Volume 8, Issue 2, Summer 2012
By: Marcus Bracklo, Chief Executive Office and Ulrike Marczak, Head of Reprocessing, Vanguard AG (Berlin).
Vanguard AG, the European market leader in the reprocessing of single-use medical devices, has collaborated on several studies which have examined patient safety . . . Both [studies] reviewed electrophysiological ablation catheters and compared patient safety data for first-use and reprocessed devices, the latter being subjected to up to six reprocessing cycles. The studies found no increased risk in those patients using reprocessed catheters. The study examined the following parameters: duration of examination, duration of screening, number of energy emissions, strength of energy emissions and radiation dosage. In addition, follow-up examinations were carried out on discharge and six months after discharge to determine whether there were any significantly higher rates of complications or arrhythmia recurrence in patients who had been treated with reprocessed ablation catheters. No differences were found.