Transporting Sterile Medical Devices – AAMI Sterilization Guidance

TIR109 applies to health care facilities and off-site reprocessing centers

Arlington, VA, March 20, 2025 (GLOBE NEWSWIRE) -- 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 like decontamination, containment breaches, staff training, and handling contaminated and processed items. 

AAMI members and non-members may purchase TIR109 on AAMI ARRAY. The guidance is also available as part of an AAMI e-subscription. Members of the trade press covering the sterilization and sterile processing beats are welcome to contact the AAMI media team with questions or requests for comment from an AAMI committee member at dvisnovsky@aami.org.