A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe-Reference-Cited by-同舟云学术

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

Published:2018-05-24 Issue:7 Volume:33 Page:553-561
ISSN:0267-6591
Container-title:Perfusion
language:en
Short-container-title:Perfusion

Author:

Di Nardo Matteo¹^ORCID,Vercaemst Leen²,Swol Justyna³^ORCID,Barret Nicholas⁴,Taccone Fabio S.⁵,Malfertheiner Maximilian V.⁶,Broman Lars M.⁷^ORCID,Pappalardo Federico⁸,Belohlavek Jan⁹,Mueller Thomas⁶,Lorusso Roberto¹⁰,Lonero Margherita¹,Belliato Mirko¹¹

Affiliation:

1. Pediatric Intensive Care Unit, Children’s Hospital Bambino Gesù, IRCCS, Rome, Italy

2. Department of Perfusion, University Hospital Gasthuisberg, Louvain, Belgium

3. Department of Pulmonology, Intensive Care Medicine, Paracelsus Medical University, Nuremberg, Germany

4. Department of Critical Care, Guy’s and St. Thomas’ NHS Foundation Trust, London, UK

5. Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium

6. Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany

7. ECMO Centre Karolinska, Department of Pediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden

8. Department of Cardiothoracic Anesthesia and Intensive Care, San Raffaele Hospital, Milan, Italy

9. Second Department of Medicine, Cardiovascular Medicine, General University Hospital in Prague, First Faculty of Medicine, Charles University in Prague, Czech Republic

10. Department of Cardio-Thoracic Surgery, Heart & Vascular Centre, Maastricht University Medical Hospital, Maastricht, The Netherlands

11. U.O.C. Anestesia e Rianimazione 1, IRCCS, Policlinico San Matteo Foundation, Pavia, Italy

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.

Publisher

SAGE Publications

Subject

Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Safety Research,Radiology, Nuclear Medicine and imaging,General Medicine

Link

http://journals.sagepub.com/doi/pdf/10.1177/0267659118772452

Reference3 articles.

1. First experience with the deltastream® DP3 in venovenous extracorporeal membrane oxygenation and air-supported inter-hospital transport

2. Impact of Pulsatile Flow Settings on Hemodynamic Energy Levels Using the Novel Diagonal Medos DP3 Pump in a Simulated Pediatric Extracorporeal Life Support System

3. Hydrodynamic performance and heat generation by centrifugal pumps

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