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by Pauline W. Fallis, R.N., B. Admin. (HS), C.I.C. Question Why are glass bead sterilizers not recommended for use in electrology? Answer In 1987 the Food and Drug Administration approved for sale endodontic dry heat sterilizers (glass beaded units). They were approved as a method of disinfecting endodontic dental instruments. The important word here is disinfecting not sterilizing. Needle electrodes, thumb forceps (sharp pointed tweezers) and other instruments frequently penetrate the skin thus becoming contaminated with blood, serum and other material found in hair follicles or on the skin in the practice of electrology. In performing procedures, like probing for and removing ingrown hairs, you must go below the skin which can result in considerable blood contamination on the instruments you are using and on the surfaces these instruments touch. You now have a situation where microorganisms may be transferred from one client to another or even the client to the electrologist if good infection control practices are not used. We now see that there is a potential for cross infection even though there has not been any studies done to prove this. All reusable instruments used to perform procedures by the electrologist must be sterilized between clients. There have been several problems identified when the glass beaded unit was being considered as a sterilizing device: Depending on the size of the instrument, the instrument may act as a heat sink which means that the instrument may reduce the temperature of the glass beads when it is placed in the unit, thus sterilization may not take place. Most glass beaded units are quite small and some instruments may be too big to be completely covered by the beads as is required. Different areas of the unit may be of different temperatures. Unless you have a thermometer that indicates temperatures in other areas of the unit besides the base, only the temperature at the base is known. Many of the units have only an indicator light to indicate that the temperature has been reached. Do you know what the temperature really is? Is it hot enough? What is the temperature to time ratio? If you do not know what the temperature is how do you know how long to leave it in the unit? Sterilization, whatever the method, when heat is involved depends on a temperature to time relationship. The higher the temperature the shorter the time. And finally, there is no method to test the process to make sure that the unit has really killed the microorganisms. The Food and Drug Administration Dental Device Classification Panel stated in the US Federal Registry Volume 45, Number 261 that the endodontic hot beaded unit is not an acceptable method of sterilization and a potential unreasonable risk of illness or injury to the patient because the device may fail to sterilize dental devices adequately. This same potential risk may be applied to the electrology client. The FDA made a final ruling published in the US Federal Register, 21 CFR Part 872 on August 12,1987 stating in part that studies indicate that the device (glass bead sterilizer) may not sterilize instruments satisfactorily, even when the device reaches and maintains the temperature it is intended to reach. And even the Centres for Disease Control in Atlanta, Georgia has stated that the glass bead unit should not be classified as a sterilizer. Remember, just like the inductive heating of a needle electrode does not sterilize it, the heating of instruments in a glass beaded unit does not guarantee sterilization. On the other hand the unit may be used successfully to decontaminate instruments to be used on the same client. That means when treating a client, instruments that have been inadvertently dropped, or needle electrodes that have touched the electrologist's glove or other contaminated surfaces may be cleaned then processed in the glass beaded unit and used again on that client. It is a misnomer that the glass beaded unit is a sterilizer. Send your infection control questions for Pauline Fallis to answer to: Editor COPE National News 410 Aspen Road, Kimberley, B.C. V1A 3B5 |
