3 Actions to Prepare for Sterile Packaging Updates

Publish Date: August 14, 2019

On Oct. 1, 2019 AORN will publish the latest update to the Guideline for Sterile Packaging.

It’s not too early to begin talking about how these changes will require updates to policies, practices and approaches to handling sterile packaging, according to Erin Kyle, DNP, RN, CNOR, NEA-BC, AORN perioperative practice specialist and lead author of the updates.

Know What to Look For

Updates in the guideline reflect evidence-based recommendations for personnel who participate in selection, use, and evaluation of packaging systems.  At a glance, Kyle says nurses can expect practice updates in each of these areas:

  • What to look for in a packaging system
  • Environmental concerns
  • Evaluation of the manufacturer’s instructions for use and validation data

“Expect more details around preparing for packaging, such as determining how to safely use sterilization accessories and performing hand hygiene before handling medical devices and reusable surgical instruments for packaging,” she advises.

Start Planning

Kyle suggests nurses take these actions now to start talking about sterile packaging changes with members of their team working in perioperative care and sterile processing:

  1. Think about standardization. Are the methods for sterile packaging of surgical instruments that are used in your own organization standardized? Is your organization’s sterile processing department engaged in standardized procedures?
  2. Assess the work environment where sterilization packaging occurs to determine whether hand hygiene is accessible (and easy) for personnel performing packaging.
  3. Engage with purchasing personnel in your organization and ask how the concept of “environmentally preferable” purchasing is integrated into existing purchasing practices.

Research Evidence Driving the Updates

As with any guideline update, changes to sterile packaging best practices reflect updates in the evidence. Kyle shares a few resources supporting guideline updates:

  • Standardizing sterile packaging—A 2017 update to the ANSI/AAMI ST79 guidance on steam sterilization and sterility assurance in health care facilities and the 2018 ANSI/AAMI ST77 guidance on containment devices for reusable medical device sterilization recommend using organizing accessories to assist personnel in facilitating standardized organization of items within the tray or set. Other research suggests that standardization of processes in sterile processing can result in fewer defects, such as missing items or incorrectly packaged items in sterilized packages. This reduction of defects can save time and money and support optimal patient care.
  • Maintaining rigid containers—Many organizations are transitioning to reusable sterilization containers from single-use options. Those reusable containers may be aging and damaged. Scheduled routine inspection and maintenance of rigid sterilization containers can be a valuable tool for detecting defects and wear of rigid containers that may compromise sterility maintenance in addition to inspection prior to each use, according to ANSI/AAMI ST79:2017.
  • Product quality assurance testing—Evidence in the update supports the importance of periodic product quality assurance testing, including one study by Prince et al (2014) that evaluated sterilization parameters for dynamic air removal steam sterilization of rigid containers compared to hospital wrap and found that placement of a rigid container in a minimally loaded sterilizer resulted in more difficulty to sterilize than in a maximally loaded chamber, which reinforces the recommendation to perform product quality assurance testing that is representative of how the products will be used in practice.

“In today’s world where both efficiency and precision in sterilization matters,” Kyle says, “it’s important to integrate emerging evidence-based practices into daily work to be confident that your patients get the best quality care.”


Additional Resources

Take a look at the evidence driving updates to the Sterile Packaging guideline for standardization through ANSI/AAMI ST79:2017 and ANSI/AAMI ST77, maintenance of rigid containers in ANSI/AAMI ST79:2017, and quality assurance testing by Prince et al.


Free Resources for Members


Guideline Update: Sterilization Packaging (1.0 CHs)

Packaging: Not Always So Simple (1.0 CHs)


AORN Journal CNE Articles

Back to Basics: Packaging Systems (1.5 CHs)