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Vigilance means "watchfulness" and to make something "known and transparent". The Swiss Agency for Therapeutic Products, Swissmedic, ensures that only high-quality, safe and effective therapeutic products may be put on the market in Switzerland. Medical products must be handled with the aforementioned vigilance. If there is an incident with a medical product, it must be made known and transparent in a report to Swissmedic.
The obligation to report serious adverse effects (incidents) with medical devices has already existed in Switzerland since 1996. Until 2002 however, this was only mandatory for distributors, i.e. for the manufacturers and suppliers of medical devices. In 2002, legislation (Therapeutic Products Act) extended this obligation to professional users in order to increase the efficacy of the system. Every hospital must appoint a designated Vigilance Contact Person (VCP), who is responsible for reports to Swissmedic. Since the 2nd revision of the Ordinance on Medical Devices (MePV) dated 21 March 2010, hospitals are required to additionally implement an internal reporting system (Materiovigilance System). In accordance with the principles of quality assurance, this internal reporting system was to be in place by 1 July 2011, following a transition period. Hirslanden has created a superimposed, electronically supported materiovigilance concept. Contact persons, as well as their responsibilities and tasks, have been defined.
Medical devices are becoming more complex and, due to their application in diagnostics, treatment and patient monitoring, influence the quality of patient care considerably. The success of medical and healthcare-related services also directly depends on the correct and safe use of medical devices. In the event of incorrect operation, inadequate knowledge may lead to safety risks, compromised quality and standstill times. Especially in departments or clinics with a high proportion of medical devices, problems resulting from incorrect operation have a negative effect on operational processes, e.g. the surgical or intensive care segment. It is therefore imperative that all users applying devices on patients are instructed or trained in the correct operation of the respective type of device. The device certificate was introduced on a group-wide basis.