Initial Report
| Establishment under investigation (name and address) | Grand River Orthodontics Brantford222 Fairview Dr, Brantford, ONN3R 4L2 |
| Establishment type | Orthodontic Office |
| Date health unit became aware of potential IPAC lapse | March 7, 2025 |
| Date of initial report posting | March 21, 2025 |
| Date of initial report update(s) (if applicable) | |
| How was the IPAC lapse identified? | Complaint made by member of the public. |
| Date of on-site investigation | March 18, 2025 |
IPAC Lapse Investigation
| Did the IPAC lapse involve a member of a regulatory college? | Yes i) College of Dental Hygienists of Ontario (CDH) ii) Royal College of Dental Surgeons of Ontario (RCDSO) |
| If yes, was the issue referred to the regulatory college? | Yes |
| Were corrective actions recommended and/or implemented? | Yes Facility was requested to suspend laboratory work (i.e., fabrication of dental appliances, pouring models) in sterilization room and relocate to alternative and appropriate area. Facility is to provide the manufacturer’s instructions for use (MIFU) of all instruments and equipment to review if sterilization parameters have been met. Lines in the suction machines are to be flushed between clients. Personal items and clutter to be removed from sterilization room. Documentation to be completed in full. Provide appropriate PPE. Items are to be reprocessed as per the MIFU, accompanied with an internal integrator (i.e., type 4 or 5) Replace impression tray soaking solution and discard on a timeframe indicated by the MIFU. Clean and disinfect container. Clean impression trays adequately. Discard all trays observed to be rusted or damaged. At minimum, high-level disinfect (sterilization is preferred) semi-critical items between use (i.e., hand piece motors). If holding back the processed load/package is not possible, evaluation and documentation of a process challenge device (PCD) containing a Type 5 or 6 chemical integrator and checking, verifying and documenting the specific cycle physical parameters may be used to justify the release of routine loads. |
| Date of any order(s) or directive(s) issued to the owner/operator (if applicable) | March 18, 2025 |
| Summary description of the IPAC lapse | Laboratory work (i.e., fabrication of dental appliances, pouring models) observed to be conducted in sterilization room. Activities that lead to creation of dust or debris should not be conducted in sterilization room to prevent contamination of sterile items. At time of the investigation instrument/equipment manufacturer’s instructions for use (MIFU’s) were not available for review Lines in suction machine not flushed between clients. Personal items and clutter observed in sterilization room. Missing or incomplete documentation and sterilization logs (e.g., load items, tests for ultrasonic cleaner, etc.). Internal integrators not used in some reprocessed items (e.g., IPR strips, green polishing stones). Impression trays observed to not be adequately cleaned. Soaking solution and container observed in unsanitary state. Semi-critical items (i.e., hand piece motors) not high-level disinfected or sterilized. Inconsistent disassembling of instruments (e.g., two-piece mouth mirrors) observed of the inspection. Sterilized items (e.g., IPR strips, green polishing stones) with no type 5 integrator released prior to knowing the BI results for the day. Some instruments did not follow the sterilization requirements and/or the time, temperature and pressure parameters set by the manufacturer. During the complaint inspection it was observed that the disinfection and sterilization of reusable instruments on site did not follow Provincial Infectious Disease Advisory Committee (PIDAC) Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment/Devices (May 2013). |
| Additional comments and/or updates to initial report | Staff members responsible for any or all steps in reprocessing are recommended to complete the PHO modules for Reprocessing in Community Health Care Settings, and the Medical Device Reprocessing Techniques Online Course through the Medical Device Reprocessing Association of Ontario. |
Final Report
| Brief description of corrective measures taken | Instruments are being pre-cleaned using Biosonic UC150 with enzymatic cleaner. MIFU's for dental instruments are available onsite. Sterile instruments observed to be in the open, disassembled, and fully extended position. Sterile packages were not overcrowded. |
| Date all corrective measures were confirmed to have been completed | March 8, 2024 |
| Date of final report posting and/or any date of any updates to final posting | March 12, 2024 |
| Date of follow-up to confirm corrective actions taken and completed | February 28, 2024 |
| Additional comments |