Best Practice Monitoring for Sterile Processing Professionals

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Dwain Bryan
6 years ago
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1 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.

2 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. Table of Contents Together we can make a difference 3 The 5 steps to sterile 4 Implement Standards Practice 6 Never Stop Learning 8 Product Guide 10 2

3 Together we can make a difference 3M 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. 3

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.

4 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. 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 centre of the pack Steam quality issues The 5 Steps to Sterile There are five essential steps in instrument in processing: 1. CLEAN & DISINFECT Cleaning 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. 5. ISSUE OR USE Finally, 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. 4

5 2. PREP & PACK When 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. STERILISE Next, 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. STORE Packages 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. 5

6 Implement Standards Practice with the 3M Core Four for Steam Sterilisation Equipment Monitoring Is 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, in an empty steriliser. Recommended 3M Product 3M Electronic Test System (ETS) provides you with more information than just a Chemical Bowie & Dick Test packs Load Monitoring 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 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 items from that load and all items from loads processed since the last load with a negative BI result should be recalled and reprocessed. Recommended 3M Product 3M Attest Super Rapid Readout Biological Indicator technology provides results in 1 hour. 6

7 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 each level. In multi-level wrapped containers supplied by the manufacturer, place a pack monitor in the centre of each level. If a pack monitor fails, that package should not be used. If the BI from the load 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. Recommended 3M Product 3M Comply (SteriGage ) Type 5 Integrating Indicators have easy to interpret moving front style ink technology. Exposure Monitoring How 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 indicator must be used. Recommended 3M Product 3M Comply Indicator Tapes are lead free, solvent free and latex free. 7

Never Stop Learning You 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.

8 Never Stop Learning You 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 Connection For 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 for information. Webinars Our 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 Seminars 3M 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. 8

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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

Results are reproducible and equivalent in performance to the standard Bowie and Dick test pack (as described in ISO 11140-4).

10 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 ). The device is tested to methods described in ISO , the 3M ETS satisfies the daily steam penetration test requirement prescribed in ISO 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 Product Code Product Description QTY per QTY 4208 ETS Sensing Unit Each ETS Data Reader Each ETS Software Each

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

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

BEFORE sterilisation process (RED) AFTER sterilisation process (BLUE) PASS P 3M Product Code Product Description QTY per 1300 3M Comply Bowie-Dick Test Pack 1300 Case 20 1 QTY 3M Comply 1301 Bowie

11 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 Type 2. Independently tested to meet the British Standards Institute Kitemark. Indicator colour change from RED to BLUE. BEFORE sterilisation process (RED) AFTER sterilisation process (BLUE) PASS P 3M Product Code Product Description QTY per M Comply Bowie-Dick Test Pack 1300 Case 20 1 QTY 3M Comply 1301 Bowie Dick Test Pack Meets performance requirements to standards Bowie & Dick test pack, as described in ISO Type 2. Independently tested to meet the British Standards Institute Kitemark. Indicator colour change from LIGHT BLUE to LIGHT PINK. BEFORE sterilisation process (BLUE) 3M Product Code Product Description QTY per M Comply Bowie-Dick Test Pack 1301 Case 20 1 AFTER sterilisation process (PINK) PASS P QTY 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 3M Product Code Product Description QTY per 1233LF Bowie-Dick Type Test Pack Case 30 1 QTY 11

12 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 :2006, ISO :2006 and are satisfactory for use under AS/NZS 4187:2014. Auto-Reader Biological Indicators Steriliser Type 3M Products Range Incubation Time Colour Change Information 3M Attest Super Rapid Readout Biological Indicator 1492V 1hr 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. 3M Attest 490 Auto-reader Vacuum Assisted Steriliser 3M Attest Super Rapid 5-Steam-Plus Challenge Packs 41482V or 41482VF 3M Attest Super Rapid Readout Steam Challenge Packs 1496V or 1496VF 1hr 1hr a) Each challenge pack has a process indicator on the pack label that changes from yellow to brown or darker when exposed to steam. b) 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. 3M Product Code Product Description QTY per QTY 1492V 41482V For 132 C C Vacuum - Assisted Steam Sterilisation cycles. For 132 C C Vacuum - Assisted Steam Sterilisation cycles. Each pack contains one 3M Attest Super Rapid Box 50 each VF Readout Biological Indicator 1492V and Case 24 challenge packs one 3M Comply SteriGage Steam 5 controls Chemical Integrator V For 132 C C Vacuum - Assisted Steam Sterilisation cycles. Each pack contains one 3M Attest Super Rapid Readout Biological Indicator 1492V Case Case 24 challenge packs 24 controls 24 challenge packs 24 controls 1496VF Case 24 challenge packs 5 controls 490 For incubating Super Rapid steam BI s. (10 vial capacity). 1 hour results Each

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

13 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. Results in three hours for vacuum assisted sterilisers (Attest 1292) & results in one hour (Attest 1291) 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. Rapid Ranges Biological Indicators Steriliser Type 3M Products Range Incubation Time Colour Change Information Gravity Steriliser 3M Attest Rapid Readout Biological Indicator hr 1. Product label strip changes from PINK to BROWN 3M Attest 390 Auto-reader Vacuum Assisted Steriliser 3M Attest Rapid Readout Biological Indicator M Attest Rapid Readout Biological Indicator hr 2. No colour changes in the ampule 3. For 1296, BEIGE circle changes to BLACK 3M Product Code Product Description QTY per QTY 1291 Rapid Biological Indicator for Flash Sterilising Cycles C/134 C Gravity Displacement Steam Sterilisers. Readout in 1 hour Rapid Biological Indicator for Pre-Vac Sterilising Cycles C Gravity & 132/134 C. Vacuum- Assisted Steam Sterilisers. Readout in 3 hours. Box 50 each 1 Box 50 each 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. Case 25 challenge packs 25 controls For incubating Rapid steam BI s. (10 vial capacity). 1 hour for 1291 BI and 3 hour for 1292 BI Log book for use with Rapid Steam Biological Indicators Each 1 1 Each

14 Load Monitoring 3M Attest Standard Readout Biological Monitoring system 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 (Attest 1261) for gravity displacement sterilisers. Regular, individual load monitoring and quarantining can eliminate recalls. Challenge packs (Attest 1276) present a challenge to the sterilisation process. Incubator Biological Indicators Steriliser Type 3M Products Range Incubation Time Colour Change Information 3M Attest 118 Incubator Vacuum Assisted Steriliser Gravity Steriliser 3M Attest Standard Biological Indicator M Attest Standard Biological Indicator Challenge Pack M Attest Standard Biological Indicator hr 24hr 2. Ampule changes from PURPLE to YELLOW 3. For 1276, BEIGE circle changes to BLACK 1. Product label strip changes from PINK to BROWN 3M Product Code Product Description QTY per QTY 1261P Standard Biological Indicator for use with 132/134 C Gravity Displacement Steam Sterilisers Box 25 each Standard Biological Indicator for use with 132/134 C Gravity Displacement Steam Sterilisers Box 100 each P Standard Biological Indicator for use with 121 C Gravity & 132/4 C Vacuum-Assisted Steam Sterilisers Box 25 each Standard Biological Indicator for use with 121 C Gravity & 132/4 C Vacuum-Assisted Steam Sterilisers Box 100 each M Attest 1276 Steam Biological Challenge Case 25 challenge packs 25 controls Incubator, 14 vial; 56 C (Steam). Suitable for incubating Standard BI s (1261 & 1262) 1266-A Log book for use with Standard Steam Biological Indicators Each 1 1 Each

15 Pack Monitoring 3M Comply (SteriGage ) Steam Chemical Integrators Type 5 Integrating Indicators as categorised by ISO :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 ºC steam sterilisation cycles. ACCEPTED REJECTED 3M Product Code Product Description QTY per QTY per 1243A 500 Each/Bag, 2 Bags/Case Case B 100 Each/Bag, 10 Bags/Case Case RE 500 Each/Bag, 2 Bags/Case - with extender Case M Comply (Thermalog ) Steam Chemical Integrators Type 5 Integrating Indicators as categorised by ISO :2014. 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 ºC steam sterilisation cycles. 3M Product Code Product Description QTY per QTY per 2134MM 250 Each/Pack, 8 Packs/Case Case

Pack Monitoring 3M Comply Steam Chemical Indicator Strips Type 4 Chemical Indicators as categorised by ISO 11140-1:2014. Distinct colour change indicates process results inside each pack.

16 Pack Monitoring 3M Comply Steam Chemical Indicator Strips Type 4 Chemical Indicators as categorised by ISO :2014. 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. UNEXPOSED EXPOSED 3M Product Code Product Description QTY per QTY per Each/Box Box M 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 REJECTED ACCEPTED 3M Product Code Product Description QTY per QTY per Each/Pack, 4 Packs/Case Case

17 Exposure Monitoring 3M Comply Lead Free Steam Indicator Tapes Type 1 Process Indicator as categorised by ISO :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. UNEXPOSED EXPOSED (Designed for use on disposable wraps) 3M Product Code Product Description QTY per (Rolls/Case) QTYper MM 18mm x 55m, Blue Rolls MM 24mm x 55m, Blue Rolls 1 20 UNEXPOSED EXPOSED (Designed for use on disposable wraps) 3M Product Code Product Description QTY per (Rolls/Case) QTYper MM 12mm x 55m, Beige Rolls MM 18mm x 55m, Beige Rolls MM 24mm x 55m, Beige Rolls

18 Exposure Monitoring 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 QTY per QTY per mm x 55m, White Case M Comply Indicator Tape for Ethylene Oxide Type 1 Process Indicator as categorised by ISO :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 3M Product Code Product Description QTY per QTY per mm x 55m Roll mm x 55m Roll

Exposure Monitoring 3M Comply Instrument Protectors 3M Comply Instrument Protectors are thick, disposable paper holders designed to protect delicate surgical instruments during the sterilisation

19 Exposure Monitoring 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. 3M Product Code Product Description QTY per QTY per cm x 12.8cm for reusable needles and small surgical unhinged instruments up to 12.9cm cm x 16.77cm for instruments up to 18.06cm cm x 24.51cm for instruments up to 28.38cm Box Box Box

Cleaning Rapid Multi Enzyme Cleaner (RMEC) Multi-Enzyme cleaner with high enzyme activity for use with surgical, medical and dental instruments.

20 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. 3M Product Code Product Description QTY per QTY D Bath Formulation, 1L/bottle B Bath Formulation, 5L/bottle Case 12 1 Case B Auto Formulation, 5L/Bottle Case

They can be used on washer-disinfectors, ultrasonic cleaners, surgical instruments and endoscopes. Page 5

They can be used on washer-disinfectors, ultrasonic cleaners, surgical instruments and endoscopes. Page 5 Rev. 0 October 2017 Terragene offers a wide range of simple and effective products to precisely control the washing, hygiene and sterilization processes in veterinary clinics. Available in a variety of