Information on specific medical devices

21.06.2016
Update on measures for improved patient safety in cardiac surgery
On 14 July 2014, the FOPH, in conjunction with Swissmedic, published safety measures in response to observed cases of Mycobacterium chimaera infection during the use of hypothermia systems (heater-cooler units, HCUs) in cardiac surgery. We would now like to bring you up to date on recent recommendations concerning the use of hypothermia systems in cardiac surgery:


15.03.2016

12.10.2015

25.03.2015

24.09.2015

Laparoscopic uterine power morcellation (tissue comminution)

Laparoscopic uterine power morcellation (tissue comminution) (PDF, 21 kB, 04.08.2015)Statement by Swissmedic in conjunction with the Study Group for Endoscopic Gynaecology of the SGGG (Swiss Society of Gynaecology and Obstetrics)


Hip implants
Metal-on-metal hip implants (MoM):

 

as at 23 January 2015

The safety of metal-on-metal hip implants has recently been called into question by several parties. A group of experts (SCENIHR – Scientific Committee on Emerging and Newly Identified Health Risks) appointed by the European Commission has produced a report on the safety of metal-on-metal joint replacements (“The safety of Metal-on-Metal joint replacements with a particular focus on hip implants”).
The full text of the report can be downloaded via the following link:


14.07.2014


PIP breast implants

Link to the European SCENIHR report:
Link to information from the UK authority MHRA:
Link to information from the French authority ANSM:
Link to information from Swissmedic:

24.06.2013




Creutzfeldt-Jakob tests

Iris implants

Intraocular iris implants NewIris, NewColorIris and BrightOcular (PDF, 15 kB, 26.10.2011)Non-compliance with Swiss and European regulations on medical devices




Please note that documents represented the latest scientific and technical findings as well as the applicable legal requirements at the moment of their publication. After being published on the News and Information on specific medical devices webpages, these documents are then moved to the archives after an appropriate amount of time, where they remain available for information purposes. However, archived documents are no longer updated. The current legislation and the latest scientific and technical findings are always authoritative.

Last modification 09.12.2019

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