| FAQ - Practice Safety/Patient Safety - Archived Through 2012
The instructions for the electrosurgery tips my practices uses say to "cold sterilize” them. What cold sterilization methods does the Food and Drug Administration (FDA) approve for use?
"Cold sterilization” entails the use of chemicals that FDA classifies as high-level disinfectants/sterilants. Chemicals in this category are required to have FDA clearance for their claims.
Ideally, all items that enter the patient's mouth and come into contact with oral tissues should be heat sterilized. If this is not feasible because the device or instrument cannot withstand the heat sterilization process, a high-level disinfectant should be used.
The FDA maintains a list of products that have received clearance as chemical sterilants.(1) The list includes information regarding proper contact time, active ingredients and reuse or shelf life. Always read instructions carefully before using a chemical germicide.
1) Food and Drug Administration. FDA-cleared sterilants and high level disinfectants with general claims for processing reusable medical and dental devices. Available at http://www.fda.gov/cdrh/ode/germlab.html