External transport of reusable medical devices for processing
A draft Technical Information Report focused on the external transportation of reusable medical devices between health care facilities and offsite processing centers. It addresses both contaminated and processed devices, with the goal of maintaining device integrity, preventing cross-contamination, and protecting personnel throughout transport. Because this version is still a draft, it is subject to change and should not yet be cited as a finalized AAMI TIR.
The document recognizes that offsite processing has become more common and introduces additional challenges such as longer transport times, selection of transport carriers and vehicles, separation of clean and contaminated items, cleaning of transport equipment, and training of transport personnel.
A major focus is establishing a formal quality system for external transport. Facilities should have policies covering documentation, traceability, inspection, personnel safety, training, supplier controls, chain of custody, cleaning of transport carriers, environmental conditions, and maximum allowable time before contaminated devices are processed.
The report places strong emphasis on segregation and containment. Clean, sterile, and contaminated items should be clearly identified and separated during loading, unloading, and transportation. Transport carriers should be closable, rigid, leak resistant, appropriately labeled, and designed to protect their contents from contamination or damage.
Transport carriers and carts should also be cleaned, disinfected, inspected, and periodically verified for cleaning effectiveness. Reusable carriers should have cleanable surfaces, while carts and vehicle cargo spaces should be maintained on defined cleaning schedules to prevent contamination of sterile packaging or other transported items.
The transport vehicle itself is treated as an important part of the process. Cargo areas should be secure, cleanable, large enough to protect the load, and arranged to minimize shock, vibration, and movement. Activities such as eating, drinking, smoking, or transporting corrosive chemicals alongside medical devices should be avoided because they may compromise the transport environment.
For contaminated devices, the report stresses preventing clinical soil from drying before cleaning. Devices should be kept moist using appropriate methods, transported as soon as possible, and protected from environmental conditions that could accelerate drying. Time, temperature, and humidity are identified as important factors influencing soil retention, biofilm formation, corrosion, and ease of subsequent cleaning.
For processed and sterile devices, transport should protect both the device and its sterile barrier system from moisture, contamination, package damage, shock, and vibration. Package integrity should be verified when items are received, and compromised items should be returned for reprocessing.
Personnel involved in transport should receive documented training and competency assessment covering safe handling, cross-contamination prevention, sterile package integrity, bloodborne pathogens, hazardous materials, ergonomics, weather exposure, and applicable OSHA and DOT requirements.
The annexes further address environmental monitoring and packing considerations, including temperature, humidity, shock, vibration, protective packaging, cushioning, and secure placement of items within transport carriers. The document notes that longer exposure to uncontrolled conditions increases the risk of product compromise.
In short: TIR109 provides a framework for safely moving reusable medical devices between facilities by emphasizing containment, separation of clean and contaminated items, environmental control, transport equipment cleanliness, traceability, package protection, trained personnel, and defined quality-management procedures throughout the external transport process.