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Instrument Set Assembly & Sterilization



Proper instrument tray setup is essential for achieving sterilization. Verification of the sterilization process assures you that your assembly process allows for the contact of the sterilant. There are many facets to building out instrument sets and achieving sterilization. The proper placement of instrumentation, utilization of containment devices, instrument accessories, and the loading of sterilizers all impact the process.


Instrument Placement

Instrument placement is crucial for sterilant contact. Sets should be designed with an even distribution of instrumentation. Multipart instruments need to be disassembled as instructed in the manufacturer's instructions for use (IFU). Ratcheted instruments need to remain unlatched. Lumen instruments need to have stopcocks and valves open if present, stylets and plugs should be removed, and the lumens should remain dry unless the manufacturer recommends moistening. Concave devices within sets need to be placed in the set so that condensation will drain from it.


Instrument/Set Accessories

There are many accessories used when preparing instrument sets. Tip protectors are used for protecting sharp instruments from damage. Foam, paper pouches, and micro trays are utilized for organizational purposes. Tray liners absorb condensation to assisted the drying of instrument trays. The IFU's of each device needs to be adhered to so as not to impede the sterilization process.


You should never be used peel pouches to secure items in a surgical tray set.


Containment Devices

Containment devices, including sterilization wrappers, rigid containers, and peel pouches, all have limitations to their designs. First, they all have limitations of mass metal weight.

  • Sterilization wrappers come in different thicknesses, limiting the weight they can support for sterilization and storage.

  • Rigid containers are designed in various configurations and sizes and also have mass metal weight limitations for sterilization.

  • Peel pouches, which may come in the largest of size variations than sterilization wrappers or rigid containers, probably have the greatest mass metal limitations. Double packing to help manage increased weights is limited to the manufacturer's instructions for use. Not all peel pouches can be double packed.

Reading the manufacturer's IFU's will help you design trays with the proper instrument load.


Instrument tray designs need to be tested to make sure proper sterilization conditions are met. The AAMI's ST79;2017 guidelines 13.9 speak to product quality assurance testing. Review the guidelines to understand better product families, process verification, and testing procedures.


Sterilizer Loading

After all of the preparations with set design, utilization of accessories, and containment devices, improper loading of sterilizers can ruin all your hard work. Manufacturer's sterilizer IFUs include mass metal load weight, instrument placement, and recommended sterilization parameters. Not following the instructions for your sterilizer can result in failed sterilization cycles. Improper loading can result in wet loads and air entrapment which can result in failed sterilization indicators. Improper loading of sterilizers, however, is not just relegated to the sterilizer manufacturer's IFU. It would be best if you also referred to the IFUs from the manufacturers of your containment devices.


In Conclusion

The proper design of instrument sets aligned with packaging and sterilization processes increases the odds of terminal sterilization. Other factors, such as poor steam quality or sterilizer maintenance, can also impact the sterilization process, but that is a thought for another day.




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