In 2023, Swissmedic conducted medical device inspections in 25 hospitals. The checks again revealed a need for action in all inspected areas, particularly in quality management, maintenance, the basic and further training of the personnel involved, as well as the infrastructure of the reprocessing departments. The identified deviations have an impact on device safety, and thus on the safety of patients.
Annual report
07.10.2024
In the field of medical devices, Swissmedic monitors maintenance, reprocessing and vigilance (monitoring systems for recording and reporting serious incidents) in around 280 Swiss hospitals. In 2023, Swissmedic carried out inspections in 25 hospitals and identified a need for action. The observed deficiencies confirm the problem areas previously identified in 2021/2022, and there was still no evident trend towards a significant quality improvement. Since the deviations have a direct or indirect impact on device safety, and thus on the safety of patients, hospitals absolutely need to implement improvement measures in order to ensure their compliance with the legal requirements.
Since these results are highly relevant for patient safety, Swissmedic has intensified both its monitoring and its collaboration with experts in jointly drawing up basic guidelines for improving quality assurance. These will include "Good Practice" standards containing binding specifications for hospitals based on the state of the art in science and technology and designed to help the hospitals independently improve their quality management in the reprocessing, maintenance and vigilance of medical devices.
The statutory enforcement remit for monitoring hospitals in the area of medical devices is regulated in the Medical Devices Ordinance and the Ordinance on In Vitro Diagnostic Medical Devices.
Supplementary information
Annual reports
Basis of the statutory enforcement remit: Medical Devices Ordinance (MedDO, SR 812.213) and Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219).
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