Sophia Antipolis, France, 11 May 2006:
There are significant differences between European Union 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.
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 patients.
Finally, EHRA envisions a role for itself in explaining scientific and medical issues associated with such advisory communications to the media and other interested persons.
These observations and ideas outline a framework for future actions on the regulatory and the public policy front and a basis for formulating clinical guidelines. The full text can be found in the May issue of the EUROPACE Journal.
The European Society of Cardiology (ESC)
The ESC represents more than 45,000 cardiology professionals across Europe and the Mediterranean. Its mission is to improve the quality of life of the European population by reducing the impact of cardiovascular disease.
The ESC achieves this through a variety of scientific and educational activities including the coordination of: clinical practice guidelines, education courses and initiatives, pan-European surveys on specific disease areas and the ESC Annual Congress, the largest medical meeting in Europe. Furthermore, the ESC promotes cardiovascular disease prevention messages to the general public, most notably during its annual ‘For Your Heart’s Sake’ event, a fun yet educational event offering risk assessment and prevention advice, held in parallel to the Congress each year.
The ESC comprises 2 Councils, 4 Associations, 23 Working Groups and 49 National Cardiac Societies. Both the ESC Congress and ‘For Your Heart’s Sake’ take place in late August/early September each year in a European ‘Heart-Healthy City’. The ESC Congress 2006, to be held from 2-6 September in Barcelona, Spain, will be a joint meeting with the World Heart Federation’s XVth World Congress of Cardiology.
The ESC administrative headquarters are based at the European Heart House, Sophia Antipolis, France.
Our mission: To reduce the burden of cardiovascular disease
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