Performing Reprocessing of Reusable Medical Devices Safely

 

To practitioners in our field, it will come as no surprise to hear that the reprocessing of reusable medical devices is complex, requires a quality system, and if not performed to Canadian Standards can place citizens at risk of obtaining disease or infection. This risk has been well documented in the Canadian media over the past five years.  These reports clearly emphasize that faulty practices have placed thousands of Canadians at risk resulting in many of them acquiring HIV, Hepatitis B and other unwelcome diseases. This all occurred as health care facilities, physician’s offices, clinics, and other medical sites did not have a quality system for reprocessing reusable medical devices. This fact is simply unacceptable. Facilities that perform invasive procedures with reusable medical devices need to ensure that the reprocessing practices meet the Canadian Standards for Reprocessing, honouring the necessary steps and considerations. The Canadian Standards (CSA) and Ministry of Ontario Health and Long Term Care Provincial Infections Disease Advisory Committee (PIDAC) Best Practices documents must be used as reference materials in our work, as both documents outline the expected practices to follow.   Patient care and their well being must remain at the forefront of our decision making and professional practices, as our patients expect and deserve the best quality care we can offer.  With this knowledge in mind, the purpose of this article is to offer options for your organization to consider if your organization cannot perform the reprocessing of reusable medical devices safely. Using a success story stemming from a remote, northern community the reader will gain a clear description of how this practice can be implemented even in the most isolated communities.  

  

In order to meet best practices for reprocessing reusable medical devices, staff must be certified, trained, orientated and receive ongoing education. Equipment needs to receive preventative maintenance, regular cleaning and have documented printouts to ensure the temperature and parameters have been met for sterilization or disinfection. Monitoring of this process is required to ensure sterility or disinfection. Furthermore, packaging must meet all requirements. The area where decontamination, packaging, sterilization and storage occur must meet CSA and PIDAC requirements. The essence of these parameters ensures what is called a quality system and without this in place, the entire process is compromised and people are placed at great risk.  Given the complex nature of this process, there must be a certified Medical Device Reprocessing Technician.  Also, the process cannot be performed in one room where cleaning, wrapping and sterilization are performed simultaneously. There must be a proper one-way flow in the department to prevent cross infection. 

 

All of the requirements listed above cost money to acquire and maintain.  However, in order to perform reprocessing safely and to avoid patient risk, the facility must find the dollars or chose to examine if they can perform reprocessing effectively and safely. The questions that must be asked are: do we have the capacity to reprocess safely and should we be reprocessing at all?

 

It is at this point that the facility management team needs to perform a risk assessment and cost analysis.  In their deliberations, they must consider whether the facility is performing surgery and endoscopy procedures.   If so, then reprocessing must be done to meet CSA standards and steps need to be taken to meet the requirements. Any healthcare facility whether it be a clinic, physician’s office, dental office or any other location performing procedures that invades the blood stream, must examine the process used to obtain safe quality medical devices.  Cutting corners in the reprocessing strategy is simply not an option. 

 

 The parameters above set the stage for sharing one specific example of this process at work.  With the assistance of a colleague, Patrick Quinn from Saskatoon, Saskatchewan, manufacturers, and extensive research we experienced positive outcomes.  Our solution should be explored by facilities that do not perform operative and endoscopy procedures, as you will soon learn that such efforts in reprocessing can work.  

 

In rural northern Ontario, fly in remote communities, reprocessing of reusable medical devices had been performed for a number of years using table top steam sterilizers and Registered Nurses trained in reprocessing. The staff was sent to M DRD Technician courses, and I went to each site twice yearly providing education, audits of practices and writing policies and procedures to better meet CSA standards. Sterilizer monitoring and maintenance was performed but not by qualified staff and not to the level required by CSA standards due to the remote location and cost implications. Monitoring of loads with biological and chemical indicators was found to be inconsistent and not compliant to CSA standards. Due to high staff turnover and nursing duties that did not allow time for reprocessing along with a general lack of education in the procedure, reprocessing of reusable medical devices continued to be an issue of great concern and compromised patient safety. 

 

With the examination of financial feasibility to acquire and maintain a quality system that met CSA standards, it was found that the method being used for the past 15 years could not meet the goals we hoped to achieve. When this was researched and reviewed, the next step was to draft a list of procedures performed and conduct a needs assessment of medical devices for each site as there were three locations already, with a possibility of two other locations to follow. Once I prepared the list of medical devices required, I then reviewed the single use disposable in stock at the healthcare facility site. I composed trays that would be required and reviewed their content with a nurse representative at each site along with a physician. We had several teleconference meetings with users, management and infection prevention and control. Once the list was adjusted, as I found a small percentage already in stock, I sent out a request for proposal to four companies that sold single use medical devices in single sterile packaged and also in trays. Once the proposals were received I narrowed down the companies to two as some only could provide limited items and others were too costly. I asked for samples of individual single sterile items so we could ensure that we would be providing a quality product that could perform the procedures safely on patients while the quality met user demands.   The infection control practitioner was involved as well as the MDRD reprocessing manager at the hospital sites.  A trip was taken to the three sites by a team consisting of the MDRD manager, material manager, infection prevention control and myself to examine the reprocessing at each site, availability of a central room for storage and a face to face discussion with the directors at each clinic site.

There were 5 trays that we could not get single use sterile so I worked with one company chosen due to the quality of their instruments, to compose custom trays with the instruments and products requested by the nurses and doctors. Samples were sent of each tray and a committee of a nurse user physician examined trays and then a few adjustments were made.   Both users groups were very satisfied with the quality of instruments and even commented they would have more variety and better quality products with single use due to poor care of reusable instruments. Foot care instruments were a challenge but with assistance from my colleague from Saskatchewan we found a company based in London, Ontario that had single use foot care kits for a reasonable price of $7.50 each kit. I contacted them and samples were provided which were of great quality for the price. The cost of reprocessing reusable medical devices factoring in a percentage cost of reusable product staff time, packaging, monitoring and sterilization was $8.00 so this was quite astounding.  

The final list of single use items included the following; 

• Blade handles with blades sized #11, 15, 21, 22
• Scissors: Straight, iris straight and curved and foot care crown & collar scissors. 
• Clamps: Mosquitoes curved Crile curved and Kelly curved, kocker, sponge stick 
• Forceps: Adson toothed and non-toothed, tenacuclum
• Bivalve vaginal speculums for sterile procedures sizes medium and large
• Bowls 6 oz., cups 5 and 2 oz.
• Linen: Sterile OBS delivery bundle, sterile impervious gown size L, sterile towels, small, and large fenestrated drapes. 
• Sterile trays consisted of the following; 
• Already in stock were laceration suturing trays, dressing trays, incision and drainage trays, small suturing kit, suture removal kit, catheter tray, irrigation tray and chest drainage tray. 
• Custom trays added were OBS delivery instruments, miscarriage/IUD tray, nasal tray, ear tray, and IV cut down tray plus the foot care instruments kit. 

There were already stock available of sterile catheters, suctions, gauze, telfa and abdominal dressings, cotton balls, q-tips, and tongue depressors. With all the research completed, there were three items that we could not find sterile single use and these were the simpson delivery forceps, mc gills intubation forceps and the ring cutter. Double stock of these items for each site was purchased so to ensure availability when one was sent for reprocessing.  I then developed policy and procedures to enable safe transport of these items to the central medical device reprocessing department at the hospital site. This department had been built to CSA specifications three years’ prior and was staffed by qualified reprocessing technicians under a qualified manager meeting all aspects of the CSA quality system for safe reprocessing.  Research was performed studying the CSA transport standards and Health Canada standards to ensure the process would meet all requirements in the policy. I researched transport containers that would meet standard and be safe for air transport to the central reprocessing site. These were purchased with back up for each site to ensure availability at all times. A tamper proof device was purchased to ensure that the container even though it latched closed, would be used to be able to detect anyone opening the container during transport.      

 

Once inventory of all items was obtained in our central stores, and stainless steel wire tracks purchased and the room prepared for sterile central storage, a trip was planned by a member of material management and myself as the nurse project leader.  Stock was bulk shipped to them, quotas decided by the team by cargo plane to each site and dropped shipped into the facilities where the room contained the 4 wire racks to set up sterile storage. A week visit occurred when we set up each site identically with stock to quotas, labels provided, shelves and carts numbered, inventory stock lists compiled and order sheets compiled. We engaged all registered nurse staff and directors in required training sessions on the product, ordering, and the policy and procedures.  At each site we packed up all sterilization supplies, sterilizers and all reusable medical devices. The supplies and medical devices were shipped back to the hospital reprocessing where they would be used at the central hospital. All sterilization supplies were removed from stock room and stock room order sheets and locations adjusted with new inventory lists.   The staff shared that they were pleased as they did not feel comfortable performing reprocessing without certification and training. They stated that they rarely performed the task as their job was direct patient care and not medical device reprocessing.  As such the stress was removed. They felt that they had more choices in products and service quality would be increased while reducing patient risk.  

 

At this point, I am certain that you recognize the value of our work but are questioning our consideration to the environment.  I too, shared this perspective and wanted to ensure that every effort was being made to be environmentally conscious.   I contacted the waste management company providing service to the sites to explore what could be done to reuse the instruments or the steel. In Saskatchewan they had arranged for the instruments to be placed in bio hazardous pails, shipped, decontaminated, packaged and sterilized for reuse in third world countries.  I was hopeful that a similar approach could be used, but regrettably such a service was not available.   The provider contacted their head office and we were able to arrange collection in red bio hazardous containers, shipped with regular bio hazardous waste then the company would decontaminate, melt steel and reuse steel product, ensuring that land fill would not be affected.  In the end our strategy responded to the needs and concerns of the communities.   

 

This project shows that everyone may not be able to provide safe quality reprocessing but with research and persistence there are alternatives available.  If a facility, office or clinic cannot meet reprocessing for reusable medical devices meeting CSA standards there are other solutions.  We cannot dismiss the urgency to adhere to the reprocessing CSA standards, and Ministry of Health and Long Term Care Provincial Infectious Disease (PIDAC) Best Practices for Cleaning, Disinfection and Sterilization.  Facilities have the responsibility to either meet CSA standards for reprocessing reusable medical devices or must find a safe solution to ensure that Canadians are receiving quality care.  It takes time, money, and creative solutions but our health care system and Canadian patients are worth the effort.