Volume 7 • 2020 • Issue 1

37 Issue 1 | 2020 | S upporting Y our P ractice Instructions from the Manufacturer There is reliance upon the manufacturer to provide clear and comprehensive instructions for reprocessing instruments and devices (referred to as ‘devices’ in this article) because only the manufacturer knows the materials that were used for fabrication of the devices. Manufacturers are required by Health Canada to provide instructions for the reprocessing and sterilization of reusable medical devices. These instructions are called manufacturers’ instructions for use or MIFUs in Canada, IFUs in the United States and DFUs or directions for use from European manufacturers. The Health Canada guidance document Information to be provided by manufacturers for the reprocessing and sterilization of reusable medical devices 6 is an invaluable resource for consumers to know what information should be provided in MIFUs. Furthermore, the instructions must be validated. The term ‘validated’ means that the instructions provided have been tested by a company whose industry is testing, to ensure that when MIFUs are followed exactly, the reprocessed instrument is safe for reuse on patients. Insist on written, validated MIFUs, not just verbal instructions. • Check MIFUs before purchase. Use the Health Canada guidance document 6 to know the right questions to ask. If the MIFUs are not available and the company is not willing or able to provide validated, written MIFUs, then the instrument or device cannot be safely reprocessed; therefore, it should not be purchased. If there is no alternate company from which to purchase, do not purchase until the company has provided MIFUs. • If MIFUs state cleaning processes or parameters that cannot be met in your office, the item should not be purchased. For example, the MIFUs only allow cleaning in a washer/disinfector and your office does not have a washer/disinfector. • Know and adhere to manufacturers’ instructions for sterilization parameters. For example, if the instructions for a device with a lumen require it to be processed at 132°C for 10 minutes, it has been validated for these specific parameters and must be processed to these parameters to be safe for patient care and the onus will be on the clinical office to tailor a cycle on their sterilizer for this purpose. If that is not possible with the equipment available, that instrument should not be purchased. What if there is only one cycle on the office sterilizer and once the 132°C for 10 minutes cycle is programmed on the sterilizer, couldn’t that be used for all instruments? Besides the additional 6 minutes per cycle time which over a day may result in one or two fewer loads being processed, sterilizing all devices to this cycle may result in early corrosion requiring new sets of instruments. This adds to environmental waste and unnecessary costs of operation. There is no ‘one cycle fits all’ for sterilization. • Disposables or recommended single use items may require reprocessing prior to use and if so, will come with MIFUs. • Some disposables or single use items, most notably cotton products, such as gauze 2x2s, 4x4s, cotton rolls, cotton pellets, and cotton tipped applicators that do not come with MIFUs, cannot be processed prior to use and if they are required to be sterile for use, must be purchased sterile. • Disposable and single use items do not come with MIFUs and cannot be reprocessed; therefore, they must be discarded following use. • Only purchase instruments and devices that have been manufactured for the primary intent of use in health care. For instance, WD40 is not a lubricant meant for health care products and toothbrushes are not manufactured for cleaning clinical instruments and devices. • If purchasing used or second-hand instruments, devices, or equipment only purchase if MIFUs are provided. • Consult the Health Canada directive Buying Medical Devices from the Internet and purchase with caution. 7 Steps for Medical Device Reprocessing in Dental Offices Step 1: Cleaning at point of use • Cleaning begins at chairside. The manufacturers of dental materials need to provide instructions for removing their materials from instruments at chairside because it takes unnecessary extra resources later to remove restorative materials and luting cements that have set and adhered to instruments. If these instructions have not been provided, contact the manufacturer. Step 2: Transport to the reprocessing area • Use puncture proof gloves when handling contaminated instruments and discard disposable sharps into a sharps container in the treatment area. Place contaminated instruments and devices into covered, puncture proof containers for transport of contaminated items from patient care to the reprocessing area. Individual offices will need to develop policy for use of personal protective equipment (PPE) during transport. Although the outside of the container is clean, every office infrastructure is different, and the roles of staff Infection Prevention and Control at the Dental Office