(September 14, 2020) The NTHSSA continues to face issues with medical device reprocessing services at Stanton, these issues started in late July, 2020. While we have made some progress on the issue and the team at Stanton continues to work to find a solution we have not yet reached a final resolution. Below you will find an update on the latest status and information on what steps have been taken to date.
From a patient impact standpoint urgent and emergency surgeries continue to go forward. To date there have been 124 elective or non-urgent surgeries cancelled. Stanton is committed to building further processes and dedicating resources to addressing any backlog after the issue with sterilization is solved. Stanton has initiated a process to triage those patients who have had cancellations and are developing contingency plans for surgeries to continue.
Some recent steps taken by Stanton include:
- We have worked closely with the facility operator Dexterra and the Boreal Health Partnership, with support from the Department of Infrastructure, to plan interventions in the search for a fix.
- Exhaust fans and associated infrastructure connected to the sterilizer units was tested by an outside contractor to confirm they are performing as designed; these tests confirmed the exhaust system to be working as designed.
- Source water for the steam generators was tested by an outside lab with results currently being examined.
- New water source, by way of a tank of deionized water, was introduced to the process so to try to eliminate mineralization in source water as a cause. This had no impact and has now been discontinued.
- Dehumidifiers have been installed in the Medical Device Reprocessing unit to try to bring the humidity to within the ideal range identified by the vendor. The external environmental humidity has now decreased and humidity is being maintained within in the idea range so the added dehumidifiers have been removed.
- Building systems that control moisture (heating/cooling systems) have been reprogrammed to reduce ambient moisture in the facility. This work was completed in collaboration with Dexterra and the engineer of record for the systems.
- The vendor of the sterilizer units completed an on-site visit to examine the units and ensure they are operating appropriately
- Worked with Dexterra and the building mechanical engineer of record to ensure that the equipment that is meant to manage the humidity in the building is working optimally.
With all of these steps minimal progress has been made. Medical device reprocessing continues to be faced with the issue of equipment and supplies coming out of the sterilization devices with moisture – known in the industry as “wet packs” – preventing them from being able to be stored for future use. The supplies and equipment that come out of the sterilization devices are sterile; we know this because we continue to run validation tests on the units that tell us that the machines are achieving appropriate chemical and biological results. The moisture prevents the sterile supplies from being stored because moisture can attract bacteria.
The team at Stanton is doing everything in their power, including leveraging partnerships and bringing outside expertise to address the issue. ChemAcqua and steam specialists will be arriving in the coming week. Laboratory analysis is again underway on both water and steam with samples sent to Ontario. The NTHSSA will continue to dedicate appropriate resources to this issue until it is solved.