7. October 2024 – Swissmedic has published its Annual Report for 2023, which outlines the findings of the medical device inspections carried out in 25 Swiss hospitals (document link). These inspections revealed significant deficiencies across all inspected areas. The identified deviations have an impact on the safety of the devices, and consequently, on the safety of the patients.

In the realm of medical devices, Swissmedic supervises maintenance, reprocessing, and vigilance (monitoring systems for the recording and reporting of serious incidents) in approximately 280 Swiss hospitals. The inspections in 2023 confirmed an ongoing need for action, with the deficiencies observed conforming the problem areas identified in the previous two years. Notably, there remains no discernible trend toward a significant improvement in quality. Given that these deviations directly or indirectly affect device safety, hospitals must implement improvement measures to ensure compliance with regulatory requirements.

Recognizing the importance of these results for patient safety, Swissmedic has intensified its monitoring efforts and collaboration with experts to develop guidelines to improve quality assurance. These guidelines will include “Good Practice” standards containing binding specifications for hospitals, reflecting the current state of science and technology. The aim is to support hospitals in independently improving their quality management with regard to the reprocessing, maintenance, and vigilance of medical devices.

For more information, see here.