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Login | Tuesday, January 06, 2009

 

THE BEST TEST
Ensuring sterilization effectiveness
The following recommendations on monitoring sterilization results are adapted from the CDC’s Guidelines for Infection Control in Dental Health-Care Settings−2003¹:

• Use mechanical, chemical and biological monitors per the manufacturer’s instructions, to ensure sterilization effectiveness.
• Monitor each sterilizer load using mechanical (e.g., time, temperature, and pressure) and chemical indicators.
• Place a chemical indicator on the inside of each package. If this internal indicator is not visible, place another exterior chemical indicator on the package.
• Monitor sterilizers at least on a weekly basis by using a biological indicator with a matching control—that is, the biological indicator and control should share the same lot number.
• Use a biological indicator for every sterilizer load that contains a device implanted into tissue.
• Verify results before using the implantable device, whenever possible.
 

Biological monitoring is best—it measures the entire process and the killing of microbes. The bacterial spores used for office spore testing are identical to those used by sterilizer manufacturers when they obtain clearance from the FDA for their steam, dry heat or unsaturated chemical vapor units. The FDA ascertains that the units actually sterilize and kill high levels of specific bacterial spores. Before the FDA clears a new sterilizer model for sale in the United States, the results from spore tests, chemical and mechanical monitoring and other tests, along with product labeling information and information about the manufacturer, are all submitted to the agency for review. To be cleared by the FDA, a new model of sterilizer must be shown to repeatedly kill a high level of spores in half the normal cycle time. This ultimately provides a considerable safety measure for the dental practice.

Biological indicators for dental office spore testing are available in three types:

1. Spore strip. This is a small strip of filter paper impregnated with the appropriate bacterial spores. The strip is enclosed in a glassine envelope. Glassine is a material that is translucent and acid-free with a wax paper-like finish. The material is resistant to the passage of grease or air, but allows the sterilizing agent to penetrate. After being processed through the sterilizer, the envelope is aseptically opened and the strip aseptically submerged into a tube of sterile culture broth.

Figure 4 Autoclave tape before (left) and after processing. Note the visible markings.

To determine whether the spores have been killed, the culture tube is incubated for 1 to 7 days, at 56°C to 60°C if using Geobacillus stearothermophilus spores for testing a steam or unsaturated chemical vapor sterilizer; or at 37°C if using Bacillus atrophaeus spores for testing a dry heat sterilizer. If the spores have been killed, the culture tube remains clear; but if they have not been killed, they grow, turning the culture tube cloudy (Figure 5). The unprocessed control tube turns cloudy as well.

2. Self-contained spore vial. Used to test steam sterilizers, this vial has a loose cap and contains a G. stearothermophilus spore strip and another inner vial of culture medium. After being processed through the sterilizer, the cap of the outer vial is pushed down or the outer vial is squeezed, breaking the inner vial and thereby mixing the culture broth with the spore strip. The outer vial and its contents then are incubated at 56°C to 60°C. If the spores have not been killed, they grow, thereby changing the color of the culture medium. The unprocessed control vial also changes color. However, if the spores have been killed, the color of the processed vial does not change.

3. Spore ampule. This test consists of G. stearothermophilus spores that are suspended in a culture broth and sealed in a glass ampule. Because this indicator is submersible, it is commonly used to analyze sterilization of liquids.

 
STERILIZER TESTING SERVICES

A common way to routinely spore test sterilizers is to use a mail-in spore testing service available commercially and through some dental schools. These services send appropriate materials, mailing envelopes and instructions to the dental office. After processing the spore tests, the practice sends them to the service for analysis and reporting. A practice usually purchases enough tests to cover 6 months to a year, but beware: Spore tests have expiration dates!

Third-party verification of spore tests is not required, so some practices purchase a kit containing the necessary materials and perform their own results analysis.

RESULTS BEYOND MEASURE

Figure 5 Spore strips results show tube at left is clear (spores are killed). Cloudy tube (right) shows spores are not killed.

Monitoring the efficacy of your sterilization procedures helps protect patients from the threat of microbes such as hepatitis, HIV, herpes, influenza, TB, MRSA, and streptococci. Following the CDC’s guidelines on testing and using mechanical, chemical and biological monitors per manufacturer’s instructions can go a long way to ensure your asepsis methods are effective.

But what happens when testing results indicate a problem? In next month’s DPR, I’ll discuss what to do when mechanical, chemical or biological monitoring indicates a sterilization failure. I’ll also discuss sterilizer maintenance.

Chris H. Miller, PhD, is Professor Emeritus of Oral Microbiology and Executive Associate Dean Emeritus at Indiana University School of Dentistry, Indianapolis. Contact him via e-mail
at chmille@iupui.edu or c/o ewhite@advanstar.com.
 
References
1. CDC. Guidelines for infection control in dentalhealth-care settings–2003. MMWR 2003;152(RR 17):43. Available at: “www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm”. Accessed December 2007.

Photos courtesy of Chris H. Miller, PhD.

Dental Products Report | February 2008

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