In 2025, Swissmedic carried out 28 inspections of reprocessing, maintenance, and vigilance activities for medical devices at 26 Swiss hospitals and two service providers, examining the quality and safety of medical devices in reprocessing units (RUMEDs) and Endoscopy departments as well as maintenance procedures and vigilance systems. The results continued to show a considerable need for action to ensure fulfilment of the legal requirements, though generally no acute threat to patients was identified; in individual cases Swissmedic ordered immediate action to rectify critical deficiencies. Recurring weak points concerned staff qualifications and further training and physical infrastructure in reprocessing, hospitals' internal processes and quality management in maintenance, and, in vigilance, staff training and awareness of the legal obligation to report serious incidents. Swissmedic noted that time, cost, and staffing pressures remained key obstacles to sustainable quality improvements. At the same time, its market surveillance was having a positive signal and steering effect, with several hospitals recognising the need for improvement at an early stage and planning or initiating actions to improve device safety of their own volition.

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