7. When the biological indicator is contained in a test pack or other heat absorbing packaging material, the test pack or any other heat absorbing packaging material should be
removed from the sterilizer and opened up for 5minutes to dissipate heat prior to removing the biological indicator. Then allow the biological indicator to cool outside the test pack
for an additional 10minutes prior tocrushing.
8. Check the throughput chemical indicator (CI) on the label of the biological indicator. A color change from rose to brown confirms that the biological indicator has been exposed to the
steam sterilization process. This CI color change does not indicate that the sterilization process was sufficient to achieve sterility. If the chemical indicator is unchanged, check the
sterilization process monitoring controls and investigate placement of the biological indicator in thesterilizer.
9. While wearing safety glasses, press the cap down. Crush the glass ampoule of the biological indicator in the crusher well of the auto‑reader. Hold the biological indicator by the
cap and tap on a hard surface, but not on the auto‑reader, until the media wets the strip at bottom of the vial. Then place the biological indicator in an auto‑reader incubation well
configured to incubate Attest™ 1292Rapid Readout Biological Indicators. See Attest™ Auto‑reader Operator’s Manual for furtherdetails.
10. Each day that a processed Attest™ 1292Rapid Readout Biological Indicator is incubated, crush, tap and incubate at least one non‑processed Attest™ 1292Rapid Readout
Biological Indicator to use as a positive control. Write a “C” (for “control”) and the date on the label. The positive control should be from the same manufacturing date and lot number
as the processed biological indicator. Incubating a positive control helpsensure:
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correct incubation temperatures aremet,
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viability of spores have not been altered due to improper storage temperature, humidity or proximity tochemicals,
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capability of media to promote rapid growth,and
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proper functioning of Attest™Auto‑reader.
11. Incubation andReading:
Incubate the positive control and sterilized Attest™ 1292Rapid Readout Biological Indicators for 3hours at 60± 2°C (140± 3°F) in a 3M™Attest™ 290Auto‑reader or a
3M™Attest™ Auto‑reader 390. See the applicable auto‑reader Operator’s Manual for the proper use of this equipment. The auto‑readers automatically take readings and indicate
a positive result as soon it is obtained. The final fluorescent negative biological indicator reading is made at 3hours. After the final reading is obtained the biological indicators may
bediscarded.
The processed biological indicator and the positive control may also be further incubated at 60°C for a visual pH color change. Examine the biological indicators for early detection
of positive results (media turns yellow) at convenient time intervals such as 12, 18and 24hours. The final negative reading (media remains purple) for a visual pH color change is
made at 48hours. The positive control should show a yellow color change of the growth media within 48hours.
Interpretation ofResults:
FluorescentResult
The positive (unprocessed) control biological indicator must provide a positive result [red light on the 3M™Attest™ 290Auto‑reader or plus symbol (+) on the LCD display of the
3M™Attest™ Auto‑reader 390]. If the positive biological indicator control reads negative [green light on the 3M™Attest™ 290Auto‑reader or minus symbol (‑) on the LCD display
of the 3M™Attest™ Auto‑reader 390], refer to the applicable auto‑reader Operator’s Manual Troubleshooting section. Retest the auto‑reader with a new positive control biological
indicator. The processed biological indicator results are not valid until the positive biological indicator control readspositive.
With a processed biological indicator, a positive [red light on the 3M™Attest™ 290Auto‑reader or plus symbol (+) on the LCD display of the 3M™Attest™ Auto‑reader 390]
means a sterilization process failure has occurred. A negative [green light on the 3M™Attest™ 290Auto‑reader or minus symbol (‑) on the LCD display of the 3M™Attest™
Auto‑reader 390] after 3hours of incubation indicates an acceptable sterilizationprocess.
pH Color Change Result(Optional)
The appearance of a yellow color in the processed indicator demonstrates bacterial growth and a sterilization process failure. No color change (i.e. media remains purple) indicates
an adequate sterilization process. A final negative result is made after 48hours of incubation. The positive control indicator should show a color change from purple to yellow for the
processed indicator results to bevalid.
12. Immediately act on any positive biological indicator results. Always retest the sterilizer and do not use sterilizer for processing loads until three consecutive biological indicator
results arenegative.
Disposal
Dispose of used Attest™ rapid readout biological indicators according to your healthcare facility’s policy. You may wish to sterilize any positive biological indicators at 121°C (250°F) for
≥ 30minutes in a gravity‑ displacement steam sterilizer or at 132°C (270°F) for ≥ 4minutes in a vacuum‑ assisted steam sterilizer prior todisposal.
Storage/ ShelfLife
•
Best stored under normal room conditions: 15‑30ºC (59‑86ºF) and 35‑60% relativehumidity.
•
Do not store these biological indicators near sterilants or otherchemicals.
•
Attest™ 1292rapid readout biological indicators have a 2‑year shelf life from the date of manufacture. The expiration date is indicated on the BI and packaging by the 4‑digit year
and 2‑digit month of expiration (e.g.2015‑05).
•
All of the information to the right of the lot‑in‑a‑box symbol indicates the lot number (e.g., 2015‑05AD).