Sterilization Monitoring Record

Documentation (Box B), in the form of a log, is an absolute requirement of quality assurance. The sterilization monitoring record (SMR), the fourth component of quality assurance, provides evidence the monitoring process is ongoing and that the cycle parameters are being confirmed in a timely manner by all appropriate indicators. The SMR also provides a mechanism for determining if a recall is indicated and, in combination with the date and sterilizer number on each pack, the extent of the recall. Finally, the SMR establishes accountability.^2,3

Box B. Essential requirements for documenting sterilization monitoring.

Sterilizer identification number
- In-office monitoring
  - Date a specific test was conducted
    - Daily Bowie-Dick test results (high-speed prevacuum)
    - Exposure time, temperature, and pressure for each load
    - Results of chemical indicators for each load
    - Weekly results of biological indicators (test BI and control BI)
      - Within 48 hours
      - Test BI: e.g., negative or (-)
      - Control BI: e.g., positive or (+)
  - Operator’s name or initials
- Mail-in biological monitoring
  - Reports from the testing agency must be maintained in the dental office and correlated to the in-office monitoring data
All documentation of testing shall be maintained for a period of at least three years and shall be made immediately available upon request by appropriate authorities
- Individual State Dental Board requirements may vary

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