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.1–4 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 community5,6 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. Participants considered how to improve CRM device technology, its performance and adverse event reporting, and market surveillance as well as how to increase the flow of appropriate information from manufacturer to physician and from physician to patient in Europe. Other international scientific groups have discussed or begun similar processes with the intention of presenting recommendations applicable to their own health care and regulatory systems.Significant differences in clinical practice exist in device monitoring, regulatory requirements, and vigilance processes between the European Union (EU) and non-EU countries, as well within the EU, which creates a role for EHRA in helping to coordinate dialogue among stakeholders. Moreover, because of well-known differences in regulatory requirements and approval processes, a new CRM product is frequently clinically tested and brought to market much earlier in Europe than elsewhere. Therefore, active monitoring of CRM products in Europe is mandatory and should be conducted independently from other international monitoring or registry activities, although data sharing is highly desirable. The European field experience data may be of great importance to manufacturers as well as to regulatory authorities elsewhere in the world. Such data may allow …