Swissmedic hospital inspections 2025: supervision having an effect, but action still needed
Berne, 13.08.2026 — In 2025, Swissmedic carried out 28 inspections of reprocessing, maintenance and vigilance activities for medical devices at 26 Swiss hospitals and two service providers. The results of the inspections show that there is still a considerable need for action to ensure fulfilment of legal requirements. At the same time, Swissmedic’s market surveillance activities are having a positive impact in terms of the signal they send and their steering effect. Several hospitals recognised the need for improvement at an early stage and have planned or already initiated actions to improve device safety of their own volition.
In the course of its hospital inspections, Swissmedic examined the quality and safety of medical devices in reprocessing units (RUMEDs) and Endoscopy departments. It also inspected maintenance procedures and vigilance systems. Facilities were chosen on the basis of a representative procedure that took account of regional and institutional differences between the hospitals.
Generally, no acute threat to patients was identified. In individual cases, however, Swissmedic ordered immediate action to rectify critical deficiencies and ensure the safety of medical devices. The findings from the inspections provide a foundation from which hospitals can implement targeted improvement measures and strengthen patient safety in the long term.
Positive effect of surveillance visible
Despite the shortcomings that still exist, the inspections also identified a heartening trend. It is positive to report that in the run-up to the inspections, hospitals increasingly undertook their own analyses of their current situation and processes on the basis of Swissmedic guidelines and checklists, and planned or initiated initial action to improve quality. This indicates that Swissmedic’s surveillance of hospitals is having an increasingly positive impact in terms of the signal it sends and its steering effect.
Swissmedic has conducted a total of 111 inspections since 2021. The knowledge gained is continually channelled into guidelines, checklists and other enforcement measures and supports hospitals in their own efforts to implement the requirements to guarantee medical device safety.
Recurring weak points
Recurring weak points were found in the areas inspected. In reprocessing – i.e. the cleaning, disinfection and sterilisation of medical devices in RUMEDs and Endoscopy departments – these are principally shortcomings in staff qualifications and further training as well as shortcomings in physical infrastructure. In maintenance, deviations often occur in hospitals’ internal processes along the medical device life cycle, management of the medical device portfolio and quality management. Shortcomings in vigilance were found particularly in staff training and awareness of the legal obligation to report serious incidents.
Structural challenges remain
The root cause analysis shows that time, cost and staffing pressures remain key obstacles to sustainable quality improvements. These are compounded by shortcomings in infrastructure, technical quality management and staff occupational safety and health protection. Furthermore, the position of RUMEDs within the organisation and hierarchy can hamper independent quality management and development.
The results of the inspections illustrate clearly that improvements are still required in several areas. At the same time, it is apparent that market surveillance is having an increasingly preventive effect and is helping hospitals to continue to develop device and patient safety autonomously and sustainably.
Annual report Swissmedic Hospital Inspections 2025 (ePaper/PDF)