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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 1492V BI to cool for 10 minutes before incubation.
•
After 1492V BI activation, ensure media has flowed to the spore growth chamber.
•
DO NOT re-incubate 1492V BIs for which the 490 or 490H Auto-reader has already determined
a result.
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 a 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V flat, with the label side
up, in the most challenging area for the sterilant to reach. This is generally on the bottom shelf, over
the drain. Do not place objects (e.g. 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. Check the 3M™ Attest™ Steam Chemical Integrator. The dark color should have entered the green
ACCEPT window. If the dark color has not entered the green ACCEPT window, this indicates a red
REJECT result which means the load was not exposed to sufficient steam sterilization conditions.
This load should not be released for use but reprocessed. Record integrator result.
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. While it is best
practice to activate and incubate the 1492V BI as soon as it has cooled, the processed BI may be
held at room temperature for up to 7 days prior to activation and incubation.
8. If utilized, fill out the required information on the record keeping card. Record the 1492V BI result
when available.
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