Frequently Asked Questions
STERILIZATION
What is the difference between an Autoclave and a Sterilizer?
What type of sterilizer (autoclave) is the STATIM?
What type of sterilizer (autoclave) is the StatClave andBravo?
What is the difference between these?
Are these units licensed by Health Canada as a Medical Device?
What is a Bowie Dick/Air Removal test?
What are the different types of Sterilization Monitoring?
There are three methods of Sterilization Monitoring:
- 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.
- Chemical Indicators (CIs) – test strips that change colour when exposed to sterilization conditions. There are 6 classes of chemical indicators:
- *Class 1 (Process Indicators)* – Tapes or strips used as external indicators to distinguish between processed and unprocessed items E.g. indicator tape
- *Class 2 (Specific Tests, e.g. Bowie-Dick Indicators)* – Used to assess a specific sterilization attribute, such as air removal, during a cycle
- *Class 3 (Single Variable Indicators)* – Indicate a specific single sterilization variable, such as temperature, has been reached in the sterilization chamber
- *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
- *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.
- *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.*
WHERE CAN I GET MORE INFORMATION ON INSTRUMENT REPROCESSING?
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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.
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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?
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?
<> 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?
<> 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?
How often should I test the cleaning performance of my ultrasonic unit?
<> 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)?
<> 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)?
<> 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?
If after 14 days the chemical test strips still show a ‘pass’ result, can I still use the solution?
<> 1 PIDAC, “Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment/Devices” Public Health Ontario, 2013. P. 26.