Instrument Processing

Instrument Preparation, Packaging Loading

Last month we focused on the cleaning process and the importance of ensuring instruments are adequately cleaned prior to packaging. Before we pick up where we left off, remember that instruments should be visually inspected for cleanliness and completely dry before they are wrapped or placed in a sterilization pouch.

Packaging Material

Instrument packaging is intended to maintain the sterility and protect the sterilized instruments until they are used.  When selecting a packaging type, it is important to keep in mind that the material must be cleared by the FDA as a medical device and that the manufacturer’s instructions for use (IFU) are followed as written.

There are many options available for sterilization packaging and include the following types:

• Woven wraps: made of materials that allow appropriate air removal, allow steam to penetrate the packaging and can dry appropriately after the sterilization process.
• Non-woven wraps: provided in single or bonded sheets.
• Paper-plastic (sterilization) pouches: intended for use with small or lightweight items.

AAMI provides guidance on the proper selection of packaging materials. It is important to choose the right product for the types and weight of instruments that will be sterilized. Consider the following qualities when making your product selection.

• Provides a barrier to microorganisms during the sterilization process, handling, storage, and transport to the area of use.
• Resists tearing or puncture.
• The sealing method results in a complete seal and is tamper resistant.
• Allows for aseptic presentation.
• Free of toxic materials and non-fast dyes.

Each package must be labeled prior to placement in the sterilizer using non-toxic ink that does not run. The label should be written on sterilization tape for wrapped packages and on the plastic (non-porous) side of sterilization pouches. The label should include at least the sterilizer used if more than one unit is on site, the cycle or load number, sterilization date and if indicated, the expiration date.

Personal Protective Equipment (PPE)

As with the other steps in the process, during the instrument wrapping phase, appropriate PPE must be used.  Determine the level of exposure risk to a contaminated item or chemical when handling instruments.  Use the appropriate PPE for the exposure assessment. Use heavy-duty utility gloves if there is a risk of exposure to a contaminated sharp.

Loading the Sterilizer

Packaged instruments are now ready to be loaded into the sterilizer. The first step is to reach for the manufacturer’s IFU. Don’t forget to maintain the unit according to the manufacture’s monthly and yearly recommendations. Understanding how the unit works will lead to the correct outcome: sterilized instruments!

There are some basic tips to keep in mind when loading the sterilizer.

• Ensure written policies/procedures are in place and that anyone involved in instrument processing has reviewed and understands the documents.
• Process items requiring the same cycle parameters together.
• Place heavier items on the bottom shelf. Sterilizers have an established weight limit.
• Do not stack items as this may prevent proper penetration of steam or other sterilant being used.
• Place sterilization pouches on edge with the paper side of one pouch facing the plastic side of the next pouch. The manufacturer may outline a process for lying packages flat. Check the IFU to see if and how packages can be loaded flat, and also whether the paper or plastic side should be facing down.
• Place items that are capable of holding water, such as a cup or basin, on edge for moisture to drain.

Packing and loading instruments into the sterilizer correctly are equally as critical to the overall success of the process. Review your packaging materials to ensure the materials have FDA clearance and that you are using them correctly. Remember that overloading is the leading cause of a sterilization failure. Just because you can fit the instrument inside the chamber doesn’t mean that is a great idea!

For more information, refer to the AAMI standard:  ANSI/AAMI ST79 2017. (2017). Arlington Virginia: AAMI, pp.50 – 61.