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Best Practice Monitoring for Sterile Processing Professionals

Sterile processing departments are faced with greater challenges than ever. Increasing demands for quick turnarounds. Pressure to streamline operations and cut costs. The need to keep policies and procedures in line with evolving standards. And of course, the growing expectation to help reduce the risks of surgical site infections and improve patient safety.

3M can help Sterile Processing professionals take on these challenges with a comprehensive approach to monitoring, record keeping, continuing education and technical support. Healthcare professionals in facilities of all kinds have trusted 3M sterilisation products for more than 60 years. We’re ready with the tools and technologies to help you do what you do best.

Together we can make a difference 3

The 5 steps to sterile 4

Implement Standards Practice 6

Never Stop Learning 8

Product Guide 10

Table of Contents

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Together we can make a difference3M understands the challenges you face in instrument reprocessing. We’re a global leader in the manufacture, supply and continuing innovation of biological and chemical indicators for sterilisation monitoring. We have led the way in developing new technologies and techniques. And we have a comprehensive portfolio of products, services and expertise to help you maintain the highest sterilisation standards.

Our Technical Service group is an integral part of our organisation. Staffed with experienced personnel with backgrounds in microbiology, chemistry and other related disciplines, they provide direct support to our customers. Drawing from our extensive experience in sterilisation, they are not only experts on product-related issues but also problem solvers with the clinical understanding and knowledge of relevant standards to advise you and rally the resources required to get your questions answered.

Organisations in more than 60 countries already depend on 3M for innovative products, new ideas and creative solutions to help reduce the risk of healthcare associated infections. We’ll work with you to meet the needs of your organisation—from the high volume of large facilities to the special needs of day surgery centres and primary care clinics.

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5. ISSUE OR USEFinally, upon request, items are retrieved from storage, checked again to ensure the external Chemical Indicator has reached its endpoint, and then issued for use. Once in the OR, the Internal Chemical Indicators are checked to ensure that the sterilisation process was sufficient to penetrate inside of the pack.

1. CLEAN & DISINFECTCleaning and disinfecting is critical to the sterilisation process. Soil CANNOT be sterilised, so the presence of soil or organic material on instruments reduces the effectiveness of disinfection or sterilisation. If your instruments need to be high level disinfected, you must check the concentration of the high level disinfectant in the processor/soaking tray to ensure it’s at or above the minimum effective concentration. When timelines are tight and ORs are requesting quick turnarounds, there may be pressure to cut corners in the cleaning process. Failure to thoroughly clean and disinfect items for sterilisation, however, can jeopardise the entire process.

The 5 Steps to Sterile to SterileThere are five essential steps in instrument in processing:

ocessing:

The fact that your instruments have been run through the steriliser does not guarantee they’re sterile. Many things can adversely affect the sterilisation process, including:

• Improper loading or packaging

• Steriliser malfunction

• Incorrect time or temperature

• Incomplete air removal

• Sterilant failing to reach the centreof the pack

• Steam quality issues

Monitoring tools verify the outcome of the “Sterilise” step and supply safeguards to the “Issue/Use” step, so patients are not exposed to non sterile medical devices.

The threat of surgical site infections (SSIs) caused by non-sterile devices makes following every step in sterilisation process monitoring absolutely critical.

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2. PREP & PACKWhen preparing items for sterilisation, instruments should be dried and inspected for cleanliness and functionality. Multipart instruments should be disassembled. Instruments should be held open and unlocked. Whether using sterilisation wrappers, paper-plastic pouches or rigid container systems, it’s important to properly place Internal and External Chemical Indicators to effectively monitor sterilant penetration and other exposure conditions.

3. STERILISENext, instruments are exposed to the actual sterilant (steam, ethylene oxide, etc.). Successful sterilisation depends on sterilant contact with all surfaces for the prescribed time.

To ensure effective sterilisation, the process must be monitored routinely through equipment displays and printouts and also through proper selection and use of Biological and Chemical Indicators.

4. STOREPackages are removed from the steriliser and quality system documentation is completed. Appropriate storage is required to ensure the integrity of the packaging and the continued sterility of the packages.

The 5 ST

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Equipment MonitoringIs your steriliser actually doing its job? That’s the role of Equipment Monitoring devices such as Bowie-Dick type tests, which detect air leaks, inadequate air removal, poor steam penetration and the presence of non-condensable gases—any of which can compromise sterility. Use daily before the first processed load.

Practical Application guidance• The Bowie-Dick test pack should always be run in a warm steriliser to avoid false failures.

• Place the Bowie-Dick test pack on the bottom shelf of the cart or rack, over the drain, inan empty steriliser.

Recommended 3M Product 3M™ Electronic Test System (ETS) provides you with more information than just a Chemical Bowie & Dick Test packs

Load MonitoringLoad 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 lethality to microbial spores in a sterilisation cycle.

Practical Application guidance• A positive control should be incubated each day a test BI is incubated in each 3M™ Attest™

Auto-reader or Incubator.

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

Recommended 3M Product 3M™ Attest™ Super Rapid Readout Biological Indicator technology provides results in 1 hour.

or Steam Sterilisation Implement Standards Practice with the 3M Core Four for Steam Sterilisation

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Implement Standarwith the 3M Core Four Pack Monitoring

Packs, trays, containers and peel pouches must be monitored internally to ensure proper sterilisation. Internal pack monitoring with Chemical Indicators verifies that the sterilant has penetrated to where the Chemical Indicator is placed in the pack, and it confirms that specific exposure conditions have been met.

Practical Application guidance• For steam sterilisation, place a pack monitor in the geometric centre of each pack, peel

pouch or tray. In rigid containers, place a pack monitor in two opposite corners of eachlevel. In multi-level wrapped containers supplied by the manufacturer, place a packmonitor in the centre of each level.

• If a pack monitor fails, that package should not be used. If the BI from the load wasnegative, you could decide to issue the remaining packs from the load. If the BI resultswere not available when the pack failure was discovered, the load contents should bequarantined until the BI results are known.

Recommended 3M Product 3M™ Comply™ (SteriGage™) Type 5 Integrating Indicators have easy to interpret “moving front style” ink technology.

Exposure MonitoringHow do you know for sure whether packs have been exposed to the sterilisation process? Exposure monitoring products assure the health care professional at a glance whether the pack has been exposed—without having to open the pack.

Practical Application guidance• Use an external Chemical Indicator on the outside of each package.

• On the exterior of each packaged reusable medical device an external indicatormust be used.

Recommended 3M Product 3M™ Comply™ Indicator Tapes are lead free, solvent free and latex free.

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Never Stop LearningYou’re busy. Your staff is busy. Yet it’s vitally important that everyone keeps up with the latest advances in sterilisation technology, processes and standards. That’s why we created 3M™ Sterile U, a network of the most up-to-date educational services and training resources.

3M Sterile U is dedicated to improving the competency and confidence of sterile processing professionals, and it’s structured to let you learn at your own pace and at times that are convenient for you.

3M™ Sterile U

The 3M Learning ConnectionFor access to a range of broader infection prevention education materials, check out the 3M Learning Connection. Self-study programs, how-to videos and many other educational resources are available. Visit www.3m.com/IPDEd for information.

WebinarsOur popular 3M™ Sterile U webinars are free, interactive programs that tackle today’s most important sterilisation issues. Register to receive invites to these sessions at www.3M.com.au/3MSterileURegister.

Seminars3M™ Sterile U Seminars are conducted by 3M technical service and industry experts from all over the world. They’re a great way to bring local sterilisation professionals together to network and stay in touch with Recommended Practices for Sterile Processing. Connect with your 3M representative to receive more information on these.

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Equipment Monitoring

3M™ Electonic Test System (ETS)

3M ETS is a unique and easy to use electronic test device which provides comprehensive, objective, independent information about the critical variables of the steam sterilisation process, providing an innovative alternative to the traditional Bowie and Dick type test and its derivatives.

Results are reproducible and equivalent in performance to the standard Bowie and Dick test pack (as described in ISO 11140-4). The device is tested to methods described in ISO 11140-4, the 3M ETS satisfies the daily steam penetration test requirement prescribed in ISO 17665-1.

In addition to the Bowie & Dick test results, the ETS also provides a number of diagnostics features including:

• Sterilisation Parameter Indication (SPI) - sterilisation hold time

• Leak Rate test (LRT)

• Superheated Steam Detection

• Engineering Tests and Help Files

• Master Overlay

• Dilution Factor

• Fo Calculation

• Multiple chart overlay

• Searchable database of results

3M Infection Prevention Solutions

3M Product Code Product Description UOM QTY per UOM

MIN Order QTY

4208 ETS Sensing Unit Each 1 1

4109 ETS Data Reader Each 1 1

4110 ETS Software Each 1 1

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Equipment Monitoring

Bowie & Dick Type Tests

The Bowie & Dick Type Test Packs are designed for use in vacuum-assisted sterilisers to test the efficacy of the vacuum system to remove air from the steriliser chamber and to detect leaks in the system that would allow air into the chamber. All disposable Bowie and Dick type test packs are lead free.

3M™ Comply™ 1300 Bowie Dick Test Pack Meets performance requirements to standards Bowie & Dick test pack, as described in ISO 11140-4 - Type 2.

Independently tested to meet the British Standards Institute Kitemark.

Indicator colour change from RED to BLUE.

3M™ Comply™ 1301 Bowie Dick Test Pack Meets performance requirements to standards Bowie & Dick test pack, as described in ISO 11140-4 - Type 2.

Independently tested to meet the British Standards Institute

Kitemark.

Indicator colour change from LIGHT BLUE to LIGHT PINK.

BEFORE sterilisation process (RED)

BEFORE sterilisation process (BLUE)

AFTER sterilisation process (BLUE)

AFTER sterilisation process (PINK)

PASS P


PASS P


MIN Order QTY

1300 3M™ Comply™

Bowie-Dick Test Pack 1300Case 20 1


MIN Order QTY

1301 3M™ Comply™

Bowie-Dick Test Pack 1301Case 20 1

3M™ Comply™ Bowie-Dick Type Test Pack Equivalent performance to the Bowie and Dick towel pack cited in ANSI/AAMI ST79.

Indicator pattern is easy to read and interpret.

Lead-free ink eliminates hazardous waste issues.

BEFORE sterilisation process (YELLOW)

AFTER sterilisation process (BLACK)

PASS P


MIN Order QTY

1233LF Bowie-Dick Type Test Pack Case 30 1

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Auto-Reader Biological Indicators

Steriliser Type 3M Products Range Incubation Time Colour Change Information

3M™ Attest™ Super Rapid Readout Biological Indicator 1492V

3M™ Attest™ Super Rapid 5-Steam-Plus Challenge Packs 41482V or 41482VF

3M™ Attest™ Super Rapid Readout Steam Challenge Packs 1496V or 1496VF

3M™ Attest™ 490 Auto-reader

1hr

1hr

1hr

Vacuum AssistedSteriliser

A chemical process indicator which changes from pink to light brown or darker upon exposure to steam is located on the top of the cap.

a) Each challenge packhas a process indicator on the pack label that changes from yellow to brown or darker whenexposed to steam.

b) A chemical processindicator which changes from pink to light brownor darker upon exposureto steam is located on thetop of the cap.

3M Product Code Product Description UOM QTY per UOM MIN Order QTY

1492V For 132°C - 135°C Vacuum - Assisted Steam Sterilisation cycles.

Box 50 each 1

41482V For 132°C - 135°C Vacuum - Assisted Steam Sterilisation cycles. Each pack contains one 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V and one 3M™ Comply™ SteriGage™ Steam Chemical Integrator 1243

Case 24 challenge packs24 controls

1

41482VF Case 24 challenge packs5 controls

1

1496V For 132°C - 135°C Vacuum - Assisted Steam Sterilisation cycles. Each pack contains one 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V


1

1496VF Case 24 challenge packs5 controls

1

490 For incubating ‘Super Rapid’ steam BI’s. (10 vial capacity). 1 hour results

Each 1 1


Load Monitoring

3M™ Attest™ Super Rapid Readout Biological Monitoring system

Get true biological results in record time with 3M Attest Super Rapid Readout Biological Indicators and put your instrument turnaround speed into overdrive. Only a biological indicator can detect the actual killing of microbial spores inside the steriliser. 3M Attest Super Rapid Readout Biological Indicators meet the performance requirements of ISO 11138-1:2006, ISO 11138-3:2006 and are satisfactory for use under AS/NZS 4187:2014.

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Rapid Ranges Biological Indicators


3M™ Attest™ Rapid Readout Biological Indicator 1291



3M™ Attest™ 390 Auto-reader

GravitySteriliser

1hr

3hrVacuum AssistedSteriliser

1. Product label stripchanges from PINK to BROWN

2. No colour changes inthe ampule

3. For 1296, BEIGE circlechanges to BLACK


1291 Rapid Biological Indicator for Flash Sterilising Cycles - 132°C/134°C Gravity Displacement Steam Sterilisers. Readout in 1 hour.

Box 50 each 1

1292 Rapid Biological Indicator for Pre-Vac Sterilising Cycles - 121°C Gravity & 132/134°C. Vacuum-Assisted Steam Sterilisers. Readout in 3 hours.

Box 50 each 1

1296 Rapid Biological Test Pack (25 controls) for 121°C Gravity & 132/134°C. Vacuum-Assisted Steam Sterilisers. Each pack contains: 1292 Rapid Readout Biological Indicator giving 3 hour readout.


1

390 For incubating ‘Rapid’ steam BI’s. (10 vial capacity). 1 hour for 1291 BI and 3 hour for 1292 BI.

Each 1 1

1266 Log book for use with Rapid Steam Biological Indicators

Each 1 1

• Results in three hours for vacuum assisted sterilisers (Attest 1292) & results in one hour (Attest1291) for gravity displacement sterilisers .

• Challenge packs (Attest 1296) present a challenge to the sterilisation process.• Malfunctioning sterilisers can be identified rapidly, repaired and put back into service sooner.


Load Monitoring

3M™ Attest™ Rapid Readout Biological Monitoring system

Enabling health care facilities to detect sterilisation process failures at the earliest stage and to respond more quickly and efficiently to such failures. You can make informed decisions and take appropriate action before surgery.

Thus Attest biological indicators become an integral part of your infection prevention program, helping reduce the costs associated with hospital acquired infections.

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Load Monitoring

Incubator Biological Indicators


3M™ Attest™ StandardBiological Indicator 1262

3M™ Attest™ StandardBiological Indicator Challenge Pack 1276

3M™ Attest™ StandardBiological Indicator 1261

GravitySteriliser

24hr

48hrVacuum AssistedSteriliser

3M™ Attest™ 118 Incubator

2. Ampule changes from PURPLE toYELLOW

3. For 1276, BEIGEcircle changes to BLACK

1. Product label stripchanges from PINKto BROWN



1261P Standard Biological Indicatorfor use with 132/134°C GravityDisplacement Steam Sterilisers

Box 25 each 4

1261 Standard Biological Indicator for use with 132/134°C Gravity Displacement Steam Sterilisers

Box 100 each 1

1262P Standard Biological Indicator foruse with 121°C Gravity & 132/4°CVacuum-Assisted Steam Sterilisers

Box 25 each 4

1262 Standard Biological Indicator for use with 121°C Gravity & 132/4°C Vacuum-Assisted Steam Sterilisers

Box 100 each 1

1276 3M™ Attest™ 1276 Steam Biological Challenge


1

118 Incubator, 14 vial; 56°C (Steam). Suitable for incubating Standard BI’s (1261 & 1262)

Each 1 1

1266-A Log book for use with Standard Steam Biological Indicators

Each 1 1

The standard Attest biological monitoring system provides assurance that each load is achieving microbial kill. Specific proof is provided to show that the conditions for sterilisation have been achieved.

• Results in 48 hours for vacuum assisted sterilisers (Attest 1262) & results in 24 hours (Attest1261) for gravity displacement sterilisers .

• Regular, individual load monitoring and quarantining can eliminate recalls.• Challenge packs (Attest 1276) present a challenge to the sterilisation process.

3M™ Attest™ Standard Readout Biological Monitoring system

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ACCEPTED REJECTED


MIN Order QTY per UOM

1243A 500 Each/Bag, 2 Bags/Case Case 1000 1

1243B 100 Each/Bag, 10 Bags/Case Case 1000 1

1243RE 500 Each/Bag, 2 Bags/Case - with extender Case 1000 1



2134MM 250 Each/Pack, 8 Packs/Case Case 2000 1

Immediate, accurate and easy-to-read monitoring of sterilisation process conditions inside packs. For use in all steam sterilisers. “Moving front” style has safe/unsafe readout for instant results with easy interpretation. Performance requirements ensure the response correlates with a biological indicator at three time/temperature relationships under ideal steam sterilisation conditions. Suitable for monitoring of all 121-135ºC steam sterilisation cycles.

3M™ Comply™ (Thermalog™) Steam Chemical IntegratorsType 5 Integrating Indicators as categorised by ISO 11140-1:2014.


Pack Monitoring

3M™ Comply™ (SteriGage™) Steam Chemical IntegratorsType 5 Integrating Indicators as categorised by ISO 11140-1:2014.

Moving front chemical integrator offers an immediate, accurate and easy-to-read method of monitoring sterilisation process conditions inside each pack. “Moving front” style has accept/reject readout for instant results with easy interpretation. Convenient size for all packs with optional extenders available. Performance requirements ensure the response correlates with a BI at three time/temperature relationships under ideal steam sterilisation conditions. Suitable for monitoring of all 118-138ºC steam sterilisation cycles.

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3M™ Comply™ Hydrogen Peroxide Chemical Indicators

An internal pack chemical indicator for use in STERRAD® 100, STERRAD® 100S, STERRAD® NX® and STERRAD® 100NX® sterilisation systems. Indicator changes from blue to pink when exposed to vapor hydrogen peroxide.

UNPROCESSED ACCEPTEDREJECTED


Pack Monitoring



1248 250 Each/Pack, 4 Packs/Case Case 1000 1

Distinct colour change indicates process results inside each pack. Colour changes to dark brown/black when exposed to steam sterilisation. For use in all steam sterilisers. Long strip of chemical indicator ink printed on perforated-style strip. Allows full- or half-length use for different pack sizes.

3M™ Comply™ Steam Chemical Indicator StripsType 4 Chemical Indicators as categorised by ISO 11140-1:2014.



1250 240 Each/Box Box 240 8

UNEXPOSED EXPOSED

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Exposure Monitoring

3M™ Comply™ Lead Free Steam Indicator TapesType 1 Process Indicator as categorised by ISO 11140-1:2014.

The 3M™ Comply™ lead free steam indicator tapes show at-a-glance whether packs have been exposed to a steam sterilisation process and function as a closure to securely seal the sterilisation packs. They accept hand-writing and labeling for record keeping information. The steam indicator range is environmentally sustainable product that is lead free, solvent free, and latex free. Its redesigned packaging also uses up to 30% less plastic.

(Designed for use on disposable wraps)

(Designed for use on disposable wraps)

3M Product Code Product Description

UOM QTY per UOM(Rolls/Case)

MIN Order QTYper UOM

1322-12MM 12mm x 55m, Beige Rolls 1 42



3M Product Code Product Description

UOM QTY per UOM(Rolls/Case)

MIN Order QTYper UOM

1355-18MM 18mm x 55m, Blue Rolls 1 28

1355-24MM 24mm x 55m, Blue Rolls 1 20

UNEXPOSED

UNEXPOSED

EXPOSED

EXPOSED

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Exposure Monitoring

3M Product Code

Product Description UOM QTY per UOM


1228 19mm x 55m, White Case 24 1

3M™ Comply™ Hydrogen Peroxide Indicator Tape

External indicator tape for use in STERRAD® 100, STERRAD® 100S, STERRAD® NX® and STERRAD® 100NX® sterilisation systems. Provides immediate identification of processed items and seals packs. The chemical indicator stripes turn from blue to pink after exposure to vaporised hydrogen peroxide.

UNEXPOSED EXPOSED

3M Product Code

Product Description UOM QTY per UOM


1224-6 19mm x 55m Roll 1 24

1224-0 24mm x 55m Roll 1 18

3M™ Comply™ Indicator Tape for Ethylene OxideType 1 Process Indicator as categorised by ISO 11140-1:2014.

External indicator tape for use in ethylene oxide sterilisation processes. Provides immediate identification of processed items and seals packs. Chemical indicator lines turn from yellow to red when exposed to an EO sterilisation process.

UNEXPOSED EXPOSED

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3M™ Comply™ Instrument Protectors

3M Comply Instrument Protectors are thick, disposable paper holders designed to protect delicate surgical instruments during the sterilisation process. Instrument tips are secured in a clear film pocket to help prevent penetration of the peel pouch. It also allows for viewing and easy identification of each instrument. The anti-lock flap keeps jawed instruments open to permit steam or gas penetration. Each instrument protector has steam and ethylene oxide (EO) indicators to verify processing. The steam indicator changes from blue to gray/black when exposed to steam sterilisation. The EO indicator changes from yellow to red/rust when exposed to EO.


Exposure Monitoring



13911 5.1cm x 12.8cm for reusable needles and small surgical unhinged instruments up to 12.9cm

Box 100 10

13913 9.03cm x 16.77cm for instruments up to 18.06cm

Box 100 10

13915 14.19cm x 24.51cm for instruments up to 28.38cm

Box 100 10

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Cleaning

Rapid Multi Enzyme Cleaner (RMEC)

Multi-Enzyme cleaner with high enzyme activity for use with surgical, medical and dental instruments. Foaming bath formulation for manual and ultrasonic cleaning. Low-foaming formulation for use in high temperature automated equipment such as tunnel and batch washers.An effective multi enzyme detergent used for cleaning metallic and plastic medical instruments, including flexible and rigid endoscopes.



MIN Order QTY

70500-D Bath Formulation,1L/bottle

Case 12 1

70500-B Bath Formulation,5L/bottle

Case 2 1

70505-B Auto Formulation, 5L/Bottle Case 2 1

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