Defects found in medical devices in Swiss hospitals
Published: Monday, Oct 7th 2024, 13:00
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The Swiss Agency for Therapeutic Products (Swissmedic) has identified deficiencies in the area of medical devices in Swiss hospitals. The deficiencies identified have a direct or indirect impact on product and therefore patient safety.
Swissmedic announced in its annual report on Monday that there was a need for action, particularly in the areas of quality management, maintenance, training and further training of the staff involved and the infrastructure of the reprocessing departments. These shortcomings were already observed in 2021 and 2022. Since then, no trend towards a significant improvement in quality has been identified, according to the Agency.
It is essential that hospitals introduce improvement measures in order to comply with the legal requirements, the statement continued. In order to ensure patient safety, Swissmedic has intensified monitoring and cooperation with specialists to improve quality assurance. So-called "good practices" are to be developed jointly.
Swissmedic monitors the maintenance, reprocessing and monitoring systems for recording serious incidents in Swiss hospitals in the area of medical devices. In 2023, the Agency carried out inspections in 25 hospitals.
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