More peer reviewed research out of Europe confirming the safety, effectiveness and cost savings with remanufactured cardiac electrophysiology catheters. The 26 December 2018 Journal of Interventional Cardiac Electrophysiology article,
“The remanufactured circular mapping catheter proved to be safe and efficient with no adverse events and with satisfactory catheter performance. The incorporation of remanufactured SUDs into standard practice in a carefully regulated system could provide significant economic benefit without compromising safety.”
For the article summary, visit ResearchGate.net .
This is yet another peer-reviewed study out of Europe in recent months. It confirms the same safety and cost-effectiveness experienced by U.S. and German hospitals, which have been using regulated, commercially reprocessed and remanufactured SUDS now for nearly two decades. In AMDR’s view, this underscores the need for EU Member States to take swift action to allow CE marked remanufactured SUDs into their respective markets, pursuant to Article 17 of the European Medical Device Regulation, as a way to usher in safe, effective, lower cost and environmentally preferable medical devices.
For more information on EU Member State ‘opt in,” click HERE.