UN Certified Compliant Packaging for Return Devices

Used Medical Devices are classified as having been in contact with patients and are being returned to the manufacturer, or shipping elsewhere for disinfection, cleaning, sterilization, repair or evaluation.

According to the ICAO TI, in order for a used medical device to be excepted from the transport regulations, it must meet a few packaging criteria. The device must be stored in a package that is designed to remain intact regardless of the handling and weather conditions it may undergo during transportation. This package must be of sufficient quality that it is not negatively affected by the temperatures, pressures, vibrations, weather, loading and unloading normally experienced during transport. In order to ensure the durability of the package design, it must be subjected to a drop test of 1.2m. The package design passes the test if the package retains the used medical device and the infectious substances do not leak.

To eliminate the guessing game for Medical Device Manufactures and to ensure the safety of their employees and those in contact with the returned device in transit, Inmark’s ExaktPak product line has engineered Used Medical Device return packaging designed to be more stringent that the current regulations.  We strive to safeguard the lives of those involved in the Used Medical Device return process. For this reason, our Used Medical Device packaging follows the Category B (UN 3373) regulations. To ensure manufactures are following international regulations, Inmark has developed online training designed to certify individuals to package and ship Used Medical Devices as UN 3373 systems.