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.
EHRA also proposed a novel approach for assessing individual hazard analysis. This risk model takes into account the condition of an arrhythmic patient and the current indication for the device implantation, i.e. primary or secondary prevention of sudden cardiac death (for patients with implantable cardioverter-defibrillators). This approach will help prioritize the patients that should be contacted in case of a field safety corrective action as well as provide the best advice to the patient.
Finally, EHRA envisions a role for itself in explaining scientific and medical issues associated with such adviso
Contact: Lisa Abdolian
European Society of Cardiology