DATE
02-2014
FSN
019
TITLE
SWISSMEDIC: Water-Borne Infection In Implant Patients
PROBLEM

We have been advised by the MHRA that Swissmedic, the Swiss Agency for Therapeutic Products has recently published a safety notice written by the Federal Office of Public Health (FOPH) in Switzerland concerning a rare number of cases of a water borne infection in cardiac surgery patients that have had implants. The effects of such a bacterial infection can take one or two years to develop in some cases.They have had 6 known cases between 2008 and 2012.

With regards to the cause of these infections the FOPH report states:

"The cause of the infection is suspected to be the contamination of a technical device (heater cooler unit) that is used in hospitals during open heart surgery to control the temperature of the blood. These devices are operated with filtered tap water. The bacterium was detected in the water and in the discharged air of the devices in several Swiss hospitals. It is possible that during very few of these operations, a transmission of the bacterium occurred. However, the exact route of transmission has not yet been established."

Whilst it is not conclusive that the heat-cooler is the cause of these infections the Safety Committee felt it helpful to remind the membership of the importance of following the manufacturers guidelines on disinfecting and cleaning their heater-coolers and ensuring the departmental protocols include these practices.

Downloads: Sorin guidelines for the disinfecting and cleaning their heater-coolers.

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