Safety Statement From AORN
It has come to our attention that shortages of sterilization wrap are affecting hospitals and ambulatory surgery centers across the country. If you are experiencing sterilization wrap shortages, please select alternative sterilization containers that are validated and FDA-cleared. The AORN Guideline for Sterilization Packaging Systems recommends that you:
Perform product quality assurance (QA) testing for new packaging, packaging accessories, and major changes in packaging type, changes in tray configuration or content density, and on a schedule defined in the manufacturers’ IFU. This is important because major changes to packaging type can affect sterilization performance in the practice setting and result in unexpected process challenges in sterilization systems. It is essential to conduct QA testing when a new packaging system is used prior to use in patient care.
Product QA testing involves placing a BI and CI inside the set, tray, or pack being tested in the areas that present the greatest challenge to sterilant contact according to the package manufacturer’s IFU and running the item in a full load. When conducting product QA testing, include the following
- evaluation of pass or fail results
- evaluation of residual moisture on or in the package; and
- documentation of product testing activities including
- the date of the test,
- a description of the package and contents,
- the location of the BIs and CIs within the test package, and
- test results.
Sterile Processing University recommends you first obtain and read the manufacturer’s instructions for use (IFUs) for any wrap/packaging you intend to purchase. Make sure it has been validated for the cycle types (e.g. gravity and/or pre-vacuum) and temperatures you will be using. This information can vary with the vendor.