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Leeds, Grenville & Lanark District Health Unit
Leeds, Grenville & Lanark District Health Unit

Health Care Professionals - Infection Prevention,
and Control Guidelines for Primary Care Physicians



Infection Prevention, and Control Guidelines for Primary Care Physicians

Cleaning, Disinfection, and Sterilization of Medical Instruments

Introduction:

Appropriate cleaning, disinfection and sterilization of patient care equipment are important in limiting the transmission of organisms related to reusable patient care equipment. The reprocessing method required for a specific item will depend on the item’s intended use, the risk of infection to the patient, and the amount of soiling. The Family Health Teams will ensure that the critical elements and methods of decontamination, disinfection and sterilization are incorporated into practice procedures.

Best Practices:

Items labeled “for single-use only” must not be reused (e.g. needles, syringes, plastic vaginal specula etc.)

Classification of Medical Devices:

A classification system was developed by E.H. Spaulding. This system divides medical devices, equipment and surgical materials into three categories based on the potential risk of infection involved in their use. The three categories are critical, semi-critical and non-critical.

 

Spaulding’s Classification of Medical Equipment and Required Level of Reprocessing 

Classification Definition Level of Processing / Reprocessing
Critical Equipment

Equipment/device that enters sterile tissues, including the vascular system.

Cleaning followed by Sterilization, which completely kills all forms of microbial life including the most
resistant forms (except prions).

Semi-Critical Equipment

Equipment/device that comes in contact with non-intact skin or mucous membranes but do not penetrate them.

Cleaning followed by High Level Disinfection (as a minimum), which kills vegetative bacteria, fungi, lipid and non-lipid viruses and mycobacteria. Sterilization is preferred.

Non-Critical Equipment

Equipment/device that touches only intact skin and not mucous membranes, or does not directly touch the client/patient/resident.

Cleaning followed by Low Level Disinfection, which kills most vegetative bacteria and some fungi as well as enveloped (lipid) viruses. Low level disinfectants do not kill mycobacteria or bacterial spores .


Purchasing Medical Equipment:

  • Do not purchase medical equipment/devices that cannot be cleaned and reprocessed according to the recommended standards

  • When purchasing reprocessing equipment or chemical products for reprocessing, consideration must be given to occupational health requirements, patient safety, and environmental safety issues

  • All medical equipment intended for use on a client/patient that are being considered for purchase or will be obtained in any other way (e.g. loaned equipment/devices, trial or research equipment/devices, physician/practitioner-owned, etc.) must meet established quality reprocessing parameters

  • Newly purchased non-sterile critical and semi-critical medical equipment/devices must first be inspected and reprocessed according to their intended use

 

Education and Training:

  • All aspects of reprocessing shall be supervised and shall be performed by knowledgeable, trained personnel

  • Supervisors involved in reprocessing must, as a minimum, have completed a recognized qualification/certification course in reprocessing practices. A plan must be in place for each person involved in reprocessing to obtain this qualification within five years.


Selection of Product/Process for Reprocessing:

  • Products used for any/all stages in reprocessing (e.g. cleaning, disinfection, sterilization) must be approved by the committee (person) responsible for product selection, by an individual with reprocessing expertise and by an individual with infection prevention and control expertise (e.g. Health Unit staff with certification in infection prevention and control, Regional Infection Control Network staff)

  • The reprocessing method and products required for medical equipment will depend on the intended use of the equipment and the potential risk of infection involved in the use of the equipment

  • Products used for decontamination must be appropriate to the level of reprocessing that is required for the use of the medical equipment

  • The process and products used for cleaning, disinfection and/or sterilization of medical equipment must be compatible with the equipment

  • All medical equipment that will be purchased and will be reprocessed must have written device-specific manufacturer’s cleaning, decontamination, disinfection, wrapping and sterilization instruction. If disassembly or reassembly is required, detailed instructions with pictures must be included. Staff training must be provided on these processes before the medical equipment is placed into circulation.

 

Environmental Issues:

  • There must be a centralized area for reprocessing medical equipment/devices. Reprocessing done outside the centralized area must be kept to a minimum and must be approved by those accountable for safe reprocessing practices and must conform to the requirements for reprocessing space.

  • Wherever chemical disinfection/sterilization is performed, air quality must be monitored when using products that produce toxic vapours

 

Occupational Health and Safety Issues:

  • Occupational Health and Safety for the health care setting will review all protocols for reprocessing medical equipment to verify that worker safety measures are followed and in compliance with the Occupational Health and Safety Act, R.S.O. 1990, c.0.1 and associated Regulations including the Health Care and Residential Facilities – O. Reg. 67/93 Amended to O. Reg 631/05

  • Prohibit eating/drinking, storage of food, smoking, application of cosmetics and handling contact lenses in the reprocessing area

  • Appropriate personal protective equipment must be worn for all reprocessing activities

  • All personnel working in reprocessing must be immune to Hepatitis B or receive Hepatitis B immunization

  • Procedures shall be in place for immediate response to worker exposure to blood and body fluids

 

Transportation and Handling of Contaminated Medical Equipment/Devices:

  • Disposable sharps such as needles and blades shall be removed and disposed of in an appropriate puncture-resistant sharps container at point of use, prior to transportation

  • If cleaning cannot be done immediately, the medical equipment/device must be submerged in tepid water and/or detergent and enzymatic to prevent organic matter from drying on it

  • Soiled equipment must be handled in a manner that reduces the risk of exposure and/or injury to personnel and clients/patients, or contamination of environmental surfaces

  • A process should be in place that will ensure that medical equipment which have been reprocessed can be differentiated from equipment which have not been reprocessed (e.g. colour coding).

 

Disassembling and Cleaning Reusable Medical Equipment:

  • Reusable medical equipment must be thoroughly cleaned before disinfection or sterilization

  • Factors that affect the ability to effectively clean medical equipment must be considered prior to cleaning

  • Instruments should be cleaned as soon as possible after use to prevent organic material drying on instruments

  • Place the instrument in a pre-soak of water or an enzymatic solution, this will prevent drying of organic material

  • Organic material must be removed before disinfection or sterilization procedures are initiated

  • The process for cleaning should include written protocols for disassembly, sorting and soaking, physical removal of organic material, rinsing, drying, physical inspection and wrapping

 

Disinfection of Reusable Medical Equipment:

  • Non-critical medical equipment are to be decontaminated using a Low Level Disinfectant.

  • Semi-critical medical equipment must be decontaminated using, at a minimum, High Level Disinfection (refer to Section III a, p 8). Sterilization is the preferred method of decontamination.

  • Non-critical and semi-critical medical equipment that are owned by the client and reused by a single client in their home do not require disinfection between uses provided that they are adequately cleaned prior to reuse

  • All disinfectants must have a Drug Identification Number (DIN) from Health Canada

  • The chemical disinfectant used for disinfecting medical equipment must be compatible with both the equipment manufacturer’s instructions for disinfection and the cleaning products involved in the reprocessing of the equipment

  • The process of high level disinfection requires monitoring and auditing. If a chemical product is used, the concentration of the active ingredient(s) must be verified and a logbook of daily concentration test results is to be maintained.
HIGH LEVEL DISINFECTANTS (HLD)
Chemical Action Exposure Time Comments

Glutaraldehyde

Sterilant HLD

> 20 minutes for HLD

> 10 hours for sterilization

  • Toxic, rinse well
  • Shelf life limited
  • Requires well vented room and safe work practices
  • Follow manufactures recommendations
  • Ortho-phthalaldehyde 0.55%

    HLD > 12 minutes
  • Rinse well
  • Shelf life limited
  • Less occupational risks

  • Sodium hypochlorite (1:50 dilution of household bleach)

    HLD > 20 minutes
  • Rinse well
  • Corrosive to metals
  • Does not clean
  • Prepare daily (if stored in opaque container weekly)
  •  

    Sterilization of Reusable Medical Equipment:

    • Critical medical equipment must be sterilized

    • Whenever possible, semi-critical medical equipment should be sterilized

    • All sterilization processes must ensure that they follow the manufacturer’s instructions for installation, operation and preventive maintenance of the equipment

    • The sterilization process must be validated and documented (refer to documentation form Section III a)

    • The sterilization process requires testing, monitoring and auditing

    • Infection Prevention and Control input should be obtained prior to the purchase of a new sterilizer (e.g. Health Unit staff with certification in infection prevention and control, Regional Infection Control Network staff)

    • Sterilizers must be subjected to rigorous testing and monitoring on installation and following disruptions to their normal activity

    • Flash sterilization shall only be used in emergency situations and must never be used for implantable equipment

    • Boiling is not an acceptable method of sterilization

    • The use of ultraviolet light is not an acceptable method of disinfection/sterilization

    • Glass bead sterilization is not an acceptable method of sterilization

    • The use of a chemiclave for sterilization poses an environmental risk and must be closely monitored

    • The use of microwave ovens for sterilization is not acceptable

    Steam sterilization is the most practical and economical method for sterilizing medical instruments. Small tabletop steam sterilizers that are carefully maintained can be used for many years and are highlyrecommended for clinic and office settings.

    Guidelines for Sterilization with Steam Autoclaves
    Unwrapped instruments, non-porous, no lumen 3 minutes exposure 132-135°C
    Small wrapped packs 30 minutes exposure 121-132°C

    Small autoclaves, similar in size to microwave ovens, are ideal for office use. Distilled water is recommended as the water source to prevent scale deposits on the instruments. Unwrapped instruments should be used immediately so as not to contaminate the item; otherwise instruments should be wrapped. 

    Dry heat sterilization should be used only for the materials that cannot be sterilized by steam. The principle advantage of dry heat sterilization is its penetrating power. The disadvantages are that heating is slow, long exposure times and high temperatures are required, which could damage materials.

    Time-Temperature Relationships for Sterilization with Hot Air

    These temperatures relate to the time of exposure after the attainment of the specific temperature. The time does not include the heating lag.

    60 minutes exposure 170°C
    120 minutes exposure 160°C
    150 minutes exposure 150°C
    180 minutes exposure 140°C

     

    Packaging and Storage of Reprocessed Medical Equipment:

    • Packaging material must:
      • 1. Allow the sterilant to enter the pack

        2. Maintain the sterility of the contents and be imperious to the environment

        3. Minimize the contamination risk when the package is opened

    • Reprocessed medical equipment shall be stored in a clean, dry location in a manner that minimizes contamination or damage

    • At point of use, upon opening the reprocessed medical equipment, check for integrity of the packaging and the equipment; validate results of chemical monitors if present; and reassemble equipment if required

     

    Monitoring the Sterilization Process:

    • The sterilization process must be monitored and recorded:

    • Manual indicators (on the machines, such as time, temperature and pressure gauges) each cycle

    • Chemical indicators (time/temperature and/or humidity sensitive tape, strips or pellets) each cycle

    • Biological indicators (BI) (spore-laden strips or vials) at least weekly, but preferably daily

    • If the failure is a positive BI;
      • 1. Repeat the test

        2. If practical, do not release any items that were processed since the last negative test

        3. If this repeat test is negative, and there is not an indication of a system malfunction – continue as normal

        4. If the repeat BI is positive again, review all items that were processed since the last negative test

        5. Review the process to ensure this is not a false positive

        6. Complete a report that includes time, date, load description, results of mechanical and chemical monitoring, contact the manufacturer, and after repair and maintenance, re-challenge the autoclave with the BI

        7. Re-sterilize the recalled items once the results of the BI are negative

        8. Have a procedure for patient notification if instrument(s) were used on patient(s)

        9. Have a back up procedure to ensure your equipment will be sterilized as required (e.g. set of disposable devices, arrangement with a colleague to use their autoclave)

    Note: Mechanical and chemical monitors merely provide a visible indicator that the    conditions required to achieve sterilization, such as time, temperature and pressure, have been met.Only biologic indicators monitor the actual effectiveness of the sterilization process, which is intended to kill all microbes, including spores. (PHAC, 1998)

     

    Preventative Maintenance:

    • Regular preventative maintenance and cleaning is required to assure the effectiveness of the machine:

      • 1. Keep any preventative maintenance and repairs performed

        2. Use the instruction manual or contact the manufacturer

        3. Assure distilled water is filled to the correct level and drained according to manufacturer’s recommendations

        4. Check the gasket for defects and deterioration

        5. Assure proper placement of packs, and do not overload the chamber

     

    High Level Disinfection (HLD) of Reusable Medical Equipment and Devices

    Date: May 2009

    Disclaimer: 

    This policy and procedure template is intended only for the purpose of guiding HLD practice where disinfectant chemicals are used. The best practices described in this procedure have been taken directly from the references listed on page 16. The creators of this policy and procedure template have 1) made every effort to follow the Canadian standards association (CSA) and the Provincial Infectious Diseases Advisory Committee (PIDAC) Best Practices Guidelines and 2) clearly documented the importance of strictly following manufactures instructions.

    Recognizing that reprocessing of medical devices is subject to a constantly evolving body of scientific knowledge and subject to operators competency the creators of this template accept no liability for loss, damage, injury or expense arising form its implementation.

    High Level Disinfection (HLD):

    HLD is a procedure which eliminates vegetative bacteria, enveloped viruses, fungi, mycobacteria and non-enveloped viruses. HLD does not kill spores.  HLD is used for semi-critical medical equipment/devices. HLD is performed after the equipment/device is thoroughly cleaned and rinsed.

    Purpose:

    To outline the correct procedure to perform HLD of reusable medical equipment.

    Policy:

    The following steps in HLD are required to be completed by staff responsible for reprocessing at (insert facility name):

      1. Put on appropriate personal protective equipment

      2. Collection at point of use, containment and transport

      3. Cleaning

      4. Rinsing-pre HLD

      5. Drying-pre HLD

      6. Inspection

      7. High Level Disinfection

      8. Sterile water rinse-post HLD

      9. Drying-post HLD

      10. Monitoring

      11. Documentation

      12. Storage

    Procedure:

    1. Personal Protective Equipment:

    • Appropriate personal protective equipment must be worn for cleaning and handling contaminated equipment/devices as per routine practices

    • Perform hand hygiene

    • Don impermeable gown, mask, eye protection and chemical safety gloves

     

    2. Collection at point of use, containment and transport:

    • Remove all disposable sharps and dispose in an appropriate puncture resistant sharps container (sharps should be removed by the user prior to collection by reprocessing staff)

    • Soiled medical equipment/devices must be contained or covered while being transported to reprocessing area

    • Items which will not be decontaminated immediately must be kept moist by either applying instrument pre-cleaner, submersion in tepid water, detergent or enzymatic solution (insert product name and dilution directions).

    • Wrap heavy or non-submersible items in a towel soaked in detergent

     

    3. Cleaning:

    Reusable medical equipment/devices must be thoroughly cleaned before HLD. The process of cleaning will include the following steps:

    • Disassembly:

      • Disassemble all equipment/devices prior to cleaning, unless otherwise recommended by the manufacturer

    • Soaking:

      • Soak all items in (enzymatic detergent, insert product name and dilution instructions) in order to soften organic material and make the item easier to clean

    • Physical removal of organic waste:

      • Completely submerge submersible items during the cleaning process

      • Remove gross soil by rubbing, scrubbing, brushing or wiping. Use soft bristle brushes (no wire bristles) or clothes. All brushing must be done under water to prevent splashes and aerosolization.

      • Use brushes of the appropriate size to fit lumens, channels, ports, connectors and openings

      • Where applicable, flush lumens, channels and ports with syringe filled with (enzymatic detergent, insert product name here)

      • Ultrasonic cleaning (optional) is strongly recommended for medical equipment/devices that has joints, crevices, lumens, or other areas that are difficult to clean. Manufactures instructions must be followed for use of the ultrasonic cleaner. The ultrasonic solution should be changed at least daily or more frequently if becomes visible soiled.

      • Clean and disinfect tools used to assist in cleaning, such as brushes after use

      • Remove personal protective equipment and perform hand hygiene. The equipment/devices are now considered clean and can be handled with bare hands.

     

    4. Rinsing-pre HLD:

    • Rinsing removes residues which may neutralize the disinfectant

    • Rinse all equipment/devices thoroughly with water

    • Rinse lumens with commercially prepared sterile water using a syringe

     

    5. Drying-pre HLD:

    • Drying is an important step that prevents dilution of chemical disinfectants

    • Follow the manufactures instructions for drying the equipment/device

    • Equipment/devices may be air-dried or dried with a clean, lint free towel

    • Lumens may be forced-air dried with medical grade air

     

    6. Inspection:

    • Visually examine all items for cleanliness and integrity (e.g. cracks or defects). Devices that are not clean must be returned to decontamination area and re-cleaned.  Items which are visibly damaged should be removed from use.

    • Follow the manufactures guidelines for lubrication. Items with movable parts need to be lubricated to prevent rusting, pitting, or eroding.

     

    7. High Level Disinfection:

    • Check expiry date on disinfectant container

    • Prepare high level disinfectant (enter product name) according to instructions, ensuring that the appropriate concentration is achieved

    • Reusable solutions shall be dated when initially opened and used, tested regularly for Minimum Effective Concentration (MEC)

    • If using gluteraldehyde or OPA the proper ventilation is required

    • Totally immerse all items and flush any lumens with the disinfectant

    • Soak items for the recommended contact time (enter number of minutes as per label instructions). Set timer to ensure contact time for the HLD is correct

    • During disinfection cover the container being used

    • Remove items from disinfectant solution immediately once the appropriate contact time has elapsed

    • Solutions shall be discarded when they fall below the MEC or the maximum in-use date has been reached, whichever comes first

    • The container used for disinfection must be washed, rinsed and dried whenever the solution is changed

     

    8. Sterile water rinse-post HLD

    • Rinse all items thoroughly three times with fresh sterile water

     

    9. Drying-post HLD:

    • Unless a device will be used immediately, it shall be thoroughly dried. Special care must be taken to ensure that lumens are completely dry.

    • Follow the manufactures instructions for drying the equipment/device

    • Equipment/devices may be air-dried or dried with a clean, lint free towel

    • Dry stainless steel devices immediately after rinsing to prevent spotting

     

    Monitoring:

    • Chemical test strips should be used to determine whether an effective concentration of active ingredients is present despite repeated use and dilution

    • Test chemical solution (enter name of product) at least daily using (test strip, enter name)

    • Chemical test strips must be checked each time a new package/bottle is opened to verify they are accurate. See manufacturer’s recommendations for appropriate controls.

     

    Documentation:

    • A permanent record of reprocessing shall be completed and retained according to the policy of the facility

    • Document the following information on the (insert title of the documentation record):

      • The identification of the equipment/device to be disinfected

      • Date and time

      • Concentration and contact time of the disinfectant used

      • Results of each inspection

      • Result of each testing of the disinfectant

      • The name of the person completing the reprocessing

    Storage:

    • Store items in an area that has limited traffic, is clean, well lit, dry and dust free

    • Store items in an area that protects from crushing, puncturing and compression

    • Use the first-in, first-out system of inventory control (rotate stock)

     

    Reprocessing of reusable medical equipment and devices using a Tabletop Steam Sterilizer

    Date: May 2009

    Disclaimer:   

    This policy and procedure template is intended only for the purpose of guiding sterilization practice where tabletop steam sterilizers are in use.  The best practices described in this procedure have been taken directly from the references listed on page 16. The creators of this policy and procedure template have 1) made every effort to follow the Canadian Standards Association (CSA) and the Provincial Infectious Diseases Advisory Committee (PIDAC) Best Practice Guidelines and 2) clearly documented the importance of strictly following manufacturer’s instructions.

    Recognizing that reprocessing of medical devices is subject to a constantly evolving body of scientific knowledge and subject to operator’s competency the creators of this template accept no liability for loss, damage, injury or expense arising from it’s implementation.

     

    Purpose:

    This policy and procedure establishes guidelines to provide safe reprocessing of medical equipment/devices. Safe reprocessing prevents transmission of microorganisms to personnel and clients/patients/residents; and minimizes damage caused by foreign material or inappropriate handling. 

     

    Policy:

    The policy of (insert company/agency name) is to ensure the following steps in reprocessing are completed by staff involved in reprocessing:

      1. Personal protective equipment

      2. Collection at point of use, containment and transport

      3. Cleaning

      4. Rinsing

      5. Drying

      6. Inspection

      7. Wrapping

      8. Loading the sterilizer

      9. Monitoring the sterilizer

      10. Documentation

      11. Storage

      12. Maintenance of sterilizer

     

    Procedure:

    1. Personal Protective Equipment:

    • Appropriate personal protective equipment must be worn for cleaning and handling contaminated equipment/devices as per routine practices.

    • Perform hand hygiene

    • Don impermeable gown, mask, eyewear and gloves

     

    2. Collection at point of use, containment and transport:

    • Remove all disposable sharps and dispose in an appropriate puncture resistant sharps container

    • Soiled medical equipment/devices must be contained or covered while being transported to reprocessing area.

    • Submerge medical equipment/device in tepid water and/or detergent and enzymatic (insert product name and dilution directions).

    • Wrap heavy or non-submersible items in a towel soaked in detergent

     

    3. Cleaning:

    Reusable medical equipment/devices must be thoroughly cleaned before sterilization. The process of cleaning will include the following steps:

    Disassembly:

    • Disassemble all equipment/devices prior to cleaning, unless otherwise recommended by the manufacturer

    Soaking:

    • Soak all items in (enzymatic detergent, insert product name and dilution instructions) in order to soften organic material and make the item easier to clean

    Physical removal of organic waste:

    • Completely submerge submersible items during the cleaning process

    • Remove gross soil by rubbing, scrubbing, brushing or wiping  using soft bristle brushes (no wire bristles) or cloths. Do this under the water to prevent aerosolization.

    • Use brushes appropriate for the size of lumens, channels, ports, connectors and openings

    • Where applicable flush lumens with syringe filled with (enzymatic detergent - insert product name here).

    • Ultrasonic cleaning (optional): are strongly recommended for medical equipment/devices that have joints, crevices, lumens, or other areas that are difficult to clean. Manufactures instructions must be followed for use of the ultrasonic cleaner. The ultrasonic washing solution should be changed at least daily or more frequently if becomes visibly soiled.

    • Clean and disinfect tools used to assist in cleaning, such as brushes after use

    • Remove personal protective equipment and perform hand hygiene. The equipment/devices are now considered clean and can be handled with bare hands.

     

    4. Rinsing:

    • Rinse all equipment/devices thoroughly with water to remove residues which might react with the sterilant

    • Rinse equipment/devices containing lumens with commercially prepared sterile water

     

    5. Drying:

    • Follow the manufactures instructions for drying of the equipment/device

    • Dry stainless steel devices immediately after rinsing to prevent spotting

    • Equipment/devices may be air-dried or dried with a clean, lint free towel

     

    6. Inspection:

    • Visually examine all items for cleanliness and integrity (e.g. cracks, defects).  Devices that are not cleaned must be returned to decontamination area and be re-cleaned.

    • Follow the manufactures guidelines for lubrication. Items with movable parts need to be lubricated to prevent rusting, pitting or eroding. 

     

    7. Wrapping:

    • Do not reassemble equipment/devices

    • Choose the wrapping material that is appropriate (e.g. wrapping, pouch)

    • Wrap/pack equipment/devices in a manner that will allow adequate air removal, steam penetration, and evacuation

    • Instruments must be evenly distributed in the package

    • Lumens must be unobstructed and instruments must be in an open and unlocked position

    • Insert an internal chemical indicator into each wrapped pack/pouch

    • Wrapping with reusable cloth materials

    • Use a “Class B” water repellant, steam permeable cloth as specified in the CSA Standard Z314.10

    • Requires 1-2 layers of cloth

    • Wrap using the square or envelope technique

    • Apply external chemical indicator tape to seal the package

    • Wrapping with paper/plastic

    • Requires 2 layers of material

    • Wrap using the square or envelope technique

    • Apply external chemical indicator tape to seal the package

    • Wrapping with plastic pouches

    • Be sure the pouch is large enough for the product

    • Do not write on the paper side of the paper/plastic pouch

    • Record date and initial on external chemical indicator tape of the wrapped pack or on the sealed seam of pouch.

    • Record all contents of the load into the log book

     

    8. Loading the Sterilizer:

    Follow the manufacturers requirements. Ensure the water reservoir is filled with distilled water. Never use tap water.

    • Load to allow for free circulation, air removal, steam penetration and evacuation

    • Paper/plastic packages, linen packs, metal basin sets shall be placed on their side. If this is not possible then they must be laid flat and no other pouch on top of each other (noting that for paper/plastic packages, the paper side must be down on the rack).

    • Paper/plastic pouches shall be placed with plastic surface of the pouch facing the paper surface of the adjacent pouch.

    • Contents shall not contact the interior surface of the sterilizer chamber

    • Do not overload sterilizer

    • Select appropriate cycle, push this button to start cycle

    • Allow for drying time

     

    9. Monitoring the Sterilizer:

    Complete all three of the following:

    • Mechanical monitoring of time, temperature and pressure will be reviewed after each load, ensuring set parameters have been met.  Enter in the parameters (e.g. 5mins, 270°F, 27psi).

    • Initial and enter mechanical parameter into log book

    • External chemical indicator tape must be checked on each pack, ensuring stripes have appeared

    • Biological indicator (BI) test pack must be put into the first load of every day the sterilizer is used

    • Enter results of biological indicator into log book

    • In the event that any of the above parameters are not met follow appropriate policy and procedure

     

    10. Documentation:

    • A permanent record of reprocessing shall be completed and retained according to the policy of the facility

    • Document the following information on the (insert title of the documentation record):

      • The identification of the equipment/device to be sterilized

      • Results of each inspection

      • Date and time

      • Results of mechanical indicator

      • Results of external chemical indicator

      • Results of biological indicator

      • The name of the person completing the reprocessing

     

    11. Storage:

    • Store sterile items in area that has limited traffic, is clean, well lit, dry, and dust free

    • Store sterile items on shelves that are at least 25 cm from the floor, 46 cm from the ceiling and 5 cm from the walls

    • Store sterile items in an area that protects packages from tears, crushing, puncturing and compression

    • Maintain relative humidity between 35% and 50%

    • Maintain temperature no higher than 21°C

    • Use the first-in, first-out system of inventory control

    • Contents of a sterilized package can remain sterile indefinitely if integrity of the package/seal is not compromised

     

    12. Maintenance of Sterilizer:

    • Follow the manufacturer’s instructions for the use, cleaning and preventative maintenance of the table top steam sterilizer

    • Maintain a record of preventative maintenance activities

     

    References:

    AORN Standards, Recommended Practices and Guidelines, 2006.

    Canadian Committee on Antibiotic Resistance (2007) Infection Prevention and Control Best Practices for Long Term Care, Home and Community Care including Health Care offices and Ambulatory Clinics. Available on line at: http://www.cpsa.ab.ca/collegeprograms/attachments_ipac/IPAC-Best_Practices_general.pdf

    Canadian Standards Association. CAN/CSA-ISO 14937-01. Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices. (Adopted ISO 14937:2000). Toronto, Ont.: Canadian Standards Association; 2001.

    Canadian Standards Association Z 314.3 Effective Sterilization in Health Care Facilities by Steam process, 2007.

    Canadian Standards Association Plus 1112. Infection prevention and control in office-based health care and allied services, March 2004.

    CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf

    The College of Physicians and Surgeons of Ontario. Infection Control in the Physician’s Office, 2004 edition. Toronto, Ont.: CPSO; 2004. Available online at: http://www.cpso.on.ca/Publications/infectioncontrolv2.pdf

    Health Canada. Hand washing, cleaning, disinfection and sterilization in health care. Can Commun Dis Rep. 1998; 24 Suppl 8: i-xi, 1-55. Available online at:
    http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/98pdf/cdr24s8e.pdf

    ORNAC. 2006. Recommended Standards, Guidelines, and Position Statements For Perioperative Nursing Practice. Module 2. 7th Edition. Operating Room Nurses Association of Canada.

    Provincial Infectious Disease Advisory Committee (PIDAC) (2006)
    Best Practices For Cleaning, Disinfection and Sterilization In All Health Care Settings




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