In Canada, CSA standards and most provincial infection prevention and control (IPAC) guidelines require biological monitoring (spore testing) daily, and with each type of sterilization cycle used.

Requirements may vary slightly depending on the province and practice setting.

Spore tests should also be performed:

• After installing or relocating a sterilizer.
• Following sterilizer malfunctions or major repairs.
• After a failed sterilization cycle.
• With every load containing implantable devices.
• When changing packaging materials, cassettes, or trays.
• After training new staff in instrument reprocessing.
• Following changes to sterilization procedures or load configuration.

Always follow applicable local infection-control requirements.

For routine testing, the BI should be placed in a standard load to simulate normal operating conditions.

Follow the sterilizer manufacturer's instructions and the applicable biological indicator instructions for use.

Place the BI in the most challenging area of the sterilizer chamber, where air removal and steam penetration are most difficult.

Follow the sterilizer manufacturer's instructions for the recommended BI placement.

Medicom recommends alternating the BI placement location periodically.

In Canada, the BI must be placed inside a Process Challenge Device (PCD) or BI challenge test pack.

The PCD or challenge test pack may be commercially purchased or assembled in-house using a pouch or cassette, according to the applicable instructions.

Label the vials with:

• Date
• Sterilizer number or identifier
• Load or cycle number

The control vial should be clearly identified as "CONTROL".

The control vial confirms that the spores in the biological indicator are viable and that the incubation conditions are capable of supporting growth.

The control vial is not processed through the sterilizer.

A control vial should be used with every BI test.

The control should come from the same BI lot as the test vial and should be incubated under the same conditions.

Yes, when the test vials are processed at approximately the same time and will be incubated together.

If tests are performed at different times and incubated separately, a new control vial should be used.

The AssureCheck™ 10H BI is compatible with steam sterilizers, including:

• Gravity displacement sterilizers
• Pre-vacuum / dynamic air removal sterilizers
• SFPP (steam-flush pressure-pulse) sterilizers

The AssureCheck™ 10HR BI is validated for use with the AssureCheck™ Dry Block Incubator.

If another incubator is used, it must reliably maintain 60°C ±2°C.

BI vials should ideally be crushed and incubated within 2 hours after the sterilization cycle ends.

Wait until all test vials from the same test batch are ready so that they can be incubated together with the control vial.

Allow the processed BI vial to cool for at least 10 minutes before crushing.

Cooling reduces internal pressure and helps prevent breakage.

Yes. The control vial should be incubated at the same time and under the same conditions as the test vials.

The correct incubation temperature is 60°C ±2°C.

Incubate the AssureCheck™ 10HR BI for the full 10-hour incubation period.

Yes. Even if a color change appears after only a few hours, the BI must complete the full 10-hour incubation period.

Allow the incubator to warm up for at least 20 minutes before use, according to the applicable instructions.

A flashing LED generally indicates that the incubator is still warming up.

When sterilization fails, the BI changes from purple to yellow after incubation.

The yellow color indicates microbial growth.

If the control vial remains purple, the test is considered invalid.

This may indicate that the spores were not viable or that the incubation conditions were not appropriate.

A brownish or bourbon-colored appearance may indicate partial growth or an incubation issue.

If the control result is unclear, the test should not be considered valid until the manufacturer's troubleshooting instructions have been followed.

Cloudiness may occur as a result of microbial growth or contamination.

Cloudiness alone should not be used to determine the final result. Evaluate the color change and control result according to the manufacturer's instructions.

Clearly label the vials before incubation.

• Control vial: should show the expected positive growth result.
• Test vial: remains purple when sterilization is successful.
• Test vial: turns yellow when sterilization fails.

If an initial BI test fails:

1. Stop using the sterilizer.
2. Notify the Infection Control Lead or responsible person.
3. Quarantine instruments from the failed load and affected loads as appropriate.
4. Review sterilizer operation, loading, packaging, and processing procedures.
5. Correct any identified problems.
6. Reprocess the instruments using the appropriate sterilization cycle.
7. Repeat testing using physical, chemical, and biological indicators.

1. Remove the sterilizer from service.
2. Recall instruments processed since the last confirmed negative BI result, according to applicable procedures.
3. Reprocess instruments using a functioning alternate sterilizer.
4. Have the sterilizer inspected and repaired by a qualified technician.
5. After repair, perform three consecutive standard-load cycles.
6. Include a new BI and chemical indicators in each cycle.
7. The sterilizer should only return to service after all three BI tests pass.

No.

A passing BI is an important part of sterilization monitoring, but it does not guarantee that every instrument in the load is sterile.

Proper cleaning, packaging, loading, sterilizer operation, and mechanical and chemical monitoring are also essential.

Maintain records of each biological monitoring test, including:

• Date and time
• Sterilizer identification
• BI lot number
• Test result
• Control result
• Name or identification of the person performing the test

Medicom recommends retaining these records for at least 3 years, or according to applicable local regulatory requirements.

Vials that remain purple after incubation can be disposed of according to applicable waste procedures.

Vials that show growth and become yellow should be placed in a sterilization pouch and reprocessed in the sterilizer according to the manufacturer's instructions before disposal.

No. The spores used in the BI are non-pathogenic and classified as Biosafety Level 1.

Standard precautions should nevertheless be followed when handling biological indicators.

Store the biological indicators in a cool, dry place.

Keep the BIs away from:

• Direct sunlight
• Excessive heat
• Moisture
• Chemicals

Always follow the storage conditions specified on the product packaging and Instructions for Use.