An AI tool was used to translate this article from German.

Who and what did Swissmedic inspect?

Swissmedic carried out inspections at 25 hospitals in Switzerland in 2023. The vigilance of medical devices was checked in 92% of the inspections. In addition to vigilance, there were inspections on the topics of endoscopes and maintenance of medical devices.

What is Swissmedic criticizing?

At 70 percent each, the training (reporting of serious incidents) and the process for safety notices (Field Safety Notice, FSN) were most frequently affected by deviations. With regard to vigilance training, the medical, medical-technical, laboratory and paramedical staff had either not been trained at all, only inadequately or not periodically. In the medical profession, training in vigilance was often completely lacking (57 percent). In addition, in most cases, the vigilance training courses were inadequate in terms of content.

With regard to the processing and analysis of incoming safety messages from suppliers, inspections often found that this process was not sufficiently regulated and documented and therefore did not meet the requirements of an appropriate QMS. In some cases, hospitals were unable to ensure that all safety notices were fully analysed and that suppliers were given the required feedback.

What conclusions does the Institute draw?

Swissmedic does not see any improvement in the situation since the last inspection in 2021/2022. The Institute concludes that: Swiss hospitals and clinics still have a considerable need for improvement and investment in the areas of technical quality management, training and further training of reprocessing staff and the infrastructure of reprocessing departments. With regard to vigilance, Swissmedic sees an urgent need for action. Hospital staff, including attending physicians, are often insufficiently trained or not trained at all and are unaware of the legal obligation to report serious incidents involving medical devices.

What does that mean for you?

The failures identified are contrary to the legal requirements and may have an impact on patient safety. You should therefore urgently review your tools and processes and ensure that they comply with Swissmedic’s requirements.

With H-VIGILANZ, we offer you the solution of an established and proven reporting system that guarantees legal certainty.
Find out more in our blog about what makes H-Vigilanz special and how our reporting system makes your life easier.