Transportation of medical devices between facilities is increasingly the norm. Health care facilities often send instruments to offsite reprocessing centers miles away from the point of care.
Keeping medical devices and medical device packaging intact and sterile during transportation can be a struggle. To assist health care and sterile processing professionals with this challenge, the Association for the Advancement of Medical Instrumentation (AAMI) has released a new guidance document that addresses the transportation of reusable medical devices for processing, including sterilization.
AAMI TIR109:2025; External transport of reusable medical devices for processing applies to any transportation of to-be-processed or sterile reusable medical devices between or among health care facilities and reprocessing facilities. The document addresses facility design, transport vehicle considerations, and personnel considerations for the entire process. It also includes relevant information on legal requirements from the Department of Transportation (DOT) Hazardous Materials Regulation and OSHA’s Bloodborne Pathogens Standard.
The document was produced by AAMI’s Steam Sterilization Hospital Practices Working Group (AAMI ST-WG40), co-chaired by Sarah Friedberg, senior microbiology manager at Stryker, and clinical education expert Susan Klacik.
According to Klacik, TIR109 is necessary because the health care industry has shifted to transporting medical devices over public roadways. Klacik comments, “Sterile processing may now take place outside of the hospital or at a central location that serves multiple facilities, such as satellite and ambulatory care centers. Additionally, the high cost of sterilization equipment, like low-temperature sterilizers, encourages hospitals to centralize these processes, which requires transporting sterilized items over longer distances.”
TIR109 provides extensive information on:
- Quality systems issues such as safety, inspection, and documentation.
- Department assets and characteristics like climate control, loading area design, and overall facility design.
- Equipment such as protective packaging, reusable and single-use transport carriers, and motor vehicles.
- Logistics such as preparing for transport, moving to or from loading areas, receipt of processed items, and clinical considerations.
- Other considerations, including decontamination, containment breaches, staff training, and handling contaminated and processed items.
AAMI members and non-members may purchase TIR109 on AAMI ARRAY. The document is also available as part of an AAMI e-subscription.
FDA Recognizes Updated AAMI Sterilization, Ethylene Oxide Guidance
The FDA has amended its database of Recognized Consensus Standards, adding multiple AAMI documents in the agency’s latest round of updates announced in March 2025. This includes one new addition and three revised versions of sterility assurance and sterilization documents previously recognized by FDA in December of 2024.
The new entry to FDA’s database of Recognized Consensus Standards is AAMI TIR106:2024: Microbiological methods—Understanding and use of product bioburden data. Three of AAMI’s most notable sterilization guidance documents were also superseded by newer versions that were recently revised and updated by AAMI. These documents are:
- ANSI/AAMI ST58:2024, Chemical sterilization and high-level disinfection in health care facilities
- ANSI/AAMI ST24:2024, General purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
- AAMI TIR17:2024, Compatibility of materials subject to sterilization
AAMI welcomes the recognition of TIR106, but the inclusion of the updated editions of the other three documents is a major milestone. ST58, ST24, and TIR17 were all recently updated by AAMI, and FDA recognition is an important validation of the new editions’ usefulness for regulators and the medical device industry.
The most recent edition of ANSI/AAMI ST58 was comprehensively revised and reorganized in 2024. The document now includes information on new technologies and chemical sterilization modalities, including ethylene oxide (EO). Prior to 2024, ST24 had not been updated in more than two decades, and the most recent edition features FDA-cleared EO sterilization systems not included in the prior edition. Finally, the new edition of TIR17 includes completely overhauled materials compatibility tables per modality.
AAMI Vice President of Sterilization Amanda Benedict said, “FDA had previously included prior editions of AAMI ST58, ST24, and TIR17 in its database of Recognized Consensus Standards, but the recognition of the recently updated documents and the new recognition of TIR106 is a welcome validation of AAMI’s efforts to promote patient well-being through the production of regulatory-ready sterilization and sterility assurance standards and technical documents.”
All four guidance documents can be found on AAMI ARRAY.
