Frequently Asked Questions

STERILIZATION

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).

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.

The Bravo is a Prevacuum autoclave, which utilizes 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.

Both prevacuum 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).

Yes. Both the STATIM and Bravo units are Health Canada licensed Medical Devices.

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.

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

      E.g. indicator tape

    2. Class 2 (Specific Tests, e.g. Bowie-Dick Indicators) – Used to assess a specific sterilization attribute, such as air removal, during a cycle
    3. Class 3 (Single Variable Indicators) – Indicate a specific single sterilization variable, such as temperature, has been reached in the sterilization chamber
    4. Class 4 (Multi-parameter indicators) – indicates that 2 or more sterilization parameters, such as time and temperature, have been met by indictor colour change
      1. Chemical indicator strips
    5. 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 a Biological Indicator.
    6. 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

  • 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 7314.3-14 - Effective Sterilization in Health Care Facilities by the Steam Process (Section 13)
  • SciCan Infection Control Binder

    http://www.scicancanada.ca/index.cfm?pagepath=Home/SciCan_University/Order_your_IC_Binder_Today_&id=16169

    This manual is a detailed guide to the day to day implementation of the Infection Control principles and practices and is based on published recommendations from government and other agencies, regulatory bodies and professional associations. This document is ideal for training staff. It covers the principles of infection control in a dental practice; choice and type of equipment used (sharps reduction, ease of cleaning and sterilizing), occupational health and safety considerations and safe disposal of clinical waste.

    This manual is an excellent guideline for maintaining detailed records. Additionally, in the event of an audit, this manual can greatly assist in satisfying the recommendations of having documented office policies and procedures in place.

HARD SURFACE DISINFECTION

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. 2014, 3-10.

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.

OPTIM 33TB has been tested to be compatible with hard surfaces, including but not limited to dental chairs, stools, lights and counter tops if used according to our instructions for use on the label.

Surfaces that are composed of brass, copper, or other ferrous metals and soft plastic may show signs of discoloration or damage if not used as directed. Anodized aluminum (often used on handpieces) and carbon tipped instruments should be avoided. Please refer to the Instructions for Use on the product label.

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.

OPTIM 33TB’s has a one-minute tuberculocidal, bactericidal and virucidal contact time, and a 3 minute fungicidal contact time. That means that the surface must remain wet for 1 minute in order to inactivate tuberculosis causing mycobacteria, other bacteria and viruses and 3 minutes to inactivate fungi.

Yes, OPTIM 33TB can kill Trichophyton mentagrophytes within 3 minutes. In the past, Health Canada only allowed one contact time to be displayed on a surface disinfectant label. To avoid confusion with the 1 minute contact time required for the inactivation of tuberculosis causing mycobacteria, other bacteria and viruses, SciCan left the 3 minute fungicidal claim off the label.

Health Canada has recently changed this restriction to allow multiple contact time claims. We updated our OPTIM 33TB liquid label to include our 3 minute fungicidal contact time. The OPTIM 33TB wipes label is currently being updated as well.

Yes, OPTIM 33TB can be used to disinfect your dental chairs.2 However, it is important to remember that it is best practice to rinse all surfaces weekly with water to prevent surfactant build

 


2 John Molinari, Ph.D., Peri Nelson, B.S. Effect of Optim 33TB on Tensile Properties of Dental Chair Fabrics. Ann Arbor: Dental Advisor, 2016.

OPTIM 33TB has a two year shelf life from date of manufacture. The expiration date is listed on each container.

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.

OPTIM 33TB should be stored in a cool dry area, away from direct sunlight and heat, and inaccessible to small children.3

 


3 OPTIM 33TB Safety Data Sheet

No, all of the ingredients in OPTIM 33TB are on the Environmental Protection Agency (EPA) Inerts List, the FDA GRAS list and Code of Federal Regulations (CFR) 21 Food Additives List

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.

Yes, OPTIM 33TB has been tested as a one-step cleaner disinfectant, meaning it cleans your surfaces as it disinfects. Please refer to the product label or our Instructions for Use to learn how to use our product as a one-step cleaner disinfectant.

Yes, OPTIM 33TB has a one-minute efficacy claim against Mycobacteria causing Tuberculosis, bacteria, viruses, and a 3 minute claim against fungi. Any disinfectant that is capable of destroying or irreversibly inactivating all microbial pathogens, including mycobacteria may be recommended for the disinfection of non-critical medical devices, environmental surface and inanimate objects.5

 


5 Health Canada, "Guidance Document – Disinfectant Drugs" Health Canada. 2014, 11.

You may have noticed many disinfectants having new labels that include hazard pictograms they didn’t have before. This is because the revised hazard communication requirements of the new globally harmonized system of classification and labelling of chemicals (GHS) has specific criteria for each health and physical hazard, and establishes both hazard classes and hazard categories. The previous hazard communication requirements did not include categories for most of the health hazards covered by the new GHS system. This new approach provides the consumer with more information for awareness and that can be used to address the hazard.6

As with the old criteria, OPTIM 33TB has been classified as non-hazardous in accordance with GHS criteria and therefore does not require any hazard pictograms, signal words or statements.7

 


6 Canadian Center for Occupational Health and Safety, "WHMIS 2015 Fact Sheets," CCOHS. https://www.ccohs.ca/products/publications/whmis_ghs/ (accessed January 2017).
7 OPTIM 33TB Safety Data Sheet

It is not recommended because the bleach in the gauze may inactivate the disinfectants.8 However, it is acceptable to spray OPTIM 33TB onto 2x2 or 4x4 gauze or c-fold towels for immediate use. Please note that it is not recommended to spray any disinfectant directly onto any surface.

 


8 OSAP, "Frequently Asked Questions (FAQs) on Dental Infection Control | Instruments & Equipment Disinfection, " OSAP. http://www.osap.org/?FAQ_Instrum_Disinf1 (accessed December 2016).

Hydrogen Peroxide purchased at a drug store contains 3% hydrogen peroxide mixed with water. Accelerated Hydrogen Peroxide is a blend of 0.5% Hydrogen Peroxide, other inert ingredients/surfactants, and water. This blend results in a better cleaning capability and a faster contact time than the hydrogen peroxide you can buy at the drugstore.

Freeze–Thaw studies have been conducted on OPTIM 33TB to ensure that freezing will not have a negative effect on the stability & efficacy of AHP. If product is frozen, simply allow the product to thaw at room temperature. Once the product is completely thawed, shake to ensure the product has not separated into different phases prior to first use of the bottle.

It is never advisable to mix different chemical products. OPTIM 33TB should never be mixed with any other chemicals.

Quaternary Ammonium Compound based products (QUATs) leave residual chemistry on surfaces. OPTIM 33TB will remove the residual chemistry that has been left on the surface; however, there may be several layers of residual chemistry to remove. The odor and film you are experiencing is caused by the QUATs reacting to OPTIM 33TB removing it. It may take between 5 and 10 days of OPTIM 33TB use before the odor and film disappear.

To prevent this from happening we recommend cleaning your surfaces with soap and water before switching to a new disinfectant.

Yes, OTPIM 33TB has been classified as non-hazardous according to the GHS requirement, and is in the Environmental Protection Agency (EPA)'s lowest toxicity category, category 4. However, in accordance with EPA's label requirements for all registered disinfectants, food contact surfaces must be rinsed with potable water. As children’s toys do have the possibility to come in contact with children’s mouths, the toy must be rinsed with potable water once disinfected.

No. Organic matter (food, blood or body fluid) on the surface forms a barrier that can either increase the contact time required to reach and kill the germs, or prevent their contact entirely.

OPTIM 33TB is effective in the presence of organic matter, meaning it is a one-step cleaner- disinfectant. OPTIM 33TB has been tested in the presence of organic matter called serum. The serum test measures the product efficacy when organic soils are present. To check whether a disinfectant has been tested with serum, check the label to see if it says "tested in the presence of serum load."

Antibiotic resistance does not mean chemical resistance. These bacteria have developed resistance to antibiotics pertaining to human clinical situations. This does not mean that these strains are resistant to chemical disinfection. Most disinfectants, such as OPTIM 33TB, are tested against antibiotic resistant strains such as VRE, MRSA etc. These are shown on the label claims.

No. Products that make this claim leave behind active residues, however the surface needs to be wet for those active residues to continue to disinfect. These products leave behind residues because they don't readily degrade, but rather build up in the environment. OPTIM 33TB does not leave behind any active residues.

Yes, studies show that disinfectants that leave an active residue behind on surfaces contribute to the development of antimicrobial resistance, a major global health crisis we are facing.

It is best practice to look for disinfectants with active ingredients that readily degrade into the environment such as hydrogen peroxide. OPTIM 33TB contains accelerated hydrogen peroxide which breaks down into water and oxygen leaving no active residues behind, ensuring that it won’t contribute to antimicrobial resistance.9

 


9 Ulas Tezel, Spyros G. Pavlostathis, "Role of Quaternary Ammonium Compounds on Antimicrobial Resistance in the Environment," in Antimicrobial Resistance in the Environment, First Edition ed. Patricia L. Keen et al. (Toronto: John Wiley & Sons, Inc, 2011), 349-387.

For environmental and health reasons there are no dyes or fragrances added to OPTIM 33TB. Most fragrances used are classified as volatile organic compounds (VOCs) which are known as one of the leading causes of fragrance sensitivity and negative affects to indoor air quality.

No. Accelerated hydrogen peroxide is acidic because it contains small amounts of food acids. Food acids are not toxic and found naturally in food, such as vinegar (acetic acid), citrus fruits (citric acid), Vitamin C (ascorbic acid), and Coca-Cola™ (phosphoric acid). If food acids are carefully formulated, like they are in OPTIM 33TB, they do not cause irritation.10

 


10 VIROX, "Disinfection Digest: pH: Is it an appropriate indicator of product safety?," VIROX. https://cdn2.hubspot.net/hubfs/241248/ph_is_it_an_appropriate_indicator_of_product_safety_HH.pdf (accessed December 2016).

Yes. A study was done to test the effects of OPTIM on VPS impression materials’ surface detail and dimensional stability. The study found that when used in accordance with our instructions for use there was no damage done to the impression.11

 


11 Dr. Raghunath Puttaiah, "Compatibility of Hydrogen Peroxide-Based Surface and Immersion Disinfectants with Elastomeric Impression Materials." Toronto: Spectrum Dialogue Volume 12, Issue 2 (2013), 66.

No, intermediate level disinfectants cannot kill C. difficile. However, accelerated hydrogen peroxide based products like OPTIM 33TB can be used as a preventative method against C. difficile outbreaks and related Hospital Acquired Infections (HAI). A study published in the American Journal of Infection Control (AJIC) concluded that daily use of accelerated hydrogen peroxide disinfectant was superior to using a cleaner alone because it resulted in significantly reduced rates of HAIs caused by C. difficile.12

 


12 M.J. Alfa et al., "Use of a daily disinfectant cleaner instead of a daily cleaner reduced hospital-acquired infection rates," AJIC Volume 43 (2015), 141-6.

 

 

 

 

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