• In this tutorial you will learn:– Why sterilization monitoring?– Steps of Instrument Processing– How SporeCheck works– Features and Benefits of SporeCheck

Instrument Processing

1. Cleaning

2. Inspection

3. Packaging

4. Sterilization

5. Storage & Delivery

6. Quality Assurance (Sterilizer Monitoring)

There are six (6) recommended steps for Instrument Processing. Sterilization monitoring is part of Quality Assurance.

Sterilization Monitoring

Let’s take just a few minutes to review sterilization monitoring before we get into the details of Hu-Friedy’s SporeCheck.

Sterilization Monitoring 101

Why use sterilization monitoring?

• Various factors may potentially cause the failure of instruments to be properly sterilized:

– Poor office procedures & safeguards– Lack of staff training – Improper cleaning of instruments– Improper packaging or incorrect packaging materials – Overloading or improper loading– Failure to allow adequate separation in the sterilizer– Improper time and/or temperature– The sterilizer may not be functioning properly

What is Monitoring?

According to CDC Guidelines …

• Monitoring of sterilization procedures should include a combination of process parameters, including mechanical, chemical, and biological.

• These parameters evaluate both the sterilizing conditions and the procedure's effectiveness.

Types of Sterilization Monitoring

Mechanical• Mechanical techniques for monitoring sterilization

include assessing cycle time, temperature, and pressure by observing the gauges or displays on the sterilizer and noting these parameters for each load prior to unloading the sterilizer.

• Correct readings do not ensure sterilization, but incorrect readings can be the first indication of a problem.

Types of Sterilization Monitoring

Chemical• Chemical indicators, internal and external, use sensitive

chemicals to assess physical conditions (e.g., time and temperature) during the sterilization process.

• Although chemical indicators do not prove sterilization has been achieved, they allow detection of certain equipment malfunctions, and they can help identify procedural errors. – It is recommended that each instrument pack have both

internal and external indicators.

IMS-1240

Types of Sterilization Monitoring

Biological Monitors (Spore Tests)• Biological indicators (BIs) are the most accepted method

for monitoring the sterilization process because they assess it directly by killing known highly resistant microorganisms.

• Because spores used in BIs are more resistant and present in greater numbers than the common microbial contaminants found on patient-care equipment, an inactivated BI indicates other potential pathogens in the load have been killed.

SporeCheck

When do I use Biological Monitors?

• Correct functioning of sterilization cycles should be verified for each sterilizer by the periodic use (at least weekly) of BIs.

• Every load containing implantable devices should be monitored.

• In-office biological monitoring and mail-in sterilization monitoring services can also be used to test both the BI and the control.

Biological Monitoring

Who recommends Biological Monitoring?

• CDC (Center for Disease Control)• OSHA (Occupational and Safety Health Administration)• ADA (American Dental Association)• OSAP (Organization of Safety and Asepsis Procedures)• VA (Veteran’s Affairs)• AAMI (Assoc. for the Advancement of Medical

Instrumentation)• AORN (Association of Operating Room Nurses)• Many state and local agencies

State Requirements For Spore Testing

Some state dental boards mandate spore testing at an indicated frequency:

Weekly:

Alabama

California

Georgia

Hawaii

Idaho

Kansas

Louisiana

Massachusetts

Minnesota

Mississippi

North Carolina

New Mexico

Ohio

Oregon

Pennsylvania

South Carolina

South Dakota

Texas

Washington

Wisconsin

Monthly:

Arkansas Florida

Indiana

Mandated (no frequency indicated):

Oklahoma Tennessee

How Do I Use An In-Office Biological Monitoring System?

Step 1

Note the sterilizer number and load number on the BI vial label.

Steps 2-4

• Step 2 - Place the BI vial inside an instrument tray, peel pouch, cassette, or challenge pack.

• Step 3 - Test the most challenging area in the sterilizer (the bottom self near the door or over the drain of a large sterilizer)

• Step 4 – Process the load according to sterilizer manufacturer’s instructions.– BI testing should be done in

a fully loaded sterilizer.– Never run a BI test on a

sterilizer that has not been properly warmed up.

Step 5-6

• Step 5 - Retrieve the BI Vial and confirm that the chemical indicator has turned brown. If not, re-run with new BI vial.

• Step 6 – After the vial has cooled, activate the processed BI vial and a control (unprocessed) BI vial by using the vial crusher.

Steps 7-8

• Step 7 – Incubate for 24 hours both the control and the processed BI vials.

• Step 8 – Test Results– No color change in

purple media after processing indicates proper sterilization.

– Color change to yellow indicates a positive result and should be reported immediately. Control vials should be yellow.

Negative (good)

Positive (bad)

(-)Good

(+)Bad

Step 9

• Record any negative (purple) results in the Sterilizer Record Notebook.

• Any positive (yellow) results should be recorded and reported immediately to a supervisor.

What if a test fails?

• If the chemical indicator fails to change color or the spore test result is positive (yellow), the following steps are recommended:– Take the sterilizer out of service– Ascertain that the sterilization process was

followed in order to rule out “operator error”– Correct any identified procedural errors and

retest the sterilizer using biological, mechanical, and chemical indicators.

• If the repeat tests are negative (purple), the sterilizer can be returned to service.

Additional Testing

• Additional testing is recommended when any changes are made in sterilization procedures.

• When a new sterilizer is used, a long duration of time exists between uses, or a repaired unit has been returned to operation.

• Every time an implant is run in a load.

• Anytime there is a positive test result. (color change from purple to yellow)

Introducing Hu-Friedy’s SporeCheck

Record Notebook

Dry Block Incubator

Vial Crusher

Self-ContainedSteam BiologicalIndicators (25 vials)

What is SporeCheck?

A quick and accurate approach to steam sterilizer testing. SporeCheck is an easy-to-use, in-office, biological monitor testing system with results in 24 hours, the fastest on the market. It is the most efficient and reliable way to validate the proper functioning of your steam sterilizer.

Features and Benefits

Features BenefitsIncubation test results in only 24 hours.

Fastest results in biological monitoring. Mail-in tests take over a week and other in-office tests can take 48 hours or more.

Testing and results in office. Complete control over all processes and gets the results first-hand. In-office testing supports high quality standards.

Meets all federal, state and local guidelines for sterilizer testing.

Regulatory compliance is an important element of a smooth-working, quality practice.

Features and Benefits

Features BenefitsSimple to use. Any staff member can be

easily and quickly trained in only minutes to conduct the BI testing and record results.

Reliable testing results. Everyone has peace of mind that the equipment used to sterilize instruments is working properly. Good records are the best insurance policy that can be purchased.

Convenience. In-office processing saves the hassle of mailing, waiting, and not promptly knowing the results.

Features and Benefits

Features BenefitsSupports all steam sterilization processes.

One vial does it all. SporeCheck can be used with all --- gravity, pre-vacuum, and flash (Statim) sterilizers.

Visible color change when results are positive.

The results are clear and require no interpretation. When the vial turns from purple to yellow after incubation, the test results are positive.

Fits existing dry block incubators.

Conversion of current users of in-office BI testing is easy since our vials will fit existing dry block incubators.

Summary

• Hu-Friedy’s SporeCheck is a quick and accurate approach to in-office steam sterilization monitoring.

• It is the fastest biological indicator (BI) monitoring system on the market, providing reliable results in 24 hours while being in compliance with local, state and federal guidelines.

• The SporeCheck starter kit includes a record notebook, self-contained steam biological indicators, vial crusher, and dry block incubator.

Conclusion

As a clinician, SporeCheck:

• Helps to optimize office flow which reduces stress• Helps to manage assets and operational costs• Allows for safer practices• Creates a professional and marketable

environment• All while promoting a positive and dedicated dental

team

Qualifying Question

• Thank you for taking the time to learn more about Hu-Friedy’s SporeCheck.

• To earn your Hu-Points towards a product evaluation, please exit and answer the following question on the Member Resources Page:

In this presentation, we illustrated the steps in the SporeCheck Monitoring process. Which step did we use the vial crusher?

a) Step 2b) Step 3c) Step 6d) Step 7e) Step 9