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3M™ Attest™
a
Super Rapid Readout Steam Challenge Pack 1496V
Product Description
The 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V is specifically designed
to qualify and monitor dynamic-air-removal steam sterilization processes at 270°F (132°C) and
275°F (135°C) in healthcare facilities. The challenge pack consists of multiple layers of medical
index cards, some of which are die-cut to contain the biological indicator. The stacked cards are
wrapped with a sterilization wrap. Each challenge pack has a process indicator on the pack label
that changes from yellow to brown or darker when exposed to steam. This convenient disposable
challenge pack presents a challenge to the sterilization process equivalent to the user-assembled
biological indicator (BI) challenge test pack (towel PCD) recommended by the Association for the
Advancement of Medical Instrumentation (AAMI). The challenge pack is a single use device.
Each challenge pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V
(brown cap), hereinafter referred to as a 1492V BI, and a record keeping sheet. When steam
processed, the process indicator bar printed on the record keeping sheet turns from yellow to
brown or darker and the process indicator on the top of the 1492V BI cap changes color from
pink to light brown or darker. The 1492V BI is a self-contained dual readout biological indicator
specifically designed for rapid and reliable monitoring of the steam sterilization process when
used in conjunction with the 3M™ Attest™ Auto-reader 490 (hereinafter referred to as the
490 Auto-reader), a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater
(hereinafter referred to as the 490H Auto-reader), or a 3M™ Attest™ Mini Auto-reader 490M
(hereinafter referred to as the 490M Auto-reader). 3M™ Attest™ 1492V biological indicator
controls are provided with the challenge packs.
The 1492V BI utilizes the α-glucosidase enzyme system, which is generated naturally within
growing cells of Geobacillus stearothermophilus. The α-glucosidase in its active state is detected
by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent
substrate, 4-methylumbelliferyl-α-D-glucoside (MUG). The resultant fluorescent by-product,
4-methylumbelliferone (MU), is detected in the Auto-reader. The presence of fluorescence within
the specified incubation time of the 1492V BI in the 490, 490H, or 490M Auto-reader indicates a
steam sterilization process failure.
The 1492V 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
metabolic 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.
1492V BIs meet ISO 11138-1:2017 and ISO 11138-3:2017.
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