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Important Information - Coronavirus (COVID-19)
Packaging

Packaging

What is the Purpose of Packaging Instruments before Sterilization?
  • Containment of the product through the different stages of the decontamination process.
  • To allow sterilization to take place.
  • To protect the product during sterilization and transportation from deterioration and damage.
  • To maintain sterility to the point of use.
  • To prevent contamination of the product following decontamination.
    • There are a variety of packaging materials available for individual surgical instruments. The choice of type and size will depend on the item to be packaged.
  • Peel-apart pouches with a see-through front and paper backing are often used for single instruments or small loads.
  • Sealing peel-apart pouches is essential to ensure that the product remains sterile after autoclaving.
  • In self-sealing pouches, adhesive is manufactured into the open end of the bag or plain top and either a heat sealing machine or autoclave tape is then required to create a seal.

Packaging for sterilization should be suitable for the sterilization method used to ensure that the packaging material can be penetrated by the sterilization agent (e.g., water vapor). The packaging also provides protection during transport and storage. Proper packaging protects the sterilized goods from microbacterial recontamination during transport and storage. The packaging units are to be kept as small as possible and provided with labels indicating the contents, date of sterilization, use-by date, batch number, and sterilization indicator.

Source: Centers for Disease Control and Prevention (CDC)

Understanding Proper Instrument Storage

The correct storage of processed instruments is important to protect them from environmental contamination. The major source of environmental contamination is airborne bacteria and viruses that settle on instruments and equipment. Critical instruments that must be sterile at the time of use must be stored bagged/wrapped until use. However, an efficient way to protect all sterilization critical instruments from environmental contamination is to bag them prior to sterilization and store them in the unopened bag/wrap. Critical instruments/items must be stored in a way that maintains the integrity of packs and prevents contamination from any source. Items required to remain sterile must not be stored in ultraviolet cabinets or disinfectants as these processes will compromise sterility. It is important that critical wrapped instruments are stored in a clean dry area and are subjected to minimal handling before use.

During storage, packs can be contaminated by:

  • over-handling—this can happen through excessive transferring from one place to another or during rotation of instrument packs from over-stocking storage areas or from bundling packs together using rubber bands;
  • moisture—if the pack is placed on a wet bench top, splashed with water, other liquids, or aerosols; or
  • penetration—if instruments break through the surface of the pack.

A package is considered to be nonsterile when it:

  • is damaged or open;
  • comes out of the steam sterilizer wet or is placed on a wet surface; or
  • is dropped or placed on a dirty surface.

Storage areas must be dedicated for that purpose only and be free of dust, insects, and vermin. For open shelving, all items must be stored above floor level by at least 250mm, from ceiling fixtures by at least 400mm, and protected from direct sunlight. This will facilitate environmental cleaning and allow unrestricted airflow and prevent heating and degradation of the packaging material.

Guidelines & Recommendations

The following recommended practices for the evaluation, selection and use of packaging systems for items to be sterilized were developed by the Association of Perioperative Registered Nurses (AORN) Recommended Practices Committee.

These recommended practices are intended as guidelines adaptable to various practice settings.

  1. Packaging systems should be evaluated before purchase and use to ensure that items to be packaged can be sterilized by the specific sterilizers and/or sterilization methods to be used.
  2. Packaging systems should be compatible with the specific sterilization process for which it is designed.
  3. Packaging materials should be stored and processed to maintain the qualities required for sterilization.
  4. Package contents should be assembled, handled and wrapped in a manner that provides for an aseptic presentation of package contents.
  5. Paper-plastic pouch packages should be used according to manufacturer's written instructions.
  6. Design, material and construction of the containment device (e.g., rigid containers, instrument cases/cassettes, organizing trays) should be considered before selection, purchase and use.
  7. Packages to be sterilized should be labeled.
  8. Sterilized packages should be considered sterile until an event occurs to compromise the package barrier integrity.
  9. A chemical indicator/integrator should be placed inside each package and external chemical indicator affixed outside each package to be processed.
  10. The healthcare organization's quality management program should include sterile packaging selection and use.
  11. Personnel should demonstrate competence in the use of sterilization packaging systems and accessories.
  12. Policies and procedures for the selection and use of packaging systems should be written, reviewed periodically and readily available within the practice setting.

For further explanation of these recommended practices, please visit www.aorn.org