Possible impact on oxygenator integrity 21.06.2016
With reference to Swissmedic's publication of 14 July 2014 concerning Mycobacterium contamination of the reservoirs of heater-cooler units (HCUs), we would like to draw your attention to the following recommendations concerning single-use disposable oxygenators connected to the HCU/extracorporeal circulation interface. We have received notifications that suggest that the cleaning and disinfection procedures applied to HCUs could affect the integrity of the single-use disposable oxygenators inserted in the extracorporeal circulation circuit.
Furthermore, the US Food and Drug Administration (FDA) recently published additional information for patients and users on Mycobacteria infection associated with HCUs.
Swissmedic is a member of the European taskforce set up to assess and oversee the measures taken by manufacturers to reduce the risks associated with the potential contamination of HCU systems.
Swissmedic, 14.07.2014
German Federal Institute for Drugs and Medical Devices (BfArM) ref. no.: 03103/16
Irish Health Products Regulatory Agency (HPRA) Safety Notice: SN2015(23)
US Food and Drug Administration (FDA) Safety Communication of June 1, 2016
Public Health England (PHE): Guidance and investigation updates concerning the risk of mycobacterial infections associated with heater cooler units used in cardiothoracic surgery (last updated November 5, 2015)
Scientific publication “Emerging Infectious Diseases”, June 2016
CDC, Emerging Infectious Diseases (EID) Journal, Volume 22, Number 6, June 2016; Sommerstein R, Rüegg C, Kohler P, Bloemberg G, Kuster SP, Sax H