The integrity of sterile medical devices during transport is a growing concern as hospitals increasingly centralize sterilization processes. Devices now travel longer distances under uncontrolled environmental conditions, which heightens the risk of contamination. The Association for the Advancement of Medical Instrumentation (AAMI) is addressing this with a new technical information report, TIR 109, due by the end of 2024.

AAMI TIR 109 is the first document specifically focused on best practices for transporting both sterile and contaminated medical devices. It considers factors such as temperature fluctuations, humidity, and road vibrations, which are unique to transportation outside hospital environments. While existing standards like ASTM D4169 simulate transport conditions, they don’t fully account for the specific challenges of medical devices. AAMI TIR 109 will fill this gap, offering guidance on how healthcare facilities can maintain packaging integrity during transit over public roadways.

With centralized sterilization, the packaging used for these devices must withstand increased environmental stress, such as temperature changes and rough handling during transportation. AAMI's new guidelines will provide strategies for ensuring these devices remain sterile, safeguarding patient safety across healthcare settings. These best practices are expected to set a new standard in the healthcare packaging industry, assisting facilities that face challenges with current transport methods.

The TIR 109 initiative, led by industry experts Ralph Basile and Sue Klacik, outlines packaging solutions that address the risks associated with external environmental factors. It will help healthcare facilities better navigate the growing complexity of transporting medical devices, supporting the safe transfer of sterilized items from processing centers to hospitals. The focus on packaging integrity during transport is especially important for critical devices that cannot risk exposure to contamination.

The document aims to offer practical guidelines for hospitals and transport services to mitigate these risks. While the exact recommendations are still forthcoming, it’s clear that the guidance will provide a framework to ensure packaging maintains its sterility under real-world transport conditions. Once released, it will help set a higher standard for medical device packaging and its role in patient safety.