Maintenance

Swissmedic is the agency responsible for the compliance monitoring with regard to the maintenance of medical devices in hospitals. The cantons are responsible for compliance monitoring of all other professional bodies that use medical devices (e.g. medical practices, outpatient clinics, dental clinics).

The legal basis is provided by Arts. 15 and 20 of the Medical Devices Ordinance.

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.

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 as an active PDF for this purpose (PDF available in German, French and Italian).

Standard SN EN 62353 details the requirements of the Medical Devices Ordinance as regards the maintenance of medical electrical equipment and is applicable to the entities responsible for maintenance, for example in hospitals.

Hypothermia devices (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):
https://www.swissmedic.ch/content/swissmedic/en/home/medical-devices/reprocessing---maintenance/maintenance.html