The Provincial Infectious Diseases Advisory Committee (PIDAC) has produced provincial documents that detail best practice requirements for cleaning, disinfection and sterilization. These documents apply to all regulated health professionals (RHP) in Ontario. To provide the highest level of client safety, and to prevent transmission of infections, current best practices and standards established by Health Canada, Public Health Agency of Canada (PHAC), PIDAC, and the Canadian Standards Association (CSA) for cleaning, disinfection and sterilization must be followed.
It is also important to follow manufacturer instructions for the maintenance, use, and reuse of medical equipment/devices. Keep the manufacturer’s instructions on-site and review these instructions for all equipment. If the manufacturer’s instructions for use do not meet the current PIDAC best practices and/or the standards established by Health Canada, PHAC, PIDAC, and the CSA, the highest level of standard must be followed.
Reprocessing medical equipment and devices
Reusable medical equipment/devices must be cleaned with friction and then either disinfected or sterilized after each use unless labelled as a single-use item. This is known as reprocessing. Items that are reprocessed are classified into three categories:
- Critical: Items that enter sterile tissue or the vascular system and must be cleaned followed by sterilization after each use (e.g., biopsy forceps, tenaculums)
- Semi-critical: Items that come in contact with non-intact skin or intact mucous membranes and must be cleaned followed by a minimum of high level disinfection. Sterilization is preferred (e.g., metal specula, respiratory therapy equipment, tonometer tip)
- Non-critical: Items that contact intact skin only and must be cleaned followed by a low level disinfectant (e.g., blood pressure cuff, stethoscope)
Tips to consider when reprocessing
(This is not an exhaustive list of requirements. Refer to the PIDAC best practice documents as well as standards established by Health Canada, PHAC and the CSA for a full list.)
- Reprocess medical equipment/devices in a separate designated area
- Disassemble items according to manufacturer’s instructions
- Reprocess hinged instruments in the open and unlocked position
- Use a dedicated sink to clean items (not a handwashing sink)
- Always clean items prior to disinfection or sterilization
- Items must be sterilized in approved packaging (wrap or pouch)
- Put an internal chemical indicator inside the sterilization package
- External chemical indicators must be used on the sterilization package
- Label the sterilization package in order to facilitate a potential recall of items (including date, lot number, staff initials)
- Log every sterilizer load, recording the date, item, time, temperature, pressure and staff initials
- Clean and disinfect reusable cleaning brushes after every use
- Do spore testing every day/cycle the sterilizer is used (or every load if using implantable devices). See PIDAC document for additional spore testing requirements.
- A Bowie-Dick test (air removal test) must be completed on pre-vacuum sterilizers every day the sterilizer is used
- Never reuse or reprocess an item labelled “for single use only” or “disposable”
Biological indicators (spore testing)
The sterilization process must be monitored to ensure the integrity of the process. Spore test vials or strips must be run in the sterilizer every day it is used (or every load if using implantable devices). Once the spore test is run, it must be incubated for the biological indicator’s (BI’s) specified period of time before the results can be read.
- Run a control test in addition to the spore test and at the same frequency
- Additional spore testing may be required (e.g., repairs, relocation of machine). See PIDAC best practice documents for more information.
- It is important that a process be in place in the event of a failed (positive) spore test.
What to do in the event of a sterilization failure
Physical, biological and chemical monitoring is done to verify the effectiveness of sterilizers and the sterilizing process. Biological testing or spore testing determines if the sterilizer is functioning correctly and is therefore able to sterilize critical reusable medical equipment and devices. A biological indicator or spore test is incubated in the sterilizer to see if the microorganism will grow, which indicates a failure of the sterilizer.
Improper sterilization includes, but is not limited to, the following situations:
- Instruments not cleaned properly prior to sterilization
- Load contains a positive biological indicator
- An incorrect reprocessing method was used on the equipment/device
- Print-outs on reprocessing equipment indicate failure to reach correct parameters (e.g., temperature, pressure, exposure time)
- Chemical indicator and/or monitoring tape has not changed colour
A written procedure must be in place in the event of improper sterilization which outlines the recall process and reprocessing of improperly reprocessed medical equipment/devices. It can include the following:
- A record of all equipment/devices in each sterilization load to enable tracking in the event of a recall1
- Removing the sterilizer from service2
- Reviewing all records of mechanical and chemical indicators since the last negative spore test2
- Repeating the spore test immediately. If practical, do not release any items that were processed since the last negative test. While waiting for the repeat test results, the sterilizer should remain out of service.1,2
- If the repeat spore test is negative, and there is no indication of a system malfunction, the sterilizer may be put back into service and continue as normal.1,2
- If the repeated spore test indicates a failure (positive):
- Document the time, date, load description and results of physical, chemical and biological indicator (BI) monitoring. 1
- Contact the sterilizer manufacturer. The sterilizer should remain out of service until it has been inspected, repaired and successfully challenged with three consecutive spore tests run in an empty chamber sterilization cycle.2
- All items from suspect loads dating back to the last negative spore test should be recalled and reprocessed once the results of the sterilizer indicators are acceptable.1,2
- Assess the risk to patients.
- Establish a procedure for notification of physicians, patients, other facilities and/ or regulatory bodies, if indicated.1
- Ontario Agency for Health Protection and Promotion (Public Health Ontario), Provincial Infectious Diseases Advisory Committee. Infection Prevention and Control for Clinical Office Practice. 1st Revision. Toronto, ON: Queen’s Printer for Ontario; April 2015. Page 56
- Royal College of Dental Surgeons of Ontario. Infection Prevention and Control in the Dental Office Guidelines; 2018.
Resources and training
All RHPs and their staff must be aware of current IPAC best practice guidelines and follow them when providing services to the public. Current PIDAC Best Practice documents are available on Public Health Ontario’s website and include:
- Infection Prevention and Control for Clinical Office Practice
- Cleaning, Disinfection and Sterilization of Medical Equipment and Devices
- Environmental Cleaning for Prevention and Control of Infections
- Routine Practices and Additional Precautions: Annexes A, B and C
- Best Practices for Hand Hygiene
WDG Public Health Resources
The CSA Standards may be purchased through the CSA Group Online Store.
- Medical Device Reprocessing Training – MDRAO (for fee, in-person)
- Public Health Ontario (free online training)
- Reprocessing in Community Health Care Settings
- Cleaning, Disinfection and Sterilization of Reusable Medical Equipment/Devices
- Environmental Cleaning Toolkit
- Public Health Ontario – Core Competencies (free online training)
- Hand Hygiene
- Personal Protective Equipment
- Chain of Transmission
- Environmental Cleaning
- Risk assessment
- Additional Precautions