Writing Committee for the European Heart Rhythm Association Guidance Document on Cardiac Rhythm Management Product Performance. European Heart Rhythm Association Guidance Document on cardiac rhythm management product performance

The comparatively large number of field safety corrective actions (FSCAs) recently issued by different device manufacturers has attracted attention to cardiac rhythm management (CRM) device performance.It has also prompted questions as to the basis for the scientifically proven efficacy of implantable cardioverter-defibrillators, pacemakers, and cardiac resynchronization therapy devices. The broad worldwide media coverage of these FSCAs demonstrates the tremendous interest in CRM products in both the scientific community and the lay public. The European stakeholders such as clinicians, CRM device industry representatives, National Competent Authorities (regulators), and the scientific society including arrhythmia experts and electrophysiologists [European Heart Rhythm Association (EHRA)] gathered recently to discuss these issues