New guidance document streamlines processes and enhancing clarity for industry compliance, AAMI officials say.

The Association for the Advancement of Medical Instrumentation (AAMI) has issued an updated guidance document on ethylene oxide (EO) sterilization, responding to industry concerns amid cost constraints and regulatory changes prompted by recent Environmental Protection Agency emissions requirements.

The revised AAMI technical information report (TIR) offers crucial updates on the microbiological aspects of ethylene oxide sterilization, along with guidance on the design and qualification of biological indicator or parametric release processes, according to AAMI officials.

AAMI TIR16:2023; Microbiological aspects of ethylene oxide sterilization is produced by AAMI’s volunteer Industrial Ethylene Oxide Sterilization Working Group, co-chaired by Nicole McLees of Olympus and Ken Gordon of STERIS Corp. It condenses relevant information into one resource, providing clarity on using process challenge devices (PCDs) alongside biological indicator release, based on successful U.S. practices.

Speaking to AAMI, McLees notes that the release of TIR16 is part of a greater international trend toward providing new guidance on methods other than the half cycle overkill sterilization method. “Actually the ethylene oxide standard ISO 11135 is being updated to include additional guidance on these methods,” she says.

Comprehensive TIR16 Guidance

The updated version of TIR16 goes in-depth regarding process and equipment characterization including physical characteristics that impact the use of EO, including:

  • EO concentration
  • EO dwell time
  • Temperature
  • Humidity

Selection of the process definition method depends on many factors, which can include:

  • Product bioburden
  • Product design
  • Packaging
  • Load considerations
  • Manufacturing conditions
  • Sterilization equipment
  • Capacity

TIR16 also provides guidance on troubleshooting, sterilization loads, and the maintenance of product effectiveness, according to AAMI.