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Use the 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382 to qualify or monitor: · 121°C (250°F) 30-minute gravity steam sterilization cycles; · 132°C (270°F) 4-minute dynamic-air-removal steam sterilization cycles.

The 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382 is specifically designed to qualify and monitor 250°F (121°C) gravity and 270°F (132°C) dynamic-air-removal steam sterilization processes in healthcare facilities. The test pack consists of multiple layers of medical index cards, some of which are die-cut to contain the monitoring products. Each test pack has a process indicator on the pack label that changes from yellow to brown or darker when exposed to steam. This convenient disposable test pack presents a challenge to the sterilization process equivalent to the user-assembled biological indicator (BI) challenge test pack (16-towel PCD) recommended by the Association for the Advancement of Medical Instrumentation (AAMI). The test pack is a single use device. Each test pack contains a 3M™ Attest™ Rapid Readout Biological Indicator 1292 (brown cap, hereinafter referred to as a 1292 BI), a 3M™ Attest™ Steam Chemical Integrator, and a record keeping sheet. AAMI recommends that steam sterilization loads containing an implant be monitored with a process challenge device (PCD) containing a biological indicator and an integrating indicator. 3MTM Attest™ Steam Chemical Integrators are Type 5 (Category i5) Integrating Indicators as categorized by ISO 11140-1:2014. 3M™ Attest™ Steam Chemical Integrators are single-use chemical indicators consisting of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a green window marked ACCEPT or a red window marked REJECT; the extent of migration depends on steam, time, and temperature. The 3MTM AttestTM Steam Chemical Integrator offers an immediate Accept/Reject reading that allows for implant load early release in emergency situations as defined in AAMI ST-79. 3M™ Attest™ Rapid Readout Biological Indicators 1292 comply with the requirements of ISO 11138-1:2017 and ISO 11138-3:2017. The 1292 BI is a dual readout biological indicator specifically designed for rapid and reliable monitoring of steam sterilization process when used in conjunction with the 3MTM Attest™ 290 Auto-reader or the 3M™ Attest™ Auto-reader 390. When steam processed, the process indicator on the 1292 BI label changes from rose to brown/black. Control 1292 BIs are provided with the test packs. The 1292 BI 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 1292 BI can also indicate the presence of G. stearothermophilus organisms by a visual pH 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, which also indicates a steam sterilization process failure. Use of this indication method is optional and is typically restricted to special studies. Due to the high sensitivity of the 3-hour fluorescent results, however, there is no advantage to incubating the 1292 BI beyond 3 hours.