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

M. Di Nardo, L. Vercaemst, J. Swol, N. Barret, FS. Taccone, MV. Malfertheiner, LM. Broman, F. Pappalardo, J. Belohlavek, T. Mueller, R. Lorusso, M. Lonero, M. Belliato, . ,

. 2018 ; 33 (7) : 553-561. [pub] 20180524

Language English Country England, Great Britain

Document type Journal Article, Review

Persistent link   https://www.medvik.cz/link/bmc19000707

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.

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$a Vercaemst, Leen $u 2 Department of Perfusion, University Hospital Gasthuisberg, Louvain, Belgium.
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$a Swol, Justyna $u 3 Department of Pulmonology, Intensive Care Medicine, Paracelsus Medical University, Nuremberg, Germany.
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$a Barret, Nicholas $u 4 Department of Critical Care, Guy's and St. Thomas' NHS Foundation Trust, London, UK.
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$a Taccone, Fabio S $u 5 Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.
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$a Malfertheiner, Maximilian V $u 6 Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany.
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$a Broman, Lars M $u 7 ECMO Centre Karolinska, Department of Pediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.
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$a Pappalardo, Federico $u 8 Department of Cardiothoracic Anesthesia and Intensive Care, San Raffaele Hospital, Milan, Italy.
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$a Belohlavek, Jan $u 9 Second Department of Medicine, Cardiovascular Medicine, General University Hospital in Prague, First Faculty of Medicine, Charles University in Prague, Czech Republic.
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$a Mueller, Thomas $u 6 Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany.
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$a Lorusso, Roberto $u 10 Department of Cardio-Thoracic Surgery, Heart & Vascular Centre, Maastricht University Medical Hospital, Maastricht, The Netherlands.
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$a Lonero, Margherita $u 1 Pediatric Intensive Care Unit, Children's Hospital Bambino Gesù, IRCCS, Rome, Italy.
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$a Belliato, Mirko $u 11 U.O.C. Anestesia e Rianimazione 1, IRCCS, Policlinico San Matteo Foundation, Pavia, Italy.
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