November 17, 2017 A Letter to Our Customers
For over 25 years, SciCan Ltd., a Canadian company, has been focused on protecting patients, doctors and healthcare providers with innovative infection control equipment. Through a sustained legacy of growth and expansion, SciCan is now a global leader in infection control specializing in dentistry and ophthalmology in more than 100 countries around the world.
In response to a number of questions which we have received from our Canadian dental providers regarding changes in infection control guidelines, SciCan would like to provide some clarity on the use of Sterilizers in a Dental Practice. All SciCan Sterilizers are Health Canada licensed Medical Devices and designed to allow users to conform to specific requirements of the CSA Standards for reprocessing medical devices in a dental practice.
There are two types of sterilization cycles available in steam sterilizers; Gravity and Dynamic Air Removal. Steam Flush Pressure-Pulse (SFPP) and Pre-Vacuum are two modes of Dynamic Air Removal technologies used for sterilization. Both deliver validated steam sterilization cycles that provide efficacious sterilization when used according to the Instructions for Use (IFU). More specifically, the STATIM® Units use Dynamic Air Removal Steam Sterilization, by the method of SFPP technology, and the BRAVO™ Units use Dynamic Air Removal Steam Sterilization, by the method of Pre-Vacuum.
Several Public Health Associations and Dental Regulatory Authorities across Canada have put together guidelines and checklists to be used as a guide during inspections of a dental office, which assess alignment with best practices for infection prevention and control. To help you understand how SciCan sterilizers meet these requirements we have included an example from Ontario using the Checklist:
Reprocessing in Dental Practice Settings
|Policy #||PIDAC Requirement||STATIM Feature||Bravo Feature|
|7.5||Items are placed in the sterilizer according to sterilizer’s MIFUs.||SciCan’s STATIM and Bravo IFUs (MIFUs) clearly outline the load configuration, type and weight for each cycle.|
|7.6||Sterilizer mechanical display, print-out or USB is checked, verified and signed for each cycle by the person sterilizing the instruments.||The STATIM includes a mechanical display, USB backup as well as storage of all cycle data on the cloud. Cycle data can be retrieved and printed from either the system’s online cycle database or the USB and then signed by the operator releasing the load.||The BRAVO cycle data can be retrieved from the unit printer or USB and then signed by the operator releasing the load.|
|7.7||Sterilizer is tested with a biological indicator (BI) each day the sterilizer is used.||SciCan offers BIs and an incubator to help dental offices fulfill this daily requirement.|
|7.9||If dynamic air removal-type (i.e., pre-vacuum) sterilizer is used, an air-detection PCD (e.g. Bowie-Dick test pack) is used.||An Air Removal Test for the STATIM has been validated, as per CSA Z314.3-14, section 184.108.40.206.||A SciCan Bowie Dick test is available to be used daily in the BRAVO unit.|
|7.12||Instrument packs are allowed to dry inside the sterilization chamber before removing and handling.||All sterilization cycles include a drying phase that has been validated to ensure packaging is dry when it is removed from the cassette (when using STATIM) or chamber (when using BRAVO).|
In summary, the use of STATIM and BRAVO Sterilizers allow users to conform to the specific requirements of the CSA Standards for reprocessing medical devices in a dental practice.
SciCan is dedicated to providing evidence-based Infection Control recommendations, best practices and the most innovative and effective infection control equipment.
Additional information pertaining to sterilization requirements and recommendations that are important to a dental clinic can be found at http://www.scicancanada.ca/faq. Should you have any questions or concerns that aren’t addressed here, please don’t hesitate to contact our Customer Service team at 800-667-7733 or firstname.lastname@example.org.