3M 1298 - Attest Rapid Ethylene Oxide Biological Indicator Test Pack, 1298, Green Cap, 4 hr, 25/BX, 2 BX/CS

The pre-assembled, disposable 3M Rapid Ethylene Oxide Biological Indicator Test Pack 1298 is designed to present a resistant challenge to the ethylene oxide (EO, EtO) sterilization process as is the AAMI routine syringe test pack.

The test pack includes a 3M Attest Rapid Ethylene Oxide Biological Indicator, 1294, Green Cap, at the end of a tortuous path and a chemical process indicator on the outside of the pack. The pack is used to monitor ethylene oxide sterilization cycles, and the BI is compliant with ISO 11138-1:2017 and ISO 11138-2:2017.

When processed, the chemical process indicator on the outside of the pack changes from red to green. The BI from the test pack is then activated and incubated in a 3M Attest 390G Auto-reader for a final fluorescent result at 4 hours.

Features and Benefits of 3M 1298 Attest Rapid Ethylene Oxide Biological Indicator Test Pack

• Each test pack contains a 3M Attest Rapid Ethylene Oxide Biological Indicator, 1294, Green Cap
• Comes pre-assembled for convenience and ease of use
• Fast and accurate 4-hour result
• Presents a challenge to ethylene oxide (EO, EtO) sterilization procedures as recommended by AAMI
• Compatible with the 3M Attest Auto-reader 390G

3M 1298 Attest Rapid Ethylene Oxide Biological Indicator Test Pack Indications for Use

The 3M Attest 1298/1298F Rapid Readout Biological Indicator for EO Test Pack is a routine test pack used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3M Attest 290G Auto-reader or the 3M Attest Auto-reader 390G.

Directions for Use of 3M 1298 Attest Rapid Ethylene Oxide Biological Indicator Test Pack

• Use an Attest 1298/1298F Rapid Readout Biological Indicator for EO Test Pack to test loads containing wrapped telescopic instruments, plastic, rubber, metal instruments, and equipment. For testing container systems, place Attest 1294 Rapid Readout Biological Indicator for EO in the areas determined by product testing to be the most resistant.
• Place the Attest 1298/1298F Rapid Readout Biological Indicator for EO Test Pack in the most challenging area for the sterilant. This is generally in the center of the load.
• Process the load as usual.
• After sterilization, two options exist:
• Aeration of Test Pack Prior to BI Incubation: Aerate the test pack for the same amount of time as the other packs from the load. At the end of the aeration cycle, check to see that the external chemical indicator on the outside of the test pack has turned from red to green, which indicates the pack has been exposed to the EO sterilization process. The external chemical indicator will turn green and may be shades of olive green to brown depending upon the relative humidity conditions of the cycle. If the chemical indicator is unchanged, check the sterilization process. Remove the Attest 1294 Rapid Readout Biological Indicator for EO from the test pack. Dispose of the remaining test pack components according to the healthcare facilitys policy.
• . Removal of Test Pack Prior to Aeration: Open the sterilizer door according to the manufacturers instructions: transfer the load to the aerator and retrieve the test pack. (If a sterilizer with aeration capability is used, follow the manufacturers instructions for opening the door and remove the test pack prior to the aeration cycle.) Check to see that the external chemical indicator on the outside of the test pack has turned from red to green, which indicates the pack has been exposed to the EO sterilization process. The external chemical indicator will turn green and may be shades of olive green to brown depending upon the relative humidity conditions of the cycle. If the chemical indicator is unchanged, check the sterilization process. Remove the Attest 1294 Rapid Readout Biological Indicator for EO from the test pack. Return the remainder of the test pack to the load for aeration according to the health care facilitys policy. When it is necessary to handle items that are not fully aerated, butyl, neoprene, or nitrile gloves should be worn. The breathing zone of personnel should be monitored to verify the safety of the practices followed.
• Check the chemical indicator on the label of the Attest 1294 Rapid Readout Biological Indicator for EO. A color change from red to green confirms that the biological indicator has been exposed to the EO sterilization process. This color change does not indicate that the process was sufficient to achieve sterility. If the chemical indicator is unchanged, check the sterilization process.
• Identify the vial by writing the sterilizer, load number, and processing date on the biological indicator label. Do not place another label or indicator tape on the biological indicator.
• Discard the test pack. Using a test pack more than once will invalidate subsequent test results.
• While wearing safety glasses, press the biological indicator cap down. Crush the glass ampoule of the biological indicator in the crusher well of the Attest Auto-reader. Hold the biological indicator by the cap and tap on a hard surface until media wets strip at bottom of vial, and then place the biological indicator in an auto-reader incubation well. See Attest Auto-reader Operators Manual for further details.
• Crush, tap and incubate at least one non-sterilized Attest 1294 Rapid Readout Biological Indicator for EO (positive control) each day a processed indicator is incubated. This helps ensure:
• correct incubation temperatures are met,
• viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals,
• capability of media to promote rapid growth, and
• proper functioning of Attest Auto-reader components