How do medical devices stay sterile in a box… in a van… or on a dogsled?! Ralph Basile and Sue Klacik are leading a team of subject matter experts in developing technical information report (TIR) 109, a new guidance document that will define best practices for ensuring packaging integrity during transportation of sterile medical devices. Key challenges like temperature, humidity, and vibration are all considered for this crucial new document. Earlier this year, AAMI News Director Brian Stallard sat down with the pair to understand what is driving this effort. Q&A answers are edited for brevity and clarity. For the full conversation, check out the AAMI News in Conversation video below:

What is Working Group 40 currently working on?

Our main focus is TIR 109, which deals with the external transportation of healthcare-processed items. This technical information report will address the transport of both sterile and contaminated items over public roadways, which are an uncontrolled environment. We're exploring the challenges these items face when exposed to external environmental factors like temperature, humidity, and vibrations during transport, which is different from the controlled hospital environment.

Why has packaging integrity become such a key focus recently?

Packaging is crucial because it ensures that medical devices stay sterile from manufacturing to delivery, whether they’re single-use or reusable devices. Manufacturers validate their packaging for transportation, but we’ve seen an increasing need to look at what happens when hospitals transport these items after they've been processed on-site. With growing centralization of sterilization, packages now face a lot more environmental stress, like temperature shifts and rough road conditions, which can affect their sterility. 

What’s causing the increase in transportation needs for sterilized medical devices?

Hospitals are centralizing their sterilization operations to save space for patient care. 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. 

What specific challenges does transportation pose to sterilized packages?

Once a package leaves the hospital, it’s exposed to uncontrolled environments. For example, packages might go from an air-conditioned facility to a hot, humid vehicle or experience vibration and shock from bumpy roads. These environmental factors can cause issues like moisture on the packaging, which leads to contamination. Public roadways are often not smooth, which introduces new risks to packaging integrity. 

Are there existing standards for transportation of sterile medical devices?

 There are standards, like ASTM D4169, which simulate transportation conditions like vibration and temperature extremes. However, these standards focus on devices being shipped from manufacturers to hospitals. They don’t account for the conditions of medical devices when healthcare facilities transport them between locations after processing. AAMI TIR 109 is the first major effort to address this gap by providing best practices for hospitals and other facilities to maintain packaging integrity during transport. 

What are the next steps for TIR 109 and its impact on the industry?

 We hope to finish the document by the end of the year. It’s been a collaborative effort between healthcare facilities, industry, and testing labs, all sharing expertise. The document will provide guidance on how to monitor conditions like temperature and humidity during transport, ensuring the sterility of items. We’ve also discovered that monitoring tools for transport are more accessible and affordable than we originally thought, which will help facilities implement these practices. 

Is there any connection between this work and other standards like ST79?

 Yes, TIR 109 supports other key standards like ST79, which is the comprehensive guide to steam sterilization in healthcare facilities, as well as ST91 for flexible and semi-rigid endoscopes and ST58, which deals with low-temperature sterilization. The report will provide critical guidance for healthcare facilities that need to transport these items while maintaining sterility. 

What’s the role of the Kilmer Innovations in Packaging Group (KIPP) in this work?

KIPP is closely aligned with AAMI’s efforts. It grew out of conversations at the Kilmer Conference in 2019, focusing on packaging innovations and challenges. One key issue we identified is repetitive handling, where packages are moved multiple times within a facility, which can compromise integrity. KIPP has been instrumental in researching these issues, and we’ve incorporated some of their findings into TIR 109. 

Any final takeaways for healthcare facilities?

A key point for healthcare facilities is to avoid letting soils dry on contaminated devices during transport. BI&T research led by Tara Kremer at J&J has shown the detrimental effects of time, temperature, and humidity on soiled devices. This impacts not only the cleaning process but also the longevity of medical devices. Keeping these soils from drying is crucial to maintaining device integrity and ensuring patient safety. 

Any calls to action for the industry?

We encourage anyone interested in improving sterile processing practices to get involved with AAMI. There are many opportunities for collaboration, whether it's through standards development or new research areas like home healthcare, where packaging and transportation will continue to be critical issues.