Steam sterilization

Purchasing a steam sterilizer

There are three key requirements that a table-top steam sterilizer must have:

1. Health Canada approval and classification
   Any sterilizer sold in Canada must be approved and classified by Health Canada otherwise it cannot be used in Canada.
2. Canadian Standard Association (CSA) electrical safety inspection sticker
   Any sterilizer sold in Canada must pass the CSA electrical safety requirements.
3. Manufacturer’s instructions (MIFU) indicate that sterilizer can reprocess packaged and lumened/cannulated medical devices. The sterilizer must be able to sterilize packaged medical devices.

Note: Registrants should be wary of purchasing a sterilizer online or second-hand. The same requirements described above apply.

Checklist for purchasing a table-top steam sterilizer

Maintaining the steam sterilizer

Sterilizer manufacturers have specific requirements for regular cleaning and maintenance of the sterilizer. The requirements can be found in user manuals or MIFU.

Regular cleaning and maintenance of a sterilizer must be documented. Current standards require that sterilizers are regularly serviced by a qualified technician. It is recommended that a sterilizer gets serviced annually if it is more than ten years old.

Record keeping and managing sterilization failure

Current standards for reprocessing medical devices require that all health-care settings carefully document the sterilization process. Documentation shows that all required parameters were met.

In the event of a steam sterilization cycle failure, sterilization load records allow clinic staff to track and retrieve any devices affected by the failure.

Sample documentation of steam sterilization failure and recall

Storage

Storage of sterile packages must keep the packages free from contamination or damage.

Requirements for sterilized packaged devices

• Store in an area that is clean and dry (e.g. the garbage or dirty utility room is not acceptable)
• Store in enclosed space (e.g. cupboards and drawers) to reduce dust and debris exposure; if necessary, a clean bin with a lid may be used to store sterile packages
• Do not store near sinks or water source due to risk of splash or spray
• Do not store under sink or in office, lab, or high-traffic areas
• Do not store in cardboard boxes. Cardboard cannot be cleaned properly and can create dust and contamination

Reprocessing off-site

Using another health-care setting sterilizer

Some physicians use a steam sterilizer in another office or health-care setting.

Off-site reprocessing is only acceptable if the off-site sterilizer is in a health authority clinic, hospital or another physician office which has undergone (or will undergo) a POMDRA assessment.

Health authorities assess and monitor reprocessing practices in their clinics and hospitals. For other health-care professionals (e.g. dentists), the College does not oversee their MDR practices and therefore are not acceptable as off-site reprocessors for physician use.

If a physician uses an off-site reprocessor the following will apply:

• The physician and/or clinic who owns the table-top steam sterilizer must be assessed with regard to their reprocessing practices by one of the following:
  • local health authority
  • the College Non-Hospital Medical and Surgical Facilities Accreditation Program
  • POMDRA
• The physician and/or clinic must be in compliance with all requirements of the assessment process prior to allowing a colleague to use their sterilizer.
• The originating physician and the physician who owns the sterilizer must obtain and retain copies of all records of sterilization, sterilization monitoring and sterilizer maintenance.
• A physician using a steam sterilizer belonging to another colleague or clinic must complete a POMDRA assessment of all reprocessing practices which are completed in their office or clinic. Examples include storage, cleaning and packaging if applicable.