3M 1291 - INDICATOR, STEAM STERILIZER, RAPID READ, 200 EA/CS, 4 BX/CS
3M Attest Rapid Readout Biological Monitoring System 1291
The 3M Attest 1291 Rapid Readout Biological Indicator (blue cap) is a dual readout biological indicator system specifically designed for rapid and reliable monitoring of the 270F (132C), gravity steam sterilization process when used in conjunction with either the 3M Attest 290 Auto-reader or the 3M Attest Auto-reader 390. The sterilizer must have a 1.5 minute come-up time to kill the 3M Attest 1291 Rapid Readout Biological Indicator in 3 minutes. If the come-up time is < 1.5 minutes, extend the cycle time to 4 minutes to achieve consistentkill.
The 3M Attest 1291 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.
- Provides results in one hour
- Self-contained biological indicators significantly reduce possibility of contamination, minimizing false positives and assuring more accurate results
- Faster result time, making it possible to quarantine every load and eliminate recalls
- System can help reduce the costs associated with fighting infections - cost measured in both dollars and time spent
- Color-coded for quick reference and easy use
The 3M Attest 1291 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 1-hour fluorescent results, however, there is no advantage to incubating the Attest 1291 Rapid Readout Biological Indicator beyond 1 hour.
Why wait 24 hours for biological results?
The difference between Conventional BI Technology and Rapid Readout BI Technology!
Advantages of 3M Attest Rapid Readout technology over conventional Biological Indicators
Fast Results
3M Attest Rapid Biological Indicators indicate microorganism activity faster than conventional biological indicators. Only 3M Attest Rapid Readout biological indicators can detect microorganism activity as early as 1 hour (1291 steam), 3 hours (1292 steam) or 4 hours (1294 EO) compared to conventional biological indicators which take 2448 hours of incubation.
Efficient
3M Attest Rapid Readout biological indicators can detect cycle failures faster than the conventional biological indicator. It allows customers to detect malfunctioning equipment sooner, and put sterilizers back into service sooner.
Helps to Reduce Risk
With faster results, you can make decisions and take action prior to surgery which may reduce the risk and cost associated with surgical infections.
Helps Reduce Recalls
When each load is monitored with a 3M Attest Rapid Readout biological indicator and quarantined until results are available, recalls may be reduced.
Biological indicators provide the best assurance of sterility by challenging the steam sterilizer with quantifiable, highly resistant Geobacillus stearothermophilus spores. The system includes Rapid Readout biological indicators, disposable test packs, an auto-reader and log books. Biological indicators are used for load control monitoring which is the process by which a load is monitored and released based on the result of a biological indicator (BI) in a test pack.
3M Attest 1291 Rapid Readout Biological Indicators for 132C/270F gravity displacement cycles Self-contained BI for gravity displacement cycles consisting of a Geobacillus stearothermophilus spore strip; sealed glass ampule with growth medium and dual indicator system; blue color-coded cap with holes for sterilant penetration and a filter as a bacterial barrier; and a chemical indicator on the label that changes from rose to brown when processed. After sterilization, the vial is "crushed" to join the growth media with the processed spore strip. The BI is incubated for one hour in the 3M Attest 290 Series Auto-reader for a fluorescent reading. Note: This product must be used with Cat. No. 290 3M Attest Auto-reader. Contact 3M Health Care sales rep for details.
Indications for Use
Use the 3M Attest 1291 Rapid Readout Biological Indicator to monitor 132C (270F) gravity steam sterilization cycles.
Suggested Applications
Monitoring 270F/132C gravity displacement steam 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.
Validation of Reduced Incubation Time (Readout Reliability Data)
The 1-hour and 24-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 1-hour fluorescence change reading and the 24-hour visual pH color change readings were compared to the 7-day visual pH color change readings to determine the readout reliability of the indicator. Readout reliability of the Attest 1291 rapid readout biological indicator was determined using the sensitivity calculation described below:
Attest 1291 Rapid Readout Biological Indicators 132C (270F) Gravity Displacement Steam Sterilization Process Validation of Reduced Incubation Time - Readout Reliability Summary
These data demonstrate that = 97% of the 7-day (i.e. 168 hours) growth visual positives were detected by fluorescence within 1 hour of incubation and by the visual pH color within 24 hours of incubation. The 3M Attest 1291 Rapid Readout Biological Indicator therefore meets readout reliability of =97% for the 1-hour fluorescence results and the 24-hour visual color change results.
Warnings
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 heat-resistant 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 3M Attest 1291 Rapid Readout Biological Indicator to monitor sterilization cycles which it is not designed to challenge:
- 132C (270F) or 121C (250F) vacuum-assisted steam sterilization cycles.
- 121C (250F) gravity steam sterilization cycles.
- Dry heat, chemical vapor, ethylene oxide or other low temperature sterilization processes.
Disposal
Dispose of used Attest rapid readout biological indicators according to your healthcare facilitys policy. You may wish to sterilize any positive biological indicators at 132C/270F for 10 minutes in a gravity- displacement steam sterilizer prior to disposal.
Storage
- Best stored in the original box under normal room conditions: 15-30C (59-86F) and 35-60% relative humidity.
- Do not store these biological indicators near sterilants or other chemicals.
Specifications
Commonly Asked Questions
Question:
Is the Attest rapid readout biological indicator a chemical or biological indicator?
Answer: The Association for the Advancement of Medical Instrumentation (AAMI) defines a biological indicator as a monitoring device consisting of a standardized, viable population of microorganisms known to be resistant to the mode of sterilization being monitored. Since viable Geobacillus stearothermophilus spores are required for the Attest 1291 and rapid readout determinations, this product meets the criteria for the AAMI definition of a biological indicator. Additionally, this product is classified as biological sterilization process indicators to be used to monitor the adequacy of the sterilization process by the Food and Drug Administration (FDA). Attest rapid readout biological indicators are biological not chemical indicators.
Question:
How long can you delay incubation of the Attest biological indicator?
Answer: We recommend a biological indicator be incubated as soon as possible so the results can be obtained sooner. 3M has not done testing to determine how long incubation can be delayed. However, there is some data on other self-contained biological indicators that suggest incubation can be delayed for up to 5 days (Graham, G.S., and C.A. Boris, Chemical and Biological Indicators, Chapter 3, Sterilization Technology. Edited by Morrisey and Phillips, 1993:36-39)
