Cardiologists seek device action

Cardiologists are calling for European regulators to move swiftly to improve oversight of medical devices.

Proposals published yesterday follow exposure of alleged problems with devices on an investigative television programme on Britain’s Channel Four.

Senior members of the European Society of Cardiology have set out their ideas in the European Heart Journal.

They call for a "single, coordinated" European system to oversee evaluation and approval of medical devices.

The European market for devices is thought to be worth about 72 billion Euros a year – with 200,000 devices on the market.

The cardiologists want more transparency from companies – enabling physicians to study technical trials and to set standards for performance and effectiveness.

President Michel Komajda said there were similarities with the ethical issues involved in the approval of new drugs. The European Union is reviewing its role – and Professor Komajda said it was "opportune" for cardiologists to share their views.

Professor Alan Fraser, who chaired a recent conference on the topic, said: “Standards of testing of medical devices are less rigorous in Europe than the US, where they have to undertake trials to show that the device has an impact on clinical outcomes, with the reality that European patients are currently exposed to an unfair proportion of the risks associated with developing new devices."

Fraser AG, Daubert JC, Van de Werf F, et al. Clinical evaluation of cardiovascular devices – principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology. European Heart Journal. Doi 10.1093/eurheartj/ehr171.