Abstract:
Medical devices are essential components of the health care system and are crucial in the prevention,
diagnosis, and treatment of disease and in rehabilitation. However, medical devices that no longer meet
specifications and inoperable (e.g., expired, contaminated, damaged, defective, etc.), or that are no longer
needed due to obsolescence, or that have met a scheduled replacement milestone or that have been
confiscated because of illegal trade should be decommissioned or disposed of properly. Medical devices
decommissioning is usually the first physical process in the disposition process and includes proper
identification, authorization for disposition, and sanitization of the equipment, as well as removal of
patient health information or software, or both. Article 4 (4) and 4 (17) of proclamation 1112/2019 decree
that the authority has the power to order the disposal of regulated product that is not in compliance with
this proclamation or other law issued to implement this proclamation and to ensure proper disposal of
the products in collaboration with appropriate bodies
