By Susan Klacik
In case you missed it, AAMI has introduced a new Technical Information Report (TIR) to provide guidance for healthcare facilities when transporting medical devices externally from their facility. This new guidance document exemplifies the synergy between users, manufacturers and regulatory sectors to develop a resource for users. Manufacturers provided their expertise on transporting medical devices over public roadways. There are many significant facets to external transport that include maintaining the integrity of processed items and following safety precautions for contaminated items, protecting personnel and the environment from contaminated items and preventing breakage of medical devices. The newly released AAMI TIR109:2025, “External Transport of Medical Devices Processed by Health Care Facilities” provides information on how to perform these practices when carrying out external transport.
External transport of healthcare processed items has increased because of logistical and financial reasons. Whether the transport is across the street, or across town there have been numerous concerns regarding the safety and effectiveness of this practice. TIR 109 delves into the challenges facing healthcare facilities and provides direction how to safely perform this task.
Items transported over public roadways must comply with the specific local, state or federal regulations of the Department of Transportation (DOT) Hazardous Materials Regulation, OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030) and the Environmental Protection Agency (EPA). TIR109 provides this regulatory information.
This new TIR provides a section describing quality system considerations so that work practices and environmental controls maintain the integrity of the product and minimize the potential for contamination of used devices. It is recommended that the healthcare facility has a policy that describes documentation and records, identification and traceability of instruments, inspection and release procedures, safety procedures, training procedures as well as supplier controls and monitoring.
A concern in healthcare facilities is providing an effective and efficient physical area for both loading and unloading. This document provides design and processes to achieve this objective.
The selection of the correct transport carrier is provided. The transport carrier is used to prevent contamination to or from the external environment and prevent items from being damaged. It should remain closed during transport with a latching mechanism and tamper evident seals. Maintaining the cleanliness of the carrier is also discussed.
All transport carriers should be clearly labeled with the processing status, identifying if the items are clean, sterile or contaminated. Identify what is contained, where it came from and is going to, along with the date and time.
Protective packaging can be used to protect the integrity of a sterile package. Advice is provided on when and how to utilize protective packaging.
Guidance is provided for the transport carts used for external transport. The recommendation includes each cart having its own unique identifier and allow for traceability to maintenance records. Recommendations for the types of carts are provided. The cart should be able to move smoothly and with little vibration and shock. For that to occur, the wheels should be able to freely turn in good working order and regular maintenance should be performed. The wheels should be lockable. Ergonomics are another consideration which includes the handle height. For employee safety, the carts maximum gross load should be followed. The carts should be clean, and guidance is provided for cleaning.
The transport vehicle is typically not managed by the sterile processing department, however TIR109 does include recommendations for the transport vehicle. It should comply with federal, state and local regulations and be safe and reliable. One of the risks to transporting items over roadways is the shock and vibration that can occur, which can damage medical devices and packaging. For that reason, it is important to minimize shock and vibration.
The area used to transport items is referred to as the cargo space, which is an enclosed area within the vehicle. There is a listing of requirements for the cargo space that includes protecting the cargo from significant changes in temperature and humidity. This document includes environmental and cleaning considerations for the transport vehicle.
Personnel performing the transport should have training and education. This TIR provides a listing of the topics that should be included. It is also recommended to have policies for any related to special licenses and other driving requirements.
If an outside transport company is used the healthcare facility should have a process in place to regularly evaluate compliance.
There are two annexes that provide information on monitoring the external transport condition, and packing considerations for transport carriers that provides information on how to protect the packaging integrity and contents from damage.
The newly released AAMI TIR109:2025, “External Transport of Medical Devices Processed by Health Care Facilities” is available at the AAMI store (www.aami.org).
– Susan Klacik, is co-chair of working group 40, which developed AAMI TIR109. She served as the HSPA voting member of AAMI for more than 35 years.
