Volume 7 • 2020 • Issue 4
Step 10: Monitoring • Monitoring ensures that all parameters required to effect sterility have been reached and were adequate for reprocessing. This is done through confirmation that physical parameters of time, temperature, and pressure were met; spore tests or biological indicators (BI) were used and incubated and that there was no growth of spores, thus confirming that parameters sufficient to destroy resistant spores were met, and chemical indicators were used under conditions adequate for sterilization to occur. • Physical parameters are displayed using gauges and/ or visual displays to indicate the time, temperature, and pressure reached during sterilization. Parameters are reported in a printout or recorded electronically as visual evidence that correct parameters for sterilization were met. Maintain documentation showing that a staff person has checked to determine that this has occurred. This is recorded as per the dental office’s standard operating procedures, either with initials on the sterilizer printout or preferably on a log, as storing printouts is inconvenient (plus the ink fades quickly). • Sterilizers that do not have printouts or electronic readouts must be monitored by a person who observes that the correct values were met and this is documented for each sterilizer and each load number, usually on the load log. Offices rarely have time to release a staff member to observe that the parameters were met. Consequently, it is strongly suggested to purchase sterilizers with such capabilities or to purchase printers as an add-on. Most dental organization guidelines provide a timeline for offices to purchase printers or electronic data recorders. If not, offices should strongly consider doing this proactively. • Chemical indicators are defined in CSA Z314-18 4 as a test system that reveals change in one or more pre-defined process variables based on a chemical or physical change resulting from exposure to a process. More simply, these are similar to litmus tests—they change when exposed to adequate conditions which effect their change. There are six types of chemical indicators, however, they are not arranged so that any one is “better than another” because of the number assigned to them. Each is specific to the task. Type 1 indicators are external indicators, also known as process indicators, and their function is to tell us at a glance if the package has been processed. A Type 2 chemical indicator is used in pre- vacuum sterilizers to inform the operator that all the air has been removed from the sterilizer. Rarely used in dentistry, Type 3 indicators are specific to only one variable. Type 4,5, and 6 indicators are internal chemical indicators which mean they express change because steam has contacted them. Type 5 indicators are also known as “integrators” and Type 6 indicators are known as “emulators.” Type 5 integrators are used more routinely while Type 6 emulators are used for specific cycles such as extended cycles as occurs when the device has a lumen (e.g., for some ultrasonic scaler handpieces and some surgical suctions). • External indicators, or process indicators, are available as tape, load cards, or labels. There have been countless incidents where offices have had one person load a sterilizer, but not power it on and then another operator unloads the un-reprocessed load and places it into storage, assuming that the load has been reprocessed. Had the person who was unloading the sterilizer checked the external indicators, it could be seen at a glance that the load had not been reprocessed. External indicators need to be checked upon unloading the sterilizer, when placing sterilized instruments and devices into storage, when removing instruments from storage for transport for patient care, and again upon delivery to the operatory for patient care. This is especially necessary in large offices where several staff members perform various duties. When an internal chemical indicator is clearly seen from the outside of the package, as occurs with peel pouches, it can also serve as an external chemical indicator. • Internal chemical indicators provide assurance that packaging and loading have been performed correctly enabling the steam to penetrate the packaging and reach 100% of the surface area of every instrument. Presently there is variable guidance from provincial dental standards organizations about the type of internal indicator that should be inside every package. First, there is controversy that internal indicators are even required inside packages because many peel pouches are available with integral internal chemical indicators. The concern is that the integral indicators are not in an area which will be most challenged; therefore, it is not a true test that the steam has reached the area where the instruments are situated, especially when a cassette is used and packaged into a peel pouch. Internal chemical indicators are placed in the most challenging area of the package as passed indicators provide assurance that conditions in that area were such that steam should have reached these instruments. Also, some people are of the opinion that as long as there is a test package or PCD with one internal chemical indicator that is a Type 5 or Type 6 in the load that the instrument packages need to have only a Type 4 indicator to monitor steam quality. The problem is that Type 4 indicators only monitor two parameters and many offices may not be aware of which parameters their Type 4 indicators are monitoring and which parameter is not being monitored (for example, time and pressure only or temperature and pressure only). Using Type 5 or Type 6 internal chemical indicators in every package provides a level of assurance that Monitoring ensures that all parameters required to effect sterility have been reached and were adequate for reprocessing. Infection Prevention and Control at the Dental Office S upporting Y our P ractice 26 | 2020 | Issue 4
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