Guideline for decommissioning and disposal of medical devices

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