3M™ Attest™ Biological IndicatorMonitoring Starter Kit

An undetected sterilization process failure can put patients, staff, and the financial health of your facility at risk. Additional costs associatedwith postoperative infections, and other healthcare liabilities, make the implementation of asterilization process monitoring program anextremely critical practice for all health carefacilities. The 3M Sterilization Assurance Programis a comprehensive and practical approach tosterilization monitoring procedures and methodsthat you can count on to reduce your risk of anundetected sterilization process failure.

The 3M Sterilization Assurance Program helpsyou control and monitor sterilization procedures.It provides you with an easy to follow set ofguidelines to help ensure safety and productsterility throughout your facility.

The 3M Sterilization Assurance Program consists of five separate, but interrelated steps:Load Control, Pack Control, Equipment Control,Exposure Control and Record Keeping. These five steps monitor every aspect of the sterilization process and help you establish,manage and maintain a consistent protocol for sterilization in your facility.

Health care professionals worldwide havecome to trust the complete line of 3M sterilizationmonitoring products to help them monitor allstages of the sterilization process. 3M sets today’sstandard for sterilization process monitoring withdependable, high-performance products, aneffective, easy-to-follow program, customerservice, and technical support.

3M Health Care Helpline:1-800-228-3957Outside the United States, contact the local 3M subsidiary.

3M Sterilization Assurance Program

Load Control 3M Ster i l i za t ion Assurance Program

3M™ Attest™ Biological Indicator Monitoring Starter Kit

Your instruments may have beenthrough the sterilizer—but that doesn’tmean they’re sterile.

Many things can adversely affect thesterilization process. The sterilizer canmalfunction. Time or temperature maybe incorrect. Air may not be removed.Or steam may not reach the center ofthe packs. Improper loading orpackaging can be problems too.

There are five basic steps in thesterilization process itself: Clean,Prep/Pack, Sterilize, Store andIssue/Use. Sterilization processmonitoring impacts just two of thesesteps, Sterilize and Issue/Use. Monitoringtools help to insure the outcome of“Sterilize” and supply safeguards to the“Issue/Use” step so that no nonsterilemedical devices can go beyond thispoint. The threat of postoperativeinfections caused by nonsterile medicaldevices makes sterilization processmonitoring extremely important.

3M™ Attest™ Biological Indicatorscontain Geobacillus stearothermophilusspores especially resistant to the steamsterilization process. Following thesterilization cycle, the vial is crushed,providing media that will promotegrowth of any spores that may not havebeen killed during the sterilizationprocess. An easily detected colorchange in the vial indicates that thesterilization process was not successful.It alerts personnel to a problem with thesterilizer or the sterilization process.

Daily monitoring of the steamsterilization process is recommended by organizations such as the Associationof Operating Room Nurses and theAmerican Society of Healthcare CentralService Professionals.

The Attest Monitoring Starter Kitmakes this process easy. 3M provideseverything your staff needs for effectivemonitoring of the steam sterilizationprocess, including:

Load ControlAttest Biological Indicators—The Attest 1262 biological indicator(brown cap) is designed formonitoring steam sterilizationprocesses. Final readout in 48 hours.

3M™ Attest™ 116 Incubator—A compact incubator designedspecifically for the needs of smallerhealth care facilities. The incubatorallows quick, on-site monitoring by non-lab personnel.

Pack Control3M™ Comply™ ChemicalIntegrators—Internal chemicalintegrators for determining that thesterilant penetrated inside the packor tray. Accept or Reject readout—no need for interpretation.

Exposure Control3M™ Comply™ Steam IndicatorTape—A tape that closes packagessecurely and quickly identifiesprocessed from unprocessed items at a glance. Chemical indicatorstripes change color when the tape is exposed to steam sterilization.

Record Keeping3M™ Attest™ Log Book—An easyway to accurately keep track of thesterilization process, which isessential to protect your practice.

In addition to this overview of the 3M Sterilization Assurance Program,your kit includes the booklet “TheFundamentals of Sterilization ProcessMonitoring”, detailing the steps of thesterilization process, and the enclosedwall chart for easy reference.

You now have everything you need toimplement a complete sterilizationprogram in your facility!

Monitoring with the Attest system is healthy for your patients. And healthy for your practice.

3M™Attest™ 1262 and 1262P Biological Indicators for steam sterilizationFor best results, use an Attest biological indicator in every load of steam sterilized supplies.Instructions below are for steam sterilization only.

Identify the Attest biological indicatorby noting the sterilizer number, loadnumber and processing date on thelabel of the vial.

Place the Attest steam biologicalindicator and the Comply chemicalintegrator in the center of a suitable testpack or tray which is representative ofthe load and is the greatest challenge to the steam sterilization process. Close the test pack with ComplyIndicator Tape.

NOTE: Do not use 3M steam monitoringproducts with dry heat, chemical vapor,ethylene oxide or other low temperaturesterilization processes.

Place the test pack or tray in a full loadin the most difficult area for steam toreach in the sterilizer. Process the loadas usual.

After completion of the cycle and while wearing safety glasses and gloves, fully open the sterilizerdoor for a minimum of 5 minutes prior to removing the Attest biological indicator.

Warning: Crushing or excessive handling ofthe biological indicator before cooling maycause the glass ampule to burst which mayresult in personal injury from flying debris.Therefore, the use of safety glasses and gloveswhen removing biological indicators from thesterilizer is recommended. Safety glassesshould also be worn when crushing biologicalindicators. All safety procedures recommendedby your facility should also be followed.

If the biological indicator is notcontained in a test pack or any otherheat absorbing packaging material,remove the biological indicator fromthe sterilizer and allow to cool for anadditional 10 minutes prior to crushing.

If the biological indicator is containedin a test pack or other heat absorbingpackaging material, the test pack orany other heat absorbing packagingmaterial should be removed from thesterilizer and opened up for 5 minutesto dissipate heat prior to removing thebiological indicator. Then allow thebiological indicator to cool outside thetest pack for an additional 10 minutesprior to crushing.

Check the indicator tape on the outside of the test pack for colorchange to black.

Check the biological indicator label for a change from rose to brown.Check the chemical integrator for anACCEPT result. An incomplete colorchange on the biological indicator labelor a REJECT result on the chemicalintegrator may indicate an inadequatesterilization process.

Incubate the biological indicator as soon as possible. For optimalperformance, leave the incubatorplugged in at all times.

As shown, place the bottom of thebiological indicator vial into theincubator’s metal heating block so that the vial is at an angle ofapproximately 45°.

Push the vial straight back. This crushes the vial and activates the indicator.

Push the activated indicator down tofirmly seat in the metal heating block.Be sure the cap remains above themetal block.

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Examine the biological indicator atregular intervals (8, 12, 24 and 48 hours)for any color change. Appearance of a yellow color (a positive readout)indicates bacterial growth and aninadequate sterilization process. No color change indicates an adequate sterilization process.

A final determination of sterility can be made at 48 hours of incubation for 3M Attest 1262 and 1262P biological indicators.

Record results in the record keepinglog book.

InterpretationUse of Positive Controls

The use of positive controls is required to ensure correct incubationconditions, viability of spores and capability of the medium to promotegrowth. A non-sterilized 3M Attest 1262 or 1262P biological indicator from the same lot should be used in each incubator each day biologicalindicators are used as a positive growth control.

Place a non-sterilized Attest biologicalindicator in the incubator each day you put in an activated sterilizedbiological indicator.

Examine the positive control indicator at regular intervals such as 8, 12, 24and 48 hours. Appearance of a yellowcolor is evidence of bacterial growth. A yellow color in the control vialdemonstrates correct incubation,viability of spores and capability of the medium to promote rapid growth.

Record results in the record keeping log book.

Dispose of used indicators in accordancewith facility policy. You may wish tosterilize any positive indicators at 250°F (121°C) for at least 15 minutes or at 270°F (132°C) for 10 minutes in a gravity displacement steam sterilizer.

SuccessfulSterilization

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FailedSterilization

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Ordering Information3M™ Attest™ Monitoring Starter Kit

Contains one roll of Comply 1222-6N Indicator Tape, one box of Attest 1262P Biological Indicators, an Attest 116 Incubator, one bag of Comply 1243B Chemical Integrators, one Attest 1266 Log Book,and wall chart.Cat No. Product Name115 3M Attest Monitoring Kit

3M™ Attest™ Biological Indicators

For use with steam sterilizers—Geobacillus stearothermophilus. Cat No. Product Name Description Indicators/Box1262 3M Attest Biological Indicators Color code: brown 100

1262P 3M Attest Biological Indicators Color code: brown 25

3M™ Attest™ Incubators

3M Attest Steam Incubator for use with 1262/1262P Attest biological indicators (56°C).Cat No. Product Name Description116 3M Attest Incubator 14 vial capacity

126 3M Attest Incubator 28 vial capacity

3M™ Comply™ (SteriGage™) Chemical Integrators

Internal chemical integrator for steam sterilization.Cat No. Product Name Indicators/Bag1243B 3M Comply (SteriGage) Chemical Integrators 100

3M™ Comply™ Steam Indicator Tape*

Individually packaged:

Cat No. Width Cat No. Width1222-0N 1/2" 1222-1N 1"

1222-6N 3/4" 1222-2N 2"

3M™ Attest™ Record Keeping System

Cat No. Product Name Description Charts/Book1266 3M Attest Log Book and Charts For use with steam sterilization 50

1266S Replacement Record Charts For use with steam sterilization 50

*These Products Contain Dry Natural Rubber.

3M, Attest and Comply are trademarks of 3M.