Sterilization

Items That Must Be Sterilized

• Any item that pierces or penetrates the skin or mucous membranes such as eyes, nose, or mouth must be sterile. These items are called critical items.
• Critical items must be sterilized because they pose the highest risk of spreading infections.
• Needles, jewelry and forceps used in body piercing are examples of critical items.
• Ideally, any item that holds sterile items should be sterilized. At a minimum these items, are to be cleaned and high level disinfected.

Acceptable Sterilizers

• Steam sterilizers (also known as autoclaves) are preferred. Dry heat sterilizers are not recommended.
• Sterilizers must meet Health Canada standards and be approved by the Canadian Standards Association (CSA).
• Verify Health your sterilizer is approved by Health Canada Medical Devices Active License Listing.
• Sterilizers should provide a printout or have a digital display for time, temperature and pressure.
• Sterilizers should have a drying cycle for packaged instruments.

Using a Sterlizer

• Any item being sterilized must first be cleaned. An ultrasonic cleaner can be used to clean instruments before sterilization.
• All items must be packaged before being sterilized.
• Sterilizers must be monitored to ensure they are working properly.
• There are three types of monitoring that is required:

1. • Biological
   • Chemical
   • Physical

Biological monitoring

Biological monitoring (also known as spore testing) must be done at least once every 2 weeks. Best practice is to test the sterilizer daily.  

• When implantable devices are used in body modification, the load must have a biological test done. The load must be held until the results are available.

You must send the biological tests to a laboratory for testing. Choose a laboratory that will:

• Provide test results electronically (email, website) within 48 hours of incubation.
• Immediately contact you if there is a failed (positive) result.
• Maintain records including date of test, date of incubation, date the results are reported, identifiers such as lot numbers, and staff who ran the test.

Spore test results:

• A passed (negative) spore test means the sterilizer is working properly.
• A failed (positive) spore test means the sterilizer is not working properly.
• Keep copies of the spore test results for three years with a minimum of one year (365 days) on site.

**Do not use sterilized items or instruments until AFTER you receive the passed (negative) spore test results**

Three consecutive spore tests must be conducted if:

• The sterilizer fails a spore test.
• Mechanical malfunctions such as incorrect temperatures or times.
• A new sterilizer is used.
• The sterilizer has been repaired.
• The business moves to a new location.
• After power outages or emergencies such as fires, floods.

The sterilizer must not be used until the results of the tests are received and all pass (negative).

Chemical monitoring

Chemical monitoring must be done every time you use the sterilizer. There are two types of chemical monitoring indicators:

• Internal chemical indicator (minimum Type 4): These must be placed inside each and every package that is undergoing sterilization.
• External chemical indicator: These are to be used if the internal chemical indicator can not be seen in the package. External chemical indicators change colour when the item has gone through a cycle n the sterilizer, but does not tell you if it was sterilized properly.

If you are using a dynamic air removal-type sterilizer, then a Bowie Dick test is required.  Refer to your sterilizer’s manufacturer’s instructions for use for more information.

Physical monitoring

Physical monitoring means keeping a record for each load. You must sign and date printouts from the sterilizers after they are reviewed.

• If there are no printouts, you must write down the date, time, duration, amount of equipment, temperature, pressure and the person responsible for the sterilization load.
• These records must be kept for three years with a minimum of one year (365 days) on site.
• The date an item is sterilized must also be written on the package. Before writing, wait for the item to dry and be careful not to tear the package with your soft tip marker. A sticker can also be used with the sterilization date.

Failed Spore Tests

• Call your public health inspector or BodySafe at 416–338-BODY (2639)

Immediately discontinue the use of the sterilizer.

• Do not use items that were sterilized in the sterilizer since the last passed spore test.
• You can use any items sterilized during the time when the sterilizer passed the spore test or use purchased pre-packaged, single-use, sterile items.
• Conduct three consecutive spore tests. The sterilizer may need to be serviced as well.
• Review the spore test results. Ensure three passed (negative) spore tests are received and approval to use the sterilizer again is received.
• Reprocess any items that were sterilized after the last passed spore test.

Failed Chemical Indicator (Did Not Change Colour)

• Reprocess items immediately using another internal chemical indicator (type 4) and external chemical indicator if the internal indicator is not visible in the package.
• If the chemical indicator fails again:

• • Stop using items from the failed indicator tests and
  • Conduct a spore test right away.

• Use items reprocessed from the last passed spore test or use purchased, pre-packaged, sterile items until you get the spore test results.

Keep Records for Purchased Pre-Packaged and Sterile Items

• You must keep a record of all items purchased as pre-packaged, sterile and single-use.
• Record where, when and who the materials were purchased from for tracking purposes. A sample record is available.
• Keep these records for three years with a minimum of one year (365 days) on site.

Protect Sterile Items

• Open sterile, pre-packaged items in front of the client. Never place items onto any surface that itself is not sterile such as a tray or table.
• Do not spray sterile items with any disinfect or solution as it could compromise the sterility.
• Sterile items must be cleaned and re-sterilized if the packaging is no longer sealed or in good condition.
• Use only packaging materials that are specifically designed for the type of sterilizer being used.
• After sterilization, let the package dry thoroughly before handling. Handling wet or warm packages can compromise the sterility of the item.
• Do not write on the paper side of paper/plastic pouches as the pen may puncture the paper.  Unless the instructions say otherwise, you can write on the plastic using a felt-tipped marker.
• Packages should be stored at least 1 metre away from sinks, drains and moisture. Do not store items under a sink.
• Containers used for storage of sterile instruments should be moisture resistant and cleanable and be labelled “sterile items”.
• Items purchased as sterile must be used before the expiration date, if one is given.