3
Precautions
1. To ensure the challenge pack delivers the intended challenge:
• DO NOT OPEN challenge pack prior to sterilization;
• DO NOT reuse challenge pack.
2. DO NOT use the challenge pack to monitor sterilization cycles which it is not designed
to challenge:
a. Gravity-displacement steam sterilization cycles;
b. 250°F (121°C) dynamic-air-removal steam sterilization cycles;
c. 270°F (132°C) dynamic-air-removal steam sterilization cycles having exposure times
<4 minutes or 275°F (135°C) dynamic-air-removal steam sterilization cycles having
exposure times <3 minutes;
d. Dry heat, chemical vapor, ethylene oxide or other low temperature
sterilization processes.
3. To reduce the risk associated with incorrect results:
• Do not place tape or labels on 1492V BI prior to incubation.
• Do not incubate a 1492V BI if, after processing and before BI activation, it is observed to
have a broken media ampoule. Retest the sterilizer with a new challenge pack.
• After processing, allow BI to cool for 10 minutes before incubation.
• After BI activation, ensure media has flowed to the spore growth chamber.
Monitoring Frequency
Follow facility Policies and Procedures which should specify a biological indicator monitoring
frequency compliant with professional association recommended practices and/or national
guidelines and standards. As a best practice and to provide optimal patient safety, 3M
recommends that every steam sterilization load be monitored with a biological indicator in an
appropriate Process Challenge Device (i.e., BI challenge test pack).
Directions for Use
1. Place an Attest™ Super Rapid Readout Steam Challenge Pack 1496V flat, with the
label side up, in a full load in the most challenging area for the sterilant to reach. This is
generally on the bottom shelf, over the drain. Do not place objects (i.e., another pack) on
top of the challenge pack. This will create too great of a challenge for air removal and
steam penetration.
2. Process the load according to established procedures.
3. After completion of the cycle, while wearing heat resistant gloves, retrieve the
challenge pack.
4. Check to see that the external process indicator on the outside of the challenge pack has
changed from yellow to brown or darker. Open the challenge pack and allow the 1492V BI to
cool outside the challenge pack for 10 minutes prior to activation.
5. Remove the record keeping card from inside the challenge pack. Check the chemical
indicator bar on the record keeping card. A color change from yellow to brown or darker
confirms the pack has been exposed to the steam process.
6. Check the process indicator on the top of the 1492V BI cap. A color change from pink to
light brown or darker confirms that the biological indicator has been exposed to the steam
process. This color change does not indicate that the steam process was sufficient to
achieve sterility. If the process indicator is unchanged, check the sterilizer physical monitors.
7. Identify the processed 1492V BI by writing the sterilizer, load number, and processing date
on the indicator label. Do not place another label or indicator tape on the biological indicator.
8. For a permanent record, fill out the required information on the record keeping card. Record
the 1492V BI result when available.
