every step. every detail. · 2010-12-20 · performance standards and recommended practices on...

3M SterilizationProducts and Services

3M Sterilization:

™ ™

Every Step. Every Detail.Every Day.

4 3M Sterilization

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Steps in the Sterilization Process

The first step in the sterilization process, clean and disinfect, addresses the removal of foreign material and makes instruments ready for further processing. The presence of soil or organic material on instruments reduces disinfection or sterilization effectiveness.

If the instruments are going to be high level disinfected, a check of the high level disinfectant concentration in the processor/soaking tray is required to ensure its minimum effective concentration.

Prep and pack is next in the sterilization process. The proper selection of internal and external chemical indicators to monitor the sterilization process is done in this step.

In the third step of the sterilization process, instruments are exposed to the actual sterilant (steam, ethylene oxide, etc.). Routine monitoring of the sterilization process is needed to ensure effective sterilization. This is done through the use of displays and printouts from the equipment and the proper selection and the use of biological and chemical indicators.

In the fourth step, instruments are removed from the sterilizer/processor and quality system documentation is completed. Then, appropriate storage is required to maintain the integrity of the packaging and level of sterility of the instrument(s) prior to use. Documentation for each individual pack is recommended by AAMI, AORN and The Joint Commission to ensure that a load or pack can be identified and found in the event of a recall. This documentation is part of a total record keeping system and is an important aspect of the department quality system.

Finally, when items are requested for use, they are retrieved from storage and checked to ensure that the external chemical monitor has reached its endpoint (e.g., color change or migration) and then issued for use. Prior to use, the internal chemical monitors are checked to ensure that sterilization process conditions penetrated to the inside of the pack.

Health care professionals worldwide have come to trust the complete line of 3M sterilization monitoring products to help them monitor all stages of the sterilization process. 3M sets today’s standard for sterilization process monitoring with a comprehensive monitoring portfolio, the 3M™ Attest™ Sterile U Network education program, world class technical service support and expert sales support.

1. Clean and Disinfect

2. Prep and Pack

3. Sterilize

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3M Sterilization 5

Who to turn to for standards and recommended practices for sterilization monitoring3M Sterilization is actively involved with various industry associations in their ongoing effort to increase the science and professionalism of reprocessing instruments. We encourage you to investigate the standards they have developed to address this subject.

AAMI The Association for the Advancement of Medical Instrumentation is a U.S. national standards organization devoted to medical technology. It is a nonprofit organization made up of representatives from healthcare, industry, governmental regulators, academia and consultants that work together to develop consensus performance standards and recommended practices on medical instrumentation and technology. The AAMI Sterilization Standards Committees comprise one of the largest divisions of AAMI. ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities is the highest selling AAMI document. In addition to standards development, AAMI also sponsors multiple educational programs.

AORNThe Association of periOperative Registered Nurses is a professional organization that provides OR nurses with education and standards of practice. AORN hosts educational meetings, national congress, publications and provides multiple other resources. AORN PeriOperative Standards and Recommended Practices are published annually and serve as the primary reference for OR best practice.

CDCThe Centers for Disease Control and Prevention is part of the U.S. Dept. of Health and Human Services and is focused on protecting public safety through the prevention and control of disease, injury and disability. CDC focuses on key aspects of infection prevention including HAIs. The Healthcare Information Control Practices Advisory Committee (HICPAC) is sponsored by the CDC and develops good practice guidelines.

ISOISO (International Organization for Standardization) is a network of the national standards institutes of 161 countries, one member per country. ISO develops and maintains consensus standards in many areas including sterilization. Often, ISO standards are adopted by countries and may be mandated by local governments. Technical Committee 198 develops and maintains standards related to Sterilization.

AAMIwww.aami.org/standards

AORNwww.aorn.org/PracticeResources

CDCwww.cdc.gov

ISOwww.iso.org

6 3M Sterilization

Standards PracticeConfidence in Sterilization with the Core Four.

Equipment Monitoring is a way to find out whether or not your sterilizer is doing its job properly. To monitor dynamic-air-removal steam sterilizers, you begin each day with a Bowie-Dick type test to detect air leaks, inadequate air removal, inadequate steam penetration and the presence of non-condensable gases, any of which can compromise sterility.

3M™ Comply™ Bowie-Dick Plus Test Pack with Early Warning Test Sheet

• Indicates problems due to air leaks or inadequate vacuum during the air removal test cycle.

• Early Warning Test Sheet provides advance notice of sterilizer problem.

• Chemical indicator ink retains final result so test sheet can be filed for quality assurance records and later compared to current results if a change in sterilizer performance occurs.

• Yellow to dark brown/black indicator ink color change is easy to interpret.

Load Monitoring is the process by which a load is monitored and released based on the result of a biological indicator (BI) in a process challenge device (PCD). Only a BI can detect the actual killing of microbial spores inside the sterilizer. If all spores die inside the BI, you have assurance that other infectious organisms have also died inside the sterilizer. For non-implant loads, may use a Class 5 integrating indicator PCD.

3M™ Attest™ Rapid 5 Steam-Plus Test Pack

• Includes a 3M™ Attest™ Rapid Readout biological indicator (BI) that provides results in three hours and a 3M™ Comply™ (SteriGage™) moving-front Class 5 Integrating Indicator .

• Meets AAMI ST79:2006/A1:2008/A2:2009 steam sterilization guidelines for process challenge device load monitoring requirements of implants.

• Reduces quarantine time by 88% providing BI results in 3 hours compared to 24 hour BIs.

• Enables you to make decisions and take action prior to surgery, reducing the risk and cost associated with recalls and surgical infections.

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Putting Standards into Practice

(1) The Bowie-Dick test should always be run in a warm sterilizer to avoid false failures.

(2) Place your Bowie-Dick on the bottom shelf of the cart, over the drain, in an empty sterilizer.


(1) A positive control should be incubated each day a test BI is incubated in each 3M™ Attest™ Auto-reader.

(2) If a test BI is positive, and the cause of the failure is not immediately identifiable, all items from that load and all items from loads processed since the last load with a negative BI result should be recalled and reprocessed.

(3) Loads containing implants should be quarantined until the BI results are known.

See product description on page 12.


Equipment Monitoring

Load Monitoring

3M Sterilization 7

Pack Monitoring is defined as the use of chemical indicators for internal monitoring of packs, trays, containers and peel pouches. Internal pack monitoring verifies that the sterilant has penetrated to the point of placement of the chemical indicator in the pack and confirms that specific exposure conditions have been met.

3M™ Comply™ (SteriGage™) Chemical Integrator

Conforms to ANSI/AAMI/ISO 11140-1:2005 Class 5 Integrating Indicator performance requirements which ensures the response correlates with a BI at three time/temperature relationships under ideal steam sterilization conditions.

• For use in all 250–275°F steam sterilization cycles which eliminates the potential error of selecting the incorrect, cycle-specific, emulating indicator and reduces your chemical indicator inventory.

• Migrating “moving front style” ink technology provides instant “Accept” or “Reject” results at a glance that do not require color interpretation. A study is available that shows higher reading accuracy than color-change indicators.

• Confirmed by BSI, a leading global independent Product Testing Services Company, to meet the performance requirements of ISO 11140-1:2005.

Exposure Monitoring Products are a way for sterilizer operators to know at a glance whether packs have been exposed to the sterilization process. It assures the operator handling the processed items that the pack has been exposed to the sterilization process without the need to open the pack.

3M™ Comply™ Steam Indicator Tapes

• Adhesives are designed specifically for disposable or reusable wraps.

– 3M Comply 1222 Steam Indicator Tape for all wraps.

– 3M Comply 1255 Steam Indicator Tape for disposable wraps.

• Adhesive seals packs securely. Backing stretches to minimize tape pop-off during sterilization.

• Can be written on or labeled with preprinted labels such as the 3M™ Comply™ Sterilization Load Labels.

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(1) Place an integrator in the geometric center of each pack, peel pouch or tray to be to be steam sterilized.

In rigid containers, place an integrator in two opposite corners of each level. In multi-level wrapped containers supplied by the manufacturer, place an integrator in the center of each level.

(2) If a pack fails, but the BI was negative, you could decide to issue the remaining packs from the load. If the BI results were not available when the pack failure was discovered, the load contents should be quarantined until the BI results are known.


(1) Use an external chemical indicator on the outside of each package.

(2) If a package allows for visual inspection of an internal indicator, such as those with paper–plastic packaging, an external indicator is not required.



Pack Monitoring

Exposure Monitoring Products

Ask your 3M Sales Professional how 3M can recognize and support your facility’s efforts to monitor the sterilization processes according to AAMI, AORN and CDC Standards and Recommended Practices.

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8 3M Sterilization

Rapid Readout Biological Indicators

Rapid Readout Biological Indicators and Test Packs • Results in one hour (1291), three hours (1292) or four hours (1294). Each test

pack contains a 3M™ Attest™ Rapid Readout Biological Indicator

• Test packs present a challenge to the sterilization process equivalent to the AAMI recommended towel pack

• Make decisions and take appropriate action before surgery

• Every-Load-Monitoring and quarantining can eliminate recalls

• Malfunctioning sterilizers can be repaired and put back into service quickly

• The 3M™ Attest™ Rapid Readout Biological Monitoring System can help reduce the costs associated with fighting infections — a cost measured in both dollars and time spent

Cat. No. Description Packaging Shipping

3M™ Attest™ Rapid Readout Biological Indicator for 132°C (270°F) Gravity Displacement Steam Sterilization

1291* Steam Biological Indicator (Blue cap) 50 each/box 4 boxes/case

3M™ Attest™ Rapid Readout Biological Indicators and Test Packs for 121°C (250°F) Gravity and 132°C (270°F) Vacuum-Assisted Steam Sterilization

1292* Steam Biological Indicator (Brown cap) 50 each/box 4 boxes/case

1296* Steam Biological Test Pack (25 controls) 25 packs/box 1 box/case

1296F* Steam Biological Test Pack (controls) 25 packs/box 1 box/case

*Must be used in conjunction with 3M™ Attest™ 290 Auto-reader

3M™ Attest™ Rapid 5 Steam-Plus Test Pack

Monitors 132°C (270°F), ≥ 4 minute vacuum-assisted and 121°C (250°F), ≥ 30 minute gravity displacement steam sterilization processes. Each pack contains a 3M™ Attest™ 1292 Rapid Readout Biological Indicator and a 3M™ Comply™ SteriGage™ 1243 Steam Chemical Integrator.

41382** Steam Plus Test Pack 16 each/box 4 boxes/case (16 controls/box)

41382F** Steam Plus Test Pack 16 each/box 4 boxes/case (4 controls/box)

**Must be used in conjunction with 3M™ Attest™ 290 Auto-reader

3M™ Attest™ Rapid Readout Biological Indicators and Test Packs for Ethylene Oxide (EO) Sterilization

1294*** EO Biological Indicator (Green cap) 50 each/box 4 boxes/case

1298*** EO Test Pack (25 controls) 25 packs/box 2 boxes/case

1298F*** EO Test Pack (5 controls) 25 packs/box 2 boxes/case

***Must be used in conjunction with 3M™ Attest™ 290G Auto-reader


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Rapid Readout Biological Indicators

Auto-readers• For use with Attest Rapid Readout Biological Indicators

• 3M™ Attest™ 290 and 290G Auto-readers do not require time-consuming calibration

• Audible alarm sounds for improved monitoring

• Do not require any routine maintenance

• 120V nominal voltage required


3M™ Attest™ 290 Auto-readers

290 Auto-reader for steam, for use with 1 unit/box 1 box/case Attest Rapid Readout Biological Indicators for Steam 1291, and 1292, 60°C (140°F)

290G Auto-reader for EO, for use with Attest 1 unit/box 1 box/case Rapid Readout Biological Indicator for EO 1294, 37°C (98.6°F)

Monitor loads using 3M™ Attest™ Rapid Readout

Biological Indicators

Enter 3M Attest Rapid Readout BI test and control lot numbers into SPM® Software and incubate BIs in the 3M™ Attest™ Auto-reader

Access real-time 3M Attest Rapid Readout BI results at all networked

workstations running SPM® Software

How SPM® Software with 3M™ Attest™ Monitoring Interface works

3M™ Attest™ Monitoring Interface software module provides automatic, real-time documentation of 3M™ Attest™ Rapid Readout Biological Indicators by connecting the 3M™ Attest™ Auto-reader directly to Sterile Processing Microsystems ‘SPM®’ Asset Management Software. It provides hospitals with the trusted, gold standard in monitoring sterilization processes with instant access to results and other sterilization load documentation. 3M, in collaboration with Materials Management Microsystems, Inc. developed this interface software product to improve the accuracy and consistency of quality control processes.

SPM® is a comprehensive, computerized asset management system for Sterile Processing. It is designed to work on a network of computers and uses bar-code technology to track the location and movement of instruments sets throughout the processing and delivery cycle. SPM® offers a guaranteed return on investment through productivity improvement. Several additional SPM modules are available to expand functionality of the system.

• Automatic, real-time documentation of 3M™ Attest™ Rapid Readout Biological Indicator results

• Supports the transition to paperless electronic record keeping

• Facility-wide availability of results

• Facilitates the recall process

3M™ Attest™ Monitoring Interface

for Software


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10 3M Sterilization


Biological Indicators and Test Packs• Biological indicator vials are easy to use and interpret with visual color readout in

24 hours (1261) or 48 hours (1262/1264)

• Test packs present a challenge to the sterilization process equivalent to the AAMI recommended packs

• Each test pack contains a 3M™ Attest™ 1262 or 1264 Biological Indicator


3M™ Attest™ Biological Indicators for 132°C (270°F) Gravity Displacement Steam Sterilization

1261 Steam Biological Indicator (Blue cap) 100 each/box 4 boxes/case

1261P Steam Biological Indicator (Blue cap) 25 each/box 4 boxes/case

3M™ Attest™ Biological Indicators for 121°C (250°F) Gravity Displacement and 132°C (270°F) Vacuum-assisted Steam Sterilization

1262 Steam Biological Indicator (Brown cap) 100 each/box 4 boxes/case

1262P Steam Biological Indicator (Brown cap) 25 each/box 4 boxes/case

1276 Steam Biological Test Pack 25 each/box 1 box/case (25 controls/box)

1276F Steam Biological Test Pack 25 each/box 1 box/case (5 controls/box)

3M™ Attest™ Steam-Plus Test Pack

Each pack consists of an Attest 1262 Biological Indicator and a 3M™ Comply™ (SteriGage™) Steam Chemical Integrator.

41380 Steam-Plus Test Pack 16 each/box 4 boxes/case (4 controls/box)

3M™ Attest™ Biological Indicators for Ethylene Oxide (EO) Sterilization

1264 EO Biological Indicator (Green cap) 100 each/box 4 boxes/case

1264P EO Biological Indicator (Green cap) 25 each/box 4 boxes/case

1278 EO Test Pack 25 each/box 2 boxes/case (25 controls/box)

1278F EO Test Pack 25 each/box 2 boxes/case (5 controls/box)

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Biological Indicator Monitoring Starter KitEverything you need for effective monitoring of the steam sterilization process.

Consists of one roll of 3M™ Comply™ 1222-6N Indicator Tape, one box of 3M™ Attest™ 1262P Biological Indicators, one 3M™ Attest™ 116 Incubator, one bag of 3M™ Comply™ (SteriGage™) 1243B Chemical Integrators, one 3M™ Attest™

1266-A Log Book and Wall Chart.


3M™ Attest™ Biological Indicator Monitoring Starter Kit

115 Monitoring Kit 1 each/box 1 box/case

Biological Indicator IncubatorsAttest Incubators provide optimal conditions for accurate readout of Attest Biological Indicators.

• Convenient, 14- or 28-vial capacity

• Dry-block design pre-set to proper incubation temperature


3M™ Attest™ Biological Indicator Incubators

116 14-vial (round), 56˚C (Steam), 120 nominal 1 each/box 1 box/case voltage required, 90–132V acceptable

117 14-vial (round), 37˚C (EO), 120 nominal 1 each/box 1 box/case voltage required, 90–132V acceptable

126 28-vial (2-tier), 56˚C (Steam), 120 nominal 1 each/box 1 box/case voltage required, 90–132V acceptable

127 28-vial (2-tier), 37˚C (EO), 120 nominal 1 each/box 1 box/case voltage required, 90–132V acceptable

130 28-vial (2-tier), 37˚C/56˚C (EO/Steam), 1 each/box 1 box/case 120 nominal voltage required, 90–132V acceptable


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Biological Indicators L o a d C o n t r o l

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Bowie-Dick Test Packs

12 3M Sterilization

Bowie-Dick Plus Test Pack with Early Warning Test SheetThe 3M™ Comply™ Bowie-Dick Plus Test Pack features the Early Warning Test Sheet that identifies potential air leaks or vacuum pump failures before they appear on the Comply Bowie-Dick Test Sheet.


3M™ Comply™ Bowie-Dick Plus Test Pack with Early Warning Test Sheet

00135* Bowie-Dick Plus Test Pack with 20 packs/box 4 boxes/case Early Warning Test Sheet

*Has equivalent performance to the Bowie-Dick towel pack cited in ANSI/AAMI ST79 .

Bowie-Dick Type Test Packs and SheetsDesigned for dynamic-air-removal sterilizers to test the efficacy of the vacuum system to remove air from the sterilizer chamber and to detect leaks in the system that would allow air into the chamber.

• Comply Bowie-Dick Test Packs make testing steam penetration and air removal, as well as detecting air leaks, more convenient and cost effective

• Designed to give results equivalent to those obtainable by the Bowie and Dick protocol

• Preassembled packs reduce both labor and material costs

• Indicator pattern is easy to read and interpret


3M™ Comply™ Bowie-Dick Type Test Pack

1233* Bowie-Dick Disposable Test Pack 6 packs/bag 5 bags/case

3M™ Comply™ Bowie-Dick Test Sheet

00130 Bowie-Dick Internal Steam Indicator Sheet 50 sheets/box 5 boxes/case

*Has equivalent performance to the Bowie-Dick towel pack cited in ANSI/AAMI ST79 .

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3M Sterilization 13

Class 5 Chemical Integrators

Steam Chemical Integrator Test PackPack consists of a 3M™ Comply™ 1243 (SteriGage™) Steam Chemical Integrator in a small test pack of porous substrate with a moisture impervious, quality disposable wrap.

• Test pack presents a challenge to the sterilization process equivalent to the AAMI recommended towel pack


3M™ Comply™ (SteriGage™) Steam Chemical Integrator Test Pack (AAMI Class 5)

41360 Test Pack with Comply (SteriGage) 16 packs/box 4 boxes/case Steam Chemical Integrator

3M™ Comply™ (SteriGage™) Steam Chemical Integrators3M Comply SteriGage Steam Chemical Integrators offer immediate, accurate and easy-to-read method of monitoring sterilization process conditions inside each pack. For use in all steam sterilizers.

• “Moving front” style has accept/reject readout for instant results with easy interpretation, convenient small size for all packs with optional extenders available for fast retrieval from inner packs

• Conforms to ANSI/AAMI/ISO 11140-1:2005 Class 5 Integrating Indicator performance requirements which ensures the response correlates with a BI at three time/temperature relationships under ideal steam sterilization conditions


3M™ Comply™ (SteriGage™) Steam Chemical Integrators (AAMI Class 5)

1243A Steam Chemical Integrator, moving front 500 each/bag 2 bags/case 5,1 cm x 1,9 cm (2" x 3/4")

1243B Steam Chemical Integrator, moving front 100 each/bag 10 bags/case 5,1 cm x 1,9 cm (2" x 3/4")

1243E Steam Chemical Integrator, moving front 1000 each/bag 1 bag/case with extender, 22,9 cm x 1,0 cm (9" x 3/8")

1240E Extender only 2500 each/bag 2 bags/case 19,1 cm x 1,0 cm (7-1/2" x 3/8")

L o a d C o n t r o l Rapid Readout Biological Indicators


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Chemical Integrators and Indicators

3M™ Comply™ (Thermalog™) Steam Chemical Integrators3M Comply Thermalog Steam Chemical Integrators offer an immediate, accurate and easy-to-read method of monitoring sterilization process conditions inside each pack.

For use in all steam sterilizers.

• “Moving front” style has safe/unsafe readout for instant results with easy interpretation for fast retrieval from inner packs

• Conforms to ANSI/AAMI/ISO 11140-1:2005 Class 5 Integrating Indicator performance requirements which ensures the response correlates with a Biological Indicator (BI) at three time/temperature relationships under ideal steam sterilization conditions


3M™ Comply™ (Thermalog™) Steam Chemical Integrators (AAMI Class 5)

2134MM Steam Chemical Integrator, moving front 250 units/pack 8 packs/case 10,16 cm x 1,91 cm (4" x 3/4")

3M™ Comply™ 6600 Steam Emulating IndicatorsClass 6 Emulating Indicators react to the critical variables required for steam sterilization for a specific sterilization cycle. A unique Class 6 Chemical Indicator is required for each time, temperature, and type of steam sterilization cycle. Unlike Class 5 Integrating Indicators, the response of Class 6 Emulating Indicators is not required to parallel the time/temperature response of a biological indicator.

• For use as an internal chemical indicator in 4 minute 132˚C/270˚F dynamic- air-removal steam sterilization cycles.

• Class 6 Emulating Indicator as classified by ANSI/AAMI/ISO 11140-1:2005

• Plastic lamination protects sterilized items from potential ink transfer


3M™ Comply™ 6600 Steam Emulating Indicators (AAMI Class 6)

6600 3M™ Comply™ Steam Emulating Indicator 250 items/pouch 20 pouches/case 4.25" x .25"

L o a d C o n t r o l L o a d C o n t r o l Rapid Readout Biological IndicatorsChemical Indicators

3M Sterilization 15

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Steam Chemical Indicator-PlusEach strip has two purple ink bars that change color in sequence during exposure to saturated steam. A clear protective coating over the ink bars prevents the ink from touching items being sterilized.


3M™ Comply™ Steam Chemical Indicator-Plus Strips

00117 Short Form—132˚C (270˚F) Indicator, 200 each/box 20 boxes/case 1,5 cm x 10,8 cm (5/8" x 4-1/4"), for use in 270˚F dynamic-air-removal and gravity sterilizers

00118 Long Form—132˚C (270˚F) Indicator, 200 each/box 20 boxes/case 1,5 cm x 18,7 cm (5/8" x 7-3/8"), for use in 270˚F dynamic-air-removal and gravity sterilizers

00119 Short Form—121˚C (250˚F) Indicator, 200 each/box 20 boxes/case 1,5 cm x 10,8 cm (5/8" x 4-1/4"), for use in 250˚F gravity sterilizers

Steam Chemical Indicators3M™ Comply™ Chemical Indicators offer distinct color change to indicate process results inside each pack. Indicator changes color to dark brown/black when exposed to steam sterilization. For use in all steam sterilizers.


3M™ Comply™ Steam Chemical Indicator Strip

Long strip of chemical indicator ink printed on perforated-style strip. Allows full- or half-length use for different pack sizes.

1250 Steam Chemical Indicator Strip 240 each/box 8 boxes/case 1,5 cm x 20 cm (5/8" x 8")

*ISO 11140-1:2005 Class 4 testing is underway.

3M™ Comply™ Steam Chemical Indicator Strips

Chemical indicator printed as a block on short or long strips.

00107 Long Form 250 each/box 20 boxes/case 1,5 cm x 22 cm (5/8" x 8-1/2")

00109 Short Form 250 each/box 20 boxes/case 1,5 cm x 11 cm (5/8" x 4-1/4")

00109A Short Form—Economy Pack 1000 each/box 4 boxes/case 1,5 cm x 11 cm (5/8" x 4-1/4")


L o a d C o n t r o l Chemical Indicators

16 3M Sterilization

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Vapor Hydrogen Peroxide Chemical IndicatorAn internal pack chemical indicator for use in STERRAD® Sterilization Processes (Models 50, 100S, and 100). Indicator changes from blue to pink when exposed to vapor hydrogen peroxide. Indicator color does not fade when exposed to light.


3M™ Comply™ Gas Plasma Chemical Indicator Strip

1248 Comply Gas Plasma Chemical Indicator 250 each/box 4 boxes/case Strip, 2,0 cm x 10 cm (13/16" x 4")

Liquid Peracetic Acid Chemical IndicatorSingle-use chemical indicator for use in the Steris® System 1 processor. Indicator changes from red (unprocessed) to lime green (processed) color for easy interpretation when exposed to the appropriate concentration of sterilant. Large size and distinct color for easy retrieval of the indicator from processor.


3M™ Comply™ Liquid Peracetic Acid Chemical Indicator

1249 Comply Liquid Peracetic Acid Chemical 50 each/bag 4 bags/case Indicator, 4,4 cm x 4,4 cm (1-3/4" x 1-3/4")

Rapid Readout Biological IndicatorsChemical Indicators

3M Sterilization 17

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Ethylene Oxide Chemical Integrators3M™ Comply™ (SteriGage™) Chemical Integrators offer an immediate, accurate and easy-to-read method of monitoring sterilization process conditions inside each pack. For use in EO/HCFC gas mixture sterilization cycles.

• “Moving front” style has accept/reject readout for instant results with easy interpretation, convenient small size for all packs with optional extenders available for easy retrieval from inner packs


3M™ Comply™ (SteriGage™) Ethylene Oxide (EO) Chemical Integrators

1244A EO Chemical Integrator, moving front, 500 each/bag 2 bags/case for gas mixture sterilizers , 5,1 cm x 1,9 cm (2" x 3/4")

1244B EO Chemical Integrator, moving front, 100 each/bag 10 bags/case for gas mixture sterilizers, 5,1 cm x 1,9 cm (2" x 3/4")

1244E EO Chemical Integrator, moving front, 1000 each/bag 1 bag/case with extender, for gas mixture sterilizers, 22,9 cm x 1,0 cm (9" x 3/8")

1240E Extender only 2500 each/box 2 bags/case 19,1 cm x 1,0 cm (7-1/2" x 3/8")

Ethylene Oxide Chemical IndicatorFor use in 100% EO and EO/HCFC gas mixtures. Long stripe of chemical indicator ink printed on perforated-style strip. Allows full- or half-length use for different pack sizes. Indicator changes color from red to green when exposed to ethylene oxide sterilization conditions.


3M™ Comply™ Ethylene Oxide (EO) Chemical Indicator Strip

1251 EO Chemical Indicator Strip 240 each/box 1 boxes/case 1,5 cm x 20 cm (5/8" x 8")


L o a d C o n t r o l Chemical Indicators

18 3M Sterilization

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Instrument ProtectorsProtect sharp-pointed surgical instruments from damage and reduce possibility of pouch puncture during sterilization and handling. Indicators on the protectors verify steam or EO gas processing.


3M™ Comply™ Instrument Protectors

13911 5,1 cm x 12,8 cm (2" x 5") 100/pack 10 packs/case

13913 9,9 cm x 16,8 cm (3-1/2" x 6-5/8") 100/pack 10 packs/case

13915 14 cm x 24 cm (5-1/2" x 9-1/2") 100/pack 10 packs/case

Steam Sterilization Indicator LabelsPeel-off, pressure-sensitive labels for hard-surfaced items such as unwrapped glass or metal.


3M™ Comply™ Chemical Indicator Label

Color changes from purple to green during steam sterilization.

00160 Steam—For use in steam sterilizers 1000 labels/roll 12 rolls/case 1,9 cm x 3,2 cm (3/4" x 1-1/4") 1 roll/box

Dry Heat Chemical IndicatorSterilization monitor for dry heat sterilizers. Indicator changes color from tan to black within 10 minutes at 160˚C (320˚F) during exposure to dry heat processing.


3M™ Comply™ Dry Heat Chemical Indicator Strip

00311 Dry Heat Chemical Indicator Strip 250 each/box 10 boxes/case 1,5 cm x 11 cm (5/8" x 4-1/4")

Rapid Readout Biological IndicatorsIndicator Tapes

3M Sterilization 19

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Indicator Tapes for Steam SterilizationA reliable steam indicator tape that provides immediate identification of processed items and also serves as a closure to seal sterilization packs. The chemical indicator lines will turn dark when exposed to a steam sterilization process.

• Class I: conforms to ANSI/AAMI/ISO 11140-1:2005


3M™ Comply™ Indicator Tapes for Steam Sterilization*

1222-0N 1,25 cm x 55 m (1/2" x 60 yds.), Tan - 36 rolls/case

1222-1N 2,5 cm x 55 m (1" x 60 yds.), Tan - 18 rolls/case

1222-2N 5 cm x 55 m (2" x 60 yds.), Tan - 10 rolls/case

1222-6N 1,9 cm x 55 m (3/4" x 60 yds.), Tan - 24 rolls/case

*Contains Dry Natural Rubber

Steam Indicator Tapes for Disposable WrapsA reliable steam indicator tape specifically designed for disposable wraps that provides immediate identification of processed items and also serves as a closure to seal sterilization packs. The chemical indicator lines will turn dark when exposed to a steam sterilization process.



3M™ Comply™ Steam Indicator Tapes for Disposable Wraps*

1255-1N 2,5 cm x 55 m (1" x 60 yds.), Blue - 18 rolls/case

1255-6N 1,9 cm x 55 m (3/4" x 60 yds.), Blue - 24 rolls/case


Indicator Tapes for EO SterilizationA reliable ethylene oxide gas indicator tape that provides immediate identification of processed items and also serves as a closure to seal sterilization packs. The chemical indicator lines will turn red when exposed to an EO sterilization process.



3M™ Comply™ Indicator Tapes for Ethylene Oxide (EO) Sterilization*

1224-0 1,25 cm x 55 m (1/2" x 60 yds.), Green - 36 rolls/case

1224-1 2,5 cm x 55 m (1" x 60 yds.), Green - 18 rolls/case

1224-6 1,9 cm x 55 m (3/4" x 60 yds.), Green - 24 rolls/case



L o a d C o n t r o l Indicator Tapes

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Indicator Tape for Vapor Hydrogen Peroxide SterilizationAn external chemical indicator tape for use in STERRAD® Sterilization Processes (Models 50, 100S, and 100). Indicator changes from blue to pink when exposed to vapor hydrogen peroxide.


3M™ Comply™ Gas Plasma Indicator Tape

1228 1,9 cm x 55 m (3/4" x 60 yds.), White - 24 rolls/case

Indicator Tape Dispensers


3M™ Comply™ M52 Tape Dispenser with Tabber

The Comply M52 Tape Dispenser with Tabber has a weighted base and is capable of handling three rolls of 1/2-inch, up to two rolls no wider than 1-inch, or one 2-inch roll of indicator tape. A tabber can be attached to the tape dispenser, which automatically folds a 1/4-inch length of tape up to a 1-inch roll width.

M52 Heavy Duty - 1 each/case

C22 Heavy Duty Tape Dispenser

The C22 heavy duty tape dispenser is made of rugged, high-impact, durable plastic and is capable of handling two rolls of 1-inch wide indicator tape.

C22 Heavy duty, holds 2 rolls - 2 each/case

L o a d C o n t r o l L o a d C o n t r o l

3M Sterilization 21

Record Keeping

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Load Record CardsFor steam and ethylene oxide (EO) gas sterilizers. Provides a permanent record of sterilizer use and work flow.


3M™ Comply™ Load Record Cards

1252 Steam Load Record Card 240 each/box 4 boxes/case 7,6 cm x 12,8 cm (3" x 5")

1253 EO Load Record Card 240 each/box 2 boxes/case 7,6 cm x 12,8 cm (3" x 5")

67200 Steam and EO Load Record Card 250 each/box 4 boxes/case 7,6 cm x 12,8 cm (3" x 5")

67201 Steam and EO Load Record Card 250 each/box 4 boxes/case 10,2 cm x 14 cm (4" x 5-1/2")

Sterilization Integrator Load Record CardA single-use device that indicates whether materials within a pack or load have been exposed to conditions necessary for sterilization. The steam sterilization record cards can be used in all steam sterilization processes.


3M™ Comply™ (SteriGage™) Load Record Card

4171MM Integrator with Load Record Card—Steam 100 each/box 1 box/case


22 3M Sterilization

Record Keeping

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Log Books, Envelopes and Record ChartsComplete record keeping systems that maintain your sterilization process information and reduce record keeping time to just minutes each day. The preprinted log books put all the information you need to help you meet requirements at your fingertips.


3M™ Attest™ Envelopes, Sheets and Binders

1254E-A Sterilization Record Envelopes, 24,13 cm x 29,21 cm 100 each/pack 5 packs/case (9-1/2" x 11-1/2") with two load-contents columns, for Steam, Flash or Low Temperature Systems

1254S-A Sterilization Record Sheets, 21,59 cm x 27,94 cm 250 each/pack 4 packs/case (8-1/2" x 11") with two load-contents columns, for Steam, Flash or Low Temperature Systems

1254E-S Steam Sterilization Record Envelopes, 24,13 cm x 29,21 cm 100 each/pack 5 packs/case (9-1/2" x 11-1/2") with one column load-contents format

1254E-F Flash Sterilization Record Envelopes, 24,13 cm x 29,21 cm 100 each/pack 5 packs/case (9-1/2" x 11-1/2") with one column load-contents format

1254E-LT Low Temperature Sterilization Record Envelopes, 100 each/pack 5 packs/case 24,13 cm x 29,21 cm (9-1/2" x 11-1/2") with one column load-contents format

1254-A Sterilization Record System, binder with 50 each 1 each 1 each/case 1254E-A envelopes and 50 each 1254S-A sheets

1254B Sterilization Record Binder (order 1254E series envelopes 1 each 1 each/case and 1254S-A sheets separately)

3M™ Attest™ Log Books

1280-A Log Book for Steam, with 50 record charts, blue, use with 50 each/pack 1 pack/case Attest 1291 Rapid Readout BIs

1283-A Log Book for Steam, with 50 record charts, brown, use with 50 each/pack 1 pack/case Attest 1292 Rapid Readout BIs

1267-A Log Book for EO, with 50 record charts, green, use with 50 each/pack 1 pack/case Attest 1294 EO Rapid Readout BIs

1266 Log Book for Steam, with 50 record charts, use with 1 each/pack 1 pack/case Attest 1291 and 1292 Rapid Readout BIs

1266-A Log Book for Steam, with 50 record charts, use with 50 each/pack 1 pack/case Attest 1261 or 1262 BIs

1268 Log Book, with 50 record charts, 1 each/pack 1 pack/case use with all Low Temperature BI and CI products

1283 Log Book, with 50 record charts, 1 each/pack 1 pack/case use with all Glutaraldehyde Indicators


3M Sterilization 23

Record Keeping

Label Gun System


3M™ Comply™ Label Gun

1256B Printing applicator—prints and applies 1 each/box 1 box/case labels directly where needed

3M™ Event Related Sterilization Record Labels*—“Sterilized”

1269B Blue labels 1125 labels/roll 1 box/case 2,85 cm x 1,58 cm (1-1/8" x 5/8") 12 rolls/box

1269BL Black labels 1125 labels/roll 1 box/case 2,85 cm x 1,58 cm (1-1/8" x 5/8") 12 rolls/box

1269G Green labels 1125 labels/roll 1 box/case 2,85 cm x 1,58 cm (1-1/8" x 5/8") 12 rolls/box

1269R Red labels 1125 labels/roll 1 box/case 2,85 cm x 1,58 cm (1-1/8" x 5/8") 12 rolls/box

3M™ Sterilization Record Labels*—“Expires”

1257B Blue labels 1125 labels/roll 1 box/case 2,85 cm x 1,58 cm (1-1/8" x 5/8") 12 rolls/box

1257BL Black labels 1125 labels/roll 1 box/case 2,85 cm x 1,58 cm (1-1/8" x 5/8") 12 rolls/box

1257G Green labels 1125 labels/roll 1 box/case 2,85 cm x 1,58 cm (1-1/8" x 5/8") 12 rolls/box

1257R Red labels 1125 labels/roll 1 box/case 2,85 cm x 1,58 cm (1-1/8" x 5/8") 12 rolls/box

Sterilization Record Labels*— Blank

1257W White labels 1125 labels/roll 1 box/case 2,85 cm x 1,58 cm (1-1/8" x 5/8") 12 rolls/box

*Transitioning to Latex-Free Product

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24 3M Sterilization

Multi-Enzyme DetergentAn effective multi-enzyme detergent used for cleaning metal and plastic medical instruments, including flexible and rigid endoscopes. Effectively digests human secretions after immersion for only 2–10 minutes. Made with biodegradable materials.


3M™ Rapid Multi-Enzyme Detergent

70500-B 5 Liter Bottle 3 each/case case

Glutaraldehyde MonitorsEach monitor consists of a plastic strip with a black-framed chemical reaction pad. Pad changes from white to yellow when immersed in glutaraldehyde solutions with adequate concentration.


3M™ Comply™ Glutaraldehyde Monitors, 1.5%, 1.8%, 2.1%

Designed to test glutaraldehyde solutions with stated manufacturer's Minimum Effective Concentration (MEC) values. Indicates safe solutions when above 1.5%, 1.8% or 2.1% MECs.

3983MM 1.5% MEC* 60 monitors/bottle 2 bottles/case

3987 1.8% MEC* 60 monitors/bottle 2 bottles/case

3989 2.1% MEC* 60 monitors/bottle 2 bottles/case

*Test strips are brand specific. Please contact 3M for details

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3M Sterilization 25

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Sterilization Equipment

100% Ethylene Oxide Sterilizers/Aerators3M™ Steri-Vac™ Models 5XL and 8XL are 100% ethylene oxide (EO) gas sterilizers/aerators available with two pre-programmed cycles. (Warm Cycle: 55°C, ~2.75 hrs exposure. Cool Cycle 37°C, ~4.75 hrs exposure.) Physical cycle parameters are displayed on video display with print capability. Designed for safety, the single unit-dose 100% EO cartridge is punctured inside the chamber only when proper chamber negative-pressure conditions are achieved. The built-in aeration cycle allows a single chamber process. Available in single or double door pass-through design.

Cat. No. Description Shipping

3M™ Steri-Vac™ 5XL Sterilizer/Aerator

The 5XL sterilizer features 4.8 cu.ft. of usable space in the chamber. The software-controlled electronic design is easy to use with built in display of cycle status. Relative humidity sensor monitors sterilization chamber RH during preconditioning phase.

5XL Sterilizer/aerator 1 unit/case Exterior: 59 cm (H) x 76 cm (W) x 90 cm (D) 23" (H) x 30" (W) x 35" (D) Chamber: 38 cm (H) x 43 cm (W) x 83 cm (D) 15" (H) x 17" (W) x 34"(D)

3M™ Steri-Vac™ 8XL Sterilizer/Aerator

Like the 5XL, the sterilizer allows full usage of the rectangular chamber, is easy to use and provides continuous display of the cycle status. The 8XL provides a 7.9 cu. ft. chamber. The relative humidity feature continuously monitors, maintains and documents the proper humidity in the sterilization chamber during the precondition phase.

8XL Sterilizer/aerator 1 unit/case Exterior: 179 cm (H) x 94 cm (W) x 109 cm (D) 70" (H) x 37" (W) x 43" (D) Chamber: 46 cm (H) x 51 cm (W) x 97 cm (D) 18-1/8" (H) x 20" (W) x 38" (D)

Remote Display Panel

The digital remote display option (RDP) allows hands-off operation and is available for both 5XL and 8XL models. Up to four Steri-Vac sterilizers can be connected to a single RDP.

RDP Remote Display 1 unit/case


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26 3M Sterilization


Steri-Gas™ 100% Ethylene Oxide (EO) Gas CartridgesThe easy-to-use, single dose 3M Steri-Gas EO cartridges are engineered for safety. The cartridge contains 3.5, 4.5 or 6 oz. of EO depending on the model Steri-Vac Sterilizer used.

• Precise usage of EO with single-dose cartridges means no waste of sterilant

• With 3M™ Steri-Gas™ Cartridges, operators have no bulky, heavy gas tanks to handle, and no hoses, valves and filters to adjust or replace

• The cartridges do not contain CFCs or HCFCs


3M™ Steri-Gas™ Cartridges

4-100 100 gram Cartridge for Models 400C, 4XL and 5XL 12 each/box 4 boxes/case

4-134 127 gram Cartridge for Model 400B 12 each/box 4 boxes/case

8-170 170 gram Cartridge for Model 8XL 12 each/box 4 boxes/case

Ethylene Oxide (EO) Monitoring Badge3M EO personal monitoring badges are lightweight and are designed with EO-sensitive material. Clips to lapel or pocket near breathing zone for passive monitoring of individual during a work shift. The monitor is mailed for analysis and a report is provided back to the user with results. The employer is notified immediately of any result that exceeds permissible exposure limits.


3M™ Ethylene Oxide (EO) Monitoring Badge

3550 EO Monitoring Badge - 5 each/case

Printer Papers


3M™ Steri-Vac™ Printer Papers

1215A Printer Paper, 51 mm (2") wide, 2 rolls/case for models 400B & 400C (discontinued models)

1216A Printer Paper, 60 mm (2-3/8") wide, 2 rolls/case for 4XL and 5XL (with serial number below 720000)

1217 Printer Paper, 79 mm (3-1/8") wide, 2 rolls/case for 8XL and 5XL (with serial number above 720000)


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Transfer CartA stainless steel transfer cart developed to assist operators to move, lift or lower materials and supplies around the Sterile Processing Department.

• Fully programmable, state-of-the-art motor controller allows for multiple adjustments to fit user’s needs

• Drifting/coasting of load is eliminated due to electromagnetic brake and drive screw design

• Battery operated with built-in, self-monitoring recharger; two rechargeable batteries provided

• Two table sizes available


3M™ Transfer Cart

6010 Vestil Loading Cart 1 cart/case Table size: 61 cm x 48 cm (24" x 19") or 76 cm x 59 cm (30" x 23.5") Raised height: 145 cm (57") Holding capacity: 68 kg (175 lbs)


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28 3M Sterilization


AeratorThe 3M Model XL aeration cabinet circulates warm, filtered air in its 5 cu. ft. chamber. Designed for compatibility with 3M™ Steri-Vac™ Sterilizers.

• Two selectable aeration temperatures, 37˚C (99˚F) or 55˚C (131˚F)

• Modular system for versatility

• Space efficient

• A door lock prevents unauthorized access


3M™ Steri-Vac™ XL Aerator

XL Aerator 1 unit/case Exterior: 62 cm (H) x 78 cm (W) x 93 cm (D) 24-3/8" (H) x 30-3/4" (W) x 36-5/8" (D) Chamber: 41 cm (H) x 46 cm (W) x 84 cm (D) 16-1/8" (H) x 18-1/8" (W) x 33" (D)

Ethylene Oxide (EO) AbatorThe 3M Abator removes EO gas exhausted from 3M™ Steri-Vac™ Sterilizers and Aerators, converting it into CO2 and water vapor. At normal operating temperatures and concentrations, removal efficiency is 99.9+ % when EO concentrations are greater than (>)100ppm.

• Works automatically with sterilization system

• Interfaces with up to two sterilizers or two aerators


3M™ Ethylene Oxide (EO) Abator

50 Abator 1 unit/case 81 cm (H) x 92 cm (W) x 107 cm (L) 32" (H) x 36" (W) x 42" (L)


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Sterilization Packaging

Packaging


3M™ Steri-Lok™ Peel Open Packages for Ethylene Oxide (EO) Sterilization (Film/Tyvek™ Component)

8502 7,9 cm x 24,8 cm (3-7/8" x 9-3/4") 250 each/box 4 boxes/case

8504 7,9 cm x 61 cm (3-1/8" x 24") 250 each/box 4 boxes/case

8505 17,8 cm x 33 cm (7" x 13") 250 each/box 2 boxes/case

8506 29,8 cm x 38 cm (11-3/4" x 14-7/8") 250 each/box 2 boxes/case

8507 40 cm x 45,7 cm (15-3/4" x 18") 250 each/box 2 boxes/case

every step. every detail. · 2010-12-20 · performance standards and recommended practices on...

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