The following document on Good Practice in the maintenance of medical devices describes the specific measures that hospitals can take to organise medical device maintenance in conformity with the existing legal requirements.
Health informatics departments – alongside medical technology departments – are playing an increasingly important and critical role within healthcare institutions in ensuring the operational security of network-compatible medical devices and in maintaining medical IT applications. Health informatics integrates the various systems into an existing network in accordance with operational and legal requirements and ensures they are operated securely and in accordance with specifications. Article 74 of the Medical Devices Ordinance sets out the cyber security requirements for network-compatible products. Healthcare institutions must put in place all state-of-the-art technical and organisational resources necessary to ensure that network-compatible products are protected against electronic attack and unauthorised access. In addition, hospitals must, in accordance with risk management system principles and as an integral part of their quality management system, identify, evaluate and document the measures that have been put in place.
Swissmedic uses the following checklist as an aid when inspecting hospitals with regard to the maintenance of medical devices. It can also, however, be used by hospitals to conduct gap analyses with regard to the requirements of an established quality management system and for internal audits. The checklist is published for this purpose (PDF available in German, French and Italian).
Heater Cooler Units
In 2017, the Federal Office of Public Health and Swissmedic issued guidelines for operating and monitoring heater-cooler devices/units in operating theatres on the basis of recommendations issued by the Swiss Mycobacterium chimaera expert task force.