Frequently Asked Questions

STERILIZATION

What is the difference between an Autoclave and a Sterilizer?

The terms autoclave and sterilizer are interchangeable. They are devices that are used to sterilize reusable instruments and use saturated steam as the sterilant. There are different types used in dentistry including prevacuum and steam flush pressure pulse (SFPP) sterilizers. The difference between these types of sterilizers is primarily the way the air is removed from the chamber during conditioning. Both Prevacuum and SFPP cycles are considered Dynamic Air Removal cycles, which means there is an active way of removing air from the chamber (using either pressure and vacuum excursions or steam flushes and pressure pulses).

What type of sterilizer (autoclave) is the STATIM?

The STATIM is a steam flush pressure pulse (SFPP) Sterilizer. With this type of Health Canada licensed technology, air is actively removed from the chamber through pressurizations and flushes with steam. No vacuum is drawn and the chamber pressure does not drop below atmospheric.

What type of sterilizer (autoclave) is the StatClave andBravo?

Both the StatClave and Bravo are Pre-vacuum autoclaves which utilize a mechanical vacuum system. With this type of Health Canada licensed technology, air is actively removed from the chamber through pressure and vacuum purges, during which the pressure drops below atmospheric.

What is the difference between these?

Both pre-vacuum and SFPP use Dynamic Air Removal; the difference is the way in which the air is removed. Both are validated steam sterilization systems that provide efficacious sterilization when used according to the Instructions for Use (Operators Manual).

Are these units licensed by Health Canada as a Medical Device?

Yes. The STATIM, Bravo and StatClave units are Health Canada licensed Medical Devices.

What is a Bowie Dick/Air Removal test?

The BOWIE DICK Test program executes a cycle at 134 °C for a duration of 3.5 min. Using a suitable test pack, it is possible to evaluate the correct penetration of the steam inside porous loads. This test is only applicable for Pre-vacuum sterilizers.

What are the different types of Sterilization Monitoring?

There are three methods of Sterilization Monitoring:

  1. Physical/Mechanical monitoring – assessing cycle parameters (visual verification of sterilization display, cycle information from USB or datalogger, printout, etc) verifying that sterilization pressure, temperature and time have reached the levels recommended by the manufacturer.
  2. Chemical Indicators (CIs) – test strips that change colour when exposed to sterilization conditions. There are 6 classes of chemical indicators:
    1. Class 1 (Process Indicators) – Tapes or strips used as external indicators to distinguish between processed and unprocessed items
    2. E.g. indicator tape
    3. Class 2 (Specific Tests, e.g. Bowie-Dick Indicators) – Used to assess a specific sterilization attribute, such as air removal, during a cycle
    4. Class 3 (Single Variable Indicators) – Indicate a specific single sterilization variable, such as temperature, has been reached in the sterilization chamber
    5. Class 4 (Multi-parameter indicators) – indicates that 2 or more sterilization parameters, such as time and temperature, have been met by indictor colour change
      E.g. Chemical indicator strips
    6. Class 5 (Integrating Indictors) – most accurate of all chemical indicators and contain a chemical ink which reacts to all three sterilization parameters. The performance of a Class 5 indicator correlates to, but isn’t a replacement for, a Biological Indicator.
    7. Class 6 (Emulating Indictors) – referred to as cycle specific indicator because it monitors all critical sterilization variables for a specified sterilization cycle.
      NOTE: Mechanical and Chemical monitoring do not ensure that sterilization of the reusable devices has been achieved; they only verify that the necessary conditions for sterilization have been met.
  3. Biological Indicators (BIs or Spore Tests) – most accepted means of monitoring sterilization because they assess the sterilizers effectiveness in killing the most resistant micro-organisms. Follow your local guidelines and manufacturer’s instructions for the appropriate frequency and location of BI testing.
    NOTE: In Ontario, BI’s must be done daily
    Please consult your local regulations, guidelines and standards for the frequency of sterilization monitoring requirements.

WHERE CAN I GET MORE INFORMATION ON INSTRUMENT REPROCESSING?

  • Manufacturers Instruction for Use – it is important to read and follow the manufacturer’s instructions for use with any medical device. This will ensure the proper and effective use of your system.
  • Provincial Infectious Diseases Advisory Committee (PIDAC) document
    http://www.publichealthontario.ca/en/eRepository/PIDAC_Cleaning_Disinfection_and_Sterilization_2013.pdf
    “This document was developed by the Provincial Infectious Diseases Advisory Committee on Infection Prevention and Control (PIDAC-IPC). PIDAC-IPC is a multidisciplinary scientific advisory body that provides evidence-based advice to Public Health Ontario (PHO) regarding multiple aspects of infectious disease identification, prevention and control. PIDAC-IPC’s work is guided by the best available evidence and updated as required. Best Practice documents and tools produced by PIDAC-IPC reflect consensus positions on what the committee deems prudent”
  • Royal College of Dental Surgeons Ontario (RCDSO) Guidelines
    http://www.rcdso.org/Assets/DOCUMENTS/Professional_Practice/Guidelines/RCDSO_Guidelines_Infection_Prevention_and_Control.pdf
    “The Guidelines of the Royal College of Dental Surgeons of Ontario contain practice parameters and standards which should be considered by all Ontario dentists in the care of their patients. It is important to note that these Guidelines may be used by the College or other bodies in determining whether appropriate standards of practice and professional responsibilities have been maintained.”

  • CSA Z314-18 – Canadian Medical Device Reprocessing.

HARD SURFACE DISINFECTION

What is a disinfectant?

A chemical agent used on inanimate objects (e.g., countertops, floors, walls, sinks, non-critical medical devices) to destroy virtually all recognized pathogenic microorganisms, but not necessarily all microbial forms (e.g., bacterial endospores). Health Canada groups disinfectants on the basis of whether the product label claims limited, general, or hospital (intermediate) disinfectant capabilities1. Manufacturers that label products with disinfectant claims are responsible for having data to demonstrate that the product is efficacious when used as labeled.

OPTIM 33TB has been proven to be effective against Mycobacteria causing Tuberculosis, Viruses (ex. Poliovirus, Norovirus, Rotavirus, RSV, HIV, HBV, HCV, and Influenza A), Bacteria (ex. MRSA, VRE, E.Coli, and PSA), and Fungi (ex. C. Albicans and Trichophyton Mentagrophytes).

 


1 Health Canada, “Guidance Document – Disinfectant Drugs” Health Canada. 2018, P. 5-6.

What is Accelerated Hydrogen Peroxide?

OPTIM 33TB’s is powered by accelerated hydrogen peroxide. It is a synergistic blend of commonly used ingredients that are listed on the Health Canada and Environmental Protection Agency (EPA) Inerts List, the FDA GRAS list and Code of Federal Regulations (CFR) 21 Food Additives List, that when combined with low levels of hydrogen peroxide, dramatically increase its germicidal potency and cleaning performance.

Does it matter which pathogens (viruses, bacteria, etc.) an intermediate level disinfectant can kill?

Yes. Disinfectant product labels often include a long list of pathogens that it can kill, but which ones are the most important? Pathogens are divided into classes, and each class has a surrogate organism that is the gold standard or more difficult-to-kill pathogen in that class. For example:

Class Surrogate Organism
Vegetative Bacteria Pseudomonas aeruginosa and Staphylococcus aureus
Viruses Poliovirus
Mycobacteria Mycobacterium bovis (Tuberculosis)
Fungi Trichophyton mentagrophytes
Bacterial Spores Bacillus subtilis and Clostridium sporogenes

When choosing a disinfectant, it is important to make sure that it can inactivate the more difficult pathogens so that you can feel confident that you are killing virtually everything.

How do I properly dispose of OPTIM 33TB?

OPTIM 33TB liquid can be poured directly down the drain. There is no need to dilute it with water since hydrogen peroxide breaks down into water and oxygen. Wipes should be disposed of in the trash after use; do not flush them down the toilet. The empty container should be recycled and if recycling is not available it can be discarded in the trash.

If the wipes have been used on surfaces where blood or body fluids were present, they should be disposed of according to federal, state and local regulations for infectious waste disposal.

Do I need to wear personal protective equipment when disinfecting clinical contact surfaces?

Yes, you should always wear appropriate personal protective equipment such as utility gloves when cleaning and disinfecting contaminated surfaces to protect against pricks and pokes.4 However, as stated in OPTIM 33TB’s Safety Data Sheet, PPE is not required to handle the product, particularly in non-clinical settings, because it is not irritating to the skin.

 


4 CDC, “Guideline for Disinfection and Sterilization in Healthcare Facilities” CDC. 2003, 26.

ULTRASONIC CLEANING

How often do I need to change my ultrasonic solution?

As per the RCDSO1 , solution must be changed daily or more frequently if it becomes visibly soiled.

 


1 Royal College of Dental Surgeons of Ontario, “Infection Prevention and Control in the Dental Office” p20, RCDSO Guidelines, 2018.

How do I test my ultrasonic unit’s cleaning performance?

Refer to your local guidelines or regulations with regard to recommended testing protocols.

How often should I test the cleaning performance of my ultrasonic unit?

The Canadian Standards Association (CSA) requires ultrasonic units to be tested at least weekly.1

 


1 CSA Z314-18, “Canadian medical device reprocessing”, Clause 11.6.6.6

HIGH LEVEL DISINFECTION

Do I have to monitor and test my sterilant and / or high-level disinfection solution(s)?

Yes, chemical strips should be used to determine whether an effective concentration of active ingredients is still present in the solution.1

 


1 PIDAC, “Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment/Devices” Public Health Ontario, 2013. P. 26.

How often should I test my sterilant and / or high-level disinfectant solution(s)?

The frequency of testing should be based on how frequently the solutions are used, i.e. test daily if used daily.1

 


1 PIDAC, “Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment/Devices” Public Health Ontario, 2013. P. 26.

How many days may OPTIM CS be reused once prepared?

It may be reused up to 14 days.

If after 14 days the chemical test strips still show a ‘pass’ result, can I still use the solution?

No, test strips may not be used as a way of extending the use of the OPTIM CS disinfectant solution beyond the 14 days.1

 


1 PIDAC, “Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment/Devices” Public Health Ontario, 2013. P. 26.