Standardizing your reprocessing of surgical instruments is difficult, if not impossible. Manual and automated instructions for use (IFU) differ from manufacturer to manufacturer. Not only do they vary from each other, but they also vary from the manufacturers of reprocessing equipment. Making even tougher on the Central Sterile Processing Department (CSSD), instrument trays usually have more than one instrument manufacturer in each set. So what do we do to maintain compliance?
First, standardize your instrument manufacturer. This allows for consistent reprocessing instructions. Cost is a major factor that limits the standardization of instruments within a set as well as physician preference. Working with your OR and Materials Management team can help you build towards this goal over the long run.
Second, begin with your manual reprocessing process. Review your IFUs from all of your instrument manufacturers and look for commonalities in the process like soak time, detergent type (e.g., enzymatic or neutral), and rinsing process. Then review the IFU for the detergent you are using to help you build compliance. Where there are mismatches, look for language in the IFUs that allows for adjustments (e.g., minimum of) or where instrument manufacturers add notes allowing to adjust to the detergent manufacturers instructions for use. Adjust your processes to fit within multiple manufacturers' guidelines to streamline your approach and create additional processes for the outliers.
Third, evaluate your automated process the same as you would for your manual process. Review your preset cycles for compliance. The silver lining is manufacturers of reprocessing equipment, within limits, allow for cycle parameter adjustments. An additional bonus is that you can also add additional cycles than what is in your preset configuration. Use these additional cycles for your outliers. I personally like to rename the automated cycles to help indicate which instrumentation to use with each cycle.
Ultrasonic reprocessing parameters can vary too. Review for compliance and adjust accordingly as listed above. Some instrument manufacturers have even removed the guidelines for ultrasonic cleaning if an automated process is in place.
The last step in compliance is evaluating your cleaning process. Daily verification is recommended with the ANSI/AAMI ST79 2017 guidelines. There are several products on the market to help verify your process is working satisfactorily. You must verify each process you are utilizing, similar to steam sterilization. Remember also to challenge each process as you make adjustments to either your manual or automated reprocessing.
I still hold out hope that the FDA will strengthen the 510K process by requiring manufacturers to develop products within limited parameters for reprocessing. Continuing to drive manufacturers towards real-life scenarios and working with CSSD professionals will help create a safer process in CSSD and a safer product for patients. Good luck!