A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe. (October 2018)

• Record Type: Journal Article
• Authors: Di Nardo, Matteo; Vercaemst, Leen; Swol, Justyna; Barret, Nicholas; Taccone, Fabio S.; Malfertheiner, Maximilian V.; Broman, Lars M.; Pappalardo, Federico; Belohlavek, Jan; Mueller, Thomas; Lorusso, Roberto; Lonero, Margherita; Belliato, Mirko
• Is Part Of: Perfusion. Volume 33:Number 7(2018)
• Page Start: 553
• Page End: 561
• Publication Date: 2018-10
• Subjects: ISO -- ECLS -- ECMO -- oxygenators -- centrifugal pumps; Perfusion (Physiology) -- Periodicals; Blood -- Circulation, Artificial -- Periodicals; Heart -- Surgery -- Periodicals; Extracorporeal Circulation -- Periodicals; Perfusion -- Periodicals; Circulation extracorporelle -- Périodiques; Perfusion -- Périodiques; 617.41
• DOI: 10.1177/0267659118772452
• Languages: English
• ISSNs: 0267-6591

Abstract

This review summarizes the European rules to control the market when introducing new products. In particular, it shows all the steps to achieve the European Conformity (CE Mark), a certification that all new medical products must achieve before being used in Europe. Extracorporeal membrane oxygenation (ECMO) devices are exposed to the same procedures. Hereby, we present some regulatory issues regarding pumps and oxygenators, providing technical details as released by the manufacturers on their websites and information charts.