|FAQ - Regulatory Processes - Archived Through 2012
If a biological test strip comes back positive indicating that the instruments should be re-sterilized/processed, are patients required to be notified that the instruments used on them didn't meet sterilization standards?
According to the Center's for Disease Control and Prevention's Infection Control Guidelines for Dental Healthcare Settings published studies are not available that document disease transmission through a non-retrieved surgical instrument after a steam sterilization cycle with a positive biological indicator. (1)
A sterilization monitoring log/record should be maintained (some states require documentation), including all test results, and appropriate actions taken when a failure has been noted. The log should also include the date of the test, type of sterilizer, temperature and time of the sterilization cycle, nature of the package containing the biological indicator, and the name of the sterilizer operator. This information documents the test so that one can identify the load and conditions if a sterilization failure occurs. These records may be needed should questions about the sterility of instruments ever arise. (2)
OSAP is not currently aware of any mandate requiring dental patients to be notified if a biological test strip is positive. However, there may be state laws/regulations/statutes that we are not aware of. You should contact the appropriate agencies for all applicable laws in your state (e.g. State Board of Dental Examiners/Licensing Board, State Public Health Agency).
1) Center's for Disease Control and Prevention's Infection Control Guidelines for Dental
2) Infection Control & Management of Hazardous Materials for the Dental Team, 3rd. Edition. By
Miller and Palenik. Elsevier/Mosby Publishers. Copyright 2005.