There are significant differences between European Union countries and non-EU countries when it comes to reporting about Cardiac Rhythm Management (CRM) device technology, performance and adverse events and these differences can cause problems for the general public if steps are not taken to minimize them, according to the results of a policy conference held by the ESC’s European Heart Rhythm Association (EHRA).
Because of variations in regulatory requirements and approval processes, a new CRM product is frequently clinically tested and commercialized much earlier in Europe than elsewhere. Because of this, the EHRA document says that active monitoring of these products in Europe is necessary and should be conducted independently from international monitoring or registry activities, although data sharing should be encouraged.
As such, National Competent Authorities should be encouraged to work with clinician/scientific societies to improve event reporting on national levels. Specifically, EHRA recommends the creation of a single, standardized multi-lingual incident notification sheet that can standardize the process of reporting incidents or near-incidents. Additionally, a confidential forum for informal discussions of product performance issue should be established to help improve communication about devices.
Lisa Abdolian | alfa
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