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Information on specific medical devices

New coronavirus: Swissmedic issues warning about non-conforming face masks

01.05.2020

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:

Heater-cooler units (HCUs) used in cardiac surgery - recent recommendations

15.03.2016

Levonorgestrel-haltige Intrauterinsysteme und kupferhaltige Intrauterine Devices: Aktualisierte Information zum Risiko einer Uterusperforation

12.10.2015

Suspension of devices manufactured by Silimed – update

25.03.2015

Alere Determine HIV-1/2 Ag/Ab Combo

24.09.2015

Sale of silicone implants manufactured by Silimed suspended

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:

The safety of Metal-on-Metal joint replacements with a particular focus on hip implants

14.07.2014

Measures for improved patient safety in cardiac surgery

Sorin heater cooler devices, mycobacterium infection risks, letter to the competent authority of 14.7.2014 (PDF, 174 kB, 14.07.2014)

Sorin heater cooler devices, mycobacterium infection risks, customer information of 14.7.2014 (PDF, 832 kB, 14.07.2014)

Sorin heater cooler devices, operating instructions excerpt (14.7.2014) (PDF, 406 kB, 30.07.2014)

PIP breast implants

Link to the European SCENIHR report:

SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Scientific opinion on the Safety of Poly Implant Prothèse (PIP) Silicone Breast Implants (2013 update), 12 May 2014

Link to information from the UK authority MHRA:

Poly Implant Prothese (PIP) Breast Implants, information of MHRA

Link to information from the French authority ANSM:

PIP breast implants with silicone gel, ANSM thematic dossier

Link to information from Swissmedic:

Defective "PIP" silicone-filled breast implants: Information from Swissmedic, Status as of 07.02.2012

24.06.2013

Magnetic field mats, information of the Federal Office of Public Health FOPH

Orientierungsveranstaltung des SVTI, Druckluftanlagen für den medizinischen Bedarf, Wallisellen, 13. Dezember 2012 (PDF, 85 kB, 26.03.2013)

Information zur Verfügbarkeit von Medizinprodukten nach dem Erdbeben in Italien im Mai 2012 (PDF, 15 kB, 31.07.2012)

Macrolane und ähnliche Produkte auf Hyaluronsäure-Basis: Anwendungseinschränkung für Brustvergrösserungen (PDF, 16 kB, 19.04.2012)

Creutzfeldt-Jakob tests

In vitro diagnostic medical devices, requirements for vCJD assays (PDF, 19 kB, 22.02.2012)

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

Information about mercury in thermometers and blood pressure devices (PDF, 23 kB, 23.11.2006)

Rekurs Helicobacter pylori

Prohibition to sell tests for Helicobacter pylori to the public

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 20.05.2021

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