3M™ Attest™ 1292 Rapid Readout Biological Indicator
Product Description
The 3M™ Attest™ 1292 Rapid Readout Biological Indicator (brown cap) is a dual readout biological indicator system specifically designed for rapid and reliable monitoring of steam
sterilization processes when used in conjunction with the 3M™ Attest™ 290 Auto‑reader or the 3M™ Attest™ Auto‑reader 390.
The Attest™ 1292 Rapid Readout Biological Indicator detects the presence of Geobacillus stearothermophilus by detecting the activity of alpha‑glucosidase, an enzyme present within
the organism. The presence of the enzyme is detected by reading fluorescence produced by the enzymatic breakdown of a non‑fluorescent substrate. This creates a fluorescence
change, which is detected by the auto‑reader. A fluorescence change indicates a steam sterilization process failure.
The Attest™ 1292 Rapid Readout Biological Indicator also detects the presence of G. stearothermophilus organisms by a visual color change reaction. Biochemical activity of the G.
stearothermophilus organism produces acid by‑products that cause the media to change color from purple to yellow. A visual pH color change also indicates a steam sterilization process
failure. Due to the high sensitivity of the 3‑hour fluorescent results, however, there is no advantage to incubating the Attest™ 1292 Rapid Readout Biological Indicator beyond 3 hours.
Indications
Use the Attest™ 1292 Rapid Readout Biological Indicator to monitor:
1. 250°F (121°C) gravity steam sterilization cycles.
2. 270°F (132°C) vacuum assisted steam sterilization cycles.
Contraindications
None.
Warning
There is a glass ampoule inside the plastic vial of the biological indicator. To avoid the risk of serious injury from flying debris due to a ruptured biological indicator:
•
Allow the biological indicator to cool for the recommended time period before crushing. Crushing or excessive handling of the biological indicator before cooling may cause the
glass ampoule to burst.
•
•
•
•
•
Wear safety glasses and gloves when removing the biological indicator from the sterilizer.
Wear safety glasses when crushing the biological indicator.
Handle the biological indicator by the cap when crushing and tapping.
Do not use your fingers to crush the glass ampoule.
Do not roll the biological indicator between fingers to wet the spore strip.
Precautions
Do not use the Attest™ 1292 Rapid Readout Biological Indicator to monitor:
1. 250°F (121°C) vacuum assisted steam sterilization cycles.
2. 270°F (132°C) gravity steam sterilization cycles.
3. Dry heat, chemical vapor, ethylene oxide or other low temperature sterilization processes.
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 an appropriate
biological indicator.
Directions for Use
1. Identify the Attest™ 1292 biological indicator by writing the sterilizer and load ID number and processing date on the indicator label. Do not place another label or indicator tape on
the vial or on the cap.
2. Place the Attest™ 1292 biological indicator in an appropriate process challenge device according to recommended practices. Do not place the Attest™ 1292 biological indicator in
direct contact with a chemical indicator. Fluorescent residue could transfer to the biological indicator and affect the result.
Appropriate process challenge devices for loads containing:
a. Fabric packs run at 250°F (121°C) for ≥40 minutes in a gravity displacement cycle or at 270°F (132°) for ≥4 minutes in a vacuum assisted cycle:
‑
Place an Attest™ 1292 biological indicator in an AAMI 16 towel pack.
b. Wrapped hard goods run at 250°F (121°C) for ≥20 minutes in a gravity displacement cycle:
Place an Attest™ 1292 biological indicator in a wrapped hard good item (e.g., instrument set) from the load.
c. Wrapped hard goods run at 270°F (132°C) for ≥4 minutes in a vacuum assisted sterilizer:
‑
‑
‑
Place an Attest™ 1292 biological indicator in a wrapped hard good item (e.g., instrument set) from the load.
Place an Attest™ 1292 biological indicator in an AAMI 16 towel pack.
d. Single wrapped hard goods run at 270°F (132°C) for ≥4 minutes in an express vacuum assisted cycle:
‑
Place an Attest™ 1292 biological indicator in a single wrapped hard goods item (e.g., instrument tray) from the load. Check recommendations of the manufacturer before
processing items with lumens or porous materials.
e. Unwrapped hard goods with no porous items run at 250°F (121°C) in a gravity displacement cycle for ≥ 15 minutes or 270°F (132°C) for ≥ 3 minutes in a vacuum
assisted sterilizer:
‑
Place an Attest™ 1292 biological indicator in unwrapped instrument hard good item (e.g., instrument set) from the load. AAMI suggests placing a biological indicator in an
empty tray.
f. Unwrapped metal hard goods with porous items run at 270°F (132°C) for ≥ 4 minutes in a vacuum assisted sterilizer:
‑
Place an Attest™ 1292 biological indicator in an unwrapped instrument hard goods item (e.g., instrument tray) from the load, including porous items. AAMI suggests placing a
biological indicator in an empty tray but include porous items if applicable.
g. Container systems run at 250°F (121°C) for ≥ 40 minutes in a gravity cycle or 270°F (132°C) for ≥ 4 minutes in a vacuum assisted cycle:
Place the Attest™ 1292 biological indicator in the areas determined by product testing to provide the greatest challenge to the sterilization process.
‑
3. Place the test tray or package in the most challenging area for the sterilant. This is typically on the bottom shelf, near the door and over the drain.
4. Process the load according to recommended practices.
5. After completion of the cycle, fully open the sterilizer door for a minimum of 5 minutes prior to removing the Attest™ 1292 biological indicator.
6. When the biological indicator is not contained in a test pack or other heat absorbing packaging material, remove the biological indicator from the sterilizer and allow it to cool for an
additional 10 minutes prior to crushing.
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Validation of Reduced Incubation Times (Readout Reliability Data)
The 3‑hour and 48‑hour incubation times have been correlated with a 7‑day incubation period. Sterilized indicators were examined daily for detection of a visual pH color change. The
3‑hour fluorescence change reading and the 48‑hour visual pH color change reading were compared to the 7‑day visual pH color change readings to determine the readout reliability of
the indicator. Readout reliability of the Attest™ 1292 rapid readout biological indicator was determined using the sensitivity calculation described below:
Sensitivity = (Number of Growth Positives after 168 hours) – (Number of False Negatives) X 100
Number of Growth Positives after 168 Hours
Attest™ 1292 Rapid Readout Biological Indicators
121°C (250°F) Gravity Displacement and 132°C (270°F) Vacuum Assisted
Steam Sterilization Processes
Validation of Reduced Incubation Time ‑ Readout Reliability Summary
Growth
Fluorescence
# Growth
Positives at
168 hours
Sterilization
Process
Incubation
#
# False
# False
Sensitivity
Sensitivity
at 3 hours
Temperature Tested
60°C (140°F) 1620
60°C (140°F) 1270
Negatives at
48 hours
Negatives at
3 hours
at 48 hours
121°C (250°F)
Gravity
800
654
5
99.4
99.7
0
100
100
Displacement
132°C (270°F)
Vacuum
2
0
Assisted
These data demonstrate that ≥ 97% of the 7‑day (i.e. 168 hours) growth visual positives were detected by fluorescence within 3 hours of incubation and by the visual pH color within
48 hours of incubation. The 3M™ Attest™ 1292 Rapid Readout Biological Indicator therefore meets readout reliability of ≥ 97% for the 3 hour fluorescence results and the 48 hour
visual color change results.
Explanation of Symbols
Caution, see instructions for use
Do not reuse
Use by date
Batch code
Manufacturer
Catalog number
For France and other countries that
recognize the CE mark for this device.
Made in U.S.A. by
3M Health Care
2510 Conway Ave.
St. Paul, MN 55144
1‑800‑228‑3957
3M Deutschland GmbH
Health Care Business
3M and Attest are trademarks of 3M.
Used under license in Canada.
© 2013, 3M. All rights reserved.
Carl‑Schurz‑Str. 1
41453 Neuss
Germany
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