Volume 7 • 2020 • Issue 4

Photos: Graduate Orthodontic Clinic, Schulich School of Medicine and Dentistry. the packages have been loaded in a configuration that ensures steam penetration to every surface of every instrument. •  Internal chemical indicators are placed in the most challenging area of the package which may or may not be in the middle of the package. •  Check internal chemical indicators upon opening packages and do not use instruments from packages where internal indicators have not passed (and document this failure on the load log). Check other packages from that load to determine if the problem was limited to one failed package. If two or more packages from a load are determined to have internal chemical indicators that have not passed, consider an active recall of the load. Have an office policy in place for such scenarios. •  Spore tests or BIs are true microbiological evidence that the parameters for sterilization have been met. They are defined in CSA Z314-18 4 as a test system containing viable micro-organisms providing a defined resistance to a specified sterilization process. The viable micro-organisms are a non- pathogenic bacterial spore. The test directly determines if parameters (time, temperature, pressure) were met to kill these highly steam resistant organisms as spores are purposefully used so that if these organisms are inactivated by the process, most other organisms will also be killed. The BI and the incubator must be compatible. For example, a BI designed to be incubated in an incubator which will produce results in 20 minutes cannot be used in an incubator designed to produce results in 24 hours. Spore tests must be conducted for each cycle of each sterilizer at least once every day that the sterilizer is used. As a reminder, spore tests can only test that conditions for sterilization were met. They cannot judge whether all the soil such as protein had been removed from the instrument, Allow the sterile packages to dry fully as part of the sterilizer cycle.Theymust also be cooled to at least roomtemperature before handling to avoid condensate formingwithin the packages. nor that the packages were loaded properly to allow steam to touch every surface of the instrument. • When the spore test is being conducted, the BI must be placed into a package that is at least as difficult for steam to access the spore test as would occur for steam to reach instruments in the most challenged package that would be sterilized in the practice. ‘Most challenged package’ is equivalent to the heaviest or has the greatest number of instruments. Placing a BI by itself or simply into an empty peel pouch, especially in a location that is readily exposed to steam, is not a good indicator of steam quality/sterilizer function and is an unacceptable way to test a sterilizer’s functionality. For this reason, a BI (and a Type 5 or a Type 6 internal chemical indicator) is processed in a ‘Process Challenge Device’ (PCD) when spore testing. Currently there is controversy about the validity of commercially available PCDs for tabletop sterilizers in Canada. In order to be used as a PCD, a commercial PCD must be validated. For any product to be validated, a third-party company tests the product and concurs that the product conforms and performs according to Standards. Controversy exists because some people feel that it is not possible for a PCD to be validated for a tabletop sterilizer as the conditions are too variable. Others feel that commercial PCDs will always either be too stringent or too lenient for a commercial PCD to be available. Some companies do provide validation material to their consumers and maintain that their company’s PCD is validated. This can leave the consumer unsure of what to do or who to believe and because of this, provincial standards are currently allowing the use of a ‘test package’ in place of a commercial PCD until this is sorted out by industry standards. There are also, currently, no definitive instructions for making up a test package from any Standards organization including Infection Prevention and Control at the Dental Office S upporting Y our P ractice