Regulatory Update: Shipping Used Medical Devices

On January 1, 2013, the international regulatory bodies who oversee the air transport of infectious and biological substances worldwide published a new exception to the regulations expressly for shipments of used medical devices.  The new exception permits used medical devices to be transported without the stringent requirements previously placed on these shipments.  With this recent publication, it is advisable to review the rationale for the development of these regulations, outline the current requirements and discuss future changes in the regulations.

For the purposes of transportation safety, infectious substances are considered dangerous goods and therefore subject to the dangerous goods transportation regulations.  The transportation regulations define used medical devices as those medical devices that have been removed from their original packaging, potentially contaminated by contact with a patient (human or animal) and are being returned to the manufacturer or other facility for repair, evaluation, sterilization, disinfection or cleaning[1].  As it pertains to the dangerous goods transportation regulations, the medical devices themselves are not the problem[2], but rather the biological material that may cause potential contamination.  The main concern with these used medical devices that have been in contact with patients is the potential for contamination by an infectious substance (a disease-causing agent).  The transportation regulations outline specific packaging and communication requirements to help ensure that anyone who comes in contact with the package during transport is protected against exposure to the potentially-infectious substances.

The transportation of dangerous goods is governed by a number of national and international regulatory bodies; however, the primary source for the regulations is the United Nations (UN). Read more…

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