| FAQ - Sterilization - Archived Through 2012
How long do spore ampules and documentation for sterilization monitoring need to be kept?
Consult with and follow the manufacturer's directions concerning the use of the spore test. Spore ampules may be disposed of after test results have been read, interpreted, and recorded, but again, consult the spore test instructions supplied by the manufacturer.
The sterilization monitoring log record book should be used to record the results of biological monitoring, as well as, mechanical, and chemical process integrators. Sterilization monitoring log record books may be purchased (e.g. through the monitor's distributor/manufacturer, dental sales representative, etc.) or can be developed by the practice. Most dental practices choose to purchase a monitor record log book because they are simple to use and maintain.
Requirements, regulations, and recommendations do vary among states, therefore, records must be maintained long enough to comply with regulations in your state or locality. Sterilization monitoring requirements, including recordkeeping, can be regulated by the State Board of Dental Examiners, through the State Health Department/Agency and/or through legislative law. To determine if you are in a state with required recordkeeping regulations and requirements contact your State Board of Dental Examiners/State licensing agency, as well as, State Public Health Agency.
OSAP is not in a position to offer legal advice. Because recordkeeping can play a role in risk management and there are no state regulations concerning this issue you should consult with the dental practice's attorney and/or attorney knowledgeable in medical law for legal advice on maintaining such records.