By Christian Zahn - 22nd October 2013
Medical devices should not only guarantee technical performance and safety but bring a health benefit to the patient. This can only be achieved by more and better clinical investigations
Parliament's medical devices legislation presents a missed opportunity that improves the situation, but not enough, writes Christian Zahn.
Although the new medical devices regulation is not going far enough, the report of Dagmar Roth-Behrendt, adopted in parliament's environment, public health and food safety (ENVI) committee, has strengthened patient safety.
But with the final vote in the plenary of the European parliament today, an opportunity to improve the safety of patients has been wasted. I am surprised that economic reasons are more important than the health and wellbeing of citizens.
Despite the fact that the ENVI committee's compromise had already been watered down by altering the proposal from a centralised system to a decentralised system, some people still wanted to go further.
During the vote in committee, MEPs voted for specialised notified bodies assessing high-risk devices. An expert panel, the assessment committee for medical device, should give an opinion on all implantable and high-risk devices. After the vote in the plenary MEPs decided that only some high-risk medical devices of class III and IIb will be assessed by the new system.
For safety reasons, all high-risk medical devices should automatically be assessed by the specialised notified bodies and not only some of them. High-risk medical devices require a special procedure. There is a good reason why they are classified as high-risk devices.
Mutuals and health insurance funds in Europe have also asked for more clinical efficacy. Medical devices should not only guarantee technical performance and safety but bring a health benefit to the patient. This can only be achieved by more and better clinical investigations.
It is also very important to have the introduction of a liability insurance for manufacturers, with an appropriate coverage which will guarantee that patients can claim compensation when faulty medical devices have caused them damage.
However, we welcome the improvement of transparency, including, for example, the access to information on clinical investigations. Moreover, the industry can no longer deny access to scientific data using the argument of commercial confidentiality.
Another goal, which was achieved with today’s vote is the introduction of the use of registries to find faulty medical devices more quickly. Indeed, registries already exist and enable the discovery of dysfunction in medical devices that have harmed patients.
In spite of some improvements, patient safety should be more in the centre of the ongoing discussions. We ask the council to stand up and introduce more improvements for the sake of patients.
Christian Zahn is a vice-president of the international association of mutual benefit societies (AIM)