What is the issue with the sterilization processes at Stanton?
The main issue is that sometimes the trays – or packs - that the instruments are sterilized in are coming out with water in them. Packs with moisture present – or wet packs - cannot be stored for future use because moisture can attract bacteria. Over the last 2-3 weeks the moisture issues have reduced but are not completely fixed. While moisture issues reduced, issues related to staining on towels and trays coming out of the devices continue to cause concern. Staining in general is very light rust colored markings on towels that wrap the trays/instruments during the sterilization process.
The Medical Reprocessing Devices at Stanton are processing sterile equipment. Stanton knows this because they have the ability to test for biological and chemical sterilization effectiveness. In a normal situation Stanton would be continually cleaning and sterilizing all surgical instruments to ensure a steady supply was ready for use, which allows for a normal amount of surgeries to take place. The wet pack issue has limited surgical services at Stanton because instruments could not be stored for use.
In normal operations at Stanton any type of staining on towels, trays or instruments would lead to them being rejected in the Operating Room and another set being used instead. Through research Stanton has learned that other hospitals in Canada have experienced staining challenges and, through risk assessment and management, have accepted limited staining when it has been proven it is caused by minerals in the water.
Stanton is currently working on a similar risk assessment and management process. The staining issue continues to be examined to determine whether or not instruments coming with stained towels or trays are acceptable for use and to determine the cause to eliminate the staining issue.
What has been done to find a solution to this issue?
The sterilization process in a hospital setting is complex and has many interrelated systems including
- sterilization devices themselves,
- steam generation equipment,
- supply lines/exhaust systems,
- water supply
- Processes related to putting equipment through the devices (how they are packaged, the weight/density/material of equipment in machines at any given time, drying time settings on machines, etc.)
Stanton has been working towards a fix by changing one element in the process at a time to ensure the source of the issue is identifiable, starting with the most likely issues.
For details on what steps have been taken see these updates:
- October 5: Stanton Surgical Capacity and Medical Device Reprocessing Update
- September 14: Stanton Medical Device Reprocessing (sterilization) and Surgery Capacity Update
What progress has been made on the wet pack issue?
Stanton is seeing significantly less “wet packs”. Stanton has been tracking relative humidity in the environment, both within the building and outside. At the start of the wet pack issue there was unseasonably high environmental humidity. Building system processes were changed to reduce humidity inside Stanton; while humidity was reduced in the building, this did not fix the wet pack issue.
In the past few weeks environmental humidity outside Stanton has dropped with the change in weather. At this point this is the suspected change that has led to the reduction of the wet pack issue.
What else is Stanton doing to address this issue?
Stanton has ruled out several of the most likely causes, and is now focused on the following as potential avenues to resolve the sterilizer issues:
- Water quality: Stanton’s water chemistry consultants have provided a proposal for a water treatment solution that is currently being reviewed for compatibility with the sterilizer system. If this water treatment can be added, the equipment and design will be coordinated in November/December 2020.
- Water testing for mineralization: water quality tests at multiple locations have been collected and analyzed. At present none of the samples have proven to show a definitive point in the system where mineralization is occurring. All samples have been within the specifications of the manufacturer of the sterilization devices. Stanton continues to consult with the manufacturer and experts on this issue, water treatment may help reduce staining.
- Instruments: Stanton is examining current instrument stock to find out whether new instruments could help fix the sterilizer issues. Currently, not all items are coming out stained.
What options are being explored for alternate surgical services/pathways?
Contingency plans for surgeries to continue have been developed, however; the current COVID 19 pandemic response adds additional challenges. These contingency plans may change in response to the pandemic. The main areas being looked at are:
- Working with partners to have surgeries completed in Alberta. The increasing numbers of COVID 19 in southern jurisdictions have increased risk to travelers and therefore this contingency is currently on hold.
- Completing certain types of surgeries at other sites in the NWT, specifically Inuvik. Inuvik Regional Hospital has the capability to do some types of surgeries done at Stanton (but not all). Specialists located at Stanton Hospital are scheduled to travel to Inuvik and do surgeries that would typically be done at Stanton. Starting the week of Nov. 30, 2020 the OBS/ GYN team will travel to Inuvik to complete some surgeries, followed by General Surgery the week of Dec. 7, 2020.
- Reprocessing of surgical supplies and instruments at other sites. Teams have travelled to Inuvik and Hay River to reprocess instruments. This has provided limited support as the type and weight of equipment used in many surgeries cannot be reprocessed at these locations.
- Testing is currently underway to evaluate whether the instruments are part of the cause to the staining. To date, Stanton has performed tests which have not produced an indication that instruments are the cause. Further testing is being organized with the Foothills Medical Centre in Calgary, AB.
- Any examination of the staining issue will be undertaken through a special risk assessment. We will not be using any material that comes out of the sterilizers with stained towels until we have completed an assessment. If this process is determined to be acceptable, all patients would be notified before surgery of any potential risks, no matter how limited they may be.
Stanton has developed plans to address the surgery backlog. This work includes:
- Proceeding with surgeries that are able to go forward within current capacity. Proceeding with certain surgeries that require low volumes of equipment or that can be done with one-time-use items will reduce future demand and waitlists.
- To date 28 of the 124 surgeries that have been cancelled since July 23, 2020 have been either been completed or rebooked. The number of cancelled surgeries has not increased as bookings have been suspended until the sterilization issues have been resolved. Stanton has been able to continue with emergency and urgent surgeries, with over 240 procedures completed to date.
- Current waitlists are being reviewed on a regular basis by each Specialist service.
- Most surgeries are triaged on a highest-need basis. Total joint replacements will proceed in the order by which they are referred because this is best practice.
- Stanton is developing strategies to manage the waitlist, including maximizing the number of surgeries that can be performed in Inuvik.
Patients are encouraged to remain in touch with their health care team and report any changes in their condition.
When will patients know when their surgeries can proceed?
A letter will be sent to each patient to update them on the overall sterilization issue. Communication on when a patient’s surgery can proceed will depend on the nature of their surgery. As we resolve issues we will communicate with those patients who are currently waiting for surgeries.
What should patients do if their condition changes or worsens?
Anyone who has a change or worsening of their condition should contact their provider or specialist clinic and discuss this with their team.