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 (MedDO, SR 812.213) and Article 65 of the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219) set 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 (available in German, French and Italian).
Maintenance of sterilization containers
The following document (available in German, French and Italian) provides details of the requirements for the maintenance of sterilization containers (in accordance with standard SN EN 868-8):
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.
Link to the information from the FOPH (in German):
New medical devices regulations
New medical devices regulations came into force on 26 May 2021. An information meeting was held (in French and German) on 2 September 2021 to explain the impact of the new regulations on the different players in the Swiss medical devices sector.
Information on the new medical devices regulations (French and German only):
One presentation dealt with healthcare institutions and the new requirements facing them, particularly as regards maintenance. This presentation is available on the Swissmedic website:
Presentation on requirements pertaining to healthcare institutions:
The following document (only available in German, French and Italian) provides further details on the legal requirements for professional users and third party maintenance of medical devices: