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Overcoming Complexities one step at a time

As we see the development of medical devices becoming more and more complex, our reprocessing equipment, solutions, resources, and tools must also evolve to support each device’s unique needs. There is no one solution fits all when it comes to our complex industry. Because of all the rapid advancements it is important for sterile processing professionals to understand exactly what the expectations are of them when handling, caring for and processing items for use with patients. Sterile Processing (SP) leaders must understand how these changes affect their workflow, staffing models, education plans and patient outcomes. Are SP leaders being given the information to properly prepare their departments and teams for these advancements or variations in reprocessing? 

We know it can take years to get approvals for purchasing new equipment and new tools needed to build out a robust reprocessing program, so how can we make sure we are helping to prepare for that change? Let’s look at a few ways to overcome complexities one step at a time. 

Advancements in the design of medical devices


  • With each new design of a medical device, surgical instrument, or flexible scope comes a wide variety of new things to learn. From the frontline direct patient care providers who must understand the application, how to operate and use the devices, to the SP professionals cleaning and sterilizing the device.
  • Make sure the reprocessing team and all healthcare workers in the facility responsible for using the device are previewed to pertinent information and instructions.
  • Incorporate healthcare members from all teams that will touch this new device in the decision-making process prior to purchasing that device.
  • Create an approval committee to help streamline the purchasing process.
  • Develop a training plan to ensure all healthcare workers who will use or reprocess the device are properly educated on how to handle, use, and reprocess the devices being implemented.


Complex Instructions for use (IFU)


  • Request the reprocessing instructions, cleaning, and handling instructions before purchasing a new device and review with the SP team to ensure the capabilities exist to properly process.
  • Review safety and hazards ahead of time before implementation. Implement any changes to relevant safety and hazard policies, if deemed necessary.
  • Ensure your unit can adhere to the proper storage and shelf-life requirements of the new item, incorporate the materials team where necessary.
  • Safety Data Sheets should be made available and implemented into your system, so the SP team has access to read and review. 


Inability to Process


  • If your SP team cannot currently support the processing of the device, communicate this as early as possible so proper planning can take place if new tools or procedures are necessary.
  • Identify if new or additional equipment is needed for inspection, such as a borescope.
  • Prepare your budget accordingly and keep emergency funds available in your operational budget to help accommodate needs required by new items, changes, and advancements.
  • Have a plan to contact the new device manufacturer, to ask for guidance in reprocessing, so your department is compliant. Equipment and device manufacturers can help properly prepare your team for the new device.


Change in parameters


  • Work with your sterilization, and reprocessing equipment manufacturer as soon as possible to set up the proper sterilization parameters/cycle necessary to follow the new product IFU.
  • Be aware of any special packaging products that might need to be ordered, such as specific wrap weights, filters, or corner guards.
  • Ensure your department has the proper cleaning products available, such as brushes, sponges, and detergents that are required for cleaning the device.
  • Identify what type of container will be needed to hold the device and obtain the reprocessing instructions for that containment.
  • Communicate the parameter change early in the process as there are documents required, and request forms that must be submitted.

Technological Advancements and Data collection 


  • Make sure to collect media and images of the devices so you can prepare your team by entering this information into your systems and instrument tracking software.
  • Identify the devices material make up and reference numbers so you can dedicate proper storage of the device after it has been re- processed.
  • Determine if there will there be any accessories necessary, or back up inventory needed, based on case volumes and usage rates.


Longer Processing Times

  • Work with the surgical team to determine when this item will be needed so you can plan to modify your schedule to accommodate the processing instead of just putting the new inventory into your normal workflow.