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Dental Sterilization 

Monitoring Solution


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Valid October 1 - December 31, 2024

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To redeem your 3M™ Attest™ Mini Auto-reader 490M offer, please contact your local CRD Clinical Advisor or call 1-800-265-3444. Please send qualifying invoice by email to mkay@mmm.com

Dental Sterilization: Follow these 5 Steps

There are five essential steps in instrument reprocessing:

  • Clean & Disinfect

  • Prep & Pack

  • Sterilize

  • Sterilization Monitoring

  • Storage

Monitoring tools verify the outcome of the “Sterilize” step and supply safeguards to whether loads should be released, so patients are not
exposed to non-sterile instruments or devices.

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

• Improper loading or packaging

• Sterilizer malfunction

• Incorrect time or temperature

• Incomplete air removal

• Sterilant failing to reach the centre of the pack

• Steam quality issue

STEP 1

Receiving, Cleaning & Decontamination

Cleaning involves the removal of debris (e.g. organic and inorganic matter). This is achieved either by scrubbing with a detergent formulated for medical device reprocessing or an enzymatic cleaner, or by an automated process (e.g. ultrasonic cleaner or automated washer with a cleaning solution). Cleaning does not kill microorganisms. Disinfection kills most pathogenic microorganisms but does not kill all bacterial spores.

STEP 2

Preparation & Packaging

In another section of the reprocessing area, cleaned and dried instruments must be inspected, assembled into sets or trays and packaged for sterilization. Critical and semi critical instruments must be reprocessed in a manner that will maintain sterility during storage.

STEP 3

Sterilize

A validated process that kills all pathogenic microorganisms The critical process variables for steam sterilization include temperature, time, and saturated steam / pressure. All instruments must be sterilized by either steam under pressure (i.e. autoclaving), which is dependable and economical, or dry heat.

STEP 4

Monitoring of Sterilization

Monitoring of sterilization must be conducted through a combination of physical, chemical and biological means, which evaluate both the sterilizing conditions and the procedure’s effectiveness. The dental office must have written policies and procedures for monitoring of sterilization.

STEP 5

Storage

Packages are removed from the sterilizer and quality system documentation is completed. Appropriate storage is required to ensure the integrity of the packaging and the continued sterility of the packages. Sterile and single-use (disposable) items must not be stored under sinks, on counters adjacent to sinks or in other locations where they might become wet or contaminated.


Packages containing sterile instruments must be inspected before use to verify the results of external and internal chemical indicators, barrier integrity and dryness. If the packaging is compromised (e.g. unsealed, damaged, wet, visibly soiled or dropped on the floor), the instruments must be cleaned, packaged and sterilized again.

Implement Standards for Steam Sterilization

Into Your Practice With the 3M™ Core Four

Is your sterilizer 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.


Practical Applications of the Standards

(1) Use daily before the first processed load in each pre-vacuum sterilizer.

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

(3) Place the Bowie-Dick test pack on the bottom shelf rack, over the drain, in an empty sterilizer.

Recommended Product: 

3M™ Comply™ Bowie-Dick Plus Test Pack 00135LF contains a proprietary early warning test sheet.

Learn how to use Bowie-Dick Test Packs for Steam Sterilization

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Learn more about 3M™ Attest™ Super Rapid Readout Biological Indicator

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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 sterilization cycle.


Practical Applications of the Standards

(1) Use at least daily in each sterilizer with the first processed load.

(2) Loads containing implants should be monitored with a BI PCD that contains a Type 5 CI and quarantined until the BI results are known.

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

(4) 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 Product: 

3M™ Attest™ Super Rapid Readout Biological Indicator technology provides fast in-house monitoring results in just 24 minutes!*

Packs, trays, containers and peel pouches must be monitored internally to ensure proper sterilization. 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 Applications of the Standards

(1) Use an internal CI in each package

(2) For steam sterilization, place a pack monitor in the geometric centre of each pack, peel pouch or tray. In multi-level wrapped containers, place a pack monitor in the centre of the top level and opposite corners of lower levels.

(3) If a pack monitor fails, it typically is an indication of incorrect packaging, poor sterilant quality, or sterilizer loading errors. In these cases, the package should not be used.

(4) A Type 4 indicator reacts to 2 or more critical variables in the sterilization cycle, while a Type 5 indicator reacts to all 3 critical variables in the sterilization cycle.

Recommended Product: 

3M™ Attest™ Type 5 Steam Chemical Integrators have moving front ink technology with vibrant "Accept" (Green) and "Reject" (Red) zones for easy interpretation within seconds.

Learn more about 3M™ Attest™ Steam Chemical Integrator

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exposure monitoring exposed unexposed

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


Practical Applications of the Standards

Use an external Chemical Indicator on the outside of each package.


Recommended Product:

3M™ Comply™ Indicator Tapes are lead free and latex free and do not require hazardous waste disposal. They change colour when exposed to steam but are not an indication of sterility.

The Types of Steam Chemical Indicators

The Canadian Standards Association (CSA) and the International Organization for Standardization (ISO) define 6 classes or types of Chemical Indicators in the

11140-1:2014 standard. Each Type of Chemical Indicator has its own unique characteristics and intended use, and the numbering system (Class or Type 1 – 6) has no hierarchical significance. In the Dental Industry products from the first five classes are the ones that will typically be used.


CSA Z314.3-14 Description
Class
PRACTICAL APPLICATIONS
Class 1 (process indicators) serve only to distinguish processed goods from items that have not been sterilized.” These indicators are also referred to as external CIs.
Process indicators
Indicator tapes, indicator labels and load cards are examples of Class 1 Process Indicators for exposure control.
Class 2 (specific tests, e.g., Bowie-Dick) are employed in special applications such as the Bowie-Dick air removal test. They measure a specific attribute such as air removal or steam penetration.
Specific test indicators
Usually called Bowie-Dick type tests, Class 2 Indicators are used to evaluate sterilizer performance.
Class 3 (single variable indicators) respond to a single sterilization variable such as time or temperature. They provide limited information regarding the overall efficacy of a sterilization process.
Single variable indicators
Single-variable Indicators may be used for pack control monitoring, but do not provide as much information as Multi-variable Indicators or Integrating Indicators. (Not typically used in U.S. healthcare facilities.)
Class 4 (multi-variable indicators) respond to two or more of the critical variables of the sterilization process.
Multi-variable indicators
Multi-variable Chemical Indicators are used for internal pack control. They usually consist of paper strips that are printed with a chemical indicator.
Class 5 (integrating indicators) are designed to react to all critical process variables. The stated values (SVs) are generated to be equivalent to, or exceed the performance requirements for biological indicators.
Integrating indicators
Use Integrating Indicators for both pack and load control monitoring in conjunction with BIs.
Class 6 (emulating indicators) are designed to react to all critical process variables for specified sterilization cycles. The SVs are generated from the critical process variables of the specified sterilization process and are related to the minimum values required to achieve sterilization.
Emulating indicators
Emulating Indicators are designed for specific sterilization cycles and should be used only to monitor the specific cycle for which they are labeled.