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James B. Edwards College of Dental Medicine

Oral Pathology

Department of Stomatology: Division of Oral Pathology

Sterilizer Monitoring Service

Guidelines: The issue of infection control has taken on greater significance in the last several years. This has culminated in a publication by the Center for Disease Control (CDC) of recommendations for preventing transmission of Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) to patients during exposure-prone procedures. Additionally, federal and state government agencies and the American Dental Association (ADA) have established guidelines which outline strict infection control practices for dental offices. Among these procedures is the proper sterilization of instruments. Included in the guidelines of the CDC, ADA, OSHA, and OSAP (Office Sterilization and Asepsis Procedures Research Foundation) is the standard that biological monitoring should be used weekly. Several states have already added legislation to their dental practice acts, requiring weekly biological monitoring of sterilization equipment.

Sterilization: Heat sensitive tape and bag markings do not ensure that sterilization has been accomplished. Sterilization quality control can only be achieved through the use of calibrated biological indicators (endospores). These organisms are difficult to kill because they are more resistant to heat than viruses and vegetative bacteria. Therefore, if they are killed during sterilization, it is assumed that all other life forms, including Herpes, Tuberculosis, Hepatitis B, and HIV (the AIDS virus) are also destroyed. Sporicidal activity by an office sterilizer is considered the most sensitive check of its efficiency. To meet this need, the Oral Pathology Laboratory of the College of Dental Medicine in collaboration with ConFirm Monitorir Systems, Inc. in Englewood, Colorado is pleased to offer dental practitioners with a Sterilizer Monitoring Service.

Operation: After receipt and processing of your application form, we will send pairs of spore strips to you. These spore strips are inoculated with Bacillus subtilis and Bacillus stearothermophilus, highly resistant but non-pathogenic organisms. You run one spore strip through your sterilizer in a typical load of instruments. The other strip is used as a control. Both are returned to us. Your processed test strip and the control strip will be incubated, read, and a report of your cultures will be sent to you on a quarterly basis. If no growth occurs on the processed spore strip, the quarterly report will so indicate. This report should be retained by your office as a permanent record. It is validation of your intent to comply with the new standard of care. If growth of organisms occurs, you will be contacted immediately (and confidentially) by telephone to discuss the possible reasons for failure to achieve sterilization. A second set of spore strips will be sent to you (at no charge) to retest your sterilizer and ensure that any malfunction has been corrected.

FDA Approval: The spore strip test kits (packets) that are used by the Medical University of South Carolina, Division of Oral Pathology, Sterilizer Monitoring Service are approved as a devise by the Food and Drug Administration and carry FDA device # K912796.

Storage: All unused test packets should be stored at room temperature in a dry area of the office. This area should be away from all sterilizing, disinfecting and radiographic developing chemicals and agents. Preferably, the packets should be stored in a sealed plastic storage bag.

Contents: The outer (white) envelope contains an inner (blue and white) pocketed envelope marked with the MUSC logo. The inner envelope is also marked with the lot # and expiration date for the test packet. The test strip is contained in the pocket marked Test Strip / Operator. The control strip is sealed in the other pocket of the blue and white envelope. This pocket is marked Control Strip / Bacteriology Laboratory.

Conduction of Test: Do not overload the sterilizer. Regardless of type, no sterilizer should be filled to more than 75% of its capacity. This holds true for both test and non-test runs. During a test run, the spore strip from the unsealed pocket of the test envelope (Test Strip / Operator) is removed from the pocket and inserted in the middle of the stack of instrument kits being sterilized. At the end of a test run this strip is placed back in its pocket in the blue and white envelope. This envelope is placed back in the white envelope and mailed to the laboratory. At no time should the control strip be removed from its pocket in the blue and white envelope, or the entire blue and white envelope be placed in the sterilizer. Check the expiration date and lot # of the test packet to insure that it is not an expired packet.

Receipt of Written Reports: New subscribers will receive a written report after the first test regardless of the results. All others will receive a quarterly report if test results are negative. If a positive test occurs, your office will be called by the laboratory and a written report will be faxed or sent immediately.

Calendar Labels: The Sterilizer Monitoring Service is pleased to provide you with materials which should facilitate the process of remembering when to run Sterilizer Monitoring Service tests. Based on your subscription plan, the appropriate number of calendar labels, with the Medical University of South Carolina logo can be easily affixed to your office calendar in weekly or monthly locations. These labels should act as reminders for those office personnel assigned to run Sterilizer Monitoring Service tests.

Cost of Service:
Weekly (48 weeks) $300.00
Monthly (1 year) $90.00

To Subscribe:
Please include the following information:

  1. Name
  2. Mailing Address
  3. Phone (including area code)
  4. E-mail (if available)
  5. Indicate how many of each type of sterilizer your office has:
    - Unsaturated Chemical Vapor (ie: Harvey Chemiclave)
    - Steam Autoclave
    - Dry HeatEthylene Oxide
  6. Please indicate whether you wish weekly or monthly monitoring
    -
    Weekly ($300 per 48 weeks for each sterilizer)
    - Monthly ($90 per year for each sterilizer)

Please make your check payable to Division of Oral Pathology and mail to:
Division of Oral Pathology
College of Dental Medicine
Room 539 Basic Science Building
173 Ashley Ave.
MSC 507
Charleston, SC 29425-5070