The Centers for Disease Control recommend at least weekly biological monitoring for dental offices and monthly monitoring for medical offices and tattoo shops.  

According to the CDC Guidelines for Disinfection and Sterilization 2008:

Use biologic indicators to monitor the effectiveness of sterilizers at least weekly with an FDA-cleared commercial preparation of spores (e.g., Geobacillus stearothermophilus for steam) intended specifically for the type and cycle parameters of the sterilizer. Category IB. 1

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003

According to AAMI: 10.5.3.2 Using biological indicators

Biological indicators should be used within PCDs (see 10.5.4, 10.7.2.1, 10.7.3.1, 10.7.4.1) for routine sterilizer efficacy monitoring at least weekly, but preferably every day that the sterilizer is in use (see 10.7). Additionally, BIs within PCDs should be used to monitor every load containing implants (see 10.6.1); implants should be quarantined until the results of the BI testing are available (CDC, 2008).

 It is recommended for veterinary offices to perform biological monitoring although a frequency is not stated.  However, testing requirements may vary according to state and it is recommended to check with your state regulatory authority for testing requirements.

The number of instruments per pouch will vary depending on the shape and size of the instruments as well as the size of the pouch.  Instruments should not overlap in the pouch.  The pouch should lay flat with no overlapping or crowding at the borders leaving at least a finger width space available on the sides and a 1 inch space available at the top of the pouch.  Overloading a pouch may cause a breach in integrity (seam break and/or tears) and may not allow the sterilant to circulate freely and fail to reach all surfaces of all instruments enclosed. Crosstex manufacturer’s pouches in numerous sizes and shapes from 2.25” x 4” up to 12” x 18”—so ensure you are starting with the best product to suit your needs.

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003

The CDC recommends cleaned instruments should be assembled into sets or trays, and wrapped or packaged for sterilization with an internal chemical indicator placed in every package.  Sure-Check Pouches with built in internal and external indicators are recommended for every load of instruments and will provide a definitive color change when two or more of the parameters for sterilization have occurred (time, temperature, steam).  Type 5 chemical indicators as defined by the Food and Drug Administration and the International Standards Organization contain a steam sensitive material that sequentially moves across the strip into a safe zone indicating all parameters of sterilization (time, temperature, steam) have been met.  The STEAMPlus Integrator is an example of a Type 5 chemical indicator and is intended for once a day use and for use in every load containing an implantable device.  The benefit of Type 5 indicators is the ability to provide a distinct pass/fail result providing the confidence of sterility prior to releasing the load.  Type 5 indicators closely mimic biological monitoring but since they do not contain spores, will not replace the need for weekly biological testing.

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003

In the event of a positive spore test, the CDC recommends:

• Take the sterilizer out of service until the cause of failure is determined. A single positive spore test probably does not indicate sterilizer malfunction. However, once a failure is detected, the sterilizer cannot be considered safe to use until the problem is identified and resolved.
• Review sterilization procedures (packaging, loading)  and  all records of chemical and mechanical monitoring since the last negative BI
• Retest sterilizer using the same cycle and approximate load and observe cycle. Observe the sterilizer physical monitoring devices to determine whether proper sterilizing conditions are indicated.
• If the spore test result is negative and if the chemical indicators have changed appropriately, the sterilizer may be put back into service.
• If the repeat BI test is positive and the processing procedures are being performed correctly, the sterilizer should remain out of service until it has been inspected, repaired, and challenged with BI tests in three consecutive loads (Gravity displacement sterilizers full load chamber and Type B sterilizers empty chambers)

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003

Sterility assurance consists of a combination of process parameters including physical, chemical and biological monitoring.

Two types of chemical indicators exist for instrument packaging.  External indicators, like autoclave tape, that change color after a certain temperature has been reached is known as a process indicator. This identifies packages that have been heat processed and those that have not. These indicators do not signify sterilization has been met.

Multi-parameter indicators respond to a combination of time and temperature or time, temperature and presence of steam. These indicators may be strips placed in a package or Sure-Check pouches with a built in multi-parameter indicators.

Instrument pouches with built-in external and internal indicators that have shown a distinct color change following the sterilization cycle indicate the sterilant has penetrated the package.  Multi-parameter indicators are a more reliable indicator and are only available for steam sterilizers. 

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003

Drying pouches and packs inside the steam sterilizer is important to maintain the sterility of the instruments.  The paper side of pouches is fragile when wet and can easily tear or be punctured, causing contamination of the instruments. Wet packs exposed to the surfaces outside of the sterilizer may result in wicking; this process allows microorganisms from the air, spatter, fingers or countertop to penetrate the wet paper and contaminate the instruments. Pouches and packs should be allowed to dry completely in the sterilizer before removing for storage.

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003