by Mary Govoni, CDA, RDA, RDH, MBA
In September, the Centers for Disease Control and Prevention confirmed that the first patient-to-patient transmission of hepatitis C occurred in a dental setting in the U.S. This transmission occurred in the oral surgery practice in Tulsa that was the subject of intense media publicity earlier this year.
Although the CDC was able to match the viruses of two of the patients through genetic testing, they may never be able to determine how the transmission took place. The suspected routes of transmission are improperly sterilized instruments and the use of unsterile needles in multiple dose medication vials. The good news is that there have not been any previously reported cases in dentistry. The bad news is that this occurred.
Once again this news prompts the need to make sure that everything we do to protect our patients is in line with the CDC Guidelines for Infection Control in Dental Health Care Settings. While the majority of practices that I interact with are clear on what must be heat sterilized, there is less clarity about verifying the sterilization process and the importance of quality control protocols in instrument sterilization.
The first of the quality control measures is the recommendation for packaging of instruments prior to sterilization to ensure sterility of the instruments until the point of use. This includes extra instruments that are stored in drawers or cabinets in the treatment rooms and includes orthodontic instruments. The second is the recommendation for using a process indicator in the instrument packages. This measures the parameters for sterilization – time, temperature, and pressure (steam penetration).
Although most sterilization pouches have indicators incorporated into the pouch, they typically measure only one or two of the parameters – time and temperature. In addition, there are indicator strips that can be placed inside instrument packs or cassettes. It is important to note that autoclave tape, which is used to seal packages and cassettes, is a single parameter indicator – temperature only.
There is one pouch, the Sure-Check Pouch from Crosstex, that is cleared by the FDA as a Class IV indicator. This pouch measures two or more of the criteria for sterilization. An indicator strip that is also cleared by the FDA as a Class V integrator is the Steam Sterilization Integrator Strip from Hu-Friedy. This strip measures all of the criteria – time, temperature, and steam penetration.
These indicators are used to make sure that the instrument packs in each sterilizer load have been exposed to the right parameters for sterilization. If the indicator shows a "failure," the instruments must be repackaged and reprocessed.
Many times it is the instruments in the center of the load that are not sterilized, due to overloading of the sterilizer and the inability of the steam to penetrate into the packages. Without the use of sterilization indicators, there is no way to know which instrument packs are at risk.
These indicators are an additional measure to protect patients, but are not a substitute for weekly monitoring of the sterilizer with a biological indicator or spore test. There are a number of in-office monitoring systems such as Attest from 3M, ConFirm from Crosstex, and SporeCheck from Hu-Friedy.
In addition, there are third-party monitoring services including many that are affiliated with dental schools and dental suppliers, as well as companies such as ConFirm, The Dental Advisor, North Bay Bioscience, and others. The dental practice should keep records of the results of these tests. If a sterilizer fails a spore test, that sterilizer must be taken out of service until the reason for the failure is determined and corrected.
Following appropriate guidelines and protocols for sterilization will not only minimize the risk of a patient-to-patient transmission of a bloodborne infectious disease such as hepatitis C; it will go a long way in reassuring patients that it is safe to go to the dentist.
Mary Govoni, CDA, RDA, RDH, MBA, is the owner of Mary Govoni & Associates, a consulting company based in Michigan. She is a member of the Organization for Safety, Asepsis and Prevention. She can be contacted at firstname.lastname@example.org or www.marygovoni.com.