can be located in the Alberta Region, First Nations & Inuit Health - Nursing Policy Manual or the Dental Therapist Employee Handbook, Alberta Region. Policy: First Nations and Inuit Health (FNIH), Alberta Region is committed to ensuring the health and safety of all clients and providing a safe and healthy work environment for all staff. Policy Rationale: The purpose of the Reprocessing Reusable Medical and Dental Equipment policy is to ensure effective reprocessing of all reusable equipment, eliminating the risk of transmission of pathogens between clients, and between clients and staff, and to ensure client and worker safety. This policy does not apply to medical or dental equipment with lumens or one-time use/disposable equipment. Policy Details: This commitment includes the development and implementation of a protocol for reprocessing reusable medical and dental equipment in order to ensure clean and sterile supplies are available for client care. This protocol is intended to provide best practice in situations where cleaning, disinfection, and sterilization of reusable medical or dental equipment is required. Process Guidelines: 1. Personnel a. Personnel who are responsible for reprocessing reusable medical or dental equipment shall review policies and procedures related to reprocessing reusable equipment. b. Personnel reprocessing medical or dental equipment shall be knowledgeable of the policies, protocols, and responsibilities for reprocessing reusable equipment. c. Personnel are responsible for ensuring that they feel confident and competent in accepting and being accountable for reprocessing reusable medical or dental equipment. d. Personnel reprocessing reusable medical or dental equipment shall adhere to policies and protocols related to reprocessing reusable equipment. 2. Reusable equipment a. The medical or dental equipment being reprocessed must be designed by the manufacturer to be reused. b. Manufacturer s instructions for reprocessing the reusable medical or dental equipment must be followed and kept on file. c. All reusable medical and dental equipment shall be reprocessed according to protocols outlined in Reprocessing Reusable Medical and Dental Equipment: Policy and Protocols. 3. Chemicals a. Chemicals used to reprocess reusable medical and dental equipment must be appropriate, according to both the equipment and chemical manufacturer s instructions, for the reprocessing task being performed. b. The manufacturer s instructions for preparation, usage, and storage for the chemicals shall be followed. Page 3-1

9 4. Personal protective equipment a. Personnel are responsible for adhering to the use of appropriate personal protective equipment, as recommended by the chemical manufacturer s instructions or Reprocessing Reusable Medical Equipment: Policy and Protocols, when cleaning, disinfecting, or sterilizing reusable medical or dental equipment. Page 3-2

10 Section 4: Purpose First Nations and Inuit Health (FNIH), Alberta Region is committed to ensuring the health and safety of all clients and providing a safe and healthy work environment for all staff. This commitment includes the development and implementation of a protocol for reprocessing reusable medical and dental equipment in order to ensure clean and sterile supplies are available for client care. This protocol is intended to provide best practice in situations where cleaning, disinfection, and sterilization of reusable medical or dental equipment is required. This document outlines the protocols for reprocessing reusable medical and dental equipment and provides detailed procedures for key processes. It is intended to be used by all personnel involved in reprocessing reusable medical or dental equipment to guide their practice, and by management to clarify responsibilities for these processes. This document does not cover the reprocessing of medical or dental equipment with lumens or single-use/disposable medical or dental equipment. This protocol has been developed in accordance with available evidence, following the standards set out by Health Canada, Canadian Standards Association (CSA), and Alberta Dental Association and College, in consultation with the FNIH Alberta Regional Infection Control Committee, FNIH Nursing, and FNIH Dental. This protocol is subject to yearly review. Note: From this point forward, the term reusable equipment will be used to make reference to both reusable medical equipment and reusable dental equipment. Page 4-1

11 Section 5: Responsibilities of Management and Health Care Personnel 5.1 Management may include: FNIH managers, health directors, and/or nurses-in-charge. 5.2 Health care personnel may include: nurses, health care aides, community health representatives, dental therapists, and/or others who reprocess or use reprocessed reusable equipment in caring for clients. 5.3 Management is responsible to: a) ensure policies and protocols are in keeping with current standards, b) review and update policies and protocols yearly, c) audit practices once per year and institute quality improvement programs if deficiencies are noted d) provide education and training as outlined in the policy and protocols, e) ensure that personal protective equipment (PPE) is available to staff and that occupational safety measures are in place, f) ensure that all client care equipment available through the Drug Distribution Centre intended for reuse is capable of being cleaned, disinfected and/or sterilized according to the manufacturer s instructions, g) make available appropriate and effective materials and devices for equipment reprocessing procedures, h) act when made aware of any potential risk to client or worker safety, i) maintain registration of sterilizers for warranty and recall purposes, j) arrange for professional preventative maintenance of reprocessing equipment, and k) retain records of processes, monitoring, and maintenance for 3 years. 5.4 Health care personnel are responsible to: a) read and understand reprocessing policies and protocols, b) act in accordance with policies and protocols, c) act only within the scope of their training and expertise, d) complete documentation as outlined in policy, protocols, and procedures, e) report to supervisor when policies and protocols have not been followed, f) identify and report procedures, situations, or conditions that could endanger client or staff safety to supervisor, and g) wear PPE that is specified in the protocols. Page 5-1

12 Section 6: Qualification, Education, and Training 6.1 All aspects of reprocessing reusable equipment shall be performed by knowledgeable, trained personnel. 6.2 Personnel who will be involved in reprocessing reusable equipment must receive a review, either in person or electronically, on the document Reprocessing Reusable Medical and Dental Equipment: Policy and Protocols prior to performing any reprocessing tasks. This review may occur: a) when first employed, b) at an annual review, c) when an authorized change in process occurs, or d) when new reprocessing equipment or reusable equipment requiring reprocessing are purchased. 6.3 Personnel involved in reprocessing reusable equipment must review the document Reprocessing Reusable Medical and Dental Equipment: Policy and Protocols on a yearly basis. 6.4 Health directors and/or nurses-in-charge are to record the dates of initial and yearly reviews of the document Reprocessing Reusable Medical and Dental Equipment: Policy and Protocols by personnel. A form, Record of Review, can be found in the Appendices section to assist with this process. 6.5 Personnel directly involved in reprocessing must be knowledgeable and/or trained in: a) routine practices, b) the correct use and requirements to wear PPE, c) hand hygiene, d) the management of blood and body fluid spills, and e) pertinent Material Safety Data Sheets (MSDS). 6.6 If the reprocessing of reusable equipment is being performed by an external contractor, the contractor will be required, at minimum, to conform to this document. Health centre management can request from the external contractor documentation showing proof of compliance to these standards. Page 6-1

13 Section 7: Worker Health and Safety 7.1 Routine infection prevention and control practices shall be adhered to. 7.2 Sharps shall be handled appropriately. 7.3 Chemicals shall be stored and handled per manufacturer s instructions. MSDS documentation shall be accessible to, and reviewed by, all reprocessing personnel. 7.4 Ventilation shall be addressed if chemicals with toxic vapours are present. 7.5 Eating, drinking, storing food, smoking, applying cosmetics (including lip balm), and handling contact lenses is prohibited in the reprocessing area. 7.6 Personnel must not wear hand or arm jewellery, or nail enhancements while reprocessing reusable equipment. 7.7 Personnel must wear PPE appropriate to the task being performed, as identified by the chemical manufacturer or the Reprocessing Reusable Medical and Dental Equipment: Policy and Protocols document, when cleaning, disinfecting, or sterilizing reusable equipment. a) Gloves must be worn when in contact with equipment or environmental surfaces that may be contaminated with blood, body fluids, secretions, or excretions from mucous membranes or non-intact skin. Utility gloves must be long enough to cover wrists and forearms, of sufficient weight to be highly tear-resistant, and allow adequate dexterity of the fingers. Disposable utility gloves are recommended. If reusable utility gloves are used, they must be decontaminated after use, inspected for tears or holes, and be staff-specific. Examination gloves worn for reprocessing must be disposed of after use. b) A gown or apron appropriate to the task being performed must be worn when it is anticipated that a procedure is likely to generate splashes. Long sleeved gowns will protect personnel s clothing and forearms from splashes. Plastic aprons will provide a impermeable barrier. c) Eye protection must be used when it is anticipated that a procedure is likely to generate a splash or spray. A full-face shield, goggles, or safety glasses will protect mucous membranes of the eyes. Prescription eye glasses alone are not acceptable as eye protection. 7.8 Donning and removing of PPE procedures must be done in a sequence which reduces the transmission of organisms. a) To put on PPE: perform hand hygiene, put on gown, put on mask, put on eye protection, put on gloves. b) To remove PPE: remove gloves, remove gown, perform hand hygiene, remove eye protection, remove mask, and then perform hand hygiene. 7.9 For worker protection, it is recommended that personnel reprocessing reusable equipment be immune to Hepatitis B or receive the Hepatitis B immunization series Copies of MSDS for all chemicals used during reprocessing reusable equipment will be placed in Section 19, Appendices Personnel at any stage of pregnancy should review safety information on chemical containers and the MSDS to determine if teratogenic effects are possible, and to avoid exposure if the possibility exists Staff members with a documented anaphylaxis or severe allergic reaction to the chemicals used to reprocess reusable equipment shall not be involved in reprocessing An eyewash station must be present in the immediate area for personnel to use. Page 7-1

14 Section 8: Single-Use/Disposable Equipment 8.1 Single-use/disposable equipment must be discarded after use and cannot be reprocessed. 8.2 Single-use/disposable equipment bears this symbol: 8.3 Sharps- including needles, lancets, blades and glass- cannot be reprocessed due to the occupational hazard they pose to personnel. Furthermore, reprocessing needles endangers clients, as there is no effective way to clean the lumen of the needle. 8.4 Single-use disposable equipment should be used whenever possible. Page 8-1

15 Section 9: Purchasing Reusable Equipment 9.1 It is management s responsibility to verify that any product used in the provision of care to clients is capable of being cleaned, disinfected and/or sterilized according to the most current standards and guidelines from the CSA and Health Canada. 9.2 Equipment or chemical products that are used to clean, disinfect or sterilize must meet standards established by Health Canada. When purchasing reprocessing equipment or chemical products, consideration must be given to occupation health requirements, client safety, and environmental safety issues. 9.3 Newly purchased reusable equipment must be inspected and reprocessed according to the required level of reprocessing and manufacturer s instructions, prior to use on a client. Page 9-1

16 Section 10: Required Level of Reprocessing 10.1 Reusable equipment, that is, equipment that has been designed by the manufacturer to be used more than once, must be reprocessed at minimum between clients, and sometimes between uses All reusable equipment used in client care shall be kept in proper working condition and must be reprocessed according to the classification of the equipment and the minimum level of reprocessing required for that specific piece of equipment, prior to using on another client The appropriate level of reprocessing for reusable equipment shall be determined by the manufacturer s instructions and by following Spaulding's Classification of Medical Equipment/Devices and Required Level of Processing/Reprocessing. See Table 10.1: Classification of Equipment and Required Level of Reprocessing on the following page to determine the level of disinfection or sterilization required following the cleaning process. Page 10-1

17 Table 10.1: Classification of Equipment and Required Level of Reprocessing Classification of Equipment Examples of Equipment Minimum Level of Reprocessing Required: Noncritical equipment: Equipment that touches only intact skin and not mucous membranes, or does not directly touch the client. Bed pans, urinals, commodes Stethoscopes Blood pressure cuffs Oximeters Glucose meters Electronic thermometers ECG machines/leads/cups etc. Baby scales Environmental surfaces (e.g. wheelchairs, beds) Examination tables Dental chairs Hand mirrors Cleaning* followed by Low-Level Disinfection Low-level disinfectants kill most vegetative bacteria and some fungi as well as enveloped (lipid) viruses. Low-level disinfectants do not kill mycobacteria or bacterial spores. Low-level disinfection is required when processing noncritical equipment or some environmental surfaces. Semicritical equipment: Equipment that comes in contact with non-intact skin or mucous membranes but does not penetrate them. Specula - nasal, anal, vaginal (disposable equipment is strongly recommended) Diaphragm fitting rings Alligator forceps Ear cleaning equipment, ear syringe nozzles, ear curettes, otoscope tips Fingernail care equipment used on multiple clients Nebulizer cups CPR face masks Cleaning* followed by High-Level Disinfection High-level disinfection destroys vegetative bacteria, mycobacteria, fungi and enveloped (lipid) and nonenveloped (non-lipid) viruses, but not necessarily bacterial spores. Critical equipment: Equipment that enters sterile tissues, including the vascular system. Surgical instruments Foot care equipment Fish hook cutters Dental equipment including dental hand pieces Cleaning* followed by Sterilization Sterilization results in the destruction of all forms of microbial life including bacteria, viruses, spores and fungi. Steam sterilization or liquid chemical sterilization may be appropriate. *Cleaning is the physical removal of soil, dust, or foreign material, and usually involves water and soap, detergent, or an enzymatic cleaner. The cleaning process must occur before disinfection or sterilization is done. See Section 13, Table 13.1: Cleaning Immersible Reusable Equipment using Accel WASH Cleaner, Table 13.2: Cleaning Immersible Reusable Equipment using an Ultrasonic Cleaner, or Table 13.3: Cleaning Large and/or Non-immersible Reusable Equipment using Accel WASH or Accel TB Wipes. Table adapted from: Ontario. Ministry of Health and Long-Term Care and the Provincial Infectious Diseases Advisory Committee (2010). Best practices for cleaning, disinfection and sterilization in all health care settings: February Available at infectious/ diseases/best_prac/bp_cds_2.pdf Page 10-2

18 Section 11: REPROCESSING ENVIRONMENT 11.1 Ideally, there should be a designated area used solely for reprocessing During reprocessing, the reprocessing work area should have restricted access. Doors to reprocessing areas should be kept closed, at minimum during the cleaning process, but preferably at all times Ideally, the reprocessing work area should be separated by walls or partitions to control traffic flow and contaminants generated during reprocessing If physical separation of decontamination areas from clean areas is not possible in an existing facility, spatial separation may be used if accompanied by good work flow patterns and good work practices Reprocessing work flow should occur in one direction, from the dirtiest to cleanest. One-way workflow ensures that each level of reprocessing including cleaning, disinfection, and sterilization, incrementally reduces the microbial load on equipment being reprocessed and reduces the likelihood of recontamination Ideally, the reprocessing environment has a sink designated as a decontamination sink which is not to be used for hand washing or any other purposes. If a separate decontamination sink is not available, disinfection to the sink and surrounding counter and wall area must occur immediately following reprocessing Packaging of equipment prior to sterilizing should not occur in soiled areas Storing food, drink, or personal items in reprocessing area is prohibited Work surfaces must be constructed of materials that are smooth, impervious, and easy to clean. Surfaces should be kept clear to facilitate regular cleaning with disinfectants The area immediately surrounding the reprocessing area must be disinfected following reprocessing Hand mopping of the floor with a clean mop head, clean fresh water, and detergent should be done following reprocessing. Spills must be cleaned up immediately Clean reprocessing supplies and PPE must be stored in a separate area from soiled items and the soiled area. Page 11-1

19 Section 12: Transporting and Handling Contaminated Equipment 12.1 Sharps shall be disposed of in an appropriate puncture-resistant container at point of use, prior to transportation Visible organic material should be removed from the equipment immediately following use If the cleaning of the reusable equipment cannot be done immediately, the equipment must be submerged in diluted Accel Wash cleaner (1 oz Accel Wash to 16 cups water) or placed in a container with a damp cloth to prevent organic material from drying and adhering to it Equipment that has been used must be handled in a manner that reduces the risk of exposure or injury to personnel and clients, or the contamination of environmental surfaces Used equipment must be transported in closed/covered carts or covered containers that are easily cleaned. These carts/containers should be transported by the most direct route to the reprocessing area, and must be cleaned after each use Contaminated equipment must be transported in a separate container than reprocessed equipment. A system must be in place to differentiate reprocessed equipment from equipment that has not been reprocessed (e.g. colour coding). Page 12-1

20 Section 13: Cleaning Equipment prior to Disinfection or Sterilization 13.1 Cleaning physically removes contaminants (e.g. blood, body fluids, dirt) from equipment. Adequate cleaning of equipment is essential because contaminants will furnish a medium for the growth of micro-organisms and can also make the sterilization or disinfection process more difficult As identified in Section 10, all reusable equipment must be thoroughly cleaned between clients and prior to disinfection or sterilization Cleaning must occur even if foreign material is not visible Cleaning may be done manually (by hand) or mechanically (using an ultrasonic cleaner) Manufacturer s instructions for the reusable equipment being cleaned must be followed Equipment must be maintained in good working condition and routinely inspected to ensure suitability for reprocessing Gross contaminants must be removed from equipment prior to the manual or mechanical cleaning processes Brushes and/or cloths used for manual cleaning: a. shall be used to assist when with removing soil; b. will be inspected and discarded if damaged; and c. will be cleaned and dried in between uses if reusable Detergent-based products can facilitate the soaking and cleaning process more effectively than using water alone Cleaning of immersible equipment (foot care equipment, scissors, forceps, etc.) must include: sorting, soaking, washing, rinsing, drying, inspecting, and lubricating Whenever possible, grossly contaminated large non-immersible equipment (commodes, etc.) should be cleaned in a contained cleaning area (janitor sink, shower stall, etc.). The contained cleaning area shall be cleaned following the removal of the equipment The following guideline, Table 13.1: Cleaning Immersible Reusable Equipment using Accel WASH Cleaner, will be used for the manual cleaning of immersible reusable equipment (scissors, foot care equipment, forceps, etc). It is specific to the cleaning product Accel WASH The following guideline, Table 13.3: Cleaning Large and/or Non-immersible Reusable Equipment using Accel WASH or Accel TB Wipes will be used for cleaning large and/or non- immersible reusable equipment (commodes, blood pressure cuffs, baby weigh scales, etc). It is specific to Accel WASH cleaner and Accel TB wipes. Ultrasonic Cleaners Ultrasonic cleaners may be used to clean equipment. Ultrasonic cleaners produce sound waves which cause the formation of millions of microscopic bubbles which collapse on impact with the equipment, releasing energy to blast away the soil accumulated on the equipment being cleaned. This process is called cavitation. Page 13-1

21 13.15 If an ultrasonic cleaning device is used for cleaning equipment: a. it must be CSA approved, b. manufacturer s instructions must be followed, and c. it must be compatible with the equipment being cleaned Ultrasonic cleaners shall be located in the decontamination area of the reprocessing environment Gross soil shall be removed from the equipment before ultrasonic cleaning is performed, as heavy soiling interferes with the ultrasonic cavitation process The manufacturer s instructions with regard to the detergent used for ultrasonic cleaning solutions shall be followed Detergents, disinfectants, or chemical additives used with the mechanical washer shall be compatible with the washer, devices being cleaned, and the types of residual solid to be removed The cleaning solution in the ultrasonic cleaner must be degassed prior to use. See Table 13.2: Cleaning Immersible Reusable Equipment using an Ultrasonic Cleaner, Section 3 d Equipment being washed in an ultrasonic cleaner must be fully immersed in the cleaning solution The lid of the ultrasonic cleaner shall be closed during storage and operation to prevent splashing and to minimize aerosols and evaporation The following guideline, Table 13.2: Cleaning Immersible Reusable Equipment using an Ultrasonic Cleaner will be used for mechanical cleaning of immersible reusable equipment (scissors, foot care equipment, forceps, etc.) with an ultrasonic cleaner The manufacturer s instructions with regard to the maintenance of the ultrasonic cleaner shall be followed The ultrasonic cleaner shall be tested for cleaning efficiency, at minimum once per month, by completing a foil test : a. Degas a tank of fresh cleaning solution (See item 3.d. in Table 13.2: Cleaning Immersible Reusable Equipment using an Ultrasonic Cleaner). b. Use scissors to cut a piece of lightweight household aluminum foil to size: a little shorter than the length of the solution tank X a little longer than the depth of the solution tank. c. Dip the piece of aluminum foil into the solution tank keeping it parallel to the sides. Do not touch the bottom or the sides of the solution tank with the aluminum foil. d. Turn on the ultrasonic cleaner. Do not turn on heater. e. Hold the aluminum foil as steady as possible in the center of the ultrasonic cleaner for 20 seconds. f. Turn off the ultrasonic cleaner. Remove the aluminum foil sample. g. The aluminum foil surface will be uniformly perforated over the entire surface if the ultrasonic cleaner is working correctly. h. If areas greater than ½ inch (1.25 cm) square are not perforated, retest the unit. If the retest also shows areas greater than ½ inch (1.25 cm) square are not perforated, the ultrasonic cleaner should be removed from service and sent for repair. i. Record results on the Ultrasonic Cleaner Maintenance form Daily degassing of the cleaning solution and monthly foil tests will be recorded on the Ultrasonic Cleaner Maintenance form. Page 13-2

22 Table 13.1: Cleaning Immersible Reusable Equipment using Accel WASH Cleaner Gather equipment: Preparation for process. Accel WASH cleaner Medicine cup and/or measuring cup Clean container/basin/sink Note: Accel WASH cleaner should not be used with chlorinated (bleach) products. Utility gloves Eye protection (glasses, goggles, or face shield) Liquid resistant gown or apron Soft bristled brush/cloth Forceps/tongs Lint-free disposable absorbent towels 1. Sorting Sorting keeps sets together and streamlines the cleaning process. a. Wash hands. Put on PPE: gown or apron, eye protection (glasses, goggles, or face shield), and then utility gloves. b. Sort equipment if needed. Identify sharps. Separates sharps. Prevents accidental exposure to chemicals and prevents contamination of clothes. c. Open all equipment and disassemble, if Facilitates access of the cleaning agent. applicable (scissors, nippers, clippers). d. Remove gross contaminants with paper towel Reduces bioburden in solution. or gloved hand. 2. Soaking Soaking prevents soil from drying on equipment, making them easier to clean. a. Soaking may be done in a sink for larger items or a container/basin for smaller items. b. Mix Accel WASH cleaner according to manufacturer s directions: 1 part Accel WASH to 128 parts potable tepid water (1 oz Accel WASH to 16 cups water). Do not use hot water. c. Entirely submerge immersible equipment in the cleaning solution for 3-5 minutes. Too little chemical will not properly clean the equipment, and too much chemical may make it difficult to rinse off. Hot water will coagulate protein making it more difficult to remove. Softens residue, making the device easier to clean. d. Avoid soaking equipment for longer time May damage equipment. periods. Do not soak over night. 3. Washing Washing is the physical removal of organic material. The detergent will lower surface tension of soil on the equipment, allowing it to penetrate, surround, and suspend the soil in the cleaning solution. a. Individually scrub each piece of equipment with a soft bristled brush or cloth. b. Keep the brush and equipment to be cleaned under the surface of the water while scrubbing. c. Clean all surfaces with particular attention to hinges, crevices, serrations, jaws and teeth. d. When cleaning heavily soiled items or a large number of items, change cleaning solution frequently. Friction assists with removal of organic matter. Minimizes the production of aerosols. These areas collect organic matter more easily. Avoids recontamination of equipment due to high bioburden in cleaning solution. (continued next page) Page 13-3

23 Table 13.1: Cleaning Immersible Reusable Equipment using Accel WASH Cleaner e. Discard brushes, or wash brushes in the Prevents transferring contaminants. cleaning solution. Wash gloved hands in cleaning solution. f. Empty detergent from container or sink. Rinse container or sink with tap water to remove Prepares container/sink and gloves for rinse process. cleaning solution and soil. Rinse gloved hands. 4. Rinsing Rinsing is required to remove excess detergent which may neutralize or react with the disinfectant/sterilant. a. Fill rinsed container or sink that was used for cleaning with tepid potable tap water. b. Place equipment into rinse water. c. Submerge equipment in the rinse water for one minute. Drain water. Repeat rinses two more times, changing water between rinses. The first rinse removes detergent and soil, the second to ensure complete cleanliness, and the third to prevent spotting. 5. Drying Drying is an important step. Drying inhibits microbial growth and prevents dilution of liquid chemical disinfectants/sterilants, if used, which may render them ineffective. a. Dry equipment. To air dry, place equipment in the open position on a lint-free disposable absorbent towel. To dry by hand, use a separate lint-free absorbent towel to wipe down each piece of equipment. Equipment must be dry prior to storage or further reprocessing. Prevents corrosion of equipment. Drying stainless steel by hand immediately will reduce water spots. Note: extended exposure to open air increases possibility of recontamination. b. Remove PPE: gloves, gown, wash hands, eye protection, wash hands. 6. Inspecting Equipment is inspected to ensure cleanliness and integrity (cracks, defects, foreign matter, etc.). a. Inspect equipment for cleanliness. Re-clean any equipment that is not free from foreign matter. b. Inspect equipment for imperfections: chips, inappropriate sharp edges, worn spots, cracked rubber or plastic, or loose hinges. Discard defective equipment appropriately. c. Equipment shall not be reassembled prior to disinfection/sterilization, unless specified in the manufacturer s instructions Soil remaining on equipment may prevent disinfectant/sterilant from reaching the surface or be transferred to the client. Ensures integrity of equipment. Client safety. Facilitates access of the disinfecting or sterilizing agent. (continued next page) Page 13-4

24 Table 13.1: Cleaning Immersible Reusable Equipment using Accel WASH Cleaner 7. Lubricating Equipment may become stiff or seized up if lubricant is removed during the cleaning process. a. Review manufacturer s instructions for equipment to determine the type and quantity of lubricant to use. Ensures proper lubrication. Equipment is now considered clean. Review Table 10.1: Classification of Equipment and Required Level of Reprocessing in Section 10 to determine if low-level, high-level, or sterilization of the equipment is also required. Page 13-5

25 Table 13.2: Cleaning Immersible Reusable Equipment using an Ultrasonic Cleaner Gather equipment: Preparation for process. Ultrasonic cleaner Two (2) Clean & Simple tablets or previously prepared solution in ultrasonic cleaner Utility gloves Eye protection (glasses, goggles, or face shield) Liquid resistant gown or apron Lint-free disposable absorbent towels 1. Sorting Sorting keeps sets together and streamlines the cleaning process. a. Wash hands. Put on PPE: gown or apron, eye protection (glasses, goggles, or face shield), and then utility gloves. b. Sort equipment if needed. Identify sharps. Separates sharps. Prevents accidental exposure to chemicals and prevents contamination of clothes. c. Open all equipment and disassemble, if Facilitates access of the cleaning agent. applicable. d. Remove gross contaminants with paper towel Reduces bioburden in solution. or gloved hand. 2. Soaking Soaking prevents soil from drying on equipment, making them easier to clean. a. Soaking may be done in a sink for larger items or a container/basin for smaller items. b. Use water, or a moist towel to keep equipment moist until washing can be completed. Softens residue, making the device easier to clean. 3. Washing with Ultrasonic Cleaner Washing is the physical removal of organic material. a. Remove lid from ultrasonic cleaner, obtain the basket or perforated tray. b. Place equipment into the basket or perforated tray for the ultrasonic equipment. c. Check solution level in the ultrasonic cleaner: Cleaning solution must be changed daily or when visibly soiled. Solution level must be maintained at 1 to 1.5 from the upper edge. Contaminated solution will reduce the ultrasonic cleaner s ability to clean effectively. Ensures sufficient amount of cleaning solution to cover equipment to perform cleaning. (continued next page) Page 13-6

26 Table 13.2: Cleaning Immersible Reusable Equipment using an Ultrasonic Cleaner d. If solution is to be changed or when preparing the ultrasonic cleaner for use with new solution: Fill ultrasonic cleaner tank with water. Degassing removes bubbles that interfere with the cleaning process of the cleaning solution. Add two (2) Clean & Simple tablets. Allow tablets to dissolve. Place the cover on the empty ultrasonic cleaner. Degas the solution: Adjust the timer to the amount of time indicated in manufacturer s instructions. Press the START key. Allow the ultrasonic cleaner to complete the degassing period. Degassing is complete when small bubbles can no longer be seen rising to the surface. Solution is now ready to use e. Slowly lower basket or perforated tray with Prepares for washing. equipment to be washed into the ultrasonic cleaner. f. Place lid on ultrasonic cleaner. Prevents splashes and minimizes aerosols and g. Set timer for time recommended in manufacturer s instructions for the cleaning process. Allow cycle to run through. evaporation. Cleans equipment. 4. Rinsing Rinsing is required to remove excess detergent which may neutralize or react with the disinfectant/sterilant. a. Fill rinsed container or sink with tepid potable tap water. b. Place equipment into rinse water. c. Submerge equipment in the rinse water for one minute. Drain water. Repeat rinses two more times, changing water between rinses. The first rinse removes detergent and soil, the second to ensure complete cleanliness, and the third to prevent spotting. 5. Drying Drying is an important step. Drying inhibits microbial growth and prevents dilution of liquid chemical disinfectants/sterilants, if used, which may render them ineffective. a. Dry equipment. To air dry, place equipment in the open position on a lint-free disposable absorbent towel. To dry by hand, use a separate lint-free absorbent towel to wipe down each piece of equipment. b. Remove PPE: gloves, gown, wash hands, eye protection, wash hands. Equipment must be dry prior to storage or further reprocessing. Prevents corrosion of equipment. Drying stainless steel by hand immediately will reduce water spots. Note: extended exposure to open air increases possibility of recontamination. (continued next page) Page 13-7

27 Table 13.2: Cleaning Immersible Reusable Equipment using an Ultrasonic Cleaner 6. Inspecting Equipment is inspected to ensure cleanliness and integrity (cracks, defects, foreign matter, etc.). a. Inspect equipment for cleanliness. Re-clean any equipment that is not free from foreign matter. b. Inspect equipment for imperfections: chips, inappropriate sharp edges, worn spots, cracked rubber or plastic, or loose hinges. Discard defective equipment appropriately. c. Equipment shall not be reassembled prior to disinfection/sterilization, unless specified in the Soil remaining on equipment may prevent disinfectant/sterilant from reaching the surface or be transferred to the client. Ensures integrity of equipment. Client safety. Facilitates access of the disinfecting or sterilizing agent. manufacturer s instructions 7. Lubricating Equipment may become stiff or seized up if lubricant is removed during the cleaning process. a. Review manufacturer s instructions for equipment to determine the type and quantity of lubricant to use. Ensures proper lubrication. Equipment is now considered clean. Review Table 10.1: Classification of Equipment and Required Level of Reprocessing in Section 10 to determine if low-level, high-level, or sterilization of the equipment is also required. Page 13-8

28 Table 13.3: Cleaning Large and/or Non-immersible Reusable Equipment using Accel WASH or Accel TB Wipes Gather equipment: Accel WASH cleaner or Accel TB wipes (will be determined by the equipment being cleaned). If using Accel WASH cleaner: Medicine cup and measuring cup Container/sink Soft bristled brush/cloth Utility gloves for Accel Wash or examination gloves for Accel TB wipes Eye protection (glasses, goggles, or face shield if required) Liquid resistant gown or apron (if required) Lint-free disposable absorbent towels (if required) Preparation for process. Eye protection and gown/apron must be used when splashing possibility exists. Note: Accel WASH cleaner and Accel TB wipes should not be used with chlorinated (bleach) products. 1. Wash hands. Don PPE appropriate for task. Prevents accidental exposure to chemicals and prevents contamination of clothes. 2. Remove visible contaminants with paper towels. Reduces bioburden on equipment prior to washing. 3. Mix Accel WASH cleaner according to manufacturer s directions: 1 part Accel WASH to 128 parts potable tepid water (1 oz Accel WASH to 16 cups water). Do not use hot water. Or, obtain an Accel TB wipe, whichever is appropriate for equipment being cleaned. 4. Wash each surface of the equipment with Accel WASH or Accel TB wipe. 5. Proceed from clean to dirty surfaces, from top to bottom. Casters or surfaces in contact with the floor should be cleaned last. 6. Rinse cloth in detergent water or use new disposable wipe often. 7. If using Accel Wash, use clean water to wipe down or spray the surfaces again. Rinsing after Accel TB wipes is not required. 8. Remove PPE. Wash hands. 9. Allow equipment to air dry, or dry with lint-free disposable absorbent towels. Selection of cleaning product will be determined by manufacturer s cleaning instructions of reusable equipment. Removes soil. Prevents spread of soil. Reduces bioburden on cloth or towelette. Rinses off detergent. Drying inhibits microbial growth. Note: extended exposure to open air increases possibility of recontamination. Equipment is now considered clean. Review Table 10.1: Classification of Equipment and Required Level of Reprocessing in Section 10 to determine if additional disinfection of the equipment is also required. If no further disinfection of equipment is required, store equipment according to Storage of Reprocessed Equipment in Section 18. Page 13-9

29 13.27 If a detergent based product other than Accel Wash or Accel TB wipes is used, the following shall be considered: The detergent or pre-saturated towelettes used for soaking and/or washing must: a. be recommended for cleaning reusable equipment; b. be compatible with the equipment to be cleaned; c. be compatible with disinfection and/or sterilization processes; d. provide recommendations for rinsing (water quality, volume, time) e. be safe to use, with minimal toxic and irritating effects to/for staff; f. not compromise client safety due to use on client equipment; and g. be environmentally safe and biodegradable Manufacturer s instructions for the detergent or pre-saturated towelettes used for cleaning must be followed pertaining to: a. recommended usage b. contact time c. rinsing d. shelf life (expiry date) e. storage f. appropriate dilution or mixing (if required); and g. personal protective equipment Phenols (for example Pinesol ) must not be used to clean items used for children. Page 13-10